Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2026-02-02 @ 1:27 AM
Study NCT ID:
NCT03627832
Status:
COMPLETED
Last Update Posted:
2020-06-16
First Post:
2018-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Insomnia Treatment and Problems (the iTAP Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'millmary@health.missouri.edu', 'phone': '573-882-1813', 'title': 'Dr. Mary Beth Miller', 'organization': 'University of Missouri'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '11 Weeks', 'eventGroups': [{'id': 'EG000', 'title': 'CBT-I', 'description': "Individual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week.\n\nParticipants will attend 1-hour individual sessions of CBT-I once a week for five weeks. Consistent with clinical guidelines (Schutte-Rodin, Broch, Buysse, Dorsey, \\& Sateia, 2008), treatment will include stimulus control (e.g., limit use of bed to sleep or sexual activity, get out of bed if lying awake for more than 20 minutes), sleep restriction (limit time in bed to amount of time spent sleeping on a typical night), sleep hygiene (e.g., avoid exercise within 2 hours of bedtime, create cool and dark sleep environment), relaxation training, and cognitive restructuring.\n\nParticipants will also receive a one-page handout on sleep hygiene that is consistent with what may be expected as standard care in a doctor's visit with a primary care physician.", 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 0, 'seriousNumAtRisk': 28, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sleep Hygiene', 'description': "Participants will receive a one-page handout on sleep hygiene that is consistent with what may be expected as standard care in a doctor's visit with a primary care physician.", 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 0, 'seriousNumAtRisk': 28, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Insomnia Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBT-I', 'description': "Individual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week.\n\nParticipants will attend 1-hour individual sessions of CBT-I once a week for five weeks. Consistent with clinical guidelines (Schutte-Rodin, Broch, Buysse, Dorsey, \\& Sateia, 2008), treatment will include stimulus control (e.g., limit use of bed to sleep or sexual activity, get out of bed if lying awake for more than 20 minutes), sleep restriction (limit time in bed to amount of time spent sleeping on a typical night), sleep hygiene (e.g., avoid exercise within 2 hours of bedtime, create cool and dark sleep environment), relaxation training, and cognitive restructuring.\n\nParticipants will also receive a one-page handout on sleep hygiene that is consistent with what may be expected as standard care in a doctor's visit with a primary care physician."}, {'id': 'OG001', 'title': 'Sleep Hygiene', 'description': "Participants will receive a one-page handout on sleep hygiene that is consistent with what may be expected as standard care in a doctor's visit with a primary care physician."}], 'classes': [{'title': 'Post Treatment', 'categories': [{'measurements': [{'value': '6.86', 'spread': '3.66', 'groupId': 'OG000'}, {'value': '10.84', 'spread': '3.5', 'groupId': 'OG001'}]}]}, {'title': '1-Month Follow-Up', 'categories': [{'measurements': [{'value': '6.58', 'spread': '3.41', 'groupId': 'OG000'}, {'value': '9.32', 'spread': '4.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12)', 'description': 'Assessed using the Insomnia Severity Index. Scores range from 0 to 28, with higher scores indicating higher insomnia severity.', 'unitOfMeasure': 'units on scale, Insomnia Severity Index', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Sleep Efficiency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBT-I', 'description': "Individual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week.\n\nParticipants will attend 1-hour individual sessions of CBT-I once a week for five weeks. Consistent with clinical guidelines (Schutte-Rodin, Broch, Buysse, Dorsey, \\& Sateia, 2008), treatment will include stimulus control (e.g., limit use of bed to sleep or sexual activity, get out of bed if lying awake for more than 20 minutes), sleep restriction (limit time in bed to amount of time spent sleeping on a typical night), sleep hygiene (e.g., avoid exercise within 2 hours of bedtime, create cool and dark sleep environment), relaxation training, and cognitive restructuring.\n\nParticipants will also receive a one-page handout on sleep hygiene that is consistent with what may be expected as standard care in a doctor's visit with a primary care physician."