Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-25 @ 5:35 PM
Study NCT ID:
NCT04937504
Status:
COMPLETED
Last Update Posted:
2025-02-14
First Post:
2021-06-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Implementing a Skills Training Evidence-Based Treatment for Posttraumatic Stress Disorder in Primary Care
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': 'sarah.valentine@bmc.org', 'phone': '(617) 414-1989', 'title': 'Sarah Valentine, PhD', 'organization': 'Boston Medical Center, Psychiatry Department'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '9 months', 'eventGroups': [{'id': 'EG000', 'title': 'STAIR-PC Group', 'description': 'Participants in the Skills Training in Affective and Interpersonal Regulation for Primary Care (STAIR-PC) group will complete five (30 minute each) therapist-led sessions in-person or via Telehealth for up to 15 weeks.', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 0, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'WebSTAIR Group', 'description': 'Participants in the WebSTAIR group will complete 10 self-guided, web-based modules for up to 15 weeks.', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 0, 'seriousNumAtRisk': 29, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Posttraumatic Stress Disorder Symptoms Measured by PTSD Checklist for DSM-5 (PCL-5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'STAIR-PC Group', 'description': 'Participants in the Skills Training in Affective and Interpersonal Regulation for Primary Care (STAIR-PC) group will complete five (30 minute each) therapist-led sessions in-person or via Telehealth for up to 15 weeks.'}, {'id': 'OG001', 'title': 'WebSTAIR Group', 'description': 'Participants in the WebSTAIR group will complete 10 self-guided, web-based modules for up to 15 weeks.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '61.48', 'spread': '10.18', 'groupId': 'OG000'}, {'value': '58.28', 'spread': '10.73', 'groupId': 'OG001'}]}]}, {'title': '15 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '39.12', 'spread': '22.32', 'groupId': 'OG000'}, {'value': '36.30', 'spread': '19.91', 'groupId': 'OG001'}]}]}, {'title': '9 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28.04', 'spread': '21.61', 'groupId': 'OG000'}, {'value': '36.39', 'spread': '18.38', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 15 weeks, and 9 months', 'description': 'The PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-report measure that assesses the 20 DSM-5 symptoms. The PCL-5 scale ranges from Not At All (0) to Extremely (4) so the PTSD checklist total scores can range from 0 to 80, where higher scores indicate higher severity of PTSD symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Refer to participant flow for numbers of participants analyzed at baseline, 15 weeks, and 9 months assessments.'}, {'type': 'PRIMARY', 'title': 'Feasibility Based on Retention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'STAIR-PC Group', 'description': 'Participants in the Skills Training in Affective and Interpersonal Regulation for Primary Care (STAIR-PC) group will complete five (30 minute each) therapist-led sessions in-person or via Telehealth for up to 15 weeks.'}, {'id': 'OG001', 'title': 'WebSTAIR Group', 'description': 'Participants in the WebSTAIR group will complete 10 self-guided, web-based modules for up to 15 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '15 weeks', 'description': 'The number of participants who completed at least 90 minutes of an intervention by 15 weeks', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'An intent to treat analysis was done at 15 weeks on all participants who were enrolled (ie the 31 participants in the STAIR-PC group and the 29 participants in the WebSTAIR group).'}, {'type': 'PRIMARY', 'title': 'Acceptability Measured by Client Satisfaction Questionnaire (CSQ-8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'STAIR-PC Group', 'description': 'Participants in the Skills Training in Affective and Interpersonal Regulation for Primary Care (STAIR-PC) group will complete five (30 minute each) therapist-led sessions in-person or via Telehealth for up to 15 weeks.'}, {'id': 'OG001', 'title': 'WebSTAIR Group', 'description': 'Participants in the WebSTAIR group will complete 10 self-guided, web-based modules for up to 15 weeks.'}], 'classes': [{'title': '15 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.6', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '23.7', 'spread': '6.3', 'groupId': 'OG001'}]}]}, {'title': '9 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.1', 'spread': '4.0', 'groupId': 'OG000'}, {'value': '23.3', 'spread': '5.