Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2026-02-22 @ 3:56 PM
Study NCT ID:
NCT02685358
Status:
COMPLETED
Last Update Posted:
2024-03-04
First Post:
2016-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An RCT of a Primary Care-Based PTSD Intervention: Clinician-Supported PTSD Coach
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'eric.kuhn@va.gov', 'phone': '650-493-5000', 'title': 'Eric Kuhn, PhD', 'phoneExt': '23160', 'organization': 'VA Palo Alto Health Care System'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'For each enrolled participant, adverse event data was collected for the duration of their study participation, which was 24 weeks.', 'eventGroups': [{'id': 'EG000', 'title': 'Clinician-Supported PTSD Coach', 'description': 'Clinician-supported PTSD Coach is primary care-based treatment. In this treatment a primary care mental health clinician guides patients in using the PTSD Coach mobile app to learn about PTSD symptoms, treatment options, and strategies to cope with common PTSD-related concerns. It consisted of 4 brief sessions over 8 weeks.\n\nClinician-Supported PTSD Coach: Clinician-supported PTSD Coach is primary care-based treatment. In this treatment a primary care mental health clinician guides patients in using the PTSD Coach mobile app to learn about PTSD symptoms, treatment options, and strategies to cope with common PTSD-related concerns. It consists of 4 brief sessions over 8 weeks.', 'otherNumAtRisk': 115, 'deathsNumAtRisk': 115, 'otherNumAffected': 1, 'seriousNumAtRisk': 115, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Primary Care Mental Health Integrated Care as Usual', 'description': 'Existing primary care mental health integrated treatment will serve as the comparison condition\n\nPrimary Care Mental Health Integrated Care as Usual: Existing primary care mental health integrated treatment will serve as the comparison condition', 'otherNumAtRisk': 119, 'deathsNumAtRisk': 119, 'otherNumAffected': 0, 'seriousNumAtRisk': 119, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Acute anger', 'notes': 'Participant became angry during the Clinician Administered PTSD Interview. The interviewer ended the assessment early. The participant was thanked for his time completing the portions of the assessment he did participate in.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Emergency Department Visit', 'notes': 'The participant presented to community ER and was discharged the next day with right leg deep vein thrombosis (DVT, blood clot). Scheduled to follow up with the Syracuse VA.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Clinician Administered PTSD Scale for DSM-5 (CAPS-5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clinician-Supported PTSD Coach', 'description': 'Clinician-supported PTSD Coach is primary care-based treatment. In this treatment a primary care mental health clinician guides patients in using the PTSD Coach mobile app to learn about PTSD symptoms, treatment options, and strategies to cope with common PTSD-related concerns. It consisted of 4 brief sessions over 8 weeks.\n\nClinician-Supported PTSD Coach: Clinician-supported PTSD Coach is primary care-based treatment. In this treatment a primary care mental health clinician guides patients in using the PTSD Coach mobile app to learn about PTSD symptoms, treatment options, and strategies to cope with common PTSD-related concerns. It consists of 4 brief sessions over 8 weeks.'}, {'id': 'OG001', 'title': 'Primary Care Mental Health Integrated Care as Usual', 'description': 'Existing primary care mental health integrated treatment will serve as the comparison condition\n\nPrimary Care Mental Health Integrated Care as Usual: Existing primary care mental health integrated treatment will serve as the comparison condition'}], 'classes': [{'categories': [{'measurements': [{'value': '28.52', 'spread': '0.97', 'groupId': 'OG000'}, {'value': '30.01', 'spread': '0.95', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'The CAPS-5 is a 30-item clinical interview that assesses the 20 DSM-5 PTSD symptoms. Scores on the CAPS-5 can range from 0 to 80, with higher scores reflecting worse PTSD symptom severity. In this study, clinician-rated PTSD symptom severity were based on blind assessor ratings.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Hospital Administrative Data Showing 2 Mental Health Visits Completed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clinician-Supported PTSD Coach', 'description': 'Clinician-supported PTSD Coach is primary care-based treatment. In this treatment a primary care mental health clinician guides patients in using the PTSD Coach mobile app to learn about PTSD symptoms, treatment options, and strategies to cope with common PTSD-related concerns. It consisted of 4 brief sessions over 8 weeks.