Ignite Creation Date:
2025-12-25 @ 1:03 AM
Ignite Modification Date:
2026-01-22 @ 11:31 AM
Study NCT ID:
NCT01992393
Status:
COMPLETED
Last Update Posted:
2022-09-28
First Post:
2013-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Targeted Self-Management for Epilepsy and Serious Mental Illness (TIME)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D011618', 'term': 'Psychotic Disorders'}, {'id': 'D001714', 'term': 'Bipolar Disorder'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013995', 'term': 'Time'}], 'ancestors': [{'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jxy790@case.edu', 'phone': '216-368-0783', 'title': 'Joy Yala, Data & Regulatory Coordinator II', 'organization': 'Case Western Reserve University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Limitations included small sample size \\& a single-site setting which may not be representative of people with E-MI. Those who agree to participate in a clinical trial may be more help-seeking than individuals with E-MI more broadly. We excluded individuals too psychiatrically ill to participate in groups. Additionally, raters were not blind to randomization assignment, we did not collect information on psychotropic medication changes or adherence, \\& epilepsy diagnosis was not verified with EEG.'}}, 'adverseEventsModule': {'timeFrame': 'All adverse events will be reviewed by study Principal Investigators on an ongoing basis during the study period of 4 months.', 'eventGroups': [{'id': 'EG000', 'title': 'TIME', 'description': 'This arm will receive the TIME intervention.\n\nTIME: TIME consists of 12 group sessions in which patients with epilepsy and mental illness will be coached on techniques to help manage their conditions. There will also be four follow-up telephone sessions after the series of group sessions is completed. In addition, approximately half of the participants will participate in qualitative interviews.', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 2, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 12}, {'id': 'EG001', 'title': 'Treatment as Usual (TAU)', 'description': 'This arm will receive treatment as usual.', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Surgeries', 'notes': 'Outpatient surgery for the arm.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Foot issue', 'notes': 'Swollen and painful foot, treated and released.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Seizures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'notes': 'Low blood pressure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Heart condition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood Sugar', 'notes': 'elevated blood sugar', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Irritable Bowel Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Mini Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Limb amputation', 'notes': 'leg amputated due to complications of vascular surgery.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Circulatory Surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Montgomery Asberg Depression Rating Scale (MADRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TIME', 'description': 'This arm will receive the TIME intervention.\n\nTIME: TIME consists of 12 group sessions in which patients with epilepsy and mental illness will be coached on techniques to help manage their conditions. There will also be four follow-up telephone sessions after the series of group sessions is completed. In addition, approximately half of the participants will participate in qualitative interviews.'}, {'id': 'OG001', 'title': 'Treatment as Usual (TAU)', 'description': 'This arm will receive treatment as usual.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '16.75', 'spread': '10.28', 'groupId': 'OG000'}, {'value': '22.94', 'spread': '11.81', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '11.21', 'spread': '9.36', 'groupId': 'OG000'}, {'value': '21.81', 'spread': '10.50', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.036', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'GEE', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 16', 'description': 'The MADRS measures symptoms of depression. Total scores on MADRS range from 0-60, with higher scores indicating more severe depression.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Individuals with epilepsy and comorbid mental illness.'}, {'type': 'SECONDARY', 'title': 'World Health Organization Disability Assessment (WHODAS II)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TIME', 'description': 'This arm will receive the TIME intervention.\n\nTIME: TIME consists of 12 group sessions in which patients with epilepsy and mental illness will be coached on techniques to help manage their conditions. There will also be four follow-up telephone sessions after the series of group sessions is completed. In addition, approximately half of the participants will participate in qualitative interviews.'}, {'id': 'OG001', 'title': 'Treatment as Usual (TAU)', 'description': 'This arm will receive treatment as usual.