Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2026-01-05 @ 5:13 PM
Study NCT ID:
NCT03810456
Status:
COMPLETED
Last Update Posted:
2023-08-28
First Post:
2019-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Transdiagnostic Cognitive Behavioral Treatment for Anxiety
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Ellen.Teng@va.gov', 'phone': '(713) 578-5513', 'title': 'Dr. Ellen Teng', 'organization': 'Michael E. DeBakey VA Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Due to the COVID-19 pandemic, all research was placed on hold for several months. All study procedures for this project had to be converted to virtual telehealth delivery. This change in modality (including intervention delivery) may have impacted study outcomes and resulted in underpowered analyses.'}}, 'adverseEventsModule': {'timeFrame': '3 years, 7 months', 'description': 'Adverse events were systematically evaluated throughout the course of the study, from baseline through the last follow-up period. At each time point, medical records for each participant were reviewed and symptoms were monitored through measures administered to each participant. One participant randomized to the sCBT arm was excluded from analyses due to not meeting study inclusion criteria.', 'eventGroups': [{'id': 'EG000', 'title': 'iCBT (Intensive Cognitive Behavioral Therapy)', 'description': 'Patients in this arm will receive transdiagnostic CBT delivered in an intensive format over one weekend.\n\nIntensive Cognitive Behavior Therapy (iCBT): Participants randomized to iCBT will receive 16 hours of cognitive behavioral therapy for anxiety over one weekend. The treatment entails psychoeducation, cognitive restructuring and exposure exercises.', 'otherNumAtRisk': 99, 'deathsNumAtRisk': 99, 'otherNumAffected': 0, 'seriousNumAtRisk': 99, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'sCBT (Standard Cognitive Behavioral Therapy)', 'description': 'Patients in this arm will receive transdiagnostic CBT delivered in a standard weekly format for 12 weeks.\n\nStandard Cognitive Behavior Therapy (sCBT): Participants randomized to sCBT will receive 16 hours of cognitive behavioral therapy for anxiety weekly over a period of 12 weeks. The treatment entails psychoeducation, cognitive restructuring and exposure exercises.', 'otherNumAtRisk': 98, 'deathsNumAtRisk': 98, 'otherNumAffected': 0, 'seriousNumAtRisk': 98, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'TAU (Treatment as Usual)', 'description': 'Patients in this arm will not receive transdiagnostic CBT but will receive treatment as usual.', 'otherNumAtRisk': 67, 'deathsNumAtRisk': 67, 'otherNumAffected': 0, 'seriousNumAtRisk': 67, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'CRIS-EPS: Comparison of Extent of Participation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'iCBT (Intensive Cognitive Behavioral Therapy)', 'description': 'Patients in this arm will receive transdiagnostic CBT delivered in an intensive format over one weekend.\n\nIntensive Cognitive Behavior Therapy (iCBT): Participants randomized to iCBT will receive 16 hours of cognitive behavioral therapy for anxiety over one weekend. The treatment entails psychoeducation, cognitive restructuring and exposure exercises.'}, {'id': 'OG001', 'title': 'sCBT (Standard Cognitive Behavioral Therapy)', 'description': 'Patients in this arm will receive transdiagnostic CBT delivered in a standard weekly format for 12 weeks.\n\nStandard Cognitive Behavior Therapy (sCBT): Participants randomized to sCBT will receive 16 hours of cognitive behavioral therapy for anxiety weekly over a period of 12 weeks. The treatment entails psychoeducation, cognitive restructuring and exposure exercises.'}, {'id': 'OG002', 'title': 'TAU (Treatment as Usual)', 'description': 'Patients in this arm will not receive transdiagnostic CBT but will receive treatment as usual.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.21', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '4.18', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '4.17', 'spread': '0.8', 'groupId': 'OG002'}]}]}, {'title': '1 Month Follow Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.52', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '4.44', 'spread': '.8', 'groupId': 'OG001'}, {'value': '4.18', 'spread': '0.8', 'groupId': 'OG002'}]}]}, {'title': '3 Month Follow Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.57', 'spread': '.7', 'groupId': 'OG000'}, {'value': '4.54', 'spread': '.9', 'groupId': 'OG001'}, {'value': '4.34', 'spread': '0.8', 'groupId': 'OG002'}]}]}, {'title': '6 Month Follow Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.70', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '4.52', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '4.36', 'spread': '0.8', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 1 Month, 3 Month, 6 Month Follow Ups', 'description': 'The Community Reintegration of Service Members (CRIS) is a commonly used measure of community reintegration in service members and participation in life roles following deployment. The Extent of Participation Subscale (EPS) asks how often an individual experiences/participates in specific activities. Scores on this subscale range from 1 - 7, with higher scores indicating greater degrees of participation in life roles.