}, {'id': 'OG001', 'title': 'Sleep Hygiene', 'description': "Participants will receive a one-page handout on sleep hygiene that is consistent with what may be expected as standard care in a doctor's visit with a primary care physician."}], 'classes': [{'title': 'Post Treatment', 'categories': [{'measurements': [{'value': '79.27', 'spread': '7.95', 'groupId': 'OG000'}, {'value': '76.48', 'spread': '7.09', 'groupId': 'OG001'}]}]}, {'title': '1-Month Follow-Up', 'categories': [{'measurements': [{'value': '76.22', 'spread': '9.8', 'groupId': 'OG000'}, {'value': '76.54', 'spread': '7.94', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12)', 'description': 'Assessed using daily sleep diaries and actigraphy -- sleep efficiency is the proportion of time spent in bed (from lights out until out of bed in the morning) that is actually spent sleeping (subtracting how long it took to fall asleep and how much time was spent awake in the middle of the night).', 'unitOfMeasure': '% of time spent in bed actually asleep', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Sleep Quality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBT-I', 'description': "Individual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week.\n\nParticipants will attend 1-hour individual sessions of CBT-I once a week for five weeks. Consistent with clinical guidelines (Schutte-Rodin, Broch, Buysse, Dorsey, \\& Sateia, 2008), treatment will include stimulus control (e.g., limit use of bed to sleep or sexual activity, get out of bed if lying awake for more than 20 minutes), sleep restriction (limit time in bed to amount of time spent sleeping on a typical night), sleep hygiene (e.g., avoid exercise within 2 hours of bedtime, create cool and dark sleep environment), relaxation training, and cognitive restructuring.\n\nParticipants will also receive a one-page handout on sleep hygiene that is consistent with what may be expected as standard care in a doctor's visit with a primary care physician."}, {'id': 'OG001', 'title': 'Sleep Hygiene', 'description': "Participants will receive a one-page handout on sleep hygiene that is consistent with what may be expected as standard care in a doctor's visit with a primary care physician."}], 'classes': [{'title': 'Post Treatment', 'categories': [{'measurements': [{'value': '2.25', 'spread': '.66', 'groupId': 'OG000'}, {'value': '2.32', 'spread': '.62', 'groupId': 'OG001'}]}]}, {'title': '1-Month Follow-Up', 'categories': [{'measurements': [{'value': '2.49', 'spread': '.62', 'groupId': 'OG000'}, {'value': '2.29', 'spread': '.55', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12)', 'description': 'Assessed using a single question on the daily sleep diary. Sleep quality score ranges from 0-4, where 0=very poor sleep quality and 4=very good sleep quality.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Drinking Quantity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBT-I', 'description': "Individual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week.\n\nParticipants will attend 1-hour individual sessions of CBT-I once a week for five weeks. Consistent with clinical guidelines (Schutte-Rodin, Broch, Buysse, Dorsey, \\& Sateia, 2008), treatment will include stimulus control (e.g., limit use of bed to sleep or sexual activity, get out of bed if lying awake for more than 20 minutes), sleep restriction (limit time in bed to amount of time spent sleeping on a typical night), sleep hygiene (e.g., avoid exercise within 2 hours of bedtime, create cool and dark sleep environment), relaxation training, and cognitive restructuring.\n\nParticipants will also receive a one-page handout on sleep hygiene that is consistent with what may be expected as standard care in a doctor's visit with a primary care physician."}, {'id': 'OG001', 'title': 'Sleep Hygiene', 'description': "Participants will receive a one-page handout on sleep hygiene that is consistent with what may be expected as standard care in a doctor's visit with a primary care physician."}], 'classes': [{'title': 'Post Treatment', 'categories': [{'measurements': [{'value': '11.45', 'spread': '8.25', 'groupId': 'OG000'}, {'value': '11.80', 'spread': '9.20', 'groupId': 'OG001'}]}]}, {'title': '1-Month Follow-Up', 'categories': [{'measurements': [{'value': '8.7', 'spread': '7.70', 'groupId': 'OG000'}, {'value': '9.33', 'spread': '8.77', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12)', 'description': 'Assessed using the Daily Drinking Questionnaire. Participants estimate how many alcoholic drinks they typically consume on each day of the week, averaged over the past 3 months.Responses for drinking quantity range from 0 to infinity, where higher numbers indicate more standard drinks consumed per day. Reports from each day are summed to create a "Drinks Per Week" score. Participants also report the amount of time they typically spend drinking during each day of the week. Responses range from 0-24 hours per day, where higher numbers indicate more hours drinking.', 'unitOfMeasure': 'Drinks per Week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Alcohol-related Consequences', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBT-I', 'description': "Individual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week.