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '80.86', 'spread': '18.76', 'groupId': 'OG000'}, {'value': '82.83', 'spread': '23.39', 'groupId': 'OG001'}]}]}, {'title': '12 week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '67.68', 'spread': '13.29', 'groupId': 'OG000'}, {'value': '79.87', 'spread': '24.44', 'groupId': 'OG001'}]}]}, {'title': '16 week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '73.39', 'spread': '24.94', 'groupId': 'OG000'}, {'value': '81.50', 'spread': '21.34', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.042', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'A two-sided two sample t-test comparing difference of values from baseline and 12 week between TIME and TAU.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.204', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'A two-sided two sample t-test comparing difference of values from baseline and 16 week between TIME and TAU', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 Week, 16 Week', 'description': 'The World Health Organization Disability Assessment Schedule (WHODAS 2.0) assess functioning and disabilities in activities of daily living, including mobility, self-care, and life activities.\n\nSum Scores from 32-180 with higher scores indicating greater degree of disability.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Individuals with epilepsy and comorbid mental illness with available data.'}, {'type': 'SECONDARY', 'title': 'Quality of Life Questionnaire (QOLIE-10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TIME', 'description': 'This arm will receive the TIME intervention.\n\nTIME: TIME consists of 12 group sessions in which patients with epilepsy and mental illness will be coached on techniques to help manage their conditions. There will also be four follow-up telephone sessions after the series of group sessions is completed. In addition, approximately half of the participants will participate in qualitative interviews.'}, {'id': 'OG001', 'title': 'Treatment as Usual (TAU)', 'description': 'This arm will receive treatment as usual.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.85', 'spread': '0.82', 'groupId': 'OG000'}, {'value': '3.34', 'spread': '0.25', 'groupId': 'OG001'}]}]}, {'title': '12 Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.38', 'spread': '0.60', 'groupId': 'OG000'}, {'value': '3.03', 'spread': '0.79', 'groupId': 'OG001'}]}]}, {'title': '16 Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.56', 'spread': '0.89', 'groupId': 'OG000'}, {'value': '2.84', 'spread': '0.73', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.129', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'A two-sided two sample t-test comparing difference of values from baseline and 12 week between TIME and TAU.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.978', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'A two-sided two sample t-test comparing difference of values from baseline and 16 week between TIME and TAU.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 Week, 16 Week', 'description': 'The QOLIE-10-P is a self-administered questionnaire and comprises 7 components including seizure worry, overall quality of life, emotional well-being, energy-fatigue, cognitive functioning, medication effect, and social function. The sum score is used in the analysis. Scores from 1-5 with lower scores indicating the least amount of problems', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Individuals with epilepsy and comorbid mental illness with available data.'}, {'type': 'SECONDARY', 'title': 'Patient Health Questionnaire (PHQ-9)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TIME', 'description': 'This arm will receive the TIME intervention.\n\nTIME: TIME consists of 12 group sessions in which patients with epilepsy and mental illness will be coached on techniques to help manage their conditions. There will also be four follow-up telephone sessions after the series of group sessions is completed. In addition, approximately half of the participants will participate in qualitative interviews.'}, {'id': 'OG001', 'title': 'Treatment as Usual (TAU)', 'description': 'This arm will receive treatment as usual.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.70', 'spread': '5.55', 'groupId': 'OG000'}, {'value': '11.76', 'spread': '5.72', 'groupId': 'OG001'}]}]}, {'title': '12 Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.24', 'spread': '4.97', 'groupId': 'OG000'}, {'value': '13.19', 'spread': '5.67', 'groupId': 'OG001'}]}]}, {'title': '16 Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.38', 'spread': '4.44', 'groupId': 'OG000'}, {'value': '12.87', 'spread': '6.63', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.128', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'A two-sided two sample t-test comparing difference of values from baseline and 12 week between TIME and TAU.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.015', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'A two-sided two sample t-test comparing difference of values from baseline and 16 week between TIME and TAU.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 Week, 16 Week', 'description': 'Scores from 0-27 with higher scores indicating more severe depressive symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Individuals with epilepsy and comorbid mental illness with available data.'}, {'type': 'SECONDARY', 'title': 'Pittsburgh Sleep Quality Index (PSQI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TIME', 'description': 'This arm will receive the TIME intervention.