Ignite Creation Date:
2025-12-26 @ 4:02 PM
Ignite Modification Date:
2025-12-31 @ 11:28 PM
Study NCT ID:
NCT01892306
Status:
COMPLETED
Last Update Posted:
2017-05-12
First Post:
2013-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pilot Study of Cognitive Behavioral Therapy for Anxiety and Bipolar I Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001714', 'term': 'Bipolar Disorder'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kellard@partners.org', 'phone': '617-726-6422', 'title': 'Kristen Ellard, PhD', 'organization': 'Massachusetts General Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Treatment as Usual Plus UP CBT', 'description': 'Existing psychiatrist-administered psychopharmacotherapy plus weekly transdiagnostic CBT\n\nUP CBT: The UP is an 18-session weekly cognitive behavioral intervention for anxiety and mood disorders', 'otherNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Treatment as Usual', 'description': 'Existing psychiatrist-administered psychopharmacotherapy\n\nTreatment as usual: Existing optimized pharmacotherapy as delivered by treating psychiatrist', 'otherNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'Hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Reductions Over Time in Anxiety Symptoms as Measured by Hamilton Anxiety Rating Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment as Usual Plus UP CBT', 'description': 'Existing psychiatrist-administered psychopharmacotherapy plus weekly transdiagnostic CBT\n\nUP CBT: The UP is an 18-session weekly cognitive behavioral intervention for anxiety and mood disorders'}, {'id': 'OG001', 'title': 'Treatment as Usual', 'description': 'Existing psychiatrist-administered psychopharmacotherapy\n\nTreatment as usual: Existing optimized pharmacotherapy as delivered by treating psychiatrist'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '14', 'spread': '7.8', 'groupId': 'OG000'}, {'value': '18.81', 'spread': '6.10', 'groupId': 'OG001'}]}]}, {'title': 'Month 2', 'categories': [{'measurements': [{'value': '11.78', 'spread': '8.99', 'groupId': 'OG000'}, {'value': '17.70', 'spread': '7.62', 'groupId': 'OG001'}]}]}, {'title': 'Month 3', 'categories': [{'measurements': [{'value': '13.86', 'spread': '9.30', 'groupId': 'OG000'}, {'value': '22.33', 'spread': '7.68', 'groupId': 'OG001'}]}]}, {'title': 'Month 4', 'categories': [{'measurements': [{'value': '13.5', 'spread': '7.03', 'groupId': 'OG000'}, {'value': '18', 'spread': '8.87', 'groupId': 'OG001'}]}]}, {'title': 'Month 5', 'categories': [{'measurements': [{'value': '10', 'spread': '5.55', 'groupId': 'OG000'}, {'value': '19.1', 'spread': '8.29', 'groupId': 'OG001'}]}]}, {'title': 'Month 6', 'categories': [{'measurements': [{'value': '15.71', 'spread': '10.29', 'groupId': 'OG000'}, {'value': '18.89', 'spread': '10.82', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.02', 'groupIds': ['OG000'], 'groupDescription': 'Scores on the HAM-A were analyzed using a mixed-effects linear regression analysis over 6 timepoints.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Six months', 'description': 'The Hamilton Anxiety Rating Scale (HAM-A) is a well-validated clinician administered rating of anxiety-related symptoms. Ratings are made on a 0 (no symptoms) to 4 (most severe in frequency/duration/interference/distress) for each item (14 items), with a minimum score of 0 and a maximum score of 56 calculated by summing scores of all 14 items. Higher scores indicate greater impairment.', 'unitOfMeasure': 'Units on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis, data imputed to account for 30% missing data. A total of 28 people were included in the ITT analysis - one TAU participant initiated CBT through a private practitioner mid-study (an exclusion criteria) and was subsequently excluded from the analysis.'