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '15 weeks, 9 months', 'description': 'The Client Satisfaction Questionnaire (CSQ-8) is an 8-item survey to measure and assess consumer satisfaction with health and human services. Response options differ for each item, the scale ranges from very negative response (1) to a very positive response (4), and the total range for the CSQ-8 can be from 1 to 32 with higher scores indicating higher satisfaction.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The numbers of participants analyzed for this outcome at 15 weeks and 9 months is provided in the the data table and in the participant flow.'}, {'type': 'SECONDARY', 'title': 'General Mental Health Functioning Measured by the Brief Symptom Inventory (BSI-18)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'STAIR-PC Group', 'description': 'Participants in the Skills Training in Affective and Interpersonal Regulation for Primary Care (STAIR-PC) group will complete five (30 minute each) therapist-led sessions in-person or via Telehealth for up to 15 weeks.'}, {'id': 'OG001', 'title': 'WebSTAIR Group', 'description': 'Participants in the WebSTAIR group will complete 10 self-guided, web-based modules for up to 15 weeks.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '37.77', 'spread': '16.40', 'groupId': 'OG000'}, {'value': '37.21', 'spread': '15.00', 'groupId': 'OG001'}]}]}, {'title': '15 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.80', 'spread': '16.65', 'groupId': 'OG000'}, {'value': '28.30', 'spread': '14.29', 'groupId': 'OG001'}]}]}, {'title': '9 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.13', 'spread': '17.57', 'groupId': 'OG000'}, {'value': '25.29', 'spread': '15.76', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 15 weeks, 9 months', 'description': 'The Brief Symptom Inventory (BSI-18) is an 18-item self-report measure to assess psychological problems. The responses for each item ranges from Not At All (0) to Extremely (4), so the toal scores can range from 0 to 72. Higher total scores indicate higher severity of psychological distress.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Refer to participant flow for numbers of participants analyzed at baseline, 15 weeks, and 9 months assessments.'}, {'type': 'SECONDARY', 'title': 'Emotional Regulation Measured by the Difficulties in Emotion Regulation Scale (DERS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'STAIR-PC Group', 'description': 'Participants in the Skills Training in Affective and Interpersonal Regulation for Primary Care (STAIR-PC) group will complete five (30 minute each) therapist-led sessions in-person or via Telehealth for up to 15 weeks.'}, {'id': 'OG001', 'title': 'WebSTAIR Group', 'description': 'Participants in the WebSTAIR group will complete 10 self-guided, web-based modules for up to 15 weeks.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '106.26', 'spread': '23.47', 'groupId': 'OG000'}, {'value': '109.83', 'spread': '28.28', 'groupId': 'OG001'}]}]}, {'title': '15 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '92.56', 'spread': '28.52', 'groupId': 'OG000'}, {'value': '97.80', 'spread': '28.58', 'groupId': 'OG001'}]}]}, {'title': '9 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '80.87', 'spread': '32.80', 'groupId': 'OG000'}, {'value': '87.35', 'spread': '22.77', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 15 weeks, 9 months', 'description': 'The Difficulties in Emotion Regulation Scale (DERS) is a 36-item self-report measure of emotion regulation difficulties. Individual item responses range from Almost never (1) to Almost always (5), creating a potential total score range for the DERS of 36 to 180. Higher total scores indicate higher symptom severity.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Refer to participant flow for numbers of participants analyzed at baseline, 15 weeks, and 9 months assessments.'}, {'type': 'SECONDARY', 'title': 'Trauma Symptoms as Assessed by the Trauma Symptoms of Discrimination Scale (TSDS) of Discrimination Scale,', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'STAIR-PC Group', 'description': 'Participants in the Skills Training in Affective and Interpersonal Regulation for Primary Care (STAIR-PC) group will complete five (30 minute each) therapist-led sessions in-person or via Telehealth for up to 15 weeks.'}, {'id': 'OG001', 'title': 'WebSTAIR Group', 'description': 'Participants in the WebSTAIR group will complete 10 self-guided, web-based modules for up to 15 weeks.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '58.39', 'spread': '16.61', 'groupId': 'OG000'}, {'value': '56.34', 'spread': '16.07', 'groupId': 'OG001'}]}]}, {'title': '15 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '53.08', 'spread': '16.99', 'groupId': 'OG000'}, {'value': '48.30', 'spread': '16.57', 'groupId': 'OG001'}]}]}, {'title': '9months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '49.83', 'spread': '18.48', 'groupId': 'OG000'}, {'value': '55.38', 'spread': '19.17', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 15 weeks, 9 months', 'description': 'The TSDS assesses discriminatory distress and anxiety-related trauma symptoms. It includes 21 items, each of which is rated on a 4-point scale ranging from 1 (Never) to 4 (Often). The total score of the TSDS is calculated by adding up the scores from all items and can range from 21 to 84. HIgher scores are asociated with more trauma.