Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2026-01-07 @ 10:58 PM
Study NCT ID:
NCT02469233
Status:
COMPLETED
Last Update Posted:
2025-08-12
First Post:
2015-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Transdiagnostic Sleep and Circadian Treatment to Improve Community SMI Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012890', 'term': 'Sleep'}], 'ancestors': [{'id': 'D009424', 'term': 'Nervous System Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'aharvey@berkeley.edu', 'phone': '5104736490', 'title': 'Professor of Clinical Psychology', 'organization': 'Department of Psychology, University of California, Berkeley'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Through study completion, an average of 6 months.', 'description': 'All-cause mortality, Serious, and Other Adverse Events were monitored through occasional assessment and self-report.\n\nAll-cause mortality did not occur during treatment in either intervention arm, and events were analyzed separately for each intervention arm. In the TranS-C arm, all-cause mortality occurred before the participant received the allocated treatment. In Usual Care, all-cause mortality occurred after the completion of the post-treatment assessment, but before the 6-month follow-up.', 'eventGroups': [{'id': 'EG000', 'title': 'TranS-C', 'description': "The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) is comprised of cross-cutting interventions, 'core modules' and 'optional modules'. TranS-C is derived and adapted from our previous disorder-focused research, firmly grounded in basic science and treatment literature.\n\nTransdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral.", 'otherNumAtRisk': 61, 'deathsNumAtRisk': 61, 'otherNumAffected': 0, 'seriousNumAtRisk': 61, 'deathsNumAffected': 1, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'UC-DT', 'description': 'Usual Care, Delayed Treatment (DT) is comprised of a case manager who co-ordinates care and refers each client for a medication review and to rehabilitation programs. At the end of 6-months in UC-DT, the participants will receive TranS-C.\n\nTransdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral.', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 0, 'seriousNumAtRisk': 60, 'deathsNumAffected': 1, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Impairment (Sheehan Disability Scale)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC-DT', 'description': 'Usual Care, Delayed Treatment (DT) is comprised of a case manager who co-ordinates care and refers each client for a medication review and to rehabilitation programs. At the end of 6-months in UC-DT, the participants will receive TranS-C.\n\nTransdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral.'}, {'id': 'OG001', 'title': 'TranS-C', 'description': "The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) is comprised of cross-cutting interventions, 'core modules' and 'optional modules'. TranS-C is derived and adapted from our previous disorder-focused research, firmly grounded in basic science and treatment literature.\n\nTransdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral."}], 'classes': [{'title': 'Pre treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.30', 'spread': '8.51', 'groupId': 'OG000'}, {'value': '12.03', 'spread': '6.20', 'groupId': 'OG001'}]}]}, {'title': 'Post treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.76', 'spread': '7.57', 'groupId': 'OG000'}, {'value': '6.57', 'spread': '7.07', 'groupId': 'OG001'}]}]}, {'title': '6-month follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.51', 'spread': '8.36', 'groupId': 'OG000'}, {'value': '7.00', 'spread': '6.41', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.025', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Time by treatment interaction coeff.', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-3.18', 'groupDescription': 'Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.', 'statisticalMethod': 'Intent-to-treat, multilevel modeling', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes'}, {'pValue': '0.28', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Time by treatment interaction coeff.', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-1.52', 'groupDescription': 'Treatment effect on change from pre to 6-month follow-up', 'statisticalMethod': 'Intent-to-treat, multilevel modeling', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes'}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup', 'description': 'Sheehan Disability Scale (SDS) (sleep). 3-item. The SDS evaluates the extent to which work/school, social life, and home/ family responsibilities are impaired on a 0-10 (not at all to extremely) scale. The 3-items are summed to compute the total score and assess global functional impairment. Scores can range from 0 to 30, with higher values indicating higher impairment.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Although all randomized participants were included in the intent-to-treat analysis, the "Number Analyzed" represents participants who contributed data at each time point. Differences from the overall number analyzed reflect missing assessments due to attrition.'}, {'type': 'PRIMARY', 'title': 'Disorder-Focused Composite Score (DSM-5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC-DT', 'description': 'Usual Care, Delayed Treatment (DT) is comprised of a case manager who co-ordinates care and refers each client for a medication review and to rehabilitation programs. At the end of 6-months in UC-DT, the participants will receive TranS-C.\n\nTransdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral.'}, {'id': 'OG001', 'title': 'TranS-C', 'description': "The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) is comprised of cross-cutting interventions, 'core modules' and 'optional modules'. TranS-C is derived and adapted from our previous disorder-focused research, firmly grounded in basic science and treatment literature.\n\nTransdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral."}], 'classes': [{'title': 'Pre treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.57', 'spread': '10.72', 'groupId': 'OG000'}, {'value': '25.05', 'spread': '9.75', 'groupId': 'OG001'}]}]}, {'title': 'Post treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.53', 'spread': '10.59', 'groupId': 'OG000'}, {'value': '17.00', 'spread': '11.23', 'groupId': 'OG001'}]}]}, {'title': '6-month follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.07', 'spread': '9.78', 'groupId': 'OG000'}, {'value': '18.67', 'spread': '11.38', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'time by treatment interaction coeff.', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-5.88', 'groupDescription': 'Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.', 'statisticalMethod': 'Intent-to-treat, multilevel modeling', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes'}, {'pValue': '0.03', 'groupIds': ['OG000', 'OG001'], 'paramType': 'maximum likelihood estimation', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-3.90', 'groupDescription': 'Treatment effect on change from pre to 6-month follow-up', 'statisticalMethod': 'Intent-to-treat, multilevel modeling', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes'}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup', 'description': 'DSM-5 Cross Cutting Measure. 23-items. Individuals report how much each domain has bothered them in the last 2 weeks on a 0-4 scale (not at all to nearly every day). The total score is calculated by summing the highest score in each of the 13 domains (depression, anger, mania, anxiety, somatic symptoms, suicidal ideation, psychosis, sleep problems, memory, repetitive thoughts and behaviors, dissociation, personality functioning, and substance use). Total scores can range from 0 to 52, with higher scores indicating greater severity of impairment. is rated on a 5-point scale, with higher scores indicating more severe impairment.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Although all randomized participants were included in the intent-to-treat analysis, the "Number Analyzed" represents participants who contributed data at each time point. Differences from the overall number analyzed reflect missing assessments due to attrition.'}, {'type': 'PRIMARY', 'title': 'Sleep and Circadian Function: PROMIS-Sleep Disturbance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC-DT', 'description': 'Usual Care, Delayed Treatment (DT) is comprised of a case manager who co-ordinates care and refers each client for a medication review and to rehabilitation programs. At the end of 6-months in UC-DT, the participants will receive TranS-C.\n\nTransdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral.'}, {'id': 'OG001', 'title': 'TranS-C', 'description': "The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) is comprised of cross-cutting interventions, 'core modules' and 'optional modules'. TranS-C is derived and adapted from our previous disorder-focused research, firmly grounded in basic science and treatment literature.\n\nTransdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral."}], 'classes': [{'title': 'PROMIS-Sleep Disturbance (Pre)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.02', 'spread': '6.57', 'groupId': 'OG000'}, {'value': '28.26', 'spread': '6.06', 'groupId': 'OG001'}]}]}, {'title': 'PROMIS-Sleep Disturbance (Post)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27.33', 'spread': '7.22', 'groupId': 'OG000'}, {'value': '20.88', 'spread': '8.91', 'groupId': 'OG001'}]}]}, {'title': 'PROMIS-Sleep Disturbance (6-month follow-up)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.40', 'spread': '8.00', 'groupId': 'OG000'}, {'value': '20.87', 'spread': '8.50', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'time by treatment interaction coeff.', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-5.55', 'groupDescription': 'Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.', 'statisticalMethod': 'Intent-to-treat, multilevel modeling', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Time by treatment interaction coeff.', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-4.92', 'groupDescription': 'Treatment effect on change from pre to 6-month follow-up', 'statisticalMethod': 'Intent-to-treat, multilevel modeling', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes'}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup', 'description': 'PROMIS-Sleep Disturbance (PROMIS = Patient-Reported Outcomes Measurement Information System). The 8-item short version assesses sleep disturbance over the past 7 days, including restlessness, sleep quality, ability to fall and stay asleep, and refreshment following sleep using a 1-5 scale (not at all or never to very much or always). Scores range from 8 to 40, with higher scores indicating increased disturbance.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Although all randomized participants were included in the intent-to-treat analysis, the "Number Analyzed" represents participants who contributed data at each time point. Differences from the overall number analyzed reflect missing assessments due to attrition.'}, {'type': 'PRIMARY', 'title': 'Sleep and Circadian Function: PROMIS-Sleep-Related Impairment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC-DT', 'description': 'Usual Care, Delayed Treatment (DT) is comprised of a case manager who co-ordinates care and refers each client for a medication review and to rehabilitation programs. At the end of 6-months in UC-DT, the participants will receive TranS-C.\n\nTransdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral.'}, {'id': 'OG001', 'title': 'TranS-C', 'description': "The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) is comprised of cross-cutting interventions, 'core modules' and 'optional modules'. TranS-C is derived and adapted from our previous disorder-focused research, firmly grounded in basic science and treatment literature.\n\nTransdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral."}], 'classes': [{'title': 'PROMIS-Sleep-Related Impairment (Pre)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '51.02', 'spread': '14.09', 'groupId': 'OG000'}, {'value': '47.93', 'spread': '11.80', 'groupId': 'OG001'}]}]}, {'title': 'PROMIS-Sleep-Related Impairment (Post)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '47.22', 'spread': '14.14', 'groupId': 'OG000'}, {'value': '35.16', 'spread': '14.01', 'groupId': 'OG001'}]}]}, {'title': 'PROMIS-Sleep-Related Impairment (6-month follow-up)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '44.30', 'spread': '15.22', 'groupId': 'OG000'}, {'value': '35.65', 'spread': '13.83', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Time by treatment interaction coeff.', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-9.14', 'groupDescription': 'Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.', 'statisticalMethod': 'Intent-to-treat, multilevel modeling', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes'}, {'pValue': '0.027', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Time by treatment interaction coeff.', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-5.37', 'groupDescription': 'Treatment effect on change from pre to 6-month follow-up', 'statisticalMethod': 'Intent-to-treat, multilevel modeling', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes'}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup', 'description': 'PROMIS-Sleep-Related Impairment (PROMIS = Patient-Reported Outcomes Measurement Information System). 16-item. Scores range from 16 to 80, with higher scores indicating increased disturbance.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Although all randomized participants were included in the intent-to-treat analysis, the "Number Analyzed" represents participants who contributed data at each time point. Differences from the overall number analyzed reflect missing assessments due to attrition.'}, {'type': 'SECONDARY', 'title': 'Depression (QIDS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC-DT', 'description': 'Usual Care, Delayed Treatment (DT) is comprised of a case manager who co-ordinates care and refers each client for a medication review and to rehabilitation programs. At the end of 6-months in UC-DT, the participants will receive TranS-C.\n\nTransdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral.'}, {'id': 'OG001', 'title': 'TranS-C', 'description': "The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) is comprised of cross-cutting interventions, 'core modules' and 'optional modules'. TranS-C is derived and adapted from our previous disorder-focused research, firmly grounded in basic science and treatment literature.\n\nTransdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral."}], 'classes': [{'title': 'Pre-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.50', 'spread': '4.71', 'groupId': 'OG000'}, {'value': '12.03', 'spread': '5.15', 'groupId': 'OG001'}]}]}, {'title': 'Post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.55', 'spread': '5.54', 'groupId': 'OG000'}, {'value': '8.88', 'spread': '5.70', 'groupId': 'OG001'}]}]}, {'title': '6-month follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.67', 'spread': '4.58', 'groupId': 'OG000'}, {'value': '8.46', 'spread': '5.03', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.32', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Time by treatment interaction coeff.', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.95', 'groupDescription': 'Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.', 'statisticalMethod': 'Intent-to-treat, multilevel modeling', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes'}, {'pValue': '0.08', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Time by treatment interaction coeff.', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-1.67', 'groupDescription': 'Treatment effect on change from pre to 6-month follow-up', 'statisticalMethod': 'Intent-to-treat, multilevel modeling', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes'}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup', 'description': 'QIDS (Quick Inventory of Depressive Symptoms). 16-item instrument assessing depressive symptoms. Each item is rated on a 4-point scale (0-3), with higher scores indicating greater symptom severity.\n\nScoring involves summing the highest score from each of the 9 DSM-IV Major Depressive Disorder symptom domains (sleep, weight, psychomotor changes, depressed mood, decreased interest, fatigue, guilt, concentration, and suicidal ideation). Total scores range from 0 (Normal/No Depression) to 27 (Very Severe Depression). Higher scores indicate greater severity of depressive symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Although all randomized participants were included in the intent-to-treat analysis, the "Number Analyzed" represents participants who contributed data at each time point. Differences from the overall number analyzed reflect missing assessments due to attrition.'}, {'type': 'SECONDARY', 'title': 'Substance Use (ASSIST )', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC-DT', 'description': 'Usual Care, Delayed Treatment (DT) is comprised of a case manager who co-ordinates care and refers each client for a medication review and to rehabilitation programs. At the end of 6-months in UC-DT, the participants will receive TranS-C.\n\nTransdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral.'}, {'id': 'OG001', 'title': 'TranS-C', 'description': "The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) is comprised of cross-cutting interventions, 'core modules' and 'optional modules'. TranS-C is derived and adapted from our previous disorder-focused research, firmly grounded in basic science and treatment literature.\n\nTransdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral."}], 'classes': [{'title': 'Pre-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.68', 'spread': '25.87', 'groupId': 'OG000'}, {'value': '39.70', 'spread': '26.68', 'groupId': 'OG001'}]}]}, {'title': 'Post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.62', 'spread': '17.15', 'groupId': 'OG000'}, {'value': '15.35', 'spread': '17.13', 'groupId': 'OG001'}]}]}, {'title': '6-month follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32.58', 'spread': '25.25', 'groupId': 'OG000'}, {'value': '34.60', 'spread': '24.10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.72', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Time by treatment interaction coeff.', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.09', 'groupDescription': 'Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.', 'statisticalMethod': 'intent-to-treat, multilevel modeling', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes'}, {'pValue': '0.74', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Time by treatment interaction coeff.', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.08', 'groupDescription': 'Treatment effect on change from pre to 6-month follow-up', 'statisticalMethod': 'Intent-to-treat, multilevel modeling', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes'}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup', 'description': 'ASSIST (Alcohol, Smoking and Substance Involvement Screening Test). Frequency of use, substance dependence, and related health, social, legal, financial, and employment problems in the past 3 months are rated on a 5-point scale (never to daily of almost daily). Problems with family and friends caused by substance use and failed attempts to cut down or quit substance use are measured on a 3-point scale (no, never, yes, in the past 3 months, yes, but not in the past 3 months). The total risk score is calculated by summing scores across all drug categories, with total scores ranging from 0 to 414. Higher scores indicate greater substance-related risks and problems.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Although all randomized participants were included in the intent-to-treat analysis, the "Number Analyzed" represents participants who contributed data at each time point. Differences from the overall number analyzed reflect missing assessments due to attrition.'}, {'type': 'SECONDARY', 'title': 'Psychotic Symptoms (PSYRATS )', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC-DT', 'description': 'Usual Care, Delayed Treatment (DT) is comprised of a case manager who co-ordinates care and refers each client for a medication review and to rehabilitation programs. At the end of 6-months in UC-DT, the participants will receive TranS-C.\n\nTransdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral.'}, {'id': 'OG001', 'title': 'TranS-C', 'description': "The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) is comprised of cross-cutting interventions, 'core modules' and 'optional modules'. TranS-C is derived and adapted from our previous disorder-focused research, firmly grounded in basic science and treatment literature.\n\nTransdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral."}], 'classes': [{'title': 'Pre-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36.60', 'spread': '5.13', 'groupId': 'OG000'}, {'value': '39.60', 'spread': '14.29', 'groupId': 'OG001'}]}]}, {'title': 'Post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41.73', 'spread': '11.39', 'groupId': 'OG000'}, {'value': '36.00', 'spread': '14.82', 'groupId': 'OG001'}]}]}, {'title': '6-month follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42.58', 'spread': '9.44', 'groupId': 'OG000'}, {'value': '25.80', 'spread': '11.23', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.73', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Time by treatment interaction coeff.', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-2.46', 'groupDescription': 'Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.', 'statisticalMethod': 'Intent-to-treat, multilevel modeling', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes'}, {'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Time by treatment interaction coeff.', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-17.52', 'groupDescription': 'Treatment effect on change from pre to 6-month follow-up', 'statisticalMethod': 'intent-to-treat, multilevel modeling', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes'}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup', 'description': 'PSYRATS (Psychotic Symptom Rating Scales). Each of the 17 items is rated on a 5-point scale from 0 (absent) to 4 (severe). Scores are summed for auditory hallucinations (sum of 11 items) and delusions (sum of 6 items). Total scores range from 0 to 68, with higher scores indicating greater severity of psychotic symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Although all randomized participants were included in the intent-to-treat analysis, the "Number Analyzed" represents participants who contributed data at each time point. Differences from the overall number analyzed reflect missing assessments due to attrition.'}, {'type': 'SECONDARY', 'title': 'Means and Variability of Sleep Efficiency (Daily Sleep Diary)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC-DT', 'description': 'Usual Care, Delayed Treatment (DT) is comprised of a case manager who co-ordinates care and refers each client for a medication review and to rehabilitation programs. At the end of 6-months in UC-DT, the participants will receive TranS-C.\n\nTransdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral.'}, {'id': 'OG001', 'title': 'TranS-C', 'description': "The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) is comprised of cross-cutting interventions, 'core modules' and 'optional modules'. TranS-C is derived and adapted from our previous disorder-focused research, firmly grounded in basic science and treatment literature.\n\nTransdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral."}], 'classes': [{'title': 'SE mean at Pre-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '77.61', 'spread': '11.89', 'groupId': 'OG000'}, {'value': '77.39', 'spread': '13.52', 'groupId': 'OG001'}]}]}, {'title': 'SE variability at Pre-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.52', 'spread': '7.63', 'groupId': 'OG000'}, {'value': '11.92', 'spread': '6.71', 'groupId': 'OG001'}]}]}, {'title': 'SE mean at Post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '78.93', 'spread': '14.50', 'groupId': 'OG000'}, {'value': '84.31', 'spread': '10.07', 'groupId': 'OG001'}]}]}, {'title': 'SE variability at Post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.86', 'spread': '8.49', 'groupId': 'OG000'}, {'value': '10.01', 'spread': '7.95', 'groupId': 'OG001'}]}]}, {'title': 'SE mean at 6-month follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '79.54', 'spread': '12.88', 'groupId': 'OG000'}, {'value': '84.78', 'spread': '10.86', 'groupId': 'OG001'}]}]}, {'title': 'SE variability at 6-month follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.25', 'spread': '6.71', 'groupId': 'OG000'}, {'value': '9.24', 'spread': '7.87', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.03', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Time by treatment interaction coeff.', 'ciNumSides': 'TWO_SIDED', 'paramValue': '5.68', 'groupDescription': 'SE mean (min): Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.', 'statisticalMethod': 'Intent-to-treat, multilevel modeling', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes'}, {'pValue': '0.03', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Time by treatment interaction coeff.', 'ciNumSides': 'TWO_SIDED', 'paramValue': '5.89', 'groupDescription': 'SE mean (min): Treatment effect on change from pre to 6-month follow-up.', 'statisticalMethod': 'intent-to-treat, multilevel modeling', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes'}, {'pValue': '0.43', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Time by treatment interaction coeff.', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-1.45', 'groupDescription': 'SE variability (min): Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.', 'statisticalMethod': 'Intent-to-treat, multilevel modeling', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes'}, {'pValue': '0.40', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Time by treatment interaction coeff.', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-1.55', 'groupDescription': 'SE variability (min): Treatment effect on change from pre to 6-month follow-up.', 'statisticalMethod': 'Intent-to-treat, multilevel modeling', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes'}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup', 'description': 'Sleep efficiency (SE), calculated as total sleep time divided by time in bed, multiplied by 100, was recorded via sleep diary over 7 consecutive days. For each participant, the mean and within-person standard deviation (SD) of SE were calculated across the days to reflect an average and night-to-night variability. Group-level outcomes reflect the average of these participant-level means and SDs.', 'unitOfMeasure': 'percentage of sleep efficiency', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Although all randomized participants were included in the intent-to-treat analysis, the "Number Analyzed" represents participants who contributed data at each time point. Differences from the overall number analyzed reflect missing assessments due to attrition.'}, {'type': 'SECONDARY', 'title': 'Actigraphy Measured Sleep (TST)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC-DT', 'description': 'Usual Care, Delayed Treatment (DT) is comprised of a case manager who co-ordinates care and refers each client for a medication review and to rehabilitation programs. At the end of 6-months in UC-DT, the participants will receive TranS-C.\n\nTransdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral.'}, {'id': 'OG001', 'title': 'TranS-C', 'description': "The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) is comprised of cross-cutting interventions, 'core modules' and 'optional modules'. TranS-C is derived and adapted from our previous disorder-focused research, firmly grounded in basic science and treatment literature.\n\nTransdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral."}], 'classes': [{'title': 'TST mean at Pre-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '421.35', 'spread': '126.92', 'groupId': 'OG000'}, {'value': '453.65', 'spread': '147.28', 'groupId': 'OG001'}]}]}, {'title': 'TST variability at Pre-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '132.08', 'spread': '75.83', 'groupId': 'OG000'}, {'value': '132.34', 'spread': '79.71', 'groupId': 'OG001'}]}]}, {'title': 'TST mean at Post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '411.82', 'spread': '108.28', 'groupId': 'OG000'}, {'value': '427.23', 'spread': '135.85', 'groupId': 'OG001'}]}]}, {'title': 'TST variability at Post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '135.38', 'spread': '75.05', 'groupId': 'OG000'}, {'value': '140.06', 'spread': '95.02', 'groupId': 'OG001'}]}]}, {'title': 'TST mean at 6-month follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '443.24', 'spread': '119.47', 'groupId': 'OG000'}, {'value': '437.69', 'spread': '137.88', 'groupId': 'OG001'}]}]}, {'title': 'TST variability at 6-month follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '144.86', 'spread': '88.72', 'groupId': 'OG000'}, {'value': '134.43', 'spread': '96.75', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.59', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Time by treatment interaction coeff.', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-12.68', 'groupDescription': 'TST mean (min): Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.', 'statisticalMethod': 'Intent-to-treat, multilevel modeling', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes'}, {'pValue': '0.22', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Time by treatment interaction coeff.', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-28.33', 'groupDescription': 'TST mean (min): Treatment effect on change from pre to 6-month follow-up.', 'statisticalMethod': 'Intent-to-treat, multilevel modeling', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes'}, {'pValue': '0.80', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Time by treatment interaction coeff.', 'ciNumSides': 'TWO_SIDED', 'paramValue': '4.65', 'groupDescription': 'TST variability (min) : Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.', 'statisticalMethod': 'Intent-to-treat, multilevel modeling', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes'}, {'pValue': '0.68', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Time by treatment interaction coeff.', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-7.57', 'groupDescription': 'TST variability (min): Treatment effect on change from pre to 6-month follow-up.', 'statisticalMethod': 'Intent-to-treat, multilevel modeling', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes'}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup', 'description': 'Actigraphy-derived total sleep time (TST) is the total amount of sleep obtained by the participant per 24 hrs, which was recorded daily over a 1-week period per timepoint. For each participant, the mean and standard deviation (SD) of TST were calculated across the days. Group-level outcomes reflect the average of these participant-level means and SDs.', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Although all randomized participants were included in the intent-to-treat analysis, the "Number Analyzed" represents participants who contributed data at each time point. Differences from the overall number analyzed reflect missing assessments due to attrition.'}, {'type': 'SECONDARY', 'title': 'Daytime Activity (Actigraphy)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC-DT', 'description': 'Usual Care, Delayed Treatment (DT) is comprised of a case manager who co-ordinates care and refers each client for a medication review and to rehabilitation programs. At the end of 6-months in UC-DT, the participants will receive TranS-C.\n\nTransdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral.'}, {'id': 'OG001', 'title': 'TranS-C', 'description': "The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) is comprised of cross-cutting interventions, 'core modules' and 'optional modules'. TranS-C is derived and adapted from our previous disorder-focused research, firmly grounded in basic science and treatment literature.\n\nTransdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral."}], 'classes': [{'title': 'Count Mean at Pre-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1309.74', 'spread': '532.79', 'groupId': 'OG000'}, {'value': '1280.09', 'spread': '607.46', 'groupId': 'OG001'}]}]}, {'title': 'Count Variability at Pre-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '379.69', 'spread': '211.65', 'groupId': 'OG000'}, {'value': '394.04', 'spread': '256.07', 'groupId': 'OG001'}]}]}, {'title': 'Count Mean at Post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1361.19', 'spread': '532.36', 'groupId': 'OG000'}, {'value': '1257.82', 'spread': '680.06', 'groupId': 'OG001'}]}]}, {'title': 'Count Variability at Post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '393.58', 'spread': '223.01', 'groupId': 'OG000'}, {'value': '371.08', 'spread': '310.24', 'groupId': 'OG001'}]}]}, {'title': 'Count Mean at 6-month follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1362.37', 'spread': '598.01', 'groupId': 'OG000'}, {'value': '1281.35', 'spread': '667.83', 'groupId': 'OG001'}]}]}, {'title': 'Count Variability at 6-month follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '447.2', 'spread': '257.81', 'groupId': 'OG000'}, {'value': '354.96', 'spread': '212.71', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.34', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Time by treatment interaction coeff.', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-76.85', 'groupDescription': 'Waking activity count mean (min): Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.', 'statisticalMethod': 'Intent-to-treat, multilevel modeling', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes'}, {'pValue': '0.28', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Time by treatment interaction coeff.', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-87.15', 'groupDescription': 'Waking activity count mean (min): Treatment effect on change from pre to 6-month follow-up.', 'statisticalMethod': 'Intent-to-treat, multilevel modeling', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes'}, {'pValue': '0.18', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Time by treatment interaction coeff.', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.15', 'groupDescription': 'Waking activity count variability (min) : Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.', 'statisticalMethod': 'Intent-to-treat, multilevel modeling', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes'}, {'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Time by treatment interaction coeff.', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.27', 'groupDescription': 'Waking activity count variability (min): Treatment effect on change from pre to 6-month follow-up.', 'statisticalMethod': 'Intent-to-treat, multilevel modeling', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes'}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup', 'description': 'Daytime activity was measured via actigraphy over 7 consecutive days per timepoint. For each participant, their daily waking activity counts were extracted, and the mean and within-person standard deviation (SD) of these counts were calculated across 7 days. Group-level outcomes reflect the average of these participant-level means and SDs.', 'unitOfMeasure': 'Activity counts', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Although all randomized participants were included in the intent-to-treat analysis, the "Number Analyzed" represents participants who contributed data at each time point. Differences from the overall number analyzed reflect missing assessments due to attrition.'}, {'type': 'SECONDARY', 'title': 'Impairment (World Health Organization Disability Assessment Schedule 2.0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC-DT', 'description': 'Usual Care, Delayed Treatment (DT) is comprised of a case manager who co-ordinates care and refers each client for a medication review and to rehabilitation programs. At the end of 6-months in UC-DT, the participants will receive TranS-C.\n\nTransdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral.'}, {'id': 'OG001', 'title': 'TranS-C', 'description': "The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) is comprised of cross-cutting interventions, 'core modules' and 'optional modules'. TranS-C is derived and adapted from our previous disorder-focused research, firmly grounded in basic science and treatment literature.\n\nTransdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral."}], 'classes': [{'title': 'Pre-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '81.53', 'spread': '25.56', 'groupId': 'OG000'}, {'value': '76.48', 'spread': '21.38', 'groupId': 'OG001'}]}]}, {'title': 'Post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '81.48', 'spread': '26.80', 'groupId': 'OG000'}, {'value': '68.93', 'spread': '25.53', 'groupId': 'OG001'}]}]}, {'title': '6-month follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '73.45', 'spread': '26.14', 'groupId': 'OG000'}, {'value': '66.63', 'spread': '23.17', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.09', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Time by treatment interaction coeff.', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-7.19', 'groupDescription': 'Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.', 'statisticalMethod': 'Intent-to-treat, multilevel modeling', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes'}, {'pValue': '0.79', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Time by treatment interaction coeff.', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-1.13', 'groupDescription': 'Treatment effect on change from pre to 6-month follow-up', 'statisticalMethod': 'Intent-to-treat, multilevel modeling', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcome.'