\n\nTIME: TIME consists of 12 group sessions in which patients with epilepsy and mental illness will be coached on techniques to help manage their conditions. There will also be four follow-up telephone sessions after the series of group sessions is completed. In addition, approximately half of the participants will participate in qualitative interviews.'}, {'id': 'OG001', 'title': 'Treatment as Usual (TAU)', 'description': 'This arm will receive treatment as usual.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.55', 'spread': '4.49', 'groupId': 'OG000'}, {'value': '12.95', 'spread': '4.38', 'groupId': 'OG001'}]}]}, {'title': '12 Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.88', 'spread': '3.30', 'groupId': 'OG000'}, {'value': '12.21', 'spread': '2.64', 'groupId': 'OG001'}]}]}, {'title': '16 Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.85', 'spread': '3.80', 'groupId': 'OG000'}, {'value': '11.45', 'spread': '3.27', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.759', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'A two-sided two sample t-test comparing difference of values from baseline and 12 week between TIME and TAU.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.471', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'A two-sided two sample t-test comparing difference of values from baseline and 16 week between TIME and TAU.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 Week, 16 Week', 'description': 'The PSQI contains 19 self-rated questions that are combined to form seven "component" scores each with a range of 0-3 points. In all cases, a score of "0" indicates no difficulty, while a score of "3" indicates severe difficulty. The seven component scores are then added to yield one "global" score, with a range of 0-21, "0" indicating no difficulty and "21" indicating severe difficulties in all areas (with higher scores indicating worse sleep quality).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Individuals with epilepsy and comorbid mental illness with available data.'}, {'type': 'SECONDARY', 'title': 'Brief Psychiatric Rating Scale (BPRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TIME', 'description': 'This arm will receive the TIME intervention.\n\nTIME: TIME consists of 12 group sessions in which patients with epilepsy and mental illness will be coached on techniques to help manage their conditions. There will also be four follow-up telephone sessions after the series of group sessions is completed. In addition, approximately half of the participants will participate in qualitative interviews.'}, {'id': 'OG001', 'title': 'Treatment as Usual (TAU)', 'description': 'This arm will receive treatment as usual.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36.90', 'spread': '11.78', 'groupId': 'OG000'}, {'value': '37.85', 'spread': '10.39', 'groupId': 'OG001'}]}]}, {'title': '12 Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.89', 'spread': '9.67', 'groupId': 'OG000'}, {'value': '35.81', 'spread': '11.24', 'groupId': 'OG001'}]}]}, {'title': '16 Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.59', 'spread': '11.36', 'groupId': 'OG000'}, {'value': '35.73', 'spread': '9.63', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.775', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'A two-sided two sample t-test comparing difference of values from baseline and 12 week between TIME and TAU.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.433', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'A two-sided two sample t-test comparing difference of values from baseline and 16 week between TIME and TAU.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 Week, 16 Week', 'description': 'The BPRS is a tool clinicians or researchers use to measure psychiatric symptoms such as anxiety, depression, and psychoses. The BPRS assesses the level of 18 symptom constructs such as hostility, suspiciousness, hallucination, and grandiosity. It is particularly useful in gauging the efficacy of treatment in patients who have moderate to severe psychoses. The total Score is the sum of all 18-items. Score ranges from 18-126 with higher scores indicating more psychiatric symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Individuals with epilepsy and comorbid mental illness with available data.'}, {'type': 'SECONDARY', 'title': 'Global Assessment of Functioning (GAF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TIME', 'description': 'This arm will receive the TIME intervention.\n\nTIME: TIME consists of 12 group sessions in which patients with epilepsy and mental illness will be coached on techniques to help manage their conditions. There will also be four follow-up telephone sessions after the series of group sessions is completed. In addition, approximately half of the participants will participate in qualitative interviews.'}, {'id': 'OG001', 'title': 'Treatment as Usual (TAU)', 'description': 'This arm will receive treatment as usual.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '59.23', 'spread': '17.06', 'groupId': 'OG000'}, {'value': '54.57', 'spread': '13.66', 'groupId': 'OG001'}]}]}, {'title': '12 Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '62.83', 'spread': '15.98', 'groupId': 'OG000'}, {'value': '59.00', 'spread': '16.78', 'groupId': 'OG001'}]}]}, {'title': '16 Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '69.50', 'spread': '18.27', 'groupId': 'OG000'}, {'value': '59.94', 'spread': '18.38', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.936', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'A two-sided two sample t-test comparing difference of values from baseline and 12 week between TIME and TAU.