}, {'type': 'PRIMARY', 'title': 'Reductions Over Time in Depression Symptoms as Measured by Hamilton Depression Rating Scale (HAM-D)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment as Usual Plus UP CBT', 'description': 'Existing psychiatrist-administered psychopharmacotherapy plus weekly transdiagnostic CBT\n\nUP CBT: The UP is an 18-session weekly cognitive behavioral intervention for anxiety and mood disorders'}, {'id': 'OG001', 'title': 'Treatment as Usual', 'description': 'Existing psychiatrist-administered psychopharmacotherapy\n\nTreatment as usual: Existing optimized pharmacotherapy as delivered by treating psychiatrist'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '10.54', 'spread': '6.96', 'groupId': 'OG000'}, {'value': '13.63', 'spread': '4.87', 'groupId': 'OG001'}]}]}, {'title': 'Month 2', 'categories': [{'measurements': [{'value': '8', 'spread': '7.94', 'groupId': 'OG000'}, {'value': '11.2', 'spread': '6.60', 'groupId': 'OG001'}]}]}, {'title': 'Month 3', 'categories': [{'measurements': [{'value': '11.86', 'spread': '6.12', 'groupId': 'OG000'}, {'value': '16.89', 'spread': '6.13', 'groupId': 'OG001'}]}]}, {'title': 'Month 4', 'categories': [{'measurements': [{'value': '11.63', 'spread': '6.63', 'groupId': 'OG000'}, {'value': '11.9', 'spread': '5.13', 'groupId': 'OG001'}]}]}, {'title': 'Month 5', 'categories': [{'measurements': [{'value': '9', 'spread': '6.36', 'groupId': 'OG000'}, {'value': '16', 'spread': '5.70', 'groupId': 'OG001'}]}]}, {'title': 'Month 6', 'categories': [{'measurements': [{'value': '10.14', 'spread': '7.69', 'groupId': 'OG000'}, {'value': '12.89', 'spread': '7.42', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Scores on the HAM-D were analyzed using a mixed-effects linear regression analysis over 6 timepoints.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Six months', 'description': 'The Hamilton Depression Rating Scale (HAM-D) is a well-validated clinician administered rating of depression-related symptoms. Scores are calculated by summing scores across all 17-items, with a minimum score of 0 and a maximum score of 54. Higher scores indicate greater impairment.', 'unitOfMeasure': 'Units on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis, data imputed to account for 30% missing data. A total of 28 people were included in the ITT analysis - one TAU participant initiated CBT through a private practitioner mid-study (an exclusion criteria) and was subsequently excluded from the analysis.'}, {'type': 'SECONDARY', 'title': 'Treatment Acceptability as Measured by Client Satisfaction Questionnaire (CSQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment as Usual Plus UP CBT', 'description': 'Existing psychiatrist-administered psychopharmacotherapy plus weekly transdiagnostic CBT\n\nUP CBT: The UP is an 18-session weekly cognitive behavioral intervention for anxiety and mood disorders'}, {'id': 'OG001', 'title': 'Treatment as Usual', 'description': 'Existing psychiatrist-administered psychopharmacotherapy\n\nTreatment as usual: Existing optimized pharmacotherapy as delivered by treating psychiatrist'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '28.5', 'spread': '3.79', 'groupId': 'OG000'}, {'value': '27.25', 'spread': '3.82', 'groupId': 'OG001'}]}]}, {'title': 'Month 2', 'categories': [{'measurements': [{'value': '29.43', 'spread': '2.64', 'groupId': 'OG000'}, {'value': '26.64', 'spread': '4.40', 'groupId': 'OG001'}]}]}, {'title': 'Month 3', 'categories': [{'measurements': [{'value': '29.63', 'spread': '3.35', 'groupId': 'OG000'}, {'value': '26.22', 'spread': '2.28', 'groupId': 'OG001'}]}]}, {'title': 'Month 4', 'categories': [{'measurements': [{'value': '28', 'spread': '4.08', 'groupId': 'OG000'}, {'value': '26.9', 'spread': '4.28', 'groupId': 'OG001'}]}]}, {'title': 'Month 5', 'categories': [{'measurements': [{'value': '29.43', 'spread': '3.46', 'groupId': 'OG000'}, {'value': '26.6', 'spread': '4.40', 'groupId': 'OG001'}]}]}, {'title': 'Month 6', 'categories': [{'measurements': [{'value': '29.75', 'spread': '3.41', 'groupId': 'OG000'}, {'value': '26.88', 'spread': '4.02', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.24', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Scores on the CSQ were analyzed using a mixed-effects linear regression analysis over 6 timepoints.