\n\nParticipants will attend 1-hour individual sessions of CBT-I once a week for five weeks. Consistent with clinical guidelines (Schutte-Rodin, Broch, Buysse, Dorsey, \\& Sateia, 2008), treatment will include stimulus control (e.g., limit use of bed to sleep or sexual activity, get out of bed if lying awake for more than 20 minutes), sleep restriction (limit time in bed to amount of time spent sleeping on a typical night), sleep hygiene (e.g., avoid exercise within 2 hours of bedtime, create cool and dark sleep environment), relaxation training, and cognitive restructuring.\n\nParticipants will also receive a one-page handout on sleep hygiene that is consistent with what may be expected as standard care in a doctor's visit with a primary care physician."}, {'id': 'OG001', 'title': 'Sleep Hygiene', 'description': "Participants will receive a one-page handout on sleep hygiene that is consistent with what may be expected as standard care in a doctor's visit with a primary care physician."}], 'classes': [{'title': 'Post Treatment', 'categories': [{'measurements': [{'value': '4.18', 'spread': '5.53', 'groupId': 'OG000'}, {'value': '5.01', 'spread': '4.18', 'groupId': 'OG001'}]}]}, {'title': '1-Month Follow-Up', 'categories': [{'measurements': [{'value': '5.04', 'spread': '5.15', 'groupId': 'OG000'}, {'value': '3.47', 'spread': '3.17', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12)', 'description': 'Assessed using the Brief Young Adult Alcohol Consequences Questionnaire. Scores range from 0-24, with higher scores indicating more alcohol-related consequences.', 'unitOfMeasure': 'units on a scale - BYAAC', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Delay Discounting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBT-I', 'description': "Individual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week.\n\nParticipants will attend 1-hour individual sessions of CBT-I once a week for five weeks. Consistent with clinical guidelines (Schutte-Rodin, Broch, Buysse, Dorsey, \\& Sateia, 2008), treatment will include stimulus control (e.g., limit use of bed to sleep or sexual activity, get out of bed if lying awake for more than 20 minutes), sleep restriction (limit time in bed to amount of time spent sleeping on a typical night), sleep hygiene (e.g., avoid exercise within 2 hours of bedtime, create cool and dark sleep environment), relaxation training, and cognitive restructuring.\n\nParticipants will also receive a one-page handout on sleep hygiene that is consistent with what may be expected as standard care in a doctor's visit with a primary care physician."}, {'id': 'OG001', 'title': 'Sleep Hygiene', 'description': "Participants will receive a one-page handout on sleep hygiene that is consistent with what may be expected as standard care in a doctor's visit with a primary care physician."}], 'timeFrame': 'Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12)', 'description': 'Assessed using the Monetary Choice Questionnaire. Responses will be used to calculate discount rate (k), consistency of the discount rate (the inferred k), and the proportion of immediate reward choices (immediate choice ratios).', 'reportingStatus': 'POSTED', 'populationDescription': 'Secondary data have not been analyzed yet.'}, {'type': 'SECONDARY', 'title': 'Negative Affect', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBT-I', 'description': "Individual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week.\n\nParticipants will attend 1-hour individual sessions of CBT-I once a week for five weeks. Consistent with clinical guidelines (Schutte-Rodin, Broch, Buysse, Dorsey, \\& Sateia, 2008), treatment will include stimulus control (e.g., limit use of bed to sleep or sexual activity, get out of bed if lying awake for more than 20 minutes), sleep restriction (limit time in bed to amount of time spent sleeping on a typical night), sleep hygiene (e.g., avoid exercise within 2 hours of bedtime, create cool and dark sleep environment), relaxation training, and cognitive restructuring.