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.600', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'A two-sided two sample t-test comparing difference of values from baseline and 16 week between TIME and TAU.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 Week, 16 Week', 'description': 'The GAF assesses psychological, social and occupational functioning on a hypothetical continuum of mental health illness. Scores range from 0-100 with higher scores indicating higher global functioning.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Individuals with epilepsy and comorbid mental illness with available data.'}, {'type': 'SECONDARY', 'title': 'Seizure Frequency - Past 30 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TIME', 'description': 'This arm will receive the TIME intervention.\n\nTIME: TIME consists of 12 group sessions in which patients with epilepsy and mental illness will be coached on techniques to help manage their conditions. There will also be four follow-up telephone sessions after the series of group sessions is completed. In addition, approximately half of the participants will participate in qualitative interviews.'}, {'id': 'OG001', 'title': 'Treatment as Usual (TAU)', 'description': 'This arm will receive treatment as usual.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.67', 'spread': '14.08', 'groupId': 'OG000'}, {'value': '8.79', 'spread': '32.01', 'groupId': 'OG001'}]}]}, {'title': '12 Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.50', 'spread': '2.68', 'groupId': 'OG000'}, {'value': '18.40', 'spread': '42.36', 'groupId': 'OG001'}]}]}, {'title': '16 Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.00', 'spread': '1.97', 'groupId': 'OG000'}, {'value': '6.44', 'spread': '15.21', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.560', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'A two-sided two sample t-test comparing difference of values from baseline and 12 week between TIME and TAU.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.305', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'A two-sided two sample t-test comparing difference of values from baseline and 12 week between TIME and TAU.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 Week, 16 Week', 'description': 'Self reported seizure frequency in the past 30 days', 'unitOfMeasure': 'number of seizures', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Individuals with epilepsy and comorbid mental illness with available data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'TIME', 'description': 'This arm will receive the TIME intervention.\n\nTIME: TIME consists of 12 group sessions in which patients with epilepsy and mental illness will be coached on techniques to help manage their conditions. There will also be four follow-up telephone sessions after the series of group sessions is completed. In addition, approximately half of the participants will participate in qualitative interviews.'}, {'id': 'FG001', 'title': 'Treatment as Usual (TAU)', 'description': 'This arm will receive treatment as usual.'}], 'periods': [{'title': 'Baseline', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Week 12 (3 Months)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}, {'title': 'Week 16 (4 Months)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'We used the electronic medical record from a large citywide healthcare system to preliminarily identify people with an epilepsy diagnosis and invited them to participate in the RCT.', 'preAssignmentDetails': '14 participants were excluded at Screening because they did not meet the inclusion criteria: 4 No SMI, 2 No epilepsy, 3 No show (unwilling to participate), 3 withdrew from study, 1 Single episode SMI,1 Pregnancy'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'TIME', 'description': 'This arm will receive the TIME intervention.\n\nTIME: TIME consists of 12 group sessions in which patients with epilepsy and mental illness will be coached on techniques to help manage their conditions. There will also be four follow-up telephone sessions after the series of group sessions is completed. In addition, approximately half of the participants will participate in qualitative interviews.'}, {'id': 'BG001', 'title': 'Treatment as Usual (TAU)', 'description': 'This arm will receive treatment as usual.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.00', 'spread': '7.58', 'groupId': 'BG000'}, {'value': '45.10', 'spread': '14.18', 'groupId': 'BG001'}, {'value': '48.25', 'spread': '11.82', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '41', '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': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White/Caucasian', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': 'Black/ African American', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Education Level', 'classes': [{'title': 'Less than a high school education', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'High school graduate, GED, or higher', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Employment Status', 'classes': [{'categories': [{'title': 'Unemployed', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Unable