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Six months', 'description': 'The Client Satisfaction Questionnaire (CSQ) is an 8-item scale that assesses perceptions of acceptability and quality of outpatient treatment. Ratings are made on a 1 (poor) to 4 (excellent) scale for each item and then summed for a total score, with a minimum score of 8 and a maximum score of 32. Higher scores indicate greater satisfaction with treatment.', 'unitOfMeasure': 'Units on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis, data imputed to account for 30% missing data. A total of 28 people were included in the ITT analysis - one TAU participant initiated CBT through a private practitioner mid-study (an exclusion criteria) and was subsequently excluded from the analysis.'}, {'type': 'SECONDARY', 'title': 'Association Between Anxiety Symptom Change (HAM-A) and Difficulties in Emotion Regulation Scale (DERS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment as Usual Plus UP CBT', 'description': 'Existing psychiatrist-administered psychopharmacotherapy plus weekly transdiagnostic CBT\n\nUP CBT: The UP is an 18-session weekly cognitive behavioral intervention for anxiety and mood disorders'}, {'id': 'OG001', 'title': 'Treatment as Usual', 'description': 'Existing psychiatrist-administered psychopharmacotherapy\n\nTreatment as usual: Existing optimized pharmacotherapy as delivered by treating psychiatrist'}], 'classes': [{'categories': [{'measurements': [{'value': '.759', 'spread': '.784', 'groupId': 'OG000'}, {'value': '.180', 'spread': '1.754', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.62', 'groupIds': ['OG001'], 'groupDescription': 'Linear regression - Dependent variable: HAM-A symptom change; Independent variable: Baseline DERS scores.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER'}, {'pValue': '.03', 'groupIds': ['OG000'], 'groupDescription': 'Linear Regression - Dependent variable: HAM-A symptom change; Independent variable: Baseline DERS scores', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Six Months', 'description': 'Emotion regulation skills were assessed using a measure of emotion regulation (Difficulties in Emotion Regulation Scale- DERS), a 36-item Likert-type scale (1-6) calculated by averaging scores across all items. See Baseline Characteristics for baseline DERS score. See Primary Outcome Measure for a description of HAM-A.', 'unitOfMeasure': 'beta coefficients', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis, data imputed to account for 30% missing data. A total of 28 people were included in the ITT analysis - one TAU participant initiated CBT through a private practitioner mid-study (an exclusion criteria) and was subsequently excluded from the analysis.'}, {'type': 'SECONDARY', 'title': 'Association Between Anxiety Symptom Change (HAM-A) and Reaction to Emotions (Affective Control Scale-ACS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment as Usual Plus UP CBT', 'description': 'Existing psychiatrist-administered psychopharmacotherapy plus weekly transdiagnostic CBT\n\nUP CBT: The UP is an 18-session weekly cognitive behavioral intervention for anxiety and mood disorders'}, {'id': 'OG001', 'title': 'Treatment as Usual', 'description': 'Existing psychiatrist-administered psychopharmacotherapy\n\nTreatment as usual: Existing optimized pharmacotherapy as delivered by treating psychiatrist'}], 'classes': [{'categories': [{'measurements': [{'value': '.766', 'spread': '.774', 'groupId': 'OG000'}, {'value': '.022', 'spread': '1.782', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.95', 'groupIds': ['OG001'], 'groupDescription': 'Linear regression - Dependent variable: HAM-A symptom change; Independent variable: Baseline ACS scores.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.03', 'groupIds': ['OG000'], 'groupDescription': 'Linear Regression - Dependent variable: HAM-A symptom change; Independent variable: Baseline ACS scores.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Reactions to emotions, were assessed using the Affective Control Scale, or ACS, a 42-item Likert-type scale (1-7) calculated by averaging scores across all items. See Baseline Characteristics for baseline ACS score. See Primary Outcome Measure for description of HAM-A.', 'unitOfMeasure': 'beta coefficients', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis, data imputed to account for 30% missing data. A total of 28 people were included in the ITT analysis - one TAU participant initiated CBT through a private practitioner mid-study (an exclusion criteria) and was subsequently excluded from the analysis.'