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants reported here differ from the numbers reported in the Participant Flow because some participants did not complete follow-up assessments at all time points. Also, some participants who completed a follow-up at a later time may not have completed a follow-up at an earlier time point.'}, {'type': 'PRIMARY', 'title': 'CRIS-PLS: Comparison of Perceived Limitation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'iCBT (Intensive Cognitive Behavioral Therapy)', 'description': 'Patients in this arm will receive transdiagnostic CBT delivered in an intensive format over one weekend.\n\nIntensive Cognitive Behavior Therapy (iCBT): Participants randomized to iCBT will receive 16 hours of cognitive behavioral therapy for anxiety over one weekend. The treatment entails psychoeducation, cognitive restructuring and exposure exercises.'}, {'id': 'OG001', 'title': 'sCBT (Standard Cognitive Behavioral Therapy)', 'description': 'Patients in this arm will receive transdiagnostic CBT delivered in a standard weekly format for 12 weeks.\n\nStandard Cognitive Behavior Therapy (sCBT): Participants randomized to sCBT will receive 16 hours of cognitive behavioral therapy for anxiety weekly over a period of 12 weeks. The treatment entails psychoeducation, cognitive restructuring and exposure exercises.'}, {'id': 'OG002', 'title': 'TAU (Treatment as Usual)', 'description': 'Patients in this arm will not receive transdiagnostic CBT but will receive treatment as usual.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.40', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '4.34', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '4.36', 'spread': '0.9', 'groupId': 'OG002'}]}]}, {'title': '1 Month Follow Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.52', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '4.44', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '4.18', 'spread': '0.8', 'groupId': 'OG002'}]}]}, {'title': '3 Month Follow Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.86', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '4.52', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '4.40', 'spread': '0.9', 'groupId': 'OG002'}]}]}, {'title': '6 Month Follow Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.70', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '4.52', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '4.36', 'spread': '0.8', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 1 Month, 3 Month, 6 Month Follow Ups', 'description': 'The Community Reintegration in Service Members (CRIS) scale is a commonly used measure of community reintegration in service members and participation in life roles following deployment. The Perceived Limitations Subscale (PLS) asks an individual their perceived limitations in participation. Scores on this subscale range from 1 - 7, with higher scores indicating fewer limitations in participation.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants reported here differ from the numbers reported in the Participant Flow because some participants did not complete follow-up assessments at all time points. Also, some participants who completed a follow-up at a later time may not have completed a follow-up at an earlier time point.'}, {'type': 'PRIMARY', 'title': 'CRIS-SPS: Comparison of Satisfaction With Participation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'iCBT (Intensive Cognitive Behavioral Therapy)', 'description': 'Patients in this arm will receive transdiagnostic CBT delivered in an intensive format over one weekend.\n\nIntensive Cognitive Behavior Therapy (iCBT): Participants randomized to iCBT will receive 16 hours of cognitive behavioral therapy for anxiety over one weekend. The treatment entails psychoeducation, cognitive restructuring and exposure exercises.'}, {'id': 'OG001', 'title': 'sCBT (Standard Cognitive Behavioral Therapy)', 'description': 'Patients in this arm will receive transdiagnostic CBT delivered in a standard weekly format for 12 weeks.