to work', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Data Missing', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Marital Status', 'classes': [{'title': 'Married', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Living Situation', 'classes': [{'title': 'Lives alone', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}, {'title': 'Only adult in household', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Lives with other adults', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': 'Homeless', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Income Level', 'classes': [{'title': 'Less than $25,000', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}, {'title': '$25,000-$50,000', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'More than $50,000', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Seizure Type', 'classes': [{'title': 'Generalized', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}, {'title': 'Partial', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'Unclassified', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': "Don't know/Not sure", 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'seizures'}, {'title': 'Mental Health Diagnosis', 'classes': [{'title': 'Depression', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'Bipolar Disorder', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': 'Schizophrenia', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Duration of Mental Health Disorder (in years)', 'classes': [{'categories': [{'measurements': [{'value': '30.27', 'spread': '17.35', 'groupId': 'BG000'}, {'value': '22.85', 'spread': '12.33', 'groupId': 'BG001'}, {'value': '26.14', 'spread': '15.76', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Duration of Epilepsy (in years)', 'classes': [{'categories': [{'measurements': [{'value': '27.55', 'spread': '16.48', 'groupId': 'BG000'}, {'value': '25.43', 'spread': '15.47', 'groupId': 'BG001'}, {'value': '26.27', 'spread': '15.74', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Charlson Comorbidity Index (CCI)', 'classes': [{'categories': [{'measurements': [{'value': '3.14', 'spread': '2.47', 'groupId': 'BG000'}, {'value': '1.86', 'spread': '2.29', 'groupId': 'BG001'}, {'value': '2.45', 'spread': '2.44', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Self-reported Charlson Comorbidity Index (CCI) is comprised of the presence of 10 medical conditions including respiratory diseases, rheumatological diseases, cancer, diabetes, digestive problems, heart trouble, HIV/ AIDS, kidney disease, liver disease, \\& stroke. Total Score is the sum of all 10-items, each item checked gets 1 point, except heart disease \\& kidney disease which get 2 points each, liver disease gets 3 points, and cancer \\& HIV/AIDS which get 6 points each. The CCI summary score range from 0-24. A higher score is associated with increased risk of mortality.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Rapid Estimate of Adult Literacy in Medicine-Revised (REALM-R)', 'classes': [{'categories': [{'measurements': [{'value': '5.18', 'spread': '2.77', 'groupId': 'BG000'}, {'value': '6.29', 'spread': '2.57', 'groupId': 'BG001'}, {'value': '5.77', 'spread': '2.69', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Rapid Estimate of Adult Literacy in Medicine-Revised (REALM-R) is an 11 item measure that identifies patients that are at high risk for having limited health literacy and identifies the grade level of the patient if they read below the ninth grade level.\n\nEach correctly pronounced word gets 1 point. The REALM-R Total Score is the sum of correct word pronunciations. With a total score ranging from 0 to 11. A score of 6 or less indicates risk for poor health literacy.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Individuals with epilepsy and comorbid mental illness.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-12', 'studyFirstSubmitDate': '2013-11-14', 'resultsFirstSubmitDate': '2021-12-17', 'studyFirstSubmitQcDate': '2013-11-19', 'lastUpdatePostDateStruct': {'date': '2022-09-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-09-12', 'studyFirstPostDateStruct': {'date': '2013-11-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Montgomery Asberg Depression Rating Scale (MADRS)', 'timeFrame': 'Baseline to Week 16', 'description': 'The MADRS measures symptoms of depression. Total scores on MADRS range from 0-60, with higher scores indicating more severe depression.'}], 'secondaryOutcomes': [{'measure': 'World Health Organization Disability Assessment (WHODAS II)', 'timeFrame': 'Baseline, 12 Week, 16 Week', 'description': 'The World Health Organization Disability Assessment Schedule (WHODAS 2.0) assess functioning and disabilities in activities of daily living, including mobility, self-care, and life activities.\n\nSum Scores from 32-180 with higher scores indicating greater degree of disability.'}, {'measure': 'Quality of Life Questionnaire (QOLIE-10)', 'timeFrame': 'Baseline, 12 Week, 16 Week', 'description': 'The QOLIE-10-P is a self-administered questionnaire and comprises 7 components including seizure worry, overall quality of life, emotional well-being, energy-fatigue, cognitive functioning, medication effect, and social function. The sum score is used in the analysis. Scores from 1-5 with lower scores indicating the least amount of problems'}, {'measure': 'Patient Health Questionnaire (PHQ-9)', 'timeFrame': 'Baseline, 12 Week, 16 Week', 'description': 'Scores from 0-27 with higher scores indicating more severe depressive symptoms.'