\n\nClinician-Supported PTSD Coach: Clinician-supported PTSD Coach is primary care-based treatment. In this treatment a primary care mental health clinician guides patients in using the PTSD Coach mobile app to learn about PTSD symptoms, treatment options, and strategies to cope with common PTSD-related concerns. It consists of 4 brief sessions over 8 weeks.'}, {'id': 'OG001', 'title': 'Primary Care Mental Health Integrated Care as Usual', 'description': 'Existing primary care mental health integrated treatment will serve as the comparison condition\n\nPrimary Care Mental Health Integrated Care as Usual: Existing primary care mental health integrated treatment will serve as the comparison condition'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '16 and 24 weeks', 'description': 'Hospital administrative data will be examined to determine if the participant completed 2 visits to any specialty mental health clinic during the follow-up period.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'For this outcome, only participants continuing to report significant PTSD symptoms (i.e., at or above the PCL-5 clinical cut score of 33) at 8 weeks were included. Per the protocol, these participants were offered a referral to specialty mental health treatment for PTSD.'}, {'type': 'SECONDARY', 'title': 'PTSD Checklist-5 (PCL-5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clinician-Supported PTSD Coach', 'description': 'Clinician-supported PTSD Coach is primary care-based treatment. In this treatment a primary care mental health clinician guides patients in using the PTSD Coach mobile app to learn about PTSD symptoms, treatment options, and strategies to cope with common PTSD-related concerns. It consisted of 4 brief sessions over 8 weeks.\n\nClinician-Supported PTSD Coach: Clinician-supported PTSD Coach is primary care-based treatment. In this treatment a primary care mental health clinician guides patients in using the PTSD Coach mobile app to learn about PTSD symptoms, treatment options, and strategies to cope with common PTSD-related concerns. It consists of 4 brief sessions over 8 weeks.'}, {'id': 'OG001', 'title': 'Primary Care Mental Health Integrated Care as Usual', 'description': 'Existing primary care mental health integrated treatment will serve as the comparison condition\n\nPrimary Care Mental Health Integrated Care as Usual: Existing primary care mental health integrated treatment will serve as the comparison condition'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '46.30', 'spread': '1.05', 'groupId': 'OG000'}, {'value': '47.18', 'spread': '1.03', 'groupId': 'OG001'}]}]}, {'title': '8-week', 'categories': [{'measurements': [{'value': '36.34', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '40.68', 'spread': '1.15', 'groupId': 'OG001'}]}]}, {'title': '16-week', 'categories': [{'measurements': [{'value': '35.42', 'spread': '1.43', 'groupId': 'OG000'}, {'value': '38.99', 'spread': '1.35', 'groupId': 'OG001'}]}]}, {'title': '24-week', 'categories': [{'measurements': [{'value': '34.61', 'spread': '1.69', 'groupId': 'OG000'}, {'value': '38.05', 'spread': '1.58', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 8 week, 16 week, 24 week', 'description': 'The PCL-5 is a 20-item self-report measure assessing how much respondents have been bothered by DSM-5 PTSD symptoms in the past month. Scores can range from 0 to 80 with higher scores reflecting worse PTSD symptom severity.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Client Satisfaction Questionnaire (CSQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clinician-Supported PTSD Coach', 'description': 'Clinician-supported PTSD Coach is primary care-based treatment. In this treatment a primary care mental health clinician guides patients in using the PTSD Coach mobile app to learn about PTSD symptoms, treatment options, and strategies to cope with common PTSD-related concerns. It consisted of 4 brief sessions over 8 weeks.\n\nClinician-Supported PTSD Coach: Clinician-supported PTSD Coach is primary care-based treatment. In this treatment a primary care mental health clinician guides patients in using the PTSD Coach mobile app to learn about PTSD symptoms, treatment options, and strategies to cope with common PTSD-related concerns. It consists of 4 brief sessions over 8 weeks.'