\n\nStandard Cognitive Behavior Therapy (sCBT): Participants randomized to sCBT will receive 16 hours of cognitive behavioral therapy for anxiety weekly over a period of 12 weeks. The treatment entails psychoeducation, cognitive restructuring and exposure exercises.'}, {'id': 'OG002', 'title': 'TAU (Treatment as Usual)', 'description': 'Patients in this arm will not receive transdiagnostic CBT but will receive treatment as usual.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.28', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '4.26', 'spread': '1.2', 'groupId': 'OG001'}, {'value': '4.15', 'spread': '1.0', 'groupId': 'OG002'}]}]}, {'title': '1 Month Follow Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.80', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '4.51', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '4.31', 'spread': '1.0', 'groupId': 'OG002'}]}]}, {'title': '3 Month Follow Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.86', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '4.60', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '4.40', 'spread': '0.9', 'groupId': 'OG002'}]}]}, {'title': '6 Month Follow Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.96', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '4.63', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '4.45', 'spread': '0.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 1 Month, 3 Month, 6 Month Follow Ups', 'description': 'The Community Reintegration Service Members (CRIS) scale is a commonly used measure of community reintegration in service members and participation in life roles following deployment. The Satisfaction with Participation Subscale (SPS) asks an individual their degree of satisfaction with participation. Scores on this subscale range from 1 - 7, with higher scores indicating greater levels of satisfaction with their participation.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants reported here differ from the numbers reported in the Participant Flow because some participants did not complete follow-up assessments at all time points. Also, some participants who completed a follow-up at a later time may not have completed a follow-up at an earlier time point.'}, {'type': 'PRIMARY', 'title': 'BAI: Comparison of Beck Anxiety Inventory Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'iCBT (Intensive Cognitive Behavioral Therapy)', 'description': 'Patients in this arm will receive transdiagnostic CBT delivered in an intensive format over one weekend.\n\nIntensive Cognitive Behavior Therapy (iCBT): Participants randomized to iCBT will receive 16 hours of cognitive behavioral therapy for anxiety over one weekend. The treatment entails psychoeducation, cognitive restructuring and exposure exercises.'}, {'id': 'OG001', 'title': 'sCBT (Standard Cognitive Behavioral Therapy)', 'description': 'Patients in this arm will receive transdiagnostic CBT delivered in a standard weekly format for 12 weeks.\n\nStandard Cognitive Behavior Therapy (sCBT): Participants randomized to sCBT will receive 16 hours of cognitive behavioral therapy for anxiety weekly over a period of 12 weeks. The treatment entails psychoeducation, cognitive restructuring and exposure exercises.'}, {'id': 'OG002', 'title': 'TAU (Treatment as Usual)', 'description': 'Patients in this arm will not receive transdiagnostic CBT but will receive treatment as usual.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '31.8', 'spread': '11.2', 'groupId': 'OG000'}, {'value': '31.7', 'spread': '10.9', 'groupId': 'OG001'}, {'value': '32.0', 'spread': '12.1', 'groupId': 'OG002'}]}]}, {'title': '1 Month Follow Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '24.0', 'spread': '12.6', 'groupId': 'OG000'}, {'value': '25.9', 'spread': '10.3', 'groupId': 'OG001'}, {'value': '26.3', 'spread': '12.6', 'groupId': 'OG002'}]}]}, {'title': '3 Month Follow Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '24.3', 'spread': '12.2', 'groupId': 'OG000'}, {'value': '25.6', 'spread': '11.8', 'groupId': 'OG001'}, {'value': '26.7', 'spread': '12.4', 'groupId': 'OG002'}]}]}, {'title': '6 Month Follow Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '21.6', 'spread': '11.6', 'groupId': 'OG000'}, {'value': '24.1', 'spread': '11.4', 'groupId': 'OG001'}, {'value': '27.0', 'spread': '12.