}, {'type': 'SECONDARY', 'title': 'Association Between Anxiety Symptom Change (HAM-A) and Anxiety Sensitivity (Anxiety Sensitivity Index-ASI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment as Usual Plus UP CBT', 'description': 'Existing psychiatrist-administered psychopharmacotherapy plus weekly transdiagnostic CBT\n\nUP CBT: The UP is an 18-session weekly cognitive behavioral intervention for anxiety and mood disorders'}, {'id': 'OG001', 'title': 'Treatment as Usual', 'description': 'Existing psychiatrist-administered psychopharmacotherapy\n\nTreatment as usual: Existing optimized pharmacotherapy as delivered by treating psychiatrist'}], 'classes': [{'categories': [{'measurements': [{'value': '0.371', 'spread': '1.118', 'groupId': 'OG000'}, {'value': '0.062', 'spread': '1.779', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.87', 'groupIds': ['OG001'], 'groupDescription': 'Linear Regression - Dependent variable: HAM-A symptom change; Independent variable: Baseline ASI scores', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.37', 'groupIds': ['OG000'], 'groupDescription': 'Linear Regression - Dependent variable: HAM-A symptom change; Independent variable: Baseline ASI scores', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Anxiety sensitivity, were assessed using the Anxiety Sensitivity Index, or ASI, a 16-item Likert-type scale (0-4) calculated by summing scores across items. See Baseline Characteristics for baseline ASI scores. See Primary Outcome Measures for a description of HAM-A.', 'unitOfMeasure': 'beta coefficients', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis, data imputed to account for 30% missing data. A total of 28 people were included in the ITT analysis - one TAU participant initiated CBT through a private practitioner mid-study (an exclusion criteria) and was subsequently excluded from the analysis.'}, {'type': 'SECONDARY', 'title': 'Association Between Anxiety Symptom Change (HAM-A) and Neuroticism (NEO Five-Factor Inventory- NEO-FFI-N)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment as Usual Plus UP CBT', 'description': 'Existing psychiatrist-administered psychopharmacotherapy plus weekly transdiagnostic CBT\n\nUP CBT: The UP is an 18-session weekly cognitive behavioral intervention for anxiety and mood disorders'}, {'id': 'OG001', 'title': 'Treatment as Usual', 'description': 'Existing psychiatrist-administered psychopharmacotherapy\n\nTreatment as usual: Existing optimized pharmacotherapy as delivered by treating psychiatrist'}], 'classes': [{'categories': [{'measurements': [{'value': '0.720', 'spread': '0.836', 'groupId': 'OG000'}, {'value': '0.471', 'spread': '1.572', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.17', 'groupIds': ['OG001'], 'groupDescription': 'Linear Regression - Dependent variable: HAM-A symptom change; Independent variable: Baseline NEO- Neuroticism scores.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER'}, {'pValue': '.04', 'groupIds': ['OG000'], 'groupDescription': 'Linear Regression - Dependent variable: HAM-A symptom change; Independent variable: Baseline NEO-Neuroticism scores', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Neuroticism was assessed using the NEO Five Factor Inventory (NEO-FFI-N) which is a subscale of the NEO-FFI, a 60-item Likert-type scale (1-5) calculated by summing scores for each subscale. Only the 15-item Neuroticism subscale is included in this study. See Baseline Characteristics for baseline NEO-FFI-N. See Primary Outcome Measure for description of HAM-A.', 'unitOfMeasure': 'beta coefficients', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis, data imputed to account for 30% missing data. A total of 28 people were included in the ITT analysis - one TAU participant initiated CBT through a private practitioner mid-study (an exclusion criteria) and was subsequently excluded from the analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Association Between Change on Depression (HAM-D) and Baseline Resting