\n\nParticipants will also receive a one-page handout on sleep hygiene that is consistent with what may be expected as standard care in a doctor's visit with a primary care physician."}, {'id': 'OG001', 'title': 'Sleep Hygiene', 'description': "Participants will receive a one-page handout on sleep hygiene that is consistent with what may be expected as standard care in a doctor's visit with a primary care physician."}], 'timeFrame': 'Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12)', 'description': 'Assessed using the Positive and Negative Affect Schedule. Participants respond to words that describe negative feelings/emotions and report the extent (1-5) that they feel each emotion presently or during the past week. Higher scores indicate higher negative affect.', 'reportingStatus': 'POSTED', 'populationDescription': 'Secondary data have not been analyzed yet.'}, {'type': 'SECONDARY', 'title': 'Emotion Regulation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBT-I', 'description': "Individual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week.\n\nParticipants will attend 1-hour individual sessions of CBT-I once a week for five weeks. Consistent with clinical guidelines (Schutte-Rodin, Broch, Buysse, Dorsey, \\& Sateia, 2008), treatment will include stimulus control (e.g., limit use of bed to sleep or sexual activity, get out of bed if lying awake for more than 20 minutes), sleep restriction (limit time in bed to amount of time spent sleeping on a typical night), sleep hygiene (e.g., avoid exercise within 2 hours of bedtime, create cool and dark sleep environment), relaxation training, and cognitive restructuring.\n\nParticipants will also receive a one-page handout on sleep hygiene that is consistent with what may be expected as standard care in a doctor's visit with a primary care physician."}, {'id': 'OG001', 'title': 'Sleep Hygiene', 'description': "Participants will receive a one-page handout on sleep hygiene that is consistent with what may be expected as standard care in a doctor's visit with a primary care physician."}], 'timeFrame': 'Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12)', 'description': 'Assessed using the Difficulties with Emotion Regulation Scale. Scores range from 36-180, with higher scores indicating more difficulty with emotion regulation.', 'reportingStatus': 'POSTED', 'populationDescription': 'Secondary data not analyzed yet.'}, {'type': 'SECONDARY', 'title': 'Alcohol Craving', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBT-I', 'description': "Individual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week.\n\nParticipants will attend 1-hour individual sessions of CBT-I once a week for five weeks. Consistent with clinical guidelines (Schutte-Rodin, Broch, Buysse, Dorsey, \\& Sateia, 2008), treatment will include stimulus control (e.g., limit use of bed to sleep or sexual activity, get out of bed if lying awake for more than 20 minutes), sleep restriction (limit time in bed to amount of time spent sleeping on a typical night), sleep hygiene (e.g., avoid exercise within 2 hours of bedtime, create cool and dark sleep environment), relaxation training, and cognitive restructuring.\n\nParticipants will also receive a one-page handout on sleep hygiene that is consistent with what may be expected as standard care in a doctor's visit with a primary care physician."}, {'id': 'OG001', 'title': 'Sleep Hygiene', 'description': "Participants will receive a one-page handout on sleep hygiene that is consistent with what may be expected as standard care in a doctor's visit with a primary care physician."}], 'timeFrame': 'Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12)', 'description': 'Assessed using the Penn Alcohol Craving Scale. Scores range from 0-30, with higher scores indicating greater alcohol craving.', 'reportingStatus': 'POSTED', 'populationDescription': 'Secondary data not analyzed yet.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CBT-I', 'description': "Individual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week.\n\nParticipants will attend 1-hour individual sessions of CBT-I once a week for five weeks. Consistent with clinical guidelines (Schutte-Rodin, Broch, Buysse, Dorsey, \\& Sateia, 2008), treatment will include stimulus control (e.g., limit use of bed to sleep or sexual activity, get out of bed if lying awake for more than 20 minutes), sleep restriction (limit time in bed to amount of time spent sleeping on a typical night), sleep hygiene (e.g., avoid exercise within 2 hours of bedtime, create cool and dark sleep environment), relaxation training, and cognitive restructuring.