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 1 Month, 3 Month, 6 Month Follow Ups', 'description': 'The Beck Anxiety Inventory (BAI) assesses the severity of anxiety symptoms across 21 items, minimizing those that overlap with depression. The BAI assesses cognitive and somatic components of anxiety. The cognitive subscale provides a measure of fearful thoughts and impaired cognitive functioning, whereas the somatic subscale measures the symptoms of physiological arousal. The total score on the BAI ranges from 0 - 63, with higher scores reflecting higher levels of anxiety.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants reported here differ from the numbers reported in the Participant Flow because some participants did not complete follow-up assessments at all time points. Also, some participants who completed a follow-up at a later time may not have completed a follow-up at an earlier time point.'}, {'type': 'SECONDARY', 'title': 'QLES-SF: Comparison of Quality of Life Enjoyment and Satisfaction Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'iCBT (Intensive Cognitive Behavioral Therapy)', 'description': 'Patients in this arm will receive transdiagnostic CBT delivered in an intensive format over one weekend.\n\nIntensive Cognitive Behavior Therapy (iCBT): Participants randomized to iCBT will receive 16 hours of cognitive behavioral therapy for anxiety over one weekend. The treatment entails psychoeducation, cognitive restructuring and exposure exercises.'}, {'id': 'OG001', 'title': 'sCBT (Standard Cognitive Behavioral Therapy)', 'description': 'Patients in this arm will receive transdiagnostic CBT delivered in a standard weekly format for 12 weeks.\n\nStandard Cognitive Behavior Therapy (sCBT): Participants randomized to sCBT will receive 16 hours of cognitive behavioral therapy for anxiety weekly over a period of 12 weeks. The treatment entails psychoeducation, cognitive restructuring and exposure exercises.'}, {'id': 'OG002', 'title': 'TAU (Treatment as Usual)', 'description': 'Patients in this arm will not receive transdiagnostic CBT but will receive treatment as usual.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '34.4', 'spread': '7.0', 'groupId': 'OG000'}, {'value': '34.8', 'spread': '5.5', 'groupId': 'OG001'}, {'value': '33.6', 'spread': '7.0', 'groupId': 'OG002'}]}]}, {'title': '1 Month Follow Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '42.9', 'spread': '9.7', 'groupId': 'OG000'}, {'value': '40.7', 'spread': '8.4', 'groupId': 'OG001'}, {'value': '37.4', 'spread': '8.3', 'groupId': 'OG002'}]}]}, {'title': '3 Month Follow Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '42.9', 'spread': '10.6', 'groupId': 'OG000'}, {'value': '42.0', 'spread': '8.9', 'groupId': 'OG001'}, {'value': '38.3', 'spread': '9.6', 'groupId': 'OG002'}]}]}, {'title': '6 Month Follow Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '43.7', 'spread': '10.1', 'groupId': 'OG000'}, {'value': '42.5', 'spread': '8.8', 'groupId': 'OG001'}, {'value': '38.0', 'spread': '8.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 1 Month, 3 Month, 6 Month Follow Ups', 'description': 'The Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (QLES-Q-SF) measures subjective functioning and satisfaction across a range of life domains including work, leisure activities, social relationships, and physical health. Satisfaction scores on this measure range from 14 (very poor) to 70 (very good). Higher scores indicate greater overall life satisfaction/functioning.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants reported here differ from the numbers reported in the Participant Flow because some participants did not complete follow-up assessments at all time points. Also, some participants who completed a follow-up at a later time may not have completed a follow-up at an earlier time point.'}, {'type': 'SECONDARY', 'title': 'BDI-II: Comparison of Beck Depression Inventory Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'iCBT (Intensive Cognitive Behavioral Therapy)', 'description': 'Patients in this arm will receive transdiagnostic CBT delivered in an intensive format over one weekend.\n\nIntensive Cognitive Behavior Therapy (iCBT): Participants randomized to iCBT will receive 16 hours of cognitive behavioral therapy for anxiety over one weekend. The treatment entails psychoeducation, cognitive restructuring and exposure exercises.'}, {'id': 'OG001', 'title': 'sCBT (Standard Cognitive Behavioral Therapy)', 'description': 'Patients in this arm will receive transdiagnostic CBT delivered in a standard weekly format for 12 weeks.\n\nStandard Cognitive Behavior Therapy (sCBT): Participants randomized to sCBT will receive 16 hours of cognitive behavioral therapy for anxiety weekly over a period of 12 weeks. The treatment entails psychoeducation, cognitive restructuring and exposure exercises.'