State Functional Connectivity of Anterior Insula and Ventrolateral Prefrontal Cortex', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment as Usual Plus UP CBT', 'description': 'Existing psychiatrist-administered psychopharmacotherapy plus weekly transdiagnostic CBT\n\nUP CBT: The UP is an 18-session weekly cognitive behavioral intervention for anxiety and mood disorders'}, {'id': 'OG001', 'title': 'Treatment as Usual', 'description': 'Existing psychiatrist-administered psychopharmacotherapy\n\nTreatment as usual: Existing optimized pharmacotherapy as delivered by treating psychiatrist'}], 'classes': [{'categories': [{'measurements': [{'value': '-.89', 'spread': '.257', 'groupId': 'OG000'}, {'value': '.57', 'spread': '.841', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.007', 'groupIds': ['OG000'], 'groupDescription': "Fisher's z-transformed values for functional connectivity between anterior insula and ventrolateral prefrontal cortex were entered in separate treatment group-specific linear regression models as the independent variable with change in primary outcomes (HAM-D) as dependent variable.", 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER'}, {'pValue': '.14', 'groupIds': ['OG001'], 'groupDescription': "Fisher's z-transformed values for functional connectivity between anterior insula and ventrolateral prefrontal cortex were entered in separate treatment group-specific linear regression models as the independent variable with change in primary outcomes (HAM-D) as dependent variable.", 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Six Months', 'description': 'Resting state functional magnetic resonance imaging (rsfMRI) data (non-task, eyes opened) was acquired to investigate anterior insula and ventrolateral prefrontal cortex functional connectivity as a predictor of change on depression (HAM-D). See primary outcome description of HAM-D.', 'unitOfMeasure': 'beta coefficient', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participating in the fMRI portion of the study was optional. A total of 15 participants consented to participate in fMRI portion (7 TAU+UP, 8 TAU). Data from all 15 subjects were analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment as Usual Plus UP CBT', 'description': 'Existing psychiatrist-administered psychopharmacotherapy plus weekly transdiagnostic CBT\n\nUP CBT: The UP is an 18-session weekly cognitive behavioral intervention for anxiety and mood disorders'}, {'id': 'FG001', 'title': 'Treatment as Usual', 'description': 'Existing psychiatrist-administered psychopharmacotherapy\n\nTreatment as usual: Existing optimized pharmacotherapy as delivered by treating psychiatrist'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}], 'recruitmentDetails': '37 were invited to consent. 34 consented to be screened for inclusion. 5 did not meet study inclusion criteria thus were not randomized (1 not on a stabilized medication; 1 did not meet criteria for anxiety disorder; 2 were currently substance dependent; 1 reported psychosis). 29 were randomized to TAU or TAU plus 18 sessions of CBT (UP+TAU).', 'preAssignmentDetails': 'Participants were excluded from the trial before assignment to study arms based on exclusion criteria related to diagnosis and unstable medication regime.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment as Usual Plus UP CBT', 'description': 'Existing psychiatrist-administered psychopharmacotherapy plus weekly transdiagnostic CBT\n\nUP CBT: The UP is an 18-session weekly cognitive behavioral intervention for anxiety and mood disorders'}, {'id': 'BG001', 'title': 'Treatment as Usual', 'description': 'Existing psychiatrist-administered psychopharmacotherapy\n\nTreatment as usual: Existing optimized pharmacotherapy as delivered by treating psychiatrist'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.08', 'spread': '13.84', 'groupId': 'BG000'}, {'value': '44.25', 'spread': '14.27', 'groupId': 'BG001'}, {'value': '43.72', 'spread': '13.84', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '24', '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': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Difficulties in Emotion Regulation Scale (DERS)', 'classes': [{'categories': [{'measurements': [{'value': '2.84', 'spread': '0.53', 'groupId': 'BG000'}, {'value': '3.00', 'spread': '0.56', 'groupId': 'BG001'}, {'value': '2.92', 'spread': '0.54', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Emotion regulation skills were assessed at baseline using a self-report questionnaire measure of emotion regulation (Difficulties in Emotion Regulation Scale- DERS), a 36-item Likert-type scale (1-6) calculated by averaging scores across all items (minimum score 1, maximum score 6). Higher scores indicate greater impairment in emotion regulation skills.