}, {'id': 'OG001', 'title': 'Primary Care Mental Health Integrated Care as Usual', 'description': 'Existing primary care mental health integrated treatment will serve as the comparison condition\n\nPrimary Care Mental Health Integrated Care as Usual: Existing primary care mental health integrated treatment will serve as the comparison condition'}], 'classes': [{'categories': [{'measurements': [{'value': '27.10', 'spread': '3.73', 'groupId': 'OG000'}, {'value': '24.60', 'spread': '4.82', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 week', 'description': 'The CSQ is a widely used 8-item self-report measure assessing patient satisfaction with care. Scores can range from 8 to 32 with higher scores reflecting greater satisfaction.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Health Questionnaire (PHQ-9)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clinician-Supported PTSD Coach', 'description': 'Clinician-supported PTSD Coach is primary care-based treatment. In this treatment a primary care mental health clinician guides patients in using the PTSD Coach mobile app to learn about PTSD symptoms, treatment options, and strategies to cope with common PTSD-related concerns. It consisted of 4 brief sessions over 8 weeks.\n\nClinician-Supported PTSD Coach: Clinician-supported PTSD Coach is primary care-based treatment. In this treatment a primary care mental health clinician guides patients in using the PTSD Coach mobile app to learn about PTSD symptoms, treatment options, and strategies to cope with common PTSD-related concerns. It consists of 4 brief sessions over 8 weeks.'}, {'id': 'OG001', 'title': 'Primary Care Mental Health Integrated Care as Usual', 'description': 'Existing primary care mental health integrated treatment will serve as the comparison condition\n\nPrimary Care Mental Health Integrated Care as Usual: Existing primary care mental health integrated treatment will serve as the comparison condition'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '12.51', 'spread': '.48', 'groupId': 'OG000'}, {'value': '13.63', 'spread': '.47', 'groupId': 'OG001'}]}]}, {'title': '8-week', 'categories': [{'measurements': [{'value': '11.03', 'spread': '.50', 'groupId': 'OG000'}, {'value': '12.12', 'spread': '.48', 'groupId': 'OG001'}]}]}, {'title': '16-week', 'categories': [{'measurements': [{'value': '10.79', 'spread': '.55', 'groupId': 'OG000'}, {'value': '11.80', 'spread': '.52', 'groupId': 'OG001'}]}]}, {'title': '24-week', 'categories': [{'measurements': [{'value': '10.22', 'spread': '.61', 'groupId': 'OG000'}, {'value': '11.30', 'spread': '.57', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 8 week, 16 week, 24 week', 'description': 'A 9-item self-report instrument used to assess depression severity. Items are scored 0 to 3, with the total score being the sum of the 9 items which can range from 0 as the minimum value to 27 as the maximum value. Higher scores indicate greater depression severity, with a score of 10 or greater indicating probable major depression, and scores of 20 or more severe major depression.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'WHOQOL-BREF Psychological Health Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clinician-Supported PTSD Coach', 'description': 'Clinician-supported PTSD Coach is primary care-based treatment. In this treatment a primary care mental health clinician guides patients in using the PTSD Coach mobile app to learn about PTSD symptoms, treatment options, and strategies to cope with common PTSD-related concerns. It consisted of 4 brief sessions over 8 weeks.\n\nClinician-Supported PTSD Coach: Clinician-supported PTSD Coach is primary care-based treatment. In this treatment a primary care mental health clinician guides patients in using the PTSD Coach mobile app to learn about PTSD symptoms, treatment options, and strategies to cope with common PTSD-related concerns. It consists of 4 brief sessions over 8 weeks.'}, {'id': 'OG001', 'title': 'Primary Care Mental Health Integrated Care as Usual', 'description': 'Existing primary care mental health integrated treatment will serve as the comparison condition\n\nPrimary Care Mental Health Integrated Care as Usual: Existing primary care mental health integrated treatment will serve as the comparison condition'}], 'classes': [{'title': 'Baseline Psych Subscale', 'categories': [{'measurements': [{'value': '17.82', 'spread': '.35', 'groupId': 'OG000'}, {'value': '17.51', 'spread': '.34', 'groupId': 'OG001'}]}]}, {'title': '8-week Psych Subscale', 'categories': [{'measurements': [{'value': '18.16', 'spread': '.37', 'groupId': 'OG000'}, {'value': '17.50', 'spread': '.35', 'groupId': 