}, {'id': 'OG002', 'title': 'TAU (Treatment as Usual)', 'description': 'Patients in this arm will not receive transdiagnostic CBT but will receive treatment as usual.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '31.0', 'spread': '10.7', 'groupId': 'OG000'}, {'value': '31.0', 'spread': '10.6', 'groupId': 'OG001'}, {'value': '32.7', 'spread': '11.1', 'groupId': 'OG002'}]}]}, {'title': '1 Month Follow Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '23.5', 'spread': '13.4', 'groupId': 'OG000'}, {'value': '24.6', 'spread': '11.8', 'groupId': 'OG001'}, {'value': '29.8', 'spread': '12.9', 'groupId': 'OG002'}]}]}, {'title': '3 Month Follow Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '25.1', 'spread': '12.7', 'groupId': 'OG000'}, {'value': '24.8', 'spread': '13.2', 'groupId': 'OG001'}, {'value': '28.5', 'spread': '13.1', 'groupId': 'OG002'}]}]}, {'title': '6 Month Follow Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '22.5', 'spread': '12.0', 'groupId': 'OG000'}, {'value': '24.4', 'spread': '13.5', 'groupId': 'OG001'}, {'value': '28.8', 'spread': '12.8', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 1 Month, 3 Month, 6 Month Follow Ups', 'description': 'The Beck Depression Inventory-II (BDI-II) is a well-validated 21-item measure that assesses symptoms of depression. The total score on the BDI-II ranges from 0 - 63, with higher scores reflecting higher levels of depression.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants reported here differ from the numbers reported in the Participant Flow because some participants did not complete follow-up assessments at all time points. Also, some participants who completed a follow-up at a later time may not have completed a follow-up at an earlier time point.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'iCBT (Intensive Cognitive Behavioral Therapy)', 'description': 'Patients in this arm will receive transdiagnostic CBT delivered in an intensive format over one weekend.\n\nIntensive Cognitive Behavior Therapy (iCBT): Participants randomized to iCBT will receive 16 hours of cognitive behavioral therapy for anxiety over one weekend. The treatment entails psychoeducation, cognitive restructuring and exposure exercises.'}, {'id': 'FG001', 'title': 'sCBT (Standard Cognitive Behavioral Therapy)', 'description': 'Patients in this arm will receive transdiagnostic CBT delivered in a standard weekly format for 12 weeks.\n\nStandard Cognitive Behavior Therapy (sCBT): Participants randomized to sCBT will receive 16 hours of cognitive behavioral therapy for anxiety weekly over a period of 12 weeks. The treatment entails psychoeducation, cognitive restructuring and exposure exercises.'}, {'id': 'FG002', 'title': 'TAU (Treatment as Usual)', 'description': 'Patients in this arm will not receive transdiagnostic CBT but will receive treatment as usual.'}], 'periods': [{'title': 'Enrolled and Randomized', 'milestones': [{'type': 'STARTED', 'comment': 'Participants enrolled and randomized to a treatment condition.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '99'}, {'groupId': 'FG001', 'numSubjects': '99'}, {'groupId': 'FG002', 'numSubjects': '67'}]}, {'type': 'COMPLETED', 'comment': 'Participants who started treatment.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '69'}, {'groupId': 'FG001', 'numSubjects': '79'}, {'comment': 'These individuals may have received standard care.', 'groupId': 'FG002', 'numSubjects': '67'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Treatment', 'milestones': [{'type': 'STARTED', 'comment': 'Participants who started treatment.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '69'}, {'groupId': 'FG001', 'numSubjects': '79'}, {'groupId': 'FG002', 'numSubjects': '67'}]}, {'type': 'COMPLETED', 'comment': 'Participants who completed treatment.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}, {'groupId': 'FG001', 'numSubjects': '55'}, {'groupId': 'FG002', 'numSubjects': '67'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Urgent Family Matters', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Scheduling Conflicts', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'No Longer Interested', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Transportation Issues', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': '1 Month Follow-Up', 'milestones': [{'type': 'STARTED', 'comment': 'Participants who completed treatment.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}, {'groupId': 'FG001', 'numSubjects': '55'}, {'groupId': 'FG002', 'numSubjects': '67'}]}, {'type': 'COMPLETED', 'comment': 'Participants who completed 1-Month Follow-Up.