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Refer to participant flow for numbers of participants analyzed at baseline, 15 weeks, and 9 months assessments.'}, {'type': 'SECONDARY', 'title': 'Social Functioning Measured by the Interpersonal Support Evaluation List - 12-item Version (ISEL-12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'STAIR-PC Group', 'description': 'Participants in the Skills Training in Affective and Interpersonal Regulation for Primary Care (STAIR-PC) group will complete five (30 minute each) therapist-led sessions in-person or via Telehealth for up to 15 weeks.'}, {'id': 'OG001', 'title': 'WebSTAIR Group', 'description': 'Participants in the WebSTAIR group will complete 10 self-guided, web-based modules for up to 15 weeks.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.48', 'spread': '7.54', 'groupId': 'OG000'}, {'value': '31.26', 'spread': '7.71', 'groupId': 'OG001'}]}]}, {'title': '15 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32.36', 'spread': '9.00', 'groupId': 'OG000'}, {'value': '31.77', 'spread': '7.74', 'groupId': 'OG001'}]}]}, {'title': '9 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '34.14', 'spread': '6.81', 'groupId': 'OG000'}, {'value': '33.50', 'spread': '9.55', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 15 weeks, 9 months', 'description': 'The Interpersonal Support Evaluation List - 12-item version (ISEL-12) is a 12-item self-report measure to assess perceptions of social supports. Each item response ranges from Definitely false (1) to Definitely true (4), creating a total score range of 12 to 48. Higher total scores indicate greater social supports.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Refer to participant flow for numbers of participants analyzed at baseline, 15 weeks, and 9 months assessments.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'STAIR-PC Group', 'description': 'Participants in the Skills Training in Affective and Interpersonal Regulation for Primary Care (STAIR-PC) group will complete five (30 minute each) therapist-led sessions in-person or via Telehealth for up to 15 weeks.'}, {'id': 'FG001', 'title': 'WebSTAIR Group', 'description': 'Participants in the WebSTAIR group will complete 10 self-guided, web-based modules for up to 15 weeks.'}], 'periods': [{'title': 'Baseline', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': '15 Weeks Assessment', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '9'}]}]}, {'title': '9 Months Assessment', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'STAIR-PC Group', 'description': 'Participants in the Skills Training in Affective and Interpersonal Regulation for Primary Care (STAIR-PC) group will complete five (30 minute each) therapist-led sessions in-person or via Telehealth for up to 15 weeks.'}, {'id': 'BG001', 'title': 'WebSTAIR Group', 'description': 'Participants in the WebSTAIR group will complete 10 self-guided, web-based modules for up to 15 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '35.69', 'spread': '14.95', 'groupId': 'BG000'}, {'value': '36.28', 'spread': '10.57', 'groupId': 'BG001'}, {'value': '35.97', 'spread': '12.92', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Male', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Female', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}, {'title': 'Queer/Non Binary/Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Declined to answer', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', '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': '18', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-11-08', 'size': 506861, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-01-24T22:09', 'hasProtocol': True}, {'date': '2021-10-18', 'size': 508060, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-02-28T20:58', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-02-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-24', 'studyFirstSubmitDate': '2021-06-15', 'resultsFirstSubmitDate': '2024-12-18', 'studyFirstSubmitQcDate': '2021-06-16', 'lastUpdatePostDateStruct': {'date': '2025-02-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-01-24', 'studyFirstPostDateStruct': {'date': '2021-06-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Posttraumatic Stress Disorder Symptoms Measured by PTSD Checklist for DSM-5 (PCL-5)', 'timeFrame': 'Baseline, 15 weeks, and 9 months', 'description': 'The PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-report measure that assesses the 20 DSM-5 symptoms. The PCL-5 scale ranges from Not At All (0) to Extremely (4) so the PTSD checklist total scores can range from 0 to 80, where higher scores indicate higher severity of PTSD symptoms.'