'OG001'}]}]}, {'title': '16-week Psych Subscale', 'categories': [{'measurements': [{'value': '18.04', 'spread': '.39', 'groupId': 'OG000'}, {'value': '17.65', 'spread': '.37', 'groupId': 'OG001'}]}]}, {'title': '24-week Psych Subscale', 'categories': [{'measurements': [{'value': '18.29', 'spread': '.42', 'groupId': 'OG000'}, {'value': '17.47', 'spread': '.40', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 8 week, 16 week, 24 week', 'description': 'The psychological health (6 items) subscale of the WHOQOL-BREF was used to assess the broader effects of the intervention on quality of life. Scores on this subscales range from 0-30 with higher scores reflecting better quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'WHOQOL-BREF Social Relationships Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clinician-Supported PTSD Coach', 'description': 'Clinician-supported PTSD Coach is primary care-based treatment. In this treatment a primary care mental health clinician guides patients in using the PTSD Coach mobile app to learn about PTSD symptoms, treatment options, and strategies to cope with common PTSD-related concerns. It consisted of 4 brief sessions over 8 weeks.\n\nClinician-Supported PTSD Coach: Clinician-supported PTSD Coach is primary care-based treatment. In this treatment a primary care mental health clinician guides patients in using the PTSD Coach mobile app to learn about PTSD symptoms, treatment options, and strategies to cope with common PTSD-related concerns. It consists of 4 brief sessions over 8 weeks.'}, {'id': 'OG001', 'title': 'Primary Care Mental Health Integrated Care as Usual', 'description': 'Existing primary care mental health integrated treatment will serve as the comparison condition\n\nPrimary Care Mental Health Integrated Care as Usual: Existing primary care mental health integrated treatment will serve as the comparison condition'}], 'classes': [{'title': 'Baseline Social Subscale', 'categories': [{'measurements': [{'value': '8.88', 'spread': '.24', 'groupId': 'OG000'}, {'value': '8.56', 'spread': '.23', 'groupId': 'OG001'}]}]}, {'title': '8-week Social Subscale', 'categories': [{'measurements': [{'value': '9.31', 'spread': '.24', 'groupId': 'OG000'}, {'value': '8.71', 'spread': '.23', 'groupId': 'OG001'}]}]}, {'title': '16-week Social Subscale', 'categories': [{'measurements': [{'value': '9.23', 'spread': '.26', 'groupId': 'OG000'}, {'value': '8.58', 'spread': '.24', 'groupId': 'OG001'}]}]}, {'title': '24-week Social Subscale', 'categories': [{'measurements': [{'value': '9.01', 'spread': '.27', 'groupId': 'OG000'}, {'value': '8.40', 'spread': '.25', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 8 week, 16 week, 24 week', 'description': 'The social relationships (3 items) subscale of the WHOQOL-BREF was used to assess the broader effects of the intervention on quality of life. Scores on this subscales range from 0-15 with higher scores reflecting better quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Clinician-Supported PTSD Coach', 'description': 'Clinician-supported PTSD Coach is primary care-based treatment. In this treatment a primary care mental health clinician guides patients in using the PTSD Coach mobile app to learn about PTSD symptoms, treatment options, and strategies to cope with common PTSD-related concerns. It consisted of 4 brief sessions over 8 weeks.\n\nClinician-Supported PTSD Coach: Clinician-supported PTSD Coach is primary care-based treatment. In this treatment a primary care mental health clinician guides patients in using the PTSD Coach mobile app to learn about PTSD symptoms, treatment options, and strategies to cope with common PTSD-related concerns. It consists of 4 brief sessions over 8 weeks.'}, {'id': 'FG001', 'title': 'Primary Care Mental Health Integrated Care as Usual', 'description': 'Existing primary care mental health integrated treatment will serve as the comparison condition\n\nPrimary Care Mental Health Integrated Care as Usual: Existing primary care mental health integrated treatment will serve as the comparison condition'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '115'}, {'groupId': 'FG001', 'numSubjects': '119'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}, {'groupId': 'FG001', 'numSubjects': '112'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '7'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'BG000'}, {'value': '119', 'groupId': 'BG001'}, {'value': '234', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Clinician-Supported PTSD Coach', 'description': 'Clinician-supported PTSD Coach is primary care-based treatment. In this treatment a primary care mental health clinician guides patients in using the PTSD Coach mobile app to learn about PTSD symptoms, treatment options, and strategies to cope with common PTSD-related concerns. It consisted of 4 brief sessions over 8 weeks.