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '51'}, {'groupId': 'FG002', 'numSubjects': '51'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '15'}]}, {'type': 'Relocated to Different State', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': '3 Month Follow-Up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}, {'groupId': 'FG001', 'numSubjects': '55'}, {'groupId': 'FG002', 'numSubjects': '67'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '44'}, {'groupId': 'FG002', 'numSubjects': '53'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '14'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '14'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': '6 Month Follow-Up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}, {'groupId': 'FG001', 'numSubjects': '55'}, {'groupId': 'FG002', 'numSubjects': '67'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '46'}, {'groupId': 'FG002', 'numSubjects': '49'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '18'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '18'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Veterans at the Michael E. DeBakey VA Medical Center and affiliated community based outpatient clinics were enrolled in this study from 08/1/2018 to 05/31/2021. Veterans were recruited through direct referrals and advertisements.', 'preAssignmentDetails': 'Enrolled participants were excluded from the study prior to randomization if they did not meet study inclusion criteria.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '264', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'iCBT (Intensive Cognitive Behavioral Therapy)', 'description': 'Patients in this arm will receive transdiagnostic CBT delivered in an intensive format over one weekend.\n\nIntensive Cognitive Behavior Therapy (iCBT): Participants randomized to iCBT will receive 16 hours of cognitive behavioral therapy for anxiety over one weekend. The treatment entails psychoeducation, cognitive restructuring and exposure exercises.'}, {'id': 'BG001', 'title': 'sCBT (Standard Cognitive Behavioral Therapy)', 'description': 'Patients in this arm will receive transdiagnostic CBT delivered in a standard weekly format for 12 weeks.\n\nStandard Cognitive Behavior Therapy (sCBT): Participants randomized to sCBT will receive 16 hours of cognitive behavioral therapy for anxiety weekly over a period of 12 weeks. The treatment entails psychoeducation, cognitive restructuring and exposure exercises.'}, {'id': 'BG002', 'title': 'TAU (Treatment a Usual)', 'description': 'Patients in this arm will not receive transdiagnostic CBT but will receive treatment as usual.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.7', 'spread': '11.2', 'groupId': 'BG000'}, {'value': '43.9', 'spread': '12.2', 'groupId': 'BG001'}, {'value': '43.6', 'spread': '11.9', 'groupId': 'BG002'}, {'value': '43.4', 'spread': '11.7', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '172', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '63', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '195', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '129', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '95', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '99', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '264', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'One participant randomized to the sCBT arm was excluded from analyses due to not meeting study inclusion criteria.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-01-18', 'size': 249629, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-08-31T21:32', 'hasProtocol': True}, {'date': '2018-01-18', 'size': 175497, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-09-07T13:19', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Persons completing follow-up assessments will be masked to the conditions to which patients were randomized.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The proposed study is a randomized controlled trial with 3 treatment arms. A transdiagnostic group CBT protocol will be compared in a compressed weekend format (iCBT) with a standard group delivery format involving 3 months of weekly sessions (sCBT). A treatment as usual (TAU) condition will be included to compare outcomes. Veterans with one or more anxiety-based disorder(s) (with or without co-occurring depression) will be randomized to one of the three treatment arms. Veterans will be asked to attend a total of four assessments during the study including a baseline evaluation, 1-month, 3-month, and 6-month follow-ups.