\n\nParticipants will also receive a one-page handout on sleep hygiene that is consistent with what may be expected as standard care in a doctor's visit with a primary care physician."}, {'id': 'FG001', 'title': 'Sleep Hygiene', 'description': "Participants will receive a one-page handout on sleep hygiene that is consistent with what may be expected as standard care in a doctor's visit with a primary care physician."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'CBT-I', 'description': "Individual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week.\n\nParticipants will attend 1-hour individual sessions of CBT-I once a week for five weeks. Consistent with clinical guidelines (Schutte-Rodin, Broch, Buysse, Dorsey, \\& Sateia, 2008), treatment will include stimulus control (e.g., limit use of bed to sleep or sexual activity, get out of bed if lying awake for more than 20 minutes), sleep restriction (limit time in bed to amount of time spent sleeping on a typical night), sleep hygiene (e.g., avoid exercise within 2 hours of bedtime, create cool and dark sleep environment), relaxation training, and cognitive restructuring.\n\nParticipants will also receive a one-page handout on sleep hygiene that is consistent with what may be expected as standard care in a doctor's visit with a primary care physician."}, {'id': 'BG001', 'title': 'Sleep Hygiene', 'description': "Participants will receive a one-page handout on sleep hygiene that is consistent with what may be expected as standard care in a doctor's visit with a primary care physician."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '22.3', 'spread': '2.7', 'groupId': 'BG000'}, {'value': '22.5', 'spread': '2.8', 'groupId': 'BG001'}, {'value': '22.5', 'spread': '2.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Alcohol Use Disorder', 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'College Enrollment', 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Comorbid Mental Health Disorder', 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Insomnia Severity', 'classes': [{'categories': [{'measurements': [{'value': '16.43', 'spread': '4.06', 'groupId': 'BG000'}, {'value': '15.93', 'spread': '2.92', 'groupId': 'BG001'}, {'value': '16.04', 'spread': '4.01', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Insomnia Severity measured using the Insomnia Severity Index. Participants rate how severe their concerns are to seven sleep-related questions on a scale of 0-4, where higher scores indicate worse insomnia. Total scores range from 0-28.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-05-22', 'size': 213551, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-03-23T11:44', 'hasProtocol': False}, {'date': '2019-03-03', 'size': 308243, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-05-08T16:38', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'PI Miller will not be blinded to block size or participant assignment because she will inform study therapists of participant assignment to conditions. However, PI Miller and study therapists will be blinded to assessment outcomes, and the assessment RA will be blinded to participant condition. All participants will be told that they will be assigned to one of two insomnia treatment conditions in order to blind them to condition assignment.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be assigned to receive either Cognitive Behavioral Therapy for Insomnia (CBT-I) or Sleep Hygiene.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2019-09-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-02', 'studyFirstSubmitDate': '2018-07-23', 'resultsFirstSubmitDate': '2020-04-27', 'studyFirstSubmitQcDate': '2018-08-08', 'lastUpdatePostDateStruct': {'date': '2020-06-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-05-19', 'studyFirstPostDateStruct': {'date': '2018-08-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Insomnia Severity', 'timeFrame': 'Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12)', 'description': 'Assessed using the Insomnia Severity Index. Scores range from 0 to 28, with higher scores indicating higher insomnia severity.'}, {'measure': 'Sleep Efficiency', 'timeFrame': 'Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12)', 'description': 'Assessed using daily sleep diaries and actigraphy -- sleep efficiency is the proportion of time spent in bed (from lights out until out of bed in the morning) that is actually spent sleeping (subtracting how long it took to fall asleep and how much time was spent awake in the middle of the night).'