}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup', 'description': 'World Health Organization Disability Assessment Schedule 2.0 (WHODAS-2.0). 36-item measure that assesses disability in adults ages 18 years and older. It assesses disability across six domains on a scale from 1-5 (none to extreme or cannot do). Each item on the self-administered version of the WHODAS-2.0 asks the individual to rate how much difficulty he or she has had in specific areas of functioning during the past 30 days. Scores are summed across the six domains (cognition, mobility, self-care, getting along, life activities, and participation). Total scores range from 36 to 180, with higher scores indicating greater levels of disability.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Although all randomized participants were included in the intent-to-treat analysis, the "Number Analyzed" represents participants who contributed data at each time point. Differences from the overall number analyzed reflect missing assessments due to attrition.'}, {'type': 'SECONDARY', 'title': "Overall Health ('Healthy Days' Core Module)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC-DT', 'description': 'Usual Care, Delayed Treatment (DT) is comprised of a case manager who co-ordinates care and refers each client for a medication review and to rehabilitation programs. At the end of 6-months in UC-DT, the participants will receive TranS-C.\n\nTransdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral.'}, {'id': 'OG001', 'title': 'TranS-C', 'description': "The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) is comprised of cross-cutting interventions, 'core modules' and 'optional modules'. TranS-C is derived and adapted from our previous disorder-focused research, firmly grounded in basic science and treatment literature.\n\nTransdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral."}], 'classes': [{'title': 'Pre-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.57', 'spread': '1.17', 'groupId': 'OG000'}, {'value': '3.44', 'spread': '1.03', 'groupId': 'OG001'}]}]}, {'title': 'Post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.40', 'spread': '1.26', 'groupId': 'OG000'}, {'value': '3.37', 'spread': '1.27', 'groupId': 'OG001'}]}]}, {'title': '6-month follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.40', 'spread': '1.26', 'groupId': 'OG000'}, {'value': '3.37', 'spread': '1.27', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.46', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Time by treatment interaction coeff.', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.16', 'groupDescription': 'Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.', 'statisticalMethod': 'Intent-to-treat, multilevel modeling', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcome,'}, {'pValue': '0.10', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Time by treatment interaction coeff.', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.34', 'groupDescription': 'Treatment effect on change from pre to 6-month follow-up', 'statisticalMethod': 'Intent-to-treat, multilevel modeling', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes'}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup', 'description': 'Four question \'healthy days\' core module developed by the Centers for Disease Control and Prevention. A summary measure combines physically and mentally unhealthy days. An "unhealthy days" summary measure based on the second and third questions and estimates the overall number of recent days (in the past 30 days) when physical or mental health was not good.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Although all randomized participants were included in the intent-to-treat analysis, the "Number Analyzed" represents participants who contributed data at each time point. Differences from the overall number analyzed reflect missing assessments due to attrition.'}, {'type': 'SECONDARY', 'title': 'Composite Sleep Health Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC-DT', 'description': 'Usual Care, Delayed Treatment (DT) is comprised of a case manager who co-ordinates care and refers each client for a medication review and to rehabilitation programs. At the end of 6-months in UC-DT, the participants will receive TranS-C.\n\nTransdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral.'}, {'id': 'OG001', 'title': 'TranS-C', 'description': "The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) is comprised of cross-cutting interventions, 'core modules' and 'optional modules'. TranS-C is derived and adapted from our previous disorder-focused research, firmly grounded in basic science and treatment literature.\n\nTransdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral."}], 'classes': [{'title': 'Pre-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.28', 'spread': '1.29', 'groupId': 'OG000'}, {'value': '2.54', 'spread': '1.60', 'groupId': 'OG001'}]}]}, {'title': 'Post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.34', 'spread': '1.33', 'groupId': 'OG000'}, {'value': '3.45', 'spread': '1.39', 'groupId': 'OG001'}]}]}, {'title': '6-month follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.53', 'spread': '1.39', 'groupId': 'OG000'}, {'value': '3.38', 'spread': '1.64', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Time by treatment interaction coeff.', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.91', 'groupDescription': 'Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.', 'statisticalMethod': 'Intent-to-treat, multilevel modeling', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes'}, {'pValue': '0.03', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Time by treatment interaction coeff.', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.64', 'groupDescription': 'Treatment effect on change from pre to 6-month follow-up.', 'statisticalMethod': 'Intent-to-treat, multilevel modeling', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes'}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup', 'description': 'Composite Sleep Health Score is defined as the sum of scores on 6 sleep health dimensions: Regularity (Midpoint sleep fluctuation across a 7-day sleep diary \\< 1 hour), Satisfaction (Sleep quality question on PROMIS-Sleep Disturbance (PROMIS = Patient-Reported Outcomes Measurement Information System)), Alertness (Daytime sleepiness question on PROMIS-Sleep Related Impairment (PROMIS = Patient-Reported Outcomes Measurement Information System)), Timing (Mean midpoint sleep across the 7 day sleep diary between 2 and 4 AM), Efficiency (Average sleep efficiency based on the 7 day sleep diary ≥ 85%), and Duration (Total Sleep Time average based on 7 day sleep diary between 7 and 9 hours).\n\nEach dimension was dichotomized such that 1 = good /yes; 0 = poor/no). Total composite sleep health score ranges from 0 to 6, with larger values indicating better sleep health.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Although all randomized participants were included in the intent-to-treat analysis, the "Number Analyzed" represents participants who contributed data at each time point. Differences from the overall number analyzed reflect missing assessments due to attrition.'}, {'type': 'SECONDARY', 'title': 'Means and Variability of Total Sleep Time (Daily Sleep Diary)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC-DT', 'description': 'Usual Care, Delayed Treatment (DT) is comprised of a case manager who co-ordinates care and refers each client for a medication review and to rehabilitation programs. At the end of 6-months in UC-DT, the participants will receive TranS-C.\n\nTransdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral.'}, {'id': 'OG001', 'title': 'TranS-C', 'description': "The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) is comprised of cross-cutting interventions, 'core modules' and 'optional modules'. TranS-C is derived and adapted from our previous disorder-focused research, firmly grounded in basic science and treatment literature.\n\nTransdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral."}], 'classes': [{'title': 'TST mean at Pre-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '452.42', 'spread': '101.37', 'groupId': 'OG000'}, {'value': '431.06', 'spread': '111.47', 'groupId': 'OG001'}]}]}, {'title': 'TST variability at Pre-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '109.59', 'spread': '55.14', 'groupId': 'OG000'}, {'value': '103.96', 'spread': '46.37', 'groupId': 'OG001'}]}]}, {'title': 'TST mean at Post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '459.09', 'spread': '100.16', 'groupId': 'OG000'}, {'value': '450.71', 'spread': '92.77', 'groupId': 'OG001'}]}]}, {'title': 'TST variability at Post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '123.59', 'spread': '79.11', 'groupId': 'OG000'}, {'value': '96.50', 'spread': '97.84', 'groupId': 'OG001'}]}]}, {'title': 'TST mean at 6-month follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '465.23', 'spread': '115.13', 'groupId': 'OG000'}, {'value': '464.90', 'spread': '106.54', 'groupId': 'OG001'}]}]}, {'title': 'TST variability at 6-month follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99.30', 'spread': '52.38', 'groupId': 'OG000'}, {'value': '90.87', 'spread': '58.77', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.23', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Time by treatment interaction coeff.', 'ciNumSides': 'TWO_SIDED', 'paramValue': '24.85', 'groupDescription': 'Means of Total sleep time: Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.', 'statisticalMethod': 'Intent-to-treat, multilevel modeling', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes'}, {'pValue': '0.09', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Time by treatment interaction coeff.', 'ciNumSides': 'TWO_SIDED', 'paramValue': '34.31', 'groupDescription': 'Means of total sleep time: Treatment effect on change from pre to 6-month follow-up', 'statisticalMethod': 'Intent-to-treat, multilevel modeling', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes'}, {'pValue': '0.19', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Time by treatment interaction coeff.', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-19.90', 'groupDescription': 'Variability of Total sleep time: Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.', 'statisticalMethod': 'Intent-to-treat, multilevel modeling', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes'}, {'pValue': '0.91', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Time by treatment interaction coeff.', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-1.76', 'groupDescription': 'Variability of Total sleep time: Treatment effect on change from pre to 6-month follow-up', 'statisticalMethod': 'Intent-to-treat, multilevel modeling', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes'}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup', 'description': "Total sleep time (TST), measured as the total amount of sleep obtained by the participant, was reported via sleep diary over 7 consecutive days. Each participant's mean and within-person SD of TST were calculated to assess typical sleep duration and night-to-night variability. Group-level outcomes reflect the average of these participant-level means and SDs.", 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Although all randomized participants were included in the intent-to-treat analysis, the "Number Analyzed" represents participants who contributed data at each time point. Differences from the overall number analyzed reflect missing assessments due to attrition.'}, {'type': 'SECONDARY', 'title': 'Means and Variability of Total Wake Time (Daily Sleep Diary)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC-DT', 'description': 'Usual Care, Delayed Treatment (DT) is comprised of a case manager who co-ordinates care and refers each client for a medication review and to rehabilitation programs. At the end of 6-months in UC-DT, the participants will receive TranS-C.\n\nTransdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral.'