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Affective Control Scale (ACS)', 'classes': [{'categories': [{'measurements': [{'value': '4.48', 'spread': '0.70', 'groupId': 'BG000'}, {'value': '4.24', 'spread': '0.53', 'groupId': 'BG001'}, {'value': '4.36', 'spread': '0.61', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Perceived controllability of emotions was assessed at baseline using the the self-report Affective Control Scale (ACS) a 42-item Likert-type scale (1-7) calculated by averaging scores across all items (minimum score 1, maximum score 7). Higher scores indicate greater impairment and less perceived control of emotions.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Anxiety Sensitivity Index (ASI)', 'classes': [{'categories': [{'measurements': [{'value': '33', 'spread': '10.07', 'groupId': 'BG000'}, {'value': '26.56', 'spread': '13.47', 'groupId': 'BG001'}, {'value': '29.45', 'spread': '12.30', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Anxiety sensitivity was assessed at baseline using the self-report Anxiety Sensitivity Index questionnaire (ASI) a 16-item likert-type scale (0-4) calculated by summing scores across items (minimum score 0, maximum score 64). Higher scores indicate greater impairment.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'NEO Five Factor Inventory of Personality, Neuroticism Subscale (NEO-FFI-N)', 'classes': [{'categories': [{'measurements': [{'value': '5.69', 'spread': '1.03', 'groupId': 'BG000'}, {'value': '5.88', 'spread': '1.54', 'groupId': 'BG001'}, {'value': '5.79', 'spread': '1.32', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Neuroticism was assessed at baseline using the NEO Five Factor Personality Inventory Neuroticism Scale (NEO-FFI-N) which is a subscale of the NEO-FFI, a 60-item scale (0-4) calculated by summing scores for each subscale. Only the 12-item Neuroticism subscale is included in this study. Higher scores indicate greater impairment.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-10', 'studyFirstSubmitDate': '2013-07-01', 'resultsFirstSubmitDate': '2016-03-21', 'studyFirstSubmitQcDate': '2013-07-01', 'lastUpdatePostDateStruct': {'date': '2017-05-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-10', 'studyFirstPostDateStruct': {'date': '2013-07-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Association Between Change on Depression (HAM-D) and Baseline Resting State Functional Connectivity of Anterior Insula and Ventrolateral Prefrontal Cortex', 'timeFrame': 'Six Months', 'description': 'Resting state functional magnetic resonance imaging (rsfMRI) data (non-task, eyes opened) was acquired to investigate anterior insula and ventrolateral prefrontal cortex functional connectivity as a predictor of change on depression (HAM-D). See primary outcome description of HAM-D.'}], 'primaryOutcomes': [{'measure': 'Reductions Over Time in Anxiety Symptoms as Measured by Hamilton Anxiety Rating Scale', 'timeFrame': 'Six months', 'description': 'The Hamilton Anxiety Rating Scale (HAM-A) is a well-validated clinician administered rating of anxiety-related symptoms. Ratings are made on a 0 (no symptoms) to 4 (most severe in frequency/duration/interference/distress) for each item (14 items), with a minimum score of 0 and a maximum score of 56 calculated by summing scores of all 14 items. Higher scores indicate greater impairment.'