}, {'measure': 'Sleep Quality', 'timeFrame': 'Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12)', 'description': 'Assessed using a single question on the daily sleep diary. Sleep quality score ranges from 0-4, where 0=very poor sleep quality and 4=very good sleep quality.'}, {'measure': 'Drinking Quantity', 'timeFrame': 'Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12)', 'description': 'Assessed using the Daily Drinking Questionnaire. Participants estimate how many alcoholic drinks they typically consume on each day of the week, averaged over the past 3 months.Responses for drinking quantity range from 0 to infinity, where higher numbers indicate more standard drinks consumed per day. Reports from each day are summed to create a "Drinks Per Week" score. Participants also report the amount of time they typically spend drinking during each day of the week. Responses range from 0-24 hours per day, where higher numbers indicate more hours drinking.'}, {'measure': 'Alcohol-related Consequences', 'timeFrame': 'Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12)', 'description': 'Assessed using the Brief Young Adult Alcohol Consequences Questionnaire. Scores range from 0-24, with higher scores indicating more alcohol-related consequences.'}], 'secondaryOutcomes': [{'measure': 'Delay Discounting', 'timeFrame': 'Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12)', 'description': 'Assessed using the Monetary Choice Questionnaire. Responses will be used to calculate discount rate (k), consistency of the discount rate (the inferred k), and the proportion of immediate reward choices (immediate choice ratios).'}, {'measure': 'Negative Affect', 'timeFrame': 'Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12)', 'description': 'Assessed using the Positive and Negative Affect Schedule. Participants respond to words that describe negative feelings/emotions and report the extent (1-5) that they feel each emotion presently or during the past week. Higher scores indicate higher negative affect.'}, {'measure': 'Emotion Regulation', 'timeFrame': 'Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12)', 'description': 'Assessed using the Difficulties with Emotion Regulation Scale. Scores range from 36-180, with higher scores indicating more difficulty with emotion regulation.'}, {'measure': 'Alcohol Craving', 'timeFrame': 'Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12)', 'description': 'Assessed using the Penn Alcohol Craving Scale. Scores range from 0-30, with higher scores indicating greater alcohol craving.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['alcohol', 'drinking', 'sleep', 'insomnia', 'young adult'], 'conditions': ['Insomnia', 'Alcohol; Harmful Use']}, 'referencesModule': {'references': [{'pmid': '34870584', 'type': 'DERIVED', 'citation': 'Miller MB, Carpenter RW, Freeman LK, Curtis AF, Yurasek AM, McCrae CS. Cannabis use as a moderator of cognitive behavioral therapy for insomnia. J Clin Sleep Med. 2022 Apr 1;18(4):1047-1054. doi: 10.5664/jcsm.9796.'}, {'pmid': '34605392', 'type': 'DERIVED', 'citation': 'Miller MB, Curtis AF, Hall NA, Freeman LK, Everson AT, Martinez LD, Park CJ, McCrae CS. Daily associations between modifiable sleep behaviors and nighttime sleep among young adult drinkers with insomnia. J Clin Sleep Med. 2022 Mar 1;18(3):703-712. doi: 10.5664/jcsm.9706.'}, {'pmid': '33773200', 'type': 'DERIVED', 'citation': 'Miller MB, Freeman LK, Deroche CB, Park CJ, Hall NA, McCrae CS. Sleep and alcohol use among young adult drinkers with Insomnia: A daily process model. Addict Behav. 2021 Aug;119:106911. doi: 10.1016/j.addbeh.2021.106911. Epub 2021 Mar 15.'}, {'pmid': '32886778', 'type': 'DERIVED', 'citation': 'Miller MB, Deroche CB, Freeman LK, Park CJ, Hall NA, Sahota PK, McCrae CS. Cognitive behavioral therapy for insomnia among young adults who are actively drinking: a randomized pilot trial. Sleep. 2021 Feb 12;44(2):zsaa171. doi: 10.1093/sleep/zsaa171.'}]}, 'descriptionModule': {'briefSummary': 'This project aims to evaluate the efficacy of insomnia treatment in improving insomnia symptoms and alcohol-related problems among heavy-drinking young adults.', 'detailedDescription': "Heavy alcohol use is prevalent among young adults and results in significant physical and psychological burden. Despite wide implementation of alcohol risk reduction efforts on college campuses, rates of heavy alcohol consumption remain high, with 35% of students reporting consumption of 5+ drinks on the same occasion in the past 2 weeks. Thus, additional strategies are needed to reduce the burden of heavy alcohol use among college students. More than half of heavy-drinking college students report symptoms of insomnia. In turn, insomnia symptoms have been associated