\n\nClinician-Supported PTSD Coach: Clinician-supported PTSD Coach is primary care-based treatment. In this treatment a primary care mental health clinician guides patients in using the PTSD Coach mobile app to learn about PTSD symptoms, treatment options, and strategies to cope with common PTSD-related concerns. It consists of 4 brief sessions over 8 weeks.'}, {'id': 'BG001', 'title': 'Primary Care Mental Health Integrated Care as Usual', 'description': 'Existing primary care mental health integrated treatment will serve as the comparison condition\n\nPrimary Care Mental Health Integrated Care as Usual: Existing primary care mental health integrated treatment will serve as the comparison condition'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.04', 'spread': '15.40', 'groupId': 'BG000'}, {'value': '51.75', 'spread': '15.47', 'groupId': 'BG001'}, {'value': '50.92', 'spread': '15.43', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '211', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '105', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '210', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'Caucasian', 'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '167', 'groupId': 'BG002'}]}, {'title': 'African American', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}, {'title': 'Asian/Pacific American', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Native American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Multiracial', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Unknown or Missing', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '115', 'groupId': 'BG000'}, {'value': '119', 'groupId': 'BG001'}, {'value': '234', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Clinician Administered PTSD Scale for DSM-5 (CAPS-5)', 'classes': [{'categories': [{'measurements': [{'value': '28.52', 'spread': '10.40', 'groupId': 'BG000'}, {'value': '30.01', 'spread': '10.36', 'groupId': 'BG001'}, {'value': '29.28', 'spread': '10.38', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The CAPS-5 is a 30-item clinical interview that assesses the 20 DSM-5 PTSD symptoms. Scores on the CAPS-5 can range from 0 to 80, with higher scores reflecting worse PTSD symptom severity. In this study, clinician-rated PTSD symptom severity were based on blind assessor ratings.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-11-16', 'size': 177566, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-02-10T17:51', 'hasProtocol': True}, {'date': '2015-12-09', 'size': 179342, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-11-09T15:46', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The CAPS-5 will be administered via phone by a central assessor, blind to condition, at baseline and post-treatment and will be the primary measure of change in PTSD symptom severity.'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Clinician-Supported PTSD Coach (CS PTSD Coach) consists of four 20-30 minute sessions focused on instructions for using the PTSD Coach app, setting symptom reductions goals, and assigning specific PTSD Coach activities (i.e., assessments, management strategies, psycho-educational readings) for completion between sessions. PC-MHI providers deliver CS PTSD Coach using a treatment manual, which was developed and piloted by the PIs. Session 1 will be face-to-face and sessions 2-4 may be face-to-face or by phone, depending on patient preference. To help participants overcome treatment barriers psycho-education about treatment options are provided and active problems solving is encouraged. Specific next steps for treatment or self-management are developed collaboratively, typically in session 4. After session 4, Participants are encouraged to continue using PTSD Coach and have access to the research version of the app until the 24-week follow-up.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 234}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-28', 'studyFirstSubmitDate': '2016-02-12', 'resultsFirstSubmitDate': '2023-02-23', 'studyFirstSubmitQcDate': '2016-02-12', 'lastUpdatePostDateStruct': {'date': '2024-03-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-02-28', 'studyFirstPostDateStruct': {'date': '2016-02-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinician Administered PTSD Scale for DSM-5 (CAPS-5)', 'timeFrame': 'Baseline', 'description': 'The CAPS-5 is a 30-item clinical interview that assesses the 20 DSM-5 PTSD symptoms. Scores on the CAPS-5 can range from 0 to 80, with higher scores reflecting worse PTSD symptom severity. In this study, clinician-rated PTSD symptom severity were based on blind assessor ratings.'