Ignite Creation Date:
2025-12-24 @ 10:31 PM
Ignite Modification Date:
2025-12-25 @ 8:04 PM
Study NCT ID:
NCT03555435
Status:
COMPLETED
Last Update Posted:
2023-07-27
First Post:
2018-06-01
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Pilot Study of Peer-Supported Online Problem-Solving Program
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'eve.carlson@va.gov', 'phone': '6504935000', 'title': 'Eve Carlson', 'phoneExt': '24058', 'organization': 'National Center for PTSD'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'This was a pilot study primarily aimed at studying feasibility and acceptability of online study enrollment and data collection that was not powered to allow definitive conclusions from analyses. Study end measures were available from only 47% of participants randomized at baseline, indicating that online data collection is insufficient to obtain complete measures after the baseline.'}}, 'adverseEventsModule': {'description': 'This study of an educational program was conducted entirely online or by phone and included no medical intervention, measures, or monitoring. Groups were assigned to benign educational interventions. Adverse Events are not monitored.', 'eventGroups': [{'id': 'EG000', 'title': 'On Your Own', 'description': 'Moving Forward On Your Own: Participants in this group will use the online program on their own for 6 weeks.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Peer Support', 'description': 'Moving Forward with Peer Support: Participants in this group will use the online program on their own for 6 weeks with the support of a peer coach. Peer coaching sessions will consist of 6 15-20 minute sessions one time per week. Sessions will be guided by a Moving Forward Peer Support Manual.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Wait', 'description': 'Wait: Participants in this group will wait 6 weeks.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Problem-Solving Skills, Knowledge, and Abilities Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'On Your Own', 'description': 'Moving Forward On Your Own: Participants in this group will use the online program on their own for 6 weeks.'}, {'id': 'OG001', 'title': 'Peer Support', 'description': 'Moving Forward with Peer Support: Participants in this group will use the online program on their own for 6 weeks with the support of a peer coach. Peer coaching sessions will consist of 6 15-20 minute sessions one time per week. Sessions will be guided by a Moving Forward Peer Support Manual.'}, {'id': 'OG002', 'title': 'Wait', 'description': 'Wait: Participants in this group will wait 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-.55', 'spread': '1.64', 'groupId': 'OG000'}, {'value': '.38', 'spread': '2.26', 'groupId': 'OG001'}, {'value': '-.17', 'spread': '1.65', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'change from baseline to study end (6 weeks)', 'description': 'The Problem-Solving Skills, Knowledge, \\& Abilities Test is a brief, multiple-choice test that measures mastery of the basic concepts and skills that are included in the Moving Forward program. Scores on the test can range from 0 to 12 with higher scores indicating greater problem-solving skills, knowledge, and abilities.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Problem-Solving Confidence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'On Your Own', 'description': 'Moving Forward On Your Own: Participants in this group will use the online program on their own for 6 weeks.'}, {'id': 'OG001', 'title': 'Peer Support', 'description': 'Moving Forward with Peer Support: Participants in this group will use the online program on their own for 6 weeks with the support of a peer coach. Peer coaching sessions will consist of 6 15-20 minute sessions one time per week. Sessions will be guided by a Moving Forward Peer Support Manual.'}, {'id': 'OG002', 'title': 'Wait', 'description': 'Wait: Participants in this group will wait 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.91', 'spread': '1.97', 'groupId': 'OG000'}, {'value': '2.63', 'spread': '2.72', 'groupId': 'OG001'}, {'value': '0.56', 'spread': '1.72', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'change from baseline to study end (6 weeks)', 'description': "The Problem-Solving Confidence Test assesses participant's confidence in his/her own problem solving abilities. Scores on this measure can range from 0 to 9 with higher scores indicating greater problem-solving confidence.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'GAD-7 Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'On Your Own', 'description': 'Moving Forward On Your Own: Participants in this group will use the online program on their own for 6 weeks.'}, {'id': 'OG001', 'title': 'Peer Support', 'description': 'Moving Forward with Peer Support: Participants in this group will use the online program on their own for 6 weeks with the support of a peer coach. Peer coaching sessions will consist of 6 15-20 minute sessions one time per week. Sessions will be guided by a Moving Forward Peer Support Manual.'