}, {'id': 'OG001', 'title': 'TranS-C', 'description': "The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) is comprised of cross-cutting interventions, 'core modules' and 'optional modules'. TranS-C is derived and adapted from our previous disorder-focused research, firmly grounded in basic science and treatment literature.\n\nTransdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral."}], 'classes': [{'title': 'TWT mean at Pre-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '131.89', 'spread': '80.47', 'groupId': 'OG000'}, {'value': '124.84', 'spread': '75.03', 'groupId': 'OG001'}]}]}, {'title': 'TWT variability at Pre-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '77.85', 'spread': '54.92', 'groupId': 'OG000'}, {'value': '74.04', 'spread': '46.48', 'groupId': 'OG001'}]}]}, {'title': 'TWT mean at Post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '131.29', 'spread': '116.57', 'groupId': 'OG000'}, {'value': '84.37', 'spread': '49.45', 'groupId': 'OG001'}]}]}, {'title': '(TWT variability at Post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '82.07', 'spread': '77.64', 'groupId': 'OG000'}, {'value': '61.33', 'spread': '62.27', 'groupId': 'OG001'}]}]}, {'title': 'TWT mean at 6-month follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '118.92', 'spread': '77.55', 'groupId': 'OG000'}, {'value': '83.55', 'spread': '65.53', 'groupId': 'OG001'}]}]}, {'title': 'TWT variability at 6-month follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '73.27', 'spread': '47.70', 'groupId': 'OG000'}, {'value': '52.69', 'spread': '52.56', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.04', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Time by treatment interaction coeff.', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-39.33', 'groupDescription': 'TWT mean (min): Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.', 'statisticalMethod': 'Intent-to-treat, multilevel modeling', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes'}, {'pValue': '0.13', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Time by treatment interaction coeff.', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-28.56', 'groupDescription': 'TWT mean (min): Treatment effect on change from pre to 6-month follow-up.', 'statisticalMethod': 'Intent-to-treat, multilevel modeling', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes'}, {'pValue': '0.21', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Time by treatment interaction coeff.', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-17.57', 'groupDescription': 'TWT variability (min) : Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.', 'statisticalMethod': 'Intent-to-treat, multilevel modeling', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes'}, {'pValue': '0.25', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Time by treatment interaction coeff.', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-16.05', 'groupDescription': 'TWT variability (min): Treatment effect on change from pre to 6-month follow-up.', 'statisticalMethod': 'Intent-to-treat, multilevel modeling', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes'}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup', 'description': "Total wake time (TWT), measured as minutes of wakefulness within a sleep period, was reported via sleep diary over 7 consecutive days. Each participant's mean and within-person SD of their TWT were calculated across days to assess means and night-to-night variability. Group-level outcomes reflect the average of these participant-level means and SDs.", 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Although all randomized participants were included in the intent-to-treat analysis, the "Number Analyzed" represents participants who contributed data at each time point. Differences from the overall number analyzed reflect missing assessments due to attrition.'}, {'type': 'SECONDARY', 'title': 'Means and Variability of Bedtime (Daily Sleep Diary)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC-DT', 'description': 'Usual Care, Delayed Treatment (DT) is comprised of a case manager who co-ordinates care and refers each client for a medication review and to rehabilitation programs. At the end of 6-months in UC-DT, the participants will receive TranS-C.\n\nTransdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral.'}, {'id': 'OG001', 'title': 'TranS-C', 'description': "The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) is comprised of cross-cutting interventions, 'core modules' and 'optional modules'. TranS-C is derived and adapted from our previous disorder-focused research, firmly grounded in basic science and treatment literature.\n\nTransdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral."}], 'classes': [{'title': 'Bedtime mean at Pre-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.20', 'spread': '1.95', 'groupId': 'OG000'}, {'value': '22.17', 'spread': '2.36', 'groupId': 'OG001'}]}]}, {'title': 'Bedtime variability at Pre-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.39', 'spread': '1.06', 'groupId': 'OG000'}, {'value': '1.28', 'spread': '0.79', 'groupId': 'OG001'}]}]}, {'title': '(Bedtime mean at Post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.39', 'spread': '1.56', 'groupId': 'OG000'}, {'value': '22.00', 'spread': '1.65', 'groupId': 'OG001'}]}]}, {'title': 'Bedtime variability at Post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.41', 'spread': '1.07', 'groupId': 'OG000'}, {'value': '1.01', 'spread': '0.93', 'groupId': 'OG001'}]}]}, {'title': 'Bedtime mean at 6-month follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.41', 'spread': '1.88', 'groupId': 'OG000'}, {'value': '21.96', 'spread': '2.13', 'groupId': 'OG001'}]}]}, {'title': 'Bedtime variability at 6-month follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.55', 'spread': '1.32', 'groupId': 'OG000'}, {'value': '1.00', 'spread': '0.68', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.10', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Time by treatment interaction coeff.', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.55', 'groupDescription': 'Bedtime (BT) mean: Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.', 'statisticalMethod': 'Intent-to-treat, multilevel modeling', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes'}, {'pValue': '0.04', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Time by treatment interaction coeff.', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.71', 'groupDescription': 'BT mean: Treatment effect on change from pre to 6-month follow-up.', 'statisticalMethod': 'Intent-to-treat, multilevel modeling', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes'}, {'pValue': '0.20', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Time by treatment interaction coeff.', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.31', 'groupDescription': 'BT variability: Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.', 'statisticalMethod': 'Intent-to-treat, multilevel modeling', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes'}, {'pValue': '0.07', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Time by treatment interaction coeff.', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.45', 'groupDescription': 'BT variability: Treatment effect on change from pre to 6-month follow-up.', 'statisticalMethod': 'Intent-to-treat, multilevel modeling', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes'}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup', 'description': "Bedtime was reported via a 7-day daily sleep diary using a 24-hour decimal format, where times after midnight are expressed as numbers above 24 (ex. 1:30 am is 25.50). Each participant's mean and within-person SD of bedtime across 7 days were computed to capture average bedtime and variability. Group-level outcomes reflect the average of these participant-level means and SDs.", 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Although all randomized participants were included in the intent-to-treat analysis, the "Number Analyzed" represents participants who contributed data at each time point. Differences from the overall number analyzed reflect missing assessments due to attrition.'}, {'type': 'SECONDARY', 'title': 'Means and Variability of Wake Time (Daily Sleep Diary)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC-DT', 'description': 'Usual Care, Delayed Treatment (DT) is comprised of a case manager who co-ordinates care and refers each client for a medication review and to rehabilitation programs. At the end of 6-months in UC-DT, the participants will receive TranS-C.\n\nTransdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral.'}, {'id': 'OG001', 'title': 'TranS-C', 'description': "The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) is comprised of cross-cutting interventions, 'core modules' and 'optional modules'. TranS-C is derived and adapted from our previous disorder-focused research, firmly grounded in basic science and treatment literature.\n\nTransdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral."}], 'classes': [{'title': 'Wake time mean at Pre-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.90', 'spread': '1.83', 'groupId': 'OG000'}, {'value': '7.31', 'spread': '2.02', 'groupId': 'OG001'}]}]}, {'title': 'Wake time variability at Pre-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.42', 'spread': '0.88', 'groupId': 'OG000'}, {'value': '1.34', 'spread': '1.00', 'groupId': 'OG001'}]}]}, {'title': 'Wake time mean at Post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.26', 'spread': '2.25', 'groupId': 'OG000'}, {'value': '7.31', 'spread': '1.82', 'groupId': 'OG001'}]}]}, {'title': 'Wake time variability at Post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.61', 'spread': '1.11', 'groupId': 'OG000'}, {'value': '1.10', 'spread': '1.08', 'groupId': 'OG001'}]}]}, {'title': 'Wake time mean at 6-month follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.95', 'spread': '1.83', 'groupId': 'OG000'}, {'value': '7.33', 'spread': '1.74', 'groupId': 'OG001'}]}]}, {'title': 'Wake time variability at 6-month follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.22', 'spread': '0.69', 'groupId': 'OG000'}, {'value': '1.26', 'spread': '0.95', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.39', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Time by treatment interaction coeff.', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.33', 'groupDescription': 'WT mean: Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.', 'statisticalMethod': 'Intent-to-treat, multilevel modeling', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes'}, {'pValue': '0.96', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Time by treatment interaction coeff.', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.02', 'groupDescription': 'WT mean: Treatment effect on change from pre to 6-month follow-up.', 'statisticalMethod': 'Intent-to-treat, multilevel modeling', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes'}, {'pValue': '0.047', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Time by treatment interaction coeff.', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.39', 'groupDescription': 'WT variability: Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.', 'statisticalMethod': 'Intent-to-treat, multilevel modeling', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes'}, {'pValue': '0.30', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Time by treatment interaction coeff.', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.20', 'groupDescription': 'WT variability: Treatment effect on change from pre to 6-month follow-up.', 'statisticalMethod': 'Intent-to-treat, multilevel modeling', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes'}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup', 'description': "Wake times, using a 24-hour decimal format, were reported daily across 7 days. The mean and within-person SD were calculated for each participant's wake time across days. Group-level outcomes reflect the average of these participant-level means and SDs.", 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Although all randomized participants were included in the intent-to-treat analysis, the "Number Analyzed" represents participants who contributed data at each time point. Differences from the overall number analyzed reflect missing assessments due to attrition.'}, {'type': 'SECONDARY', 'title': 'Actigraphy Measured Sleep (TWT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC-DT', 'description': 'Usual Care, Delayed Treatment (DT) is comprised of a case manager who co-ordinates care and refers each client for a medication review and to rehabilitation programs. At the end of 6-months in UC-DT, the participants will receive TranS-C.