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 359}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-07', 'studyFirstSubmitDate': '2019-01-16', 'resultsFirstSubmitDate': '2022-10-07', 'studyFirstSubmitQcDate': '2019-01-17', 'lastUpdatePostDateStruct': {'date': '2023-08-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-10-07', 'studyFirstPostDateStruct': {'date': '2019-01-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CRIS-EPS: Comparison of Extent of Participation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups', 'timeFrame': 'Baseline, 1 Month, 3 Month, 6 Month Follow Ups', 'description': 'The Community Reintegration of Service Members (CRIS) is a commonly used measure of community reintegration in service members and participation in life roles following deployment. The Extent of Participation Subscale (EPS) asks how often an individual experiences/participates in specific activities. Scores on this subscale range from 1 - 7, with higher scores indicating greater degrees of participation in life roles.'}, {'measure': 'CRIS-PLS: Comparison of Perceived Limitation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups', 'timeFrame': 'Baseline, 1 Month, 3 Month, 6 Month Follow Ups', 'description': 'The Community Reintegration in Service Members (CRIS) scale is a commonly used measure of community reintegration in service members and participation in life roles following deployment. The Perceived Limitations Subscale (PLS) asks an individual their perceived limitations in participation. Scores on this subscale range from 1 - 7, with higher scores indicating fewer limitations in participation.'}, {'measure': 'CRIS-SPS: Comparison of Satisfaction With Participation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups', 'timeFrame': 'Baseline, 1 Month, 3 Month, 6 Month Follow Ups', 'description': 'The Community Reintegration Service Members (CRIS) scale is a commonly used measure of community reintegration in service members and participation in life roles following deployment. The Satisfaction with Participation Subscale (SPS) asks an individual their degree of satisfaction with participation. Scores on this subscale range from 1 - 7, with higher scores indicating greater levels of satisfaction with their participation.'}, {'measure': 'BAI: Comparison of Beck Anxiety Inventory Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups', 'timeFrame': 'Baseline, 1 Month, 3 Month, 6 Month Follow Ups', 'description': 'The Beck Anxiety Inventory (BAI) assesses the severity of anxiety symptoms across 21 items, minimizing those that overlap with depression. The BAI assesses cognitive and somatic components of anxiety. The cognitive subscale provides a measure of fearful thoughts and impaired cognitive functioning, whereas the somatic subscale measures the symptoms of physiological arousal. The total score on the BAI ranges from 0 - 63, with higher scores reflecting higher levels of anxiety.'}], 'secondaryOutcomes': [{'measure': 'QLES-SF: Comparison of Quality of Life Enjoyment and Satisfaction Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups', 'timeFrame': 'Baseline, 1 Month, 3 Month, 6 Month Follow Ups', 'description': 'The Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (QLES-Q-SF) measures subjective functioning and satisfaction across a range of life domains including work, leisure activities, social relationships, and physical health. Satisfaction scores on this measure range from 14 (very poor) to 70 (very good). Higher scores indicate greater overall life satisfaction/functioning.'}, {'measure': 'BDI-II: Comparison of Beck Depression Inventory Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups', 'timeFrame': 'Baseline, 1 Month, 3 Month, 6 Month Follow Ups', 'description': 'The Beck Depression Inventory-II (BDI-II) is a well-validated 21-item measure that assesses symptoms of depression. The total score on the BDI-II ranges from 0 - 63, with higher scores reflecting higher levels of depression.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cognitive Behavior Therapy'], 'conditions': ['Anxiety Disorders']}, 'descriptionModule': {'briefSummary': "This study is a randomized controlled trial examining the effectiveness of a transdiagnostic cognitive behavioral treatment (CBT) in improving Veterans' community reintegration and quality of life. Veterans with anxiety-based disorders, including posttraumatic stress, panic, social anxiety, and generalized anxiety disorders (with or without co-occurring depression) will be randomized to an intensive CBT (iCBT) treatment delivered over one weekend, standard CBT (sCBT) delivered over 12 weeks or treatment as usual (TAU). The study will also evaluate the potential of the compressed weekend format of iCBT in producing