}, {'id': 'OG002', 'title': 'Wait', 'description': 'Wait: Participants in this group will wait 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.00', 'spread': '4.80', 'groupId': 'OG000'}, {'value': '-0.87', 'spread': '5.67', 'groupId': 'OG001'}, {'value': '1.06', 'spread': '4.26', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'change from baseline to study end (6 weeks)', 'description': 'The GAD-7 assesses the severity of anxiety symptoms associated with generalized anxiety in terms of the proportion of days assessed in which the symptoms were present. Score range 0-21. Positive values for change from baseline to study end represent decreases in anxiety. Negative values for change from baseline to end represent increases in anxiety.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Posttraumatic Stress Symptoms Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'On Your Own', 'description': 'Moving Forward On Your Own: Participants in this group will use the online program on their own for 6 weeks.'}, {'id': 'OG001', 'title': 'Peer Support', 'description': 'Moving Forward with Peer Support: Participants in this group will use the online program on their own for 6 weeks with the support of a peer coach. Peer coaching sessions will consist of 6 15-20 minute sessions one time per week. Sessions will be guided by a Moving Forward Peer Support Manual.'}, {'id': 'OG002', 'title': 'Wait', 'description': 'Wait: Participants in this group will wait 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.55', 'spread': '7.01', 'groupId': 'OG000'}, {'value': '3.50', 'spread': '9.09', 'groupId': 'OG001'}, {'value': '1.89', 'spread': '5.82', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'change from baseline to study end (6 weeks)', 'description': 'Symptom change was measured by 7 items from the Screen for Posttraumatic Stress Symptoms (SPTSS) and 4 items from the Dissociative Symptoms Scale (DSS). Scores for all items could range from 0 to 47. Scores on change could range from -47 to 47. Positive values for change from baseline to study end represent reductions in PTSD symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'WHO-5 Well-Being Index Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'On Your Own', 'description': 'Moving Forward On Your Own: Participants in this group will use the online program on their own for 6 weeks.'}, {'id': 'OG001', 'title': 'Peer Support', 'description': 'Moving Forward with Peer Support: Participants in this group will use the online program on their own for 6 weeks with the support of a peer coach. Peer coaching sessions will consist of 6 15-20 minute sessions one time per week. Sessions will be guided by a Moving Forward Peer Support Manual.'}, {'id': 'OG002', 'title': 'Wait', 'description': 'Wait: Participants in this group will wait 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.09', 'spread': '4.30', 'groupId': 'OG000'}, {'value': '-3.12', 'spread': '7.08', 'groupId': 'OG001'}, {'value': '-5.89', 'spread': '5.51', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'change from baseline to study end (6 weeks)', 'description': 'The World Health Organization Well-Being Index (WHO-5) is a widely-used 5-item measure assessing subjective psychological well-being. Its design for use around the world and translation into 30 languages are indicative of its usefulness as a measure for a diverse population. Score range 0-25. Positive changes from baseline to study end represent decreases in well-being. Negative values for change from baseline to end represent increases in well-being.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'PHQ-9 Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'On Your Own', 'description': 'Moving Forward On Your Own: Participants in this group will use the online program on their own for 6 weeks.'}, {'id': 'OG001', 'title': 'Peer Support', 'description': 'Moving Forward with Peer Support: Participants in this group will use the online program on their own for 6 weeks with the support of a peer coach. Peer coaching sessions will consist of 6 15-20 minute sessions one time per week. Sessions will be guided by a Moving Forward Peer Support Manual.'}, {'id': 'OG002', 'title': 'Wait', 'description': 'Wait: Participants in this group will wait 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.82', 'spread': '4.69', 'groupId': 'OG000'}, {'value': '-0.75', 'spread': '6.63', 'groupId': 'OG001'}, {'value': '1.61', 'spread': '2.83', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'change from baseline to study end (6 weeks)', 'description': 'The PHQ-9 assesses the severity of depression in terms of the proportion of days assessed in which the symptoms were present. Score range 0-27. Positive values for change from baseline to end represent reductions in depression. Negative values for change from baseline to end represent increases in depression.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Client Satisfaction Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'On Your Own', 'description': 'Moving Forward On Your Own: Participants in this group will use the online program on their own for 6 weeks.'