\n\nTransdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral.'}, {'id': 'OG001', 'title': 'TranS-C', 'description': "The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) is comprised of cross-cutting interventions, 'core modules' and 'optional modules'. TranS-C is derived and adapted from our previous disorder-focused research, firmly grounded in basic science and treatment literature.\n\nTransdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral."}], 'classes': [{'title': 'TWT mean at Pre-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '91.06', 'spread': '41.52', 'groupId': 'OG000'}, {'value': '94.95', 'spread': '55.18', 'groupId': 'OG001'}]}]}, {'title': 'TWT variability at Pre-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '55.65', 'spread': '51.16', 'groupId': 'OG000'}, {'value': '54.46', 'spread': '48.26', 'groupId': 'OG001'}]}]}, {'title': 'TWT mean at Post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '91.39', 'spread': '48.65', 'groupId': 'OG000'}, {'value': '90.80', 'spread': '44.85', 'groupId': 'OG001'}]}]}, {'title': 'TWT variability at Post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '60.36', 'spread': '68.61', 'groupId': 'OG000'}, {'value': '51.72', 'spread': '41.86', 'groupId': 'OG001'}]}]}, {'title': 'TWT mean at 6-month follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '92.73', 'spread': '41.87', 'groupId': 'OG000'}, {'value': '84.51', 'spread': '45.84', 'groupId': 'OG001'}]}]}, {'title': 'TWT variability at 6-month follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '56.22', 'spread': '48.70', 'groupId': 'OG000'}, {'value': '41.41', 'spread': '30.65', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.66', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Time by treatment interaction coeff.', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-4.42', 'groupDescription': 'TWT mean (min): Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.', 'statisticalMethod': 'Intent-to-treat, multilevel modeling', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes'}, {'pValue': '0.19', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Time by treatment interaction coeff.', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-13.34', 'groupDescription': 'TWT mean (min): Treatment effect on change from pre to 6-month follow-up.', 'statisticalMethod': 'Intent-to-treat, multilevel modeling', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes'}, {'pValue': '0.77', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Time by treatment interaction coeff.', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.05', 'groupDescription': 'TWT variability (min): Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.', 'statisticalMethod': 'Intent-to-treat, multilevel modeling', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes'}, {'pValue': '0.20', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Time by treatment interaction coeff.', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.22', 'groupDescription': 'TWT variability (min): Treatment effect on change from pre to 6-month follow-up.', 'statisticalMethod': 'Intent-to-treat, multilevel modeling', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes'}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup', 'description': "Actigraphy-derived total wake time (TWT), measured as minutes of wakefulness within a sleep period, was collected daily over a 1-week period. Each participant's mean and within-person SD were calculated across the 7 days. Group-level outcomes reflect the average of these participant-level means and SDs.", 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Although all randomized participants were included in the intent-to-treat analysis, the "Number Analyzed" represents participants who contributed data at each time point. Differences from the overall number analyzed reflect missing assessments due to attrition.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Diagnosis of Psychiatric Disorders (MINI International Neuropsychiatric Interview )', 'timeFrame': 'Documenting diagnosis at baseline, 10-14 weeks after the beginning of treatment, and 6-month follow-up, no change predicted', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Diagnosis of Sleep Disorders (Duke Structured Interview for Sleep Disorder, DSM-V)', 'timeFrame': 'Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Sleep and Circadian Problems Interview', 'timeFrame': 'Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Insomnia Severity Index', 'timeFrame': 'Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Hypersomnia Severity Index', 'timeFrame': 'Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Therapy Process Measure', 'timeFrame': 'Administered at the end of Session 2 of treatment', 'description': 'Credibility Expectancy Questionnaire', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Medication and Other Treatment Tracking Form', 'timeFrame': 'Stability in baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Additional Screen for Sleep Apnea', 'timeFrame': 'Baseline Only', 'description': 'Snoring, tiredness/sleepiness, observed apneas, hypertension, BMI \\> 35 kg/m2, age \\> 50 years, neck circumference \\> 40 cm, and male gender (STOP-BANG) Questionnaire. 8-item screen for obstructive sleep apnea.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Brief Pain Inventory (Short Form)', 'timeFrame': 'Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month follow-up', 'description': 'Current symptoms of chronic pain', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Clinic Staff Qualitative Assessment', 'timeFrame': 'One time at the convenience of clinic staff', 'description': 'Explore barriers and facilitators to implementing an evidence-based sleep treatment in a community setting', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Client Behavior Change Interview', 'timeFrame': 'One time following the completion of the first post-treatment assessment', 'description': 'Exploration of barriers and facilitators to behavior change', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Salivary Cytokine Assay', 'timeFrame': 'Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month follow-up', 'description': 'Measure of cytokines present in saliva (e.g., Interleukin (IL) -1 beta, IL-6, IL-8, Tumor necrosis factor (TNF) alpha, and/or C-reactive protein (CRP)) to assess immune function', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Credibility Evaluation Questionnaire (CEQ)', 'timeFrame': 'Session 2 and Post treatment, which is 9-14 weeks after the beginning of treatment.', 'description': 'Client evaluation of treatment', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Patient Recall Task', 'timeFrame': 'Post treatment, which is 9-14 weeks after the beginning of treatment, and 6-month follow-up', 'description': 'Participant recall of sleep coaching treatment', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Patient Learning Task (Application and Thoughts Subsections)', 'timeFrame': 'Post treatment, which is 9-14 weeks after the beginning of treatment, and at 6-month follow-up', 'description': 'Client feedback and application of treatment', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Useful and Utilized Questionnaire', 'timeFrame': 'Post treatment, which is 9-14 weeks after the beginning of treatment, and at 6-month follow-up', 'description': 'Measure of sleep coaching elements used/useful to clients', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Treatment Adherence Rating Scale-Therapist Version', 'timeFrame': 'After each treatment session filled out by therapist (8 times)', 'description': 'Therapist evaluation of client adherence to treatment', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Body Weight', 'timeFrame': 'Pre-treatment, post treatment, which is 9-14 weeks after the beginning of treatment, and at 6-month follow-up', 'description': 'To calculate BMI', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Height', 'timeFrame': 'Pre-treatment', 'description': 'To calculate BMI', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'TranS-C', 'description': "The 'Transdiagnostic' Intervention for Sleep and Circadian Dysfunction (TranS-C) is comprised of cross-cutting interventions, 'core modules' and 'optional modules'. TranS-C is derived and adapted from our previous disorder-focused research, firmly grounded in basic science and treatment literature.\n\nTransdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral."}, {'id': 'FG001', 'title': 'UC-DT', 'description': 'Usual Care, Delayed Treatment (DT) is comprised of a case manager who co-ordinates care and refers each client for a medication review and to rehabilitation programs. At the end of 6-months in UC-DT, the participants will receive TranS-C.\n\nTransdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': 'Received Allocated Intervention', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': 'Completed Post-assessment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '58'}]}, {'type': 'Completed Follow-up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '57'}]}, {'type': 'Analyzed', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': 'COMPLETED', 'comment': 'Completed 6-month follow-up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '57'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to post or 6 month follow up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'UC-DT', 'description': 'Usual Care, Delayed Treatment (UC-DT) is comprised of a case manager who co-ordinates care and refers each client for a medication review and to rehabilitation programs. At the end of 6-months in UC-DT, the participants will receive TranS-C.\n\nTransdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral.'}, {'id': 'BG001', 'title': 'TranS-C', 'description': "The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) is comprised of cross-cutting interventions, 'core modules' and 'optional modules'. TranS-C is derived and adapted from our previous disorder-focused research, firmly grounded in basic science and treatment literature.\n\nTransdiagnostic Intervention for Sleep and Circadian Dysfunction: The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.45', 'spread': '13.25', 'groupId': 'BG000'}, {'value': '47.97', 'spread': '11.51', 'groupId': 'BG001'}, {'value': '46.72', 'spread': '12.41', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Civil status', 'classes': [{'categories': [{'title': 'Single', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}, {'title': 'Married/common law partner', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Separated/divorced/widowed', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Education', 'classes': [{'categories': [{'title': 'High school or below', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'Vocational school', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Some college or completed college', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}, {'title': 'Graduate school', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Employment', 'classes': [{'categories': [{'title': 'Full-time', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Part-time', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Unemployed', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Living arrangement', 'classes': [{'categories': [{'title': 'Alone', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'With family (spouse or children)', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'With friend or roommate or pet', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Supported housing', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Note: Supported housing includes living in board \\& care homes, senior housing, transitional housing, and homeless shelters.', 'unitOfMeasure': 'Participants'}, {'title': 'MINI Diagnosis at pre-treatment (current or past)', 'classes': [{'title': 'Schizophrenia spectrum disorder', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}, {'title': 'Bipolar disorder', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}, {'title': 'Major depressive disorder', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}, {'title': 'Any anxiety disorder', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}]}, {'title': 'Obsessive compulsive disorder', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': 'Post-traumatic stress disorder', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}, {'title': 'Substance use disorder', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}, {'title': 'Psychotic symptoms/features', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The