}, {'measure': 'Pittsburgh Sleep Quality Index (PSQI)', 'timeFrame': 'Baseline, 12 Week, 16 Week', 'description': 'The PSQI contains 19 self-rated questions that are combined to form seven "component" scores each with a range of 0-3 points. In all cases, a score of "0" indicates no difficulty, while a score of "3" indicates severe difficulty. The seven component scores are then added to yield one "global" score, with a range of 0-21, "0" indicating no difficulty and "21" indicating severe difficulties in all areas (with higher scores indicating worse sleep quality).'}, {'measure': 'Brief Psychiatric Rating Scale (BPRS)', 'timeFrame': 'Baseline, 12 Week, 16 Week', 'description': 'The BPRS is a tool clinicians or researchers use to measure psychiatric symptoms such as anxiety, depression, and psychoses. The BPRS assesses the level of 18 symptom constructs such as hostility, suspiciousness, hallucination, and grandiosity. It is particularly useful in gauging the efficacy of treatment in patients who have moderate to severe psychoses. The total Score is the sum of all 18-items. Score ranges from 18-126 with higher scores indicating more psychiatric symptoms.'}, {'measure': 'Global Assessment of Functioning (GAF)', 'timeFrame': 'Baseline, 12 Week, 16 Week', 'description': 'The GAF assesses psychological, social and occupational functioning on a hypothetical continuum of mental health illness. Scores range from 0-100 with higher scores indicating higher global functioning.'}, {'measure': 'Seizure Frequency - Past 30 Days', 'timeFrame': 'Baseline, 12 Week, 16 Week', 'description': 'Self reported seizure frequency in the past 30 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Epilepsy', 'Schizophrenia', 'Schizoaffective Disorder', 'Bipolar Disorder', 'Depression', 'Intervention', 'Treatment', 'Adherence'], 'conditions': ['Epilepsy', 'Schizophrenia', 'Schizoaffective Disorder', 'Bipolar Disorder', 'Depression']}, 'descriptionModule': {'briefSummary': 'For this project we propose to refine the psychosocial intervention developed in phase one, based on input from key stakeholders, and to test the feasibility, acceptability and preliminary efficacy of the intervention. The proposed project addresses unmet public health needs for a historically hard-to-reach group of individuals with epilepsy and comorbid serious mental illnesses, and as the intervention is an adjunct to care that individuals with serious mental illness are already receiving, and uses staff already likely to be present in a care system, it is ideally suited for "real-world" implementation in people with epilepsy and serious mental illness (E-SMI).\n\nThe purpose of this study is to try and engage individuals with E-SMI to actively participate in illness self-management and treatment adherence that are crucial in minimizing the morbidity and mortality associated with both chronic mental disorders and chronic neurological conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able to provide written consent\n* Able to speak and understand English\n* Age 18 and older\n* Diagnosed with epilepsy\n* Diagnosed with serious mental illness (DSM IV diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder or chronic/recurrent depression confirmed with the Mini-International Neuropsychiatric Interview (MINI))\n* Receive care at a community mental health center or other publicly funded community healthcare entity\n\nExclusion Criteria:\n\n* Actively suicidal/homicidal individuals\n* Individuals with dementia\n* Unable to be rated on study rating scales\n* Pregnant women'}, 'identificationModule': {'nctId': 'NCT01992393', 'briefTitle': 'Targeted Self-Management for Epilepsy and Serious Mental Illness (TIME)', 'organization': {'class': 'OTHER', 'fullName': 'Case Western Reserve University'}, 'officialTitle': 'Targeted Self-Management for Epilepsy and Serious Mental Illness', 'orgStudyIdInfo': {'id': '11-12-17'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TIME', 'description': 'This arm will receive the TIME intervention.', 'interventionNames': ['Behavioral: TIME']}, {'type': 'NO_INTERVENTION', 'label': 'Treatment as Usual (TAU)', 'description': 'This arm will receive treatment as usual.'}], 'interventions': [{'name': 'TIME', 'type': 'BEHAVIORAL', 'description': 'TIME consists of 12 group sessions in which patients with epilepsy and mental illness will be coached on techniques to help manage their conditions. There will also be four follow-up telephone sessions after the series of group sessions is completed. In addition, approximately half of the participants will participate in qualitative interviews.', 'armGroupLabels': ['TIME']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals Case Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Martha Sajatovic, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Case Western Reserve University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Case Western Reserve University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centers for Disease Control and Prevention', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Psychiatry', 'investigatorFullName': 'Martha Sajatovic, MD', 'investigatorAffiliation': 'Case Western Reserve University'}}}}