}, {'id': 'OG001', 'title': 'Peer Support', 'description': 'Moving Forward with Peer Support: Participants in this group will use the online program on their own for 6 weeks with the support of a peer coach. Peer coaching sessions will consist of 6 15-20 minute sessions one time per week. Sessions will be guided by a Moving Forward Peer Support Manual.'}, {'id': 'OG002', 'title': 'Wait', 'description': 'Wait: Participants in this group will wait 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.9', 'spread': '3.09', 'groupId': 'OG000'}, {'value': '19.6', 'spread': '6.09', 'groupId': 'OG001'}, {'value': '17.9', 'spread': '5.03', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at study end (6 weeks)', 'description': 'The Client Satisfaction Questionnaire (CSQ) is a standardized, widely-used measure of customer satisfaction with health services and programs. Total scores on the 7-items we used range from 7 to 28. Higher scores represent greater satisfaction.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Stigma Measure (EZ-EASI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'On Your Own', 'description': 'Moving Forward On Your Own: Participants in this group will use the online program on their own for 6 weeks.'}, {'id': 'OG001', 'title': 'Peer Support', 'description': 'Moving Forward with Peer Support: Participants in this group will use the online program on their own for 6 weeks with the support of a peer coach. Peer coaching sessions will consist of 6 15-20 minute sessions one time per week. Sessions will be guided by a Moving Forward Peer Support Manual.'}, {'id': 'OG002', 'title': 'Wait', 'description': 'Wait: Participants in this group will wait 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.5', 'spread': '7.46', 'groupId': 'OG000'}, {'value': '14.5', 'spread': '8.36', 'groupId': 'OG001'}, {'value': '15.7', 'spread': '7.40', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'measured once at baseline', 'description': 'The Endorsed and Anticipated Stigma Inventory (EASI) is a tool for assessing different dimensions of stigma-related beliefs about mental health among military and veteran populations. Findings based on a national sample of U.S. veterans deployed in support of Operation Enduring Freedom (OEF) in Afghanistan or Operation Iraqi Freedom (OIF) in Iraq suggest that the EASI is a psychometrically sound instrument. Specifically, results revealed evidence for the internal consistency reliability, content validity, convergent and discriminant validity, and discriminative validity of EASI scales. Total scores on 13 items used range from 0 to 39. Higher scores represent greater endorsement of stigma-related beliefs.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data from this measure were available for all participants because it was administered with baseline measures at the time of enrollment.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Moving Forward Usage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'On Your Own', 'description': 'Moving Forward On Your Own: Participants in this group will use the online program on their own for 6 weeks.'}, {'id': 'OG001', 'title': 'Peer Support', 'description': 'Moving Forward with Peer Support: Participants in this group will use the online program on their own for 6 weeks with the support of a peer coach. Peer coaching sessions will consist of 6 15-20 minute sessions one time per week. Sessions will be guided by a Moving Forward Peer Support Manual.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.2', 'spread': '1.23', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '4.52', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'daily for 6 weeks', 'description': 'Usage was assessed by total number of days logging in to online course Moving Forward. This data was collected daily and automatically during study participation.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data from this measure were available for all participants because they were collected automatically via programming that collected and reported log ins to use the course. The course was mounted on a learning management platform and participants were given anonymized links to access the course.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'On Your Own', 'description': 'Moving Forward On Your Own: Participants in this group will use the online program on their own for 6 weeks.'}, {'id': 'FG001', 'title': 'Peer Support', 'description': 'Moving Forward with Peer Support: Participants in this group will use the online program on their own for 6 weeks with the support of a peer coach. Peer coaching sessions will consist of 6 15-20 minute sessions one time per week. Sessions will be guided by a Moving Forward Peer Support Manual.'}, {'id': 'FG002', 'title': 'Wait', 'description': 'Wait: Participants in this group will wait 6 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '8'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '81', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'On Your Own', 'description': 'Moving Forward On Your Own: Participants in this group will use the online program on their own for 6 weeks.'}, {'id': 'BG001', 'title': 'Peer Support', 'description': 'Moving Forward with Peer Support: Participants in this group will use the online program on their own for 6 weeks with the support of a peer coach. Peer coaching sessions will consist of 6 15-20 minute sessions one time per week. Sessions will be guided by a Moving Forward Peer Support Manual.'