}, {'measure': 'Feasibility Based on Retention', 'timeFrame': '15 weeks', 'description': 'The number of participants who completed at least 90 minutes of an intervention by 15 weeks'}, {'measure': 'Acceptability Measured by Client Satisfaction Questionnaire (CSQ-8)', 'timeFrame': '15 weeks, 9 months', 'description': 'The Client Satisfaction Questionnaire (CSQ-8) is an 8-item survey to measure and assess consumer satisfaction with health and human services. Response options differ for each item, the scale ranges from very negative response (1) to a very positive response (4), and the total range for the CSQ-8 can be from 1 to 32 with higher scores indicating higher satisfaction.'}], 'secondaryOutcomes': [{'measure': 'General Mental Health Functioning Measured by the Brief Symptom Inventory (BSI-18)', 'timeFrame': 'Baseline, 15 weeks, 9 months', 'description': 'The Brief Symptom Inventory (BSI-18) is an 18-item self-report measure to assess psychological problems. The responses for each item ranges from Not At All (0) to Extremely (4), so the toal scores can range from 0 to 72. Higher total scores indicate higher severity of psychological distress.'}, {'measure': 'Emotional Regulation Measured by the Difficulties in Emotion Regulation Scale (DERS)', 'timeFrame': 'Baseline, 15 weeks, 9 months', 'description': 'The Difficulties in Emotion Regulation Scale (DERS) is a 36-item self-report measure of emotion regulation difficulties. Individual item responses range from Almost never (1) to Almost always (5), creating a potential total score range for the DERS of 36 to 180. Higher total scores indicate higher symptom severity.'}, {'measure': 'Trauma Symptoms as Assessed by the Trauma Symptoms of Discrimination Scale (TSDS) of Discrimination Scale,', 'timeFrame': 'Baseline, 15 weeks, 9 months', 'description': 'The TSDS assesses discriminatory distress and anxiety-related trauma symptoms. It includes 21 items, each of which is rated on a 4-point scale ranging from 1 (Never) to 4 (Often). The total score of the TSDS is calculated by adding up the scores from all items and can range from 21 to 84. HIgher scores are asociated with more trauma.'}, {'measure': 'Social Functioning Measured by the Interpersonal Support Evaluation List - 12-item Version (ISEL-12)', 'timeFrame': 'Baseline, 15 weeks, 9 months', 'description': 'The Interpersonal Support Evaluation List - 12-item version (ISEL-12) is a 12-item self-report measure to assess perceptions of social supports. Each item response ranges from Definitely false (1) to Definitely true (4), creating a total score range of 12 to 48. Higher total scores indicate greater social supports.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mental health treatment', 'Primary Care', 'STAIR intervention', 'webSTAIR intervention'], 'conditions': ['Posttraumatic Stress Disorder']}, 'referencesModule': {'references': [{'pmid': '37244367', 'type': 'BACKGROUND', 'citation': 'Godfrey LB, Cloitre M, Elwy AR, Fortuna LR, Fuchs C, Valentine SE. Study protocol for a hybrid 1 effectiveness-implementation trial of Brief Skills Training in Affective and Interpersonal Regulation (Brief STAIR) and web-administered STAIR (webSTAIR) for posttraumatic stress disorder in integrated primary care. Contemp Clin Trials. 2023 Aug;131:107241. doi: 10.1016/j.cct.2023.107241. Epub 2023 May 25.'}]}, 'descriptionModule': {'briefSummary': "A majority of residents in low income communities have been exposed to a potentially traumatic event, and up to half (30-50%) of trauma-exposed residents in safety net clinical settings meet criteria for posttraumatic stress disorder (PTSD). Despite this, only 13% receive treatment. Poor access to PTSD treatment is due to a shortage of mental health specialists.\n\nThis study aims to evaluate the implementation and effectiveness of a brief, cognitive-behavioral intervention for posttraumatic stress disorder (PTSD)-Skills Training in Affective and Interpersonal Regulation (STAIR)- that will be offered in Boston Medical Center (BMC)'s primary care clinics as the new standard of care following integrated behavioral healthcare (IBH) therapist training. In response to clinician capacity concerns and the impact of the COVID-19 pandemic, we will be offering the intervention in both clinician-administered and self-paced, web-administered formats. The evidence base suggests that STAIR, delivered both synchronously (in-person/telehealth STAIR) and asynchronously (webSTAIR), is associated with significant improvements in PTSD and depression symptoms.", 'detailedDescription': "Participants who enroll in the study will be randomized to either in-person/telehealth STAIR or webSTAIR. Those who do not enroll in the study will still be able to receive STAIR in person or via telehealth as part of usual care.