}, {'measure': 'Hospital Administrative Data Showing 2 Mental Health Visits Completed', 'timeFrame': '16 and 24 weeks', 'description': 'Hospital administrative data will be examined to determine if the participant completed 2 visits to any specialty mental health clinic during the follow-up period.'}], 'secondaryOutcomes': [{'measure': 'PTSD Checklist-5 (PCL-5)', 'timeFrame': 'Baseline, 8 week, 16 week, 24 week', 'description': 'The PCL-5 is a 20-item self-report measure assessing how much respondents have been bothered by DSM-5 PTSD symptoms in the past month. Scores can range from 0 to 80 with higher scores reflecting worse PTSD symptom severity.'}, {'measure': 'Client Satisfaction Questionnaire (CSQ)', 'timeFrame': '8 week', 'description': 'The CSQ is a widely used 8-item self-report measure assessing patient satisfaction with care. Scores can range from 8 to 32 with higher scores reflecting greater satisfaction.'}, {'measure': 'Patient Health Questionnaire (PHQ-9)', 'timeFrame': 'Baseline, 8 week, 16 week, 24 week', 'description': 'A 9-item self-report instrument used to assess depression severity. Items are scored 0 to 3, with the total score being the sum of the 9 items which can range from 0 as the minimum value to 27 as the maximum value. Higher scores indicate greater depression severity, with a score of 10 or greater indicating probable major depression, and scores of 20 or more severe major depression.'}, {'measure': 'WHOQOL-BREF Psychological Health Subscale', 'timeFrame': 'Baseline, 8 week, 16 week, 24 week', 'description': 'The psychological health (6 items) subscale of the WHOQOL-BREF was used to assess the broader effects of the intervention on quality of life. Scores on this subscales range from 0-30 with higher scores reflecting better quality of life.'}, {'measure': 'WHOQOL-BREF Social Relationships Subscale', 'timeFrame': 'Baseline, 8 week, 16 week, 24 week', 'description': 'The social relationships (3 items) subscale of the WHOQOL-BREF was used to assess the broader effects of the intervention on quality of life. Scores on this subscales range from 0-15 with higher scores reflecting better quality of life.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stress Disorders, Post-traumatic', 'Primary Health Care', 'Mobile Applications', 'Veterans'], 'conditions': ['Posttraumatic Stress Disorder']}, 'referencesModule': {'references': [{'pmid': '36932268', 'type': 'RESULT', 'citation': 'Possemato K, Johnson E, Barrie K, Ghaus S, Noronha D, Wade M, Greenbaum MA, Rosen C, Cloitre M, Owen J, Jain S, Beehler G, Prins A, Seal K, Kuhn E. A Randomized Clinical Trial of Clinician-Supported PTSD Coach in VA Primary Care Patients. J Gen Intern Med. 2023 Jul;38(Suppl 3):905-912. doi: 10.1007/s11606-023-08130-6. Epub 2023 Mar 17.'}]}, 'descriptionModule': {'briefSummary': 'Posttraumatic Stress Disorder (PTSD) is an often severe and frequently disabling condition. It is associated with compromised health, early mortality, and substantial economic costs. PTSD is common in VA primary care patients; however, brief, effective treatments for PTSD are not available in the primary care setting. Instead, patients with PTSD are referred to mental health settings, yet many patients do not accept these referrals or do not adequately engage in such services. Thus, this project seeks to improve health care for Veterans by testing the effectiveness of a primary care-based treatment called clinician-supported PTSD Coach. In this treatment a primary care mental health clinician guides patients in using the PTSD Coach mobile app to learn about PTSD symptoms, treatment options, and strategies to cope with common PTSD-related concerns. If this treatment is found to be effective at reducing PTSD symptoms and increasing use of mental health care, it will provide a tremendous benefit to Veterans with PTSD seen in VA primary care.', 'detailedDescription': 'Posttraumatic Stress Disorder (PTSD) is an often severe and frequently disabling condition. It is associated with compromised health, early mortality, and substantial economic costs. PTSD is common in VA primary care patients; however, brief, effective treatments for PTSD are not available in the primary care setting. Instead, patients with PTSD are referred to mental health settings, yet many patients do