Mini-International Neuropsychiatric Interview (MINI; DSM-5, Version 7.0.0 including Schizophrenia and Psychotic Disorders) was included as an evaluation of the presence of current and past Severe mental illness. Note: Comorbidity was common', 'unitOfMeasure': 'Participants'}, {'title': 'DUKE diagnoses at pre-treatment (current)', 'classes': [{'title': 'Insomnia disorder', 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}]}, {'title': 'Hypersomnolence disorder', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}, {'title': 'Circadian Rhythm Disorder: Delayed sleep phase type', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Circadian Rhythm Disorder: Advanced sleep phase type', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Circadian Rhythm Disorder: Irregular sleep-wake type', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Circadian Rhythm Disorder: Restless leg syndrome', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Circadian Rhythm Disorder: Periodic limb movement disorder', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Duke Structured Interview for Sleep Disorders (DUKE) diagnoses at pre-treatment (current): The diagnostic measure for sleep disorders was the Duke Structured Interview for Sleep Disorders. Note: Comorbidity was common', 'unitOfMeasure': 'Participants'}, {'title': 'Education (in years)', 'classes': [{'categories': [{'measurements': [{'value': '13.38', 'spread': '3.89', 'groupId': 'BG000'}, {'value': '13.80', 'spread': '3.05', 'groupId': 'BG001'}, {'value': '13.59', 'spread': '3.48', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Annual personal income', 'classes': [{'categories': [{'measurements': [{'value': '12,429', 'spread': '15,317', 'groupId': 'BG000'}, {'value': '12,636', 'spread': '9,850', 'groupId': 'BG001'}, {'value': '12,531', 'spread': '12,838', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Dollars ($)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Annual household income', 'classes': [{'categories': [{'measurements': [{'value': '24,091', 'spread': '27,507', 'groupId': 'BG000'}, {'value': '26,537', 'spread': '23,576', 'groupId': 'BG001'}, {'value': '25,216', 'spread': '25,546', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Dollars ($)', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-10-25', 'size': 399755, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-04-01T19:40', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 121}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2019-04-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-23', 'studyFirstSubmitDate': '2015-06-09', 'resultsFirstSubmitDate': '2024-04-02', 'studyFirstSubmitQcDate': '2015-06-10', 'lastUpdatePostDateStruct': {'date': '2025-08-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-07-23', 'studyFirstPostDateStruct': {'date': '2015-06-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Diagnosis of Psychiatric Disorders (MINI International Neuropsychiatric Interview )', 'timeFrame': 'Documenting diagnosis at baseline, 10-14 weeks after the beginning of treatment, and 6-month follow-up, no change predicted'}, {'measure': 'Diagnosis of Sleep Disorders (Duke Structured Interview for Sleep Disorder, DSM-V)', 'timeFrame': 'Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup'}, {'measure': 'Sleep and Circadian Problems Interview', 'timeFrame': 'Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup'}, {'measure': 'Insomnia Severity Index', 'timeFrame': 'Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup'}, {'measure': 'Hypersomnia Severity Index', 'timeFrame': 'Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup'}, {'measure': 'Therapy Process Measure', 'timeFrame': 'Administered at the end of Session 2 of treatment', 'description': 'Credibility Expectancy Questionnaire'}, {'measure': 'Medication and Other Treatment Tracking Form', 'timeFrame': 'Stability in baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup'}, {'measure': 'Additional Screen for Sleep Apnea', 'timeFrame': 'Baseline Only', 'description': 'Snoring, tiredness/sleepiness, observed apneas, hypertension, BMI \\> 35 kg/m2, age \\> 50 years, neck circumference \\> 40 cm, and male gender (STOP-BANG) Questionnaire. 8-item screen for obstructive sleep apnea.'}, {'measure': 'Brief Pain Inventory (Short Form)', 'timeFrame': 'Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month follow-up', 'description': 'Current symptoms of chronic pain'}, {'measure': 'Clinic Staff Qualitative Assessment', 'timeFrame': 'One time at the convenience of clinic staff', 'description': 'Explore barriers and facilitators to implementing an evidence-based sleep treatment in a community setting'}, {'measure': 'Client Behavior Change Interview', 'timeFrame': 'One time following the completion of the first post-treatment assessment', 'description': 'Exploration of barriers and facilitators to behavior change'}, {'measure': 'Salivary Cytokine Assay', 'timeFrame': 'Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month follow-up', 'description': 'Measure of cytokines present in saliva (e.g., Interleukin (IL) -1 beta, IL-6, IL-8, Tumor necrosis factor (TNF) alpha, and/or C-reactive protein (CRP)) to assess immune function'}, {'measure': 'Credibility Evaluation Questionnaire (CEQ)', 'timeFrame': 'Session 2 and Post treatment, which is 9-14 weeks after the beginning of treatment.', 'description': 'Client evaluation of treatment'}, {'measure': 'Patient Recall Task', 'timeFrame': 'Post treatment, which is 9-14 weeks after the beginning of treatment, and 6-month follow-up', 'description': 'Participant recall of sleep coaching treatment'}, {'measure': 'Patient Learning Task (Application and Thoughts Subsections)', 'timeFrame': 'Post treatment, which is 9-14 weeks after the beginning of treatment, and at 6-month follow-up', 'description': 'Client feedback and application of treatment'}, {'measure': 'Useful and Utilized Questionnaire', 'timeFrame': 'Post treatment, which is 9-14 weeks after the beginning of treatment, and at 6-month follow-up', 'description': 'Measure of sleep coaching elements used/useful to clients'}, {'measure': 'Treatment Adherence Rating Scale-Therapist Version', 'timeFrame': 'After each treatment session filled out by therapist (8 times)', 'description': 'Therapist evaluation of client adherence to treatment'}, {'measure': 'Body Weight', 'timeFrame': 'Pre-treatment, post treatment, which is 9-14 weeks after the beginning of treatment, and at 6-month follow-up', 'description': 'To calculate BMI'}, {'measure': 'Height', 'timeFrame': 'Pre-treatment', 'description': 'To calculate BMI'}], 'primaryOutcomes': [{'measure': 'Impairment (Sheehan Disability Scale)', 'timeFrame': 'Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup', 'description': 'Sheehan Disability Scale (SDS) (sleep). 3-item. The SDS evaluates the extent to which work/school, social life, and home/ family responsibilities are impaired on a 0-10 (not at all to extremely) scale. The 3-items are summed to compute the total score and assess global functional impairment. Scores can range from 0 to 30, with higher values indicating higher impairment.'}, {'measure': 'Disorder-Focused Composite Score (DSM-5)', 'timeFrame': 'Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup', 'description': 'DSM-5 Cross Cutting Measure. 23-items. Individuals report how much each domain has bothered them in the last 2 weeks on a 0-4 scale (not at all to nearly every day). The total score is calculated by summing the highest score in each of the 13 domains (depression, anger, mania, anxiety, somatic symptoms, suicidal ideation, psychosis, sleep problems, memory, repetitive thoughts and behaviors, dissociation, personality functioning, and substance use). Total scores can range from 0 to 52, with higher scores indicating greater severity of impairment. is rated on a 5-point scale, with higher scores indicating more severe impairment.'}, {'measure': 'Sleep and Circadian Function: PROMIS-Sleep Disturbance', 'timeFrame': 'Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup', 'description': 'PROMIS-Sleep Disturbance (PROMIS = Patient-Reported Outcomes Measurement Information System). The 8-item short version assesses sleep disturbance over the past 7 days, including restlessness, sleep quality, ability to fall and stay asleep, and refreshment following sleep using a 1-5 scale (not at all or never to very much or always). Scores range from 8 to 40, with higher scores indicating increased disturbance.'}, {'measure': 'Sleep and Circadian Function: PROMIS-Sleep-Related Impairment', 'timeFrame': 'Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup', 'description': 'PROMIS-Sleep-Related Impairment (PROMIS = Patient-Reported Outcomes Measurement Information System). 16-item. Scores range from 16 to 80, with higher scores indicating increased disturbance.'}], 'secondaryOutcomes': [{'measure': 'Depression (QIDS)', 'timeFrame': 'Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup', 'description': 'QIDS (Quick Inventory of Depressive Symptoms). 16-item instrument assessing depressive symptoms. Each item is rated on a 4-point scale (0-3), with higher scores indicating greater symptom severity.\n\nScoring involves summing the highest score from each of the 9 DSM-IV Major Depressive Disorder symptom domains (sleep, weight, psychomotor changes, depressed mood, decreased interest, fatigue, guilt, concentration, and suicidal ideation). Total scores range from 0 (Normal/No Depression) to 27 (Very Severe Depression). Higher scores indicate greater severity of depressive symptoms.'}, {'measure': 'Substance Use (ASSIST )', 'timeFrame': 'Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup', 'description': 'ASSIST (Alcohol, Smoking and Substance Involvement Screening Test). Frequency of use, substance dependence, and related health, social, legal, financial, and employment problems in the past 3 months are rated on a 5-point scale (never to daily of almost daily). Problems with family and friends caused by substance use and failed attempts to cut down or quit substance use are measured on a 3-point scale (no, never, yes, in the past 3 months, yes, but not in the past 3 months). The total risk score is calculated by summing scores across all drug categories, with total scores ranging from 0 to 414. Higher scores indicate greater substance-related risks and problems.'}, {'measure': 'Psychotic Symptoms (PSYRATS )', 'timeFrame': 'Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup', 'description': 'PSYRATS (Psychotic Symptom Rating Scales). Each of the 17 items is rated on a 5-point scale from 0 (absent) to 4 (severe). Scores are summed for auditory hallucinations (sum of 11 items) and delusions (sum of 6 items). Total scores range from 0 to 68, with higher scores indicating greater severity of psychotic symptoms.'}, {'measure': 'Means and Variability of Sleep Efficiency (Daily Sleep Diary)', 'timeFrame': 'Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup', 'description': 'Sleep efficiency (SE), calculated as total sleep time divided by time in bed, multiplied by 100, was recorded via sleep diary over 7 consecutive days. For each participant, the mean and within-person standard deviation (SD) of SE were calculated across the days to reflect an average and night-to-night variability. Group-level outcomes reflect the average of these participant-level means and SDs.'}, {'measure': 'Actigraphy Measured Sleep (TST)', 'timeFrame': 'Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup', 'description': 'Actigraphy-derived total sleep time (TST) is the total amount of sleep obtained by the participant per 24 hrs, which was recorded daily over a 1-week period per timepoint. For each participant, the mean and standard deviation (SD) of TST were calculated across the days. Group-level outcomes reflect the average of these participant-level means and SDs.'}, {'measure': 'Daytime Activity (Actigraphy)', 'timeFrame': 'Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup', 'description': 'Daytime activity was measured via actigraphy over 7 consecutive days per timepoint. For each participant, their daily waking activity counts were extracted, and the mean and within-person standard deviation (SD) of these counts were calculated across 7 days. Group-level outcomes reflect the average of these participant-level means and SDs.'}, {'measure': 'Impairment (World Health Organization Disability Assessment Schedule 2.0)', 'timeFrame': 'Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup', 'description': 'World Health Organization Disability Assessment Schedule 2.0 (WHODAS-2.0). 