}, {'measure': 'Reductions Over Time in Depression Symptoms as Measured by Hamilton Depression Rating Scale (HAM-D)', 'timeFrame': 'Six months', 'description': 'The Hamilton Depression Rating Scale (HAM-D) is a well-validated clinician administered rating of depression-related symptoms. Scores are calculated by summing scores across all 17-items, with a minimum score of 0 and a maximum score of 54. Higher scores indicate greater impairment.'}], 'secondaryOutcomes': [{'measure': 'Treatment Acceptability as Measured by Client Satisfaction Questionnaire (CSQ)', 'timeFrame': 'Six months', 'description': 'The Client Satisfaction Questionnaire (CSQ) is an 8-item scale that assesses perceptions of acceptability and quality of outpatient treatment. Ratings are made on a 1 (poor) to 4 (excellent) scale for each item and then summed for a total score, with a minimum score of 8 and a maximum score of 32. Higher scores indicate greater satisfaction with treatment.'}, {'measure': 'Association Between Anxiety Symptom Change (HAM-A) and Difficulties in Emotion Regulation Scale (DERS)', 'timeFrame': 'Six Months', 'description': 'Emotion regulation skills were assessed using a measure of emotion regulation (Difficulties in Emotion Regulation Scale- DERS), a 36-item Likert-type scale (1-6) calculated by averaging scores across all items. See Baseline Characteristics for baseline DERS score. See Primary Outcome Measure for a description of HAM-A.'}, {'measure': 'Association Between Anxiety Symptom Change (HAM-A) and Reaction to Emotions (Affective Control Scale-ACS)', 'timeFrame': '6 months', 'description': 'Reactions to emotions, were assessed using the Affective Control Scale, or ACS, a 42-item Likert-type scale (1-7) calculated by averaging scores across all items. See Baseline Characteristics for baseline ACS score. See Primary Outcome Measure for description of HAM-A.'}, {'measure': 'Association Between Anxiety Symptom Change (HAM-A) and Anxiety Sensitivity (Anxiety Sensitivity Index-ASI)', 'timeFrame': '6 months', 'description': 'Anxiety sensitivity, were assessed using the Anxiety Sensitivity Index, or ASI, a 16-item Likert-type scale (0-4) calculated by summing scores across items. See Baseline Characteristics for baseline ASI scores. See Primary Outcome Measures for a description of HAM-A.'}, {'measure': 'Association Between Anxiety Symptom Change (HAM-A) and Neuroticism (NEO Five-Factor Inventory- NEO-FFI-N)', 'timeFrame': '6 months', 'description': 'Neuroticism was assessed using the NEO Five Factor Inventory (NEO-FFI-N) which is a subscale of the NEO-FFI, a 60-item Likert-type scale (1-5) calculated by summing scores for each subscale. Only the 15-item Neuroticism subscale is included in this study. See Baseline Characteristics for baseline NEO-FFI-N. See Primary Outcome Measure for description of HAM-A.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Bipolar Disorder', 'Anxiety Disorders']}, 'descriptionModule': {'briefSummary': 'The specific goal of this research study is to investigate the feasibility, acceptability, and preliminary efficacy of a transdiagnostic, cognitive-behavioral therapy developed specifically to target common core processes across mood and anxiety disorders \\[Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP)\\], for the treatment of patients with bipolar I disorder (BD-I) and comorbid anxiety. The study will compare treatment-as-usual with pharmacotherapy (TAU) plus 18 one-hour sessions of treatment with the UP to TAU alone. Patients in both treatment conditions will be followed over a 12-month period and will be assessed monthly to track changes in mood, anxiety and emotion-related symptoms; functional impairment; and relapse rates. Data on the acceptability of the treatment will be gathered concurrently through monthly patient self-reported ratings of treatment satisfaction, and by tracking rates of acceptance for randomization into the study, number of completed sessions, and dropout rates. The study will examine: 1) whether combined cognitive behavioral treatment (UP) for BD-I and comorbid anxiety disorders is an acceptable and feasible approach to treatment; 2) whether treatment with the UP for BD-I and comorbid anxiety disorders as an adjunct to pharmacotherapy treatment-as-usual (TAU) leads to greater symptom reduction and reduced functional impairment than pharmacotherapy alone, 3) whether treatment for BD-I and comorbid anxiety disorders with the UP improves relapse rates over a 6-month follow-up relative to TAU; and 4) whether reduction in symptoms, relapse rates, and functional impairment are mediated by changes in emotion regulation skills. The broader aim of this study is to address the need for improved treatments for bipolar disorder.