with increased risk of alcohol-related problems. The proposed project aims to reduce the burden of heavy alcohol use on college campuses by examining the efficacy of Cognitive Behavioral Therapy for Insomnia (CBT-I) in reducing alcohol use and related problems among heavy-drinking college students. Twenty seven young adults who indicate risk for problem drinking and meet DSM-5 criteria for Insomnia Disorder will participate in a 5-week pilot trial. Participants will complete five individual sessions of CBT-I. Outcomes will be assessed at the end of the active intervention period (6 weeks) and 1 month post-intervention. Outcomes of interest include insomnia severity, total wake time, sleep quality, drinking quantity, and alcohol-related consequences. The proposed research aims to reduce the harms associated with heavy alcohol use among young adults by improving the availability of efficacious treatment. It will impact understanding of the benefits of CBT-I, and it is innovative because it evaluates improvement in insomnia as a mechanism for improvements in alcohol use disorder (AUD). This research is consistent with the National Institute on Alcohol Abuse and Alcoholism's initiative to evaluate and promote interventions that prevent the progression of AUD in diverse populations. It will enhance the stature of the university by improving our ability to compete successfully for federal funding to conduct high-quality research."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-30 years\n* Heavy episodic drinking, defined as 1 heavy drinking episode (4/5+ drinks for women/men) in the past 30 days on the Timeline Followback\n* DSM-5 criteria for insomnia, with "daytime impairment" operationalized as ISI scores =\\>10\n\nExclusion Criteria:\n\n* Unable to provide informed consent\n* New sleep medication in the past 6 weeks\n* Contraindications for CBT-I (mania or seizure disorder)\n* Severe psychiatric disorder that requires clinical attention (PTSD, major depression)\n* Current treatment for insomnia or alcohol use'}, 'identificationModule': {'nctId': 'NCT03627832', 'acronym': 'iTAP', 'briefTitle': 'Insomnia Treatment and Problems (the iTAP Study)', 'organization': {'class': 'OTHER', 'fullName': 'University of Missouri-Columbia'}, 'officialTitle': 'Insomnia Treatment and Problems (the iTAP Study)', 'orgStudyIdInfo': {'id': '2010684'}, 'secondaryIdInfos': [{'id': 'DXV15', 'type': 'OTHER_GRANT', 'domain': 'University of Missouri Research Board'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CBT-I', 'description': 'Individual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week for 6 weeks', 'interventionNames': ['Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)', 'Behavioral: Sleep Hygiene']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sleep Hygiene', 'description': 'Sleep hygiene handout delivered once to all participants', 'interventionNames': ['Behavioral: Sleep Hygiene']}], 'interventions': [{'name': 'Cognitive Behavioral Therapy for Insomnia (CBT-I)', 'type': 'BEHAVIORAL', 'description': 'Participants assigned to the CBT-I condition will attend 1-hour individual sessions of CBT-I once a week for five weeks. Consistent with clinical guidelines (Schutte-Rodin, Broch, Buysse, Dorsey, \\& Sateia, 2008), treatment will include stimulus control (e.g., limit use of bed to sleep or sexual activity, get out of bed if lying awake for more than 20 minutes), sleep restriction (limit time in bed to amount of time spent sleeping on a typical night), sleep hygiene (e.g., avoid exercise within 2 hours of bedtime, create cool and dark sleep environment), relaxation training, and cognitive restructuring.', 'armGroupLabels': ['CBT-I']}, {'name': 'Sleep Hygiene', 'type': 'BEHAVIORAL', 'description': "All participants will receive a one-page handout on sleep hygiene. This is the only intervention that participants assigned to the Sleep Hygiene condition will receive and is consistent with what may be expected as standard care in a doctor's visit with a primary care physician.", 'armGroupLabels': ['CBT-I', 'Sleep Hygiene']}]}, 'contactsLocationsModule': {'locations': [{'zip': '65212', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'University of Missouri-Columbia', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}], 'overallOfficials': [{'name': 'Mary Beth Miller, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Missouri-Columbia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Missouri-Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Psychiatry', 'investigatorFullName': 'Mary E Miller', 'investigatorAffiliation': 'University of Missouri-Columbia'}}}}