36-item measure that assesses disability in adults ages 18 years and older. It assesses disability across six domains on a scale from 1-5 (none to extreme or cannot do). Each item on the self-administered version of the WHODAS-2.0 asks the individual to rate how much difficulty he or she has had in specific areas of functioning during the past 30 days. Scores are summed across the six domains (cognition, mobility, self-care, getting along, life activities, and participation). Total scores range from 36 to 180, with higher scores indicating greater levels of disability.'}, {'measure': "Overall Health ('Healthy Days' Core Module)", 'timeFrame': 'Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup', 'description': 'Four question \'healthy days\' core module developed by the Centers for Disease Control and Prevention. A summary measure combines physically and mentally unhealthy days. An "unhealthy days" summary measure based on the second and third questions and estimates the overall number of recent days (in the past 30 days) when physical or mental health was not good.'}, {'measure': 'Composite Sleep Health Score', 'timeFrame': 'Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup', 'description': 'Composite Sleep Health Score is defined as the sum of scores on 6 sleep health dimensions: Regularity (Midpoint sleep fluctuation across a 7-day sleep diary \\< 1 hour), Satisfaction (Sleep quality question on PROMIS-Sleep Disturbance (PROMIS = Patient-Reported Outcomes Measurement Information System)), Alertness (Daytime sleepiness question on PROMIS-Sleep Related Impairment (PROMIS = Patient-Reported Outcomes Measurement Information System)), Timing (Mean midpoint sleep across the 7 day sleep diary between 2 and 4 AM), Efficiency (Average sleep efficiency based on the 7 day sleep diary ≥ 85%), and Duration (Total Sleep Time average based on 7 day sleep diary between 7 and 9 hours).\n\nEach dimension was dichotomized such that 1 = good /yes; 0 = poor/no). Total composite sleep health score ranges from 0 to 6, with larger values indicating better sleep health.'}, {'measure': 'Means and Variability of Total Sleep Time (Daily Sleep Diary)', 'timeFrame': 'Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup', 'description': "Total sleep time (TST), measured as the total amount of sleep obtained by the participant, was reported via sleep diary over 7 consecutive days. Each participant's mean and within-person SD of TST were calculated to assess typical sleep duration and night-to-night variability. Group-level outcomes reflect the average of these participant-level means and SDs."}, {'measure': 'Means and Variability of Total Wake Time (Daily Sleep Diary)', 'timeFrame': 'Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup', 'description': "Total wake time (TWT), measured as minutes of wakefulness within a sleep period, was reported via sleep diary over 7 consecutive days. Each participant's mean and within-person SD of their TWT were calculated across days to assess means and night-to-night variability. Group-level outcomes reflect the average of these participant-level means and SDs."}, {'measure': 'Means and Variability of Bedtime (Daily Sleep Diary)', 'timeFrame': 'Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup', 'description': "Bedtime was reported via a 7-day daily sleep diary using a 24-hour decimal format, where times after midnight are expressed as numbers above 24 (ex. 1:30 am is 25.50). Each participant's mean and within-person SD of bedtime across 7 days were computed to capture average bedtime and variability. Group-level outcomes reflect the average of these participant-level means and SDs."}, {'measure': 'Means and Variability of Wake Time (Daily Sleep Diary)', 'timeFrame': 'Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup', 'description': "Wake times, using a 24-hour decimal format, were reported daily across 7 days. The mean and within-person SD were calculated for each participant's wake time across days. Group-level outcomes reflect the average of these participant-level means and SDs."}, {'measure': 'Actigraphy Measured Sleep (TWT)', 'timeFrame': 'Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup', 'description': "Actigraphy-derived total wake time (TWT), measured as minutes of wakefulness within a sleep period, was collected daily over a 1-week period. Each participant's mean and within-person SD were calculated across the 7 days. Group-level outcomes reflect the average of these participant-level means and SDs."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Mental Disorders']}, 'referencesModule': {'references': [{'pmid': '37478529', 'type': 'DERIVED', 'citation': 'Callaway CA, Sarfan LD, Gumport NB, Harvey AG. The impact of module dosage on treatment response in a modular transdiagnostic intervention for sleep and circadian dysfunction (TranS-C). Behav Res Ther. 2023 Sep;168:104368. doi: 10.1016/j.brat.2023.104368. Epub 2023 Jul 5.'}, {'pmid': '34264701', 'type': 'DERIVED', 'citation': 'Harvey AG, Dong L, Hein K, Yu SH, Martinez AJ, Gumport NB, Smith FL, Chapman A, Lisman M, Mirzadegan IA, Mullin AC, Fine E, Dolsen EA, Gasperetti CE, Bukosky J, Alvarado-Martinez CG, Kilbourne AM, Rabe-Hesketh S, Buysse DJ. A randomized controlled trial of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) to improve serious mental illness outcomes in a community setting. J Consult Clin Psychol. 2021 Jun;89(6):537-550. doi: 10.1037/ccp0000650.'}, {'pmid': '32890862', 'type': 'DERIVED', 'citation': 'Gumport NB, Yu SH, Harvey AG. Implementing a transdiagnostic sleep and circadian intervention in a community mental health setting: A qualitative process evaluation with community stakeholders. Psychiatry Res. 2020 Nov;293:113443. doi: 10.1016/j.psychres.2020.113443. Epub 2020 Aug 31.'}, {'pmid': '27998295', 'type': 'DERIVED', 'citation': 'Harvey AG, Hein K, Dong L, Smith FL, Lisman M, Yu S, Rabe-Hesketh S, Buysse DJ. A transdiagnostic sleep and circadian treatment to improve severe mental illness outcomes in a community setting: study protocol for a randomized controlled trial. Trials. 2016 Dec 20;17(1):606. doi: 10.1186/s13063-016-1690-9.'}]}, 'descriptionModule': {'briefSummary': 'Mental illness is often severe, chronic and difficult to treat. The sleep disturbance commonly experienced by individuals with a severe mental illness reduces capacity to function and contributes to key symptoms. This study seeks to determine if an intervention to improve sleep can improve functioning and reduce symptoms and impairment. The investigators will conduct this study in community mental health centers to ensure that the results contribute to closing the worrisome gap between research and practice and to ensure that the findings are generalizable to the real world.', 'detailedDescription': "Despite advances in treatment, severe mental illness (SMI) remains common, chronic and difficult to treat. SMI is defined as having at least one mental disorder that lasts for 12-months and leads to substantial life interference. Sleep and circadian dysfunctions are among the most prominent correlates of SMI, yet have been minimally studied in ways that reflect the complexity of the sleep problems experienced by people with SMI. In SMI, sleep and circadian dysfunction undermines affect regulation, cognitive function and physical health, predicts onset and worsening of symptoms and is often chronic even with evidence-based SMI treatment. Prior treatment studies have been disorder-focused-they have treated a specific sleep problem (e.g., insomnia) in a specific diagnostic group (e.g., depression). However, real life sleep and circadian problems are not so neatly categorized, particularly in SMI where features of insomnia overlap with hypersomnia, delayed sleep phase and irregular sleep-wake schedules. Accordingly, the investigators aim to test the hypothesis that a Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) will improve functional impairment, disorder-focused symptoms and sleep and circadian functioning. The investigators will recruit participants across Diagnostic and Statistical Manual of Mental Disorders (DSM) diagnoses and across common sleep and circadian problems. The elements of TranS-C are efficacious across SMI in research settings with research-based providers. The next step is to test TranS-C in community settings with community-based providers. Accordingly, the investigators propose to conduct an 'efficacy in the real world' randomized controlled trial within Alameda County Behavioral Health Care Services (ACBHCS), the community mental health center (CMHC) for Alameda County. The investigators will recruit 120 adults diagnosed with SMI and sleep and circadian dysfunction within ACBHCS. Individuals will be randomly allocated to TranS-C (n = 60) or 6-months of Usual Care followed by Delayed Treatment with TranS-C (UC-DT; n = 60). TranS-C is modularized and delivered across eight to twelve 50-minute, weekly, individual sessions. All participants will be assessed before, immediately following treatment (ie. 9-14 weeks later) and again 6 months later."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18+ years\n* English language fluency\n* Presence of at least one DSM-V mental disorder for 12 months\n* One or more of the following sleep or circadian problems for 3 month as assessed with the Sleep and Circadian Problems Interview:\n\n * ≥30 mins to get to sleep , 3 or more nights per week\n * Waking in the middle of the night for ≥30 minutes, 3 or more nights per week\n * Obtaining less than 6 hours of sleep per night, 3 or more nights per week\n * Obtaining more than 9 hours of sleep per 24 hour period (i.e., nighttime sleep plus daytime napping), 3 or more nights per week\n * More than 2.78 hours of variability in sleep-wake schedule across one week\n * Bedtime later than 2 am, 3 or more nights per week\n* Guaranteed bed to sleep in for the duration of the treatment phase\n* Receiving care for SMI at ACBHCS and consent to regular communications between research team and psychiatrist and/or case manager\n\nExclusion Criteria:\n\n* Presence of an active and progressive physical illness or neurological degenerative disease AND/OR substance abuse/dependence making participation in the study unfeasible.\n* Current serious suicide risk (assessed by our staff, a case manager or psychiatrist) or homicide risk (assessed by our staff, a case manager or psychiatrist)\n* Night shift work \\>2 nights per week in the past 3 months\n* Pregnancy or breast-feeding\n* Not able/willing to participate in and/or complete the pre-treatment assessments'}, 'identificationModule': {'nctId': 'NCT02469233', 'briefTitle': 'A Transdiagnostic Sleep and Circadian Treatment to Improve Community SMI Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Berkeley'}, 'officialTitle': 'A Transdiagnostic Sleep and Circadian Treatment to Improve Community SMI Outcomes', 'orgStudyIdInfo': {'id': 'R01MH105513', 'link': 'https://reporter.nih.gov/quickSearch/R01MH105513', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TranS-C', 'description': "The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) is comprised of cross-cutting interventions, 'core modules' and 'optional modules'. TranS-C is derived and adapted from our previous disorder-focused research, firmly grounded in basic science and treatment literature.", 'interventionNames': ['Behavioral: Transdiagnostic Intervention for Sleep and Circadian Dysfunction']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'UC-DT', 'description': 'Usual Care, Delayed Treatment (DT) is comprised of a case manager who co-ordinates care and refers each client for a medication review and to rehabilitation programs. At the end of 6-months in UC-DT, the participants will receive TranS-C.', 'interventionNames': ['Behavioral: Transdiagnostic Intervention for Sleep and Circadian Dysfunction']}], 'interventions': [{'name': 'Transdiagnostic Intervention for Sleep and Circadian Dysfunction', 'type': 'BEHAVIORAL', 'description': 'The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral.', 'armGroupLabels': ['TranS-C', 'UC-DT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94605', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': 'Alameda Country Behavioral Health Care Services', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}], 'overallOfficials': [{'name': 'Allison G Harvey, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Berkeley'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Berkeley', 'class': 'OTHER'}, 'collaborators': [{'name': 'Alameda County Behavioral Health Care Services', 'class': 'UNKNOWN'}, {'name': 'University of Pittsburgh', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}