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women age 18-65\n* DSM-IV diagnosis of bipolar I disorder and at least one of three additional anxiety disorders:\n\ngeneralized anxiety disorder, panic disorder, or social phobia.\n\n* HAM-D-17 score \\<16 (i.e. depressive symptoms)\n* YMRS score \\< 12 (i.e. no or very low manic symptoms)\n* Current, stabilized (\\> 3 months) pharmacotherapy treatment under the care of a psychiatrist consisting of optimized, stable maintenance pharmacotherapy at maximum tolerated dosages according to Texas Implementation of Medication Algorithm.\n\nExclusion Criteria:\n\n* Active suicidality (HAM-D-17 suicide item #3 score \\> 3) in the past 2 months. Potential participants scoring 3 or higher on the HAM-D-17 suicide item will be immediately evaluated by the PI and Sponsor and referred to a higher level of care if clinically indicated.\n* DSM-IV bipolar I disorder subtype rapid cycling\n* DSM-IV manic or mixed episode in the past 2 months\n* DSM-IV major depressive episode in the past 2 months\n* Psychotropic medication not in accordance with the revised Texas Implementation of Medication Algorithm\n* Current Pregnancy\n* Medical illness or non-psychiatric medical treatment that would likely interfere with study participation.\n* Neurologic disorder, previous ECT, or history of head trauma (i.e. known structural brain lesion)\n* Current or past history of selected DSM-IV Axis I disorders other than bipolar disorder including: organic mental disorder, substance abuse within the past 12 months and/or history of substance abuse for \\> 1 year; current substance dependence (including alcohol), as assessed by the Structured Clinical Interview for DSM-IV-TR, Substance Use Disorders (Section E); schizophrenia, delusional disorder, psychotic disorders not otherwise specified, obsessive compulsive disorder and posttraumatic stress disorder (due to low prevalence of \\~6.5% each).\n* Concurrent psychotherapy other than cognitive-behavioral therapy as provided in this study (to rule out other uncontrolled effects of concurrent psychotherapies)\n* Presence of metallic implants that would interfere with safety during fMRI scanning (i.e. cardiac pacemaker, metal plates, etc.)\n* Claustrophobia'}, 'identificationModule': {'nctId': 'NCT01892306', 'briefTitle': 'Pilot Study of Cognitive Behavioral Therapy for Anxiety and Bipolar I Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Transdiagnostic Treatment for Anxiety and Bipolar I Disorder', 'orgStudyIdInfo': {'id': '1F32MH098490-01', 'link': 'https://reporter.nih.gov/quickSearch/1F32MH098490-01', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment as usual plus UP CBT', 'description': 'Existing psychiatrist-administered psychopharmacotherapy plus weekly transdiagnostic CBT', 'interventionNames': ['Behavioral: UP CBT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment as usual', 'description': 'Existing psychiatrist-administered psychopharmacotherapy', 'interventionNames': ['Drug: Treatment as usual']}], 'interventions': [{'name': 'UP CBT', 'type': 'BEHAVIORAL', 'otherNames': ['Unified Protocol (UP) for transdiagnostic treatment of emotional disorders'], 'description': 'The UP is an 18-session weekly cognitive behavioral intervention for anxiety and mood disorders', 'armGroupLabels': ['Treatment as usual plus UP CBT']}, {'name': 'Treatment as usual', 'type': 'DRUG', 'description': 'Existing optimized pharmacotherapy as delivered by treating psychiatrist', 'armGroupLabels': ['Treatment as usual']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital Bipolar Clinic and Research Program', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Bipolar Clinic and Research Program', 'investigatorFullName': 'Andrew A. Nierenberg, MD', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}