not accept these referrals or do not adequately engage in such services. Thus, this project represents a unique opportunity to improve health care for Veterans by examining the effectiveness of a primary care-based treatment called Clinician-Supported PTSD Coach. In this treatment a primary care mental health clinician guides patients in using the PTSD Coach mobile app to learn about PTSD symptoms, treatment options, and strategies to cope with common PTSD-related concerns. This randomized clinical trial will enroll and treat 260 VA primary care patients (female and male) who have PTSD and are not currently being treated for it. Commonly used, well-established clinical interviews and self-report measures will be used to assess important clinical outcomes. If this direct treatment is found to be effective at reducing PTSD symptoms and increasing use of mental health care, it will provide a tremendous benefit to Veterans with PTSD seen in VA primary care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Veterans enrolled in primary care within the VA Syracuse and Palo Alto healthcare systems reporting 33 on the PTSD Checklist-5 (PCL-5) and a traumatic event on the Criterion A screener\n\nExclusion Criteria:\n\n* Patients will be excluded if they demonstrate symptoms that would not allow them to actively engage in the CS PTSD Coach, i.e.,\n\n * gross cognitive impairment\n* Current symptoms of mania or psychosis or who have more pressing concerns that need to be addressed first, i.e.,\n\n * suicide attempt in the last two months or current intent to commit suicide\n* Patients with recent suicide attempts or intent are eligible to be enrolled follow the receipt of suicide prevention services\n* The investigators will also exclude patients that are already receiving psychotherapy or MH counseling for PTSD outside of PC\n* Started or changed the dose of a psychotropic medication for PTSD in the last two months that was prescribed outside of VA PC\n* Voice a preference to be directly referred to MH specialty care'}, 'identificationModule': {'nctId': 'NCT02685358', 'briefTitle': 'An RCT of a Primary Care-Based PTSD Intervention: Clinician-Supported PTSD Coach', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'An RCT of a Primary Care-Based PTSD Intervention: Clinician-Supported PTSD Coach', 'orgStudyIdInfo': {'id': 'IIR 14-288'}, 'secondaryIdInfos': [{'id': 'HX-001790-1', 'type': 'OTHER_GRANT', 'domain': 'U.S. Department of Veterans Affairs, HSR&D'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Clinician-Supported PTSD Coach', 'description': 'Clinician-supported PTSD Coach is primary care-based treatment. In this treatment a primary care mental health clinician guides patients in using the PTSD Coach mobile app to learn about PTSD symptoms, treatment options, and strategies to cope with common PTSD-related concerns. It consisted of 4 brief sessions over 8 weeks.', 'interventionNames': ['Behavioral: Clinician-Supported PTSD Coach']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Primary Care Mental Health Integrated Care as Usual', 'description': 'Existing primary care mental health integrated treatment will serve as the comparison condition', 'interventionNames': ['Behavioral: Primary Care Mental Health Integrated Care as Usual']}], 'interventions': [{'name': 'Clinician-Supported PTSD Coach', 'type': 'BEHAVIORAL', 'description': 'Clinician-supported PTSD Coach is primary care-based treatment. In this treatment a primary care mental health clinician guides patients in using the PTSD Coach mobile app to learn about PTSD symptoms, treatment options, and strategies to cope with common PTSD-related concerns. It consists of 4 brief sessions over 8 weeks.', 'armGroupLabels': ['Clinician-Supported PTSD Coach']}, {'name': 'Primary Care Mental Health Integrated Care as Usual', 'type': 'BEHAVIORAL', 'description': 'Existing primary care mental health integrated treatment will serve as the comparison condition', 'armGroupLabels': ['Primary Care Mental Health Integrated Care as Usual']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304-1290', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'VA Palo Alto Health Care System, Palo Alto, CA', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '13210', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'Syracuse VA Medical Center, Syracuse, NY', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}], 'overallOfficials': [{'name': 'Eric R Kuhn, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Palo Alto Health Care System, Palo Alto, CA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}