more rapid improvement in outcomes and increasing psychotherapy engagement compared with a standard psychotherapy format. Qualitative interviews will be conducted with Veterans who receive iCBT and their family members to examine how iCBT and environmental factors impacted their process of recovery.", 'detailedDescription': 'The current project proposes to evaluate a brief but intensive transdiagnostic CBT that simultaneously targets multiple anxiety disorders with or without co-occurring depression. This will be accomplished by evaluating an innovative treatment delivery method that directly addresses barriers associated with standard psychotherapy delivery. The main objectives are to (1) determine if an intensive CBT protocol (iCBT) delivered over one weekend can improve community reintegration, quality of life, and emotional functioning compared with standard CBT (sCBT) and treatment as usual (TAU); (2) examine the rates of psychotherapy engagement in iCBT compared with sCBT; and (3) obtain a deeper understanding, through qualitative interviews with Veterans and their family members, of how iCBT and environmental factors may impact the process of reintegration and quality of life.\n\nThe proposed study is a randomized controlled trial with 3 treatment arms. A transdiagnostic group CBT protocol will be compared in a compressed weekend format (iCBT) with a standard group delivery format involving 3 months of weekly sessions (sCBT). A treatment as usual (TAU) condition will be included to compare outcomes. Veterans with one or more anxiety-based disorder(s) (with or without co-occurring depression) will be randomized to one of the three treatment arms. Veterans will be asked to attend a total of four assessments during the study including a baseline evaluation, 1-month, 3-month, and 6-month follow-ups. Qualitative interviews will be conducted with Veterans who completed iCBT and family members.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Veterans enrolled to receive VA medical care\n* Current diagnosis of at least one anxiety-based disorder\n* Moderate-to-poor life enjoyment and satisfaction\n* Stable on psychotropic medication 4 weeks prior to participation\n* Willing to be randomized to treatment condition\n\nExclusion Criteria:\n\n* Active symptoms of mania or psychosis at baseline\n* Depression with active suicidal ideation/intent\n* Moderate-to-severe cognitive impairment\n* Active drug/alcohol abuse during initial 3 months of study enrollment\n* Undergoing concurrent transdiagnostic CBT for anxiety'}, 'identificationModule': {'nctId': 'NCT03810456', 'briefTitle': 'Transdiagnostic Cognitive Behavioral Treatment for Anxiety', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Improving Veteran Functioning With Intensive Transdiagnostic CBT for Anxiety', 'orgStudyIdInfo': {'id': 'D2160-R'}, 'secondaryIdInfos': [{'id': '5I01RX002160-02', 'link': 'https://reporter.nih.gov/quickSearch/5I01RX002160-02', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'iCBT', 'description': 'Patients in this arm will receive transdiagnostic CBT delivered in an intensive format over one weekend.', 'interventionNames': ['Behavioral: Intensive Cognitive Behavior Therapy (iCBT)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'sCBT', 'description': 'Patients in this arm will receive transdiagnostic CBT delivered in a standard weekly format for 12 weeks.', 'interventionNames': ['Behavioral: Standard Cognitive Behavior Therapy (sCBT)']}, {'type': 'NO_INTERVENTION', 'label': 'TAU', 'description': 'Patients in this arm will not receive transdiagnostic CBT but will receive treatment as usual.'}], 'interventions': [{'name': 'Intensive Cognitive Behavior Therapy (iCBT)', 'type': 'BEHAVIORAL', 'description': 'Participants randomized to iCBT will receive 16 hours of cognitive behavioral therapy for anxiety over one weekend. The treatment entails psychoeducation, cognitive restructuring and exposure exercises.', 'armGroupLabels': ['iCBT']}, {'name': 'Standard Cognitive Behavior Therapy (sCBT)', 'type': 'BEHAVIORAL', 'description': 'Participants randomized to sCBT will receive 16 hours of cognitive behavioral therapy for anxiety weekly over a period of 12 weeks. The treatment entails psychoeducation, cognitive restructuring and exposure exercises.', 'armGroupLabels': ['sCBT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Michael E. DeBakey VA Medical Center, Houston, TX', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Ellen Teng, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Michael E. DeBakey VA Medical Center, Houston, TX'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}