\n\nParticipant data will be for 9 months. Treatment plans will continue to be determined by usual care providers, the study has no involvement in any decisions regarding care. This means that a participant's IBH therapist can continue the therapy, offer a different treatment option, or refer to other services at any time in the study and after the study is completed. At any time, patients can also choose to change their treatment plans, for example from webSTAIR to in-person/telehealth STAIR, or to another treatment option in the clinic. Access to webSTAIR will be discontinued at 9 months.\n\nThe investigators hypothesize that offering a low intensity treatment for PTSD through primary care will improve access to and engagement in care for PTSD among BMC's patient population. The feasibility of two modes of treatment delivery will be compared, while gathering further evidence of the effectiveness of the intervention in our local setting. It is also hypothesized that both formats will be effective in reducing mental health symptoms, while webSTAIR may have some advantages in regard to uptake and long-term sustainability in usual care."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Client seen in integrated behavioral health in Boston Medical Center's General Internal Medicine and Family Medicine clinics.\n* Able to receive therapy in English (per participant report)\n* Exposure to trauma (as indicated by Life Events Checklist (LEC) for the Diagnostic and Statistical Manual of Mental Disorders (DSM) DSM-5 \\[LEC-5\\])\n* Subthreshold or Full Criteria for PTSD (as indicated by the PTSD Checklist Posttraumatic Stress Disorder Checklist (PCL) for the DSM-5 \\[PCL-5\\])\n* Reasonable to access to technology needed to support either condition (e.g., phone, computer, internet access).\n\nExclusion Criteria:\n\n* Patient is not appropriate for outpatient level of care / standard of care provided in Integrated behavioral health (IBH) per clinician judgement\n* Currently receiving cognitive behavioral therapy for PTSD elsewhere e.g., cognitive processing theory (CPT), prolonged exposure (PE), eye movement desensitization and reprocessing (EMDR).\n* Patient is experiencing bereavement (death of someone close) as primary clinical concern, and is therefore not a good fit for a PTSD-specific treatment at this time."}, 'identificationModule': {'nctId': 'NCT04937504', 'acronym': 'I-STEP', 'briefTitle': 'Implementing a Skills Training Evidence-Based Treatment for Posttraumatic Stress Disorder in Primary Care', 'organization': {'class': 'OTHER', 'fullName': 'Boston Medical Center'}, 'officialTitle': 'Implementing a Skills Training Evidence-Based Treatment for Posttraumatic Stress Disorder in Primary Care (I-STEP)', 'orgStudyIdInfo': {'id': 'H-41323'}, 'secondaryIdInfos': [{'id': 'K23MH117221-03', 'link': 'https://reporter.nih.gov/quickSearch/K23MH117221-03', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'STAIR-PC Group', 'description': 'Participants in the Skills Training in Affective and Interpersonal Regulation for Primary Care (STAIR-PC) group will complete five (30 minute each) therapist-led sessions in-person or via Telehealth for up to 15 weeks.', 'interventionNames': ['Behavioral: STAIR-PC Group']}, {'type': 'EXPERIMENTAL', 'label': 'WebSTAIR Group', 'description': 'Participants in the WebSTAIR group will complete 10 self-guided, web-based modules for up to 15 weeks.', 'interventionNames': ['Behavioral: WebSTAIR Group']}], 'interventions': [{'name': 'STAIR-PC Group', 'type': 'BEHAVIORAL', 'description': 'Skills Training in Affective and Interpersonal Regulation for Primary Care (STAIR-PC) is a face-to-face, individual, brief (5 session) therapy adapted from the STAIR program. STAIR-PC is an appropriate treatment for individuals who have experienced traumatic stressors, and addresses symptom targets by teaching skills to improve coping with emotions and strengthen interpersonal relationships.', 'armGroupLabels': ['STAIR-PC Group']}, {'name': 'WebSTAIR Group', 'type': 'BEHAVIORAL', 'description': 'WebSTAIR is a web-based self-help program adapted from the STAIR program for individuals who have experienced traumatic stressors. WebSTAIR contains 10 self-guided interactive modules that teach skills to improve coping with emotions and strengthen interpersonal relationships.', 'armGroupLabels': ['WebSTAIR Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston Medical Center Clinics', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Sarah Valentine, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Boston Medical Center, Psychiatry Department'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}