}, {'id': 'BG002', 'title': 'Wait', 'description': 'Wait: Participants in this group will wait 6 weeks.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '76', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52', 'spread': '10.3', 'groupId': 'BG000'}, {'value': '54', 'spread': '11.0', 'groupId': 'BG001'}, {'value': '56', 'spread': '9.4', 'groupId': 'BG002'}, {'value': '54', 'spread': '9.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '73', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '81', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-12-09', 'size': 241135, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-11-13T16:14', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "Randomized controlled trial with three groups: 1) Use of online problem-solving program on one's own. 2) Use of online problem-solving program with peer support. 3) Wait control group."}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2019-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-19', 'studyFirstSubmitDate': '2018-06-01', 'resultsFirstSubmitDate': '2020-11-17', 'studyFirstSubmitQcDate': '2018-06-01', 'lastUpdatePostDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-11-17', 'studyFirstPostDateStruct': {'date': '2018-06-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-12-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Stigma Measure (EZ-EASI)', 'timeFrame': 'measured once at baseline', 'description': 'The Endorsed and Anticipated Stigma Inventory (EASI) is a tool for assessing different dimensions of stigma-related beliefs about mental health among military and veteran populations. Findings based on a national sample of U.S. veterans deployed in support of Operation Enduring Freedom (OEF) in Afghanistan or Operation Iraqi Freedom (OIF) in Iraq suggest that the EASI is a psychometrically sound instrument. Specifically, results revealed evidence for the internal consistency reliability, content validity, convergent and discriminant validity, and discriminative validity of EASI scales. Total scores on 13 items used range from 0 to 39. Higher scores represent greater endorsement of stigma-related beliefs.'}, {'measure': 'Moving Forward Usage', 'timeFrame': 'daily for 6 weeks', 'description': 'Usage was assessed by total number of days logging in to online course Moving Forward. This data was collected daily and automatically during study participation.'}], 'primaryOutcomes': [{'measure': 'Problem-Solving Skills, Knowledge, and Abilities Test', 'timeFrame': 'change from baseline to study end (6 weeks)', 'description': 'The Problem-Solving Skills, Knowledge, \\& Abilities Test is a brief, multiple-choice test that measures mastery of the basic concepts and skills that are included in the Moving Forward program. Scores on the test can range from 0 to 12 with higher scores indicating greater problem-solving skills, knowledge, and abilities.'}, {'measure': 'Problem-Solving Confidence', 'timeFrame': 'change from baseline to study end (6 weeks)', 'description': "The Problem-Solving Confidence Test assesses participant's confidence in his/her own problem solving abilities. Scores on this measure can range from 0 to 9 with higher scores indicating greater problem-solving confidence."}], 'secondaryOutcomes': [{'measure': 'GAD-7 Change', 'timeFrame': 'change from baseline to study end (6 weeks)', 'description': 'The GAD-7 assesses the severity of anxiety symptoms associated with generalized anxiety in terms of the proportion of days assessed in which the symptoms were present. Score range 0-21. Positive values for change from baseline to study end represent decreases in anxiety. Negative values for change from baseline to end represent increases in anxiety.'}, {'measure': 'Posttraumatic Stress Symptoms Change', 'timeFrame': 'change from baseline to study end (6 weeks)', 'description': 'Symptom change was measured by 7 items from the Screen for Posttraumatic Stress Symptoms (SPTSS) and 4 items from the Dissociative Symptoms Scale (DSS). Scores for all items could range from 0 to 47. Scores on change could range from -47 to 47. Positive values for change from baseline to study end represent reductions in PTSD symptoms.'}, {'measure': 'WHO-5 Well-Being Index Change', 'timeFrame': 'change from baseline to study end (6 weeks)', 'description': 'The World Health Organization Well-Being Index (WHO-5) is a widely-used 5-item measure assessing subjective psychological well-being. Its design for use around the world and translation into 30 languages are indicative of its usefulness as a measure for a diverse population. Score range 0-25. Positive changes from baseline to study end represent decreases in well-being. Negative values for change from baseline to end represent increases in well-being.'}, {'measure': 'PHQ-9 Change', 'timeFrame': 'change from baseline to study end (6 weeks)', 'description': 'The PHQ-9 assesses the severity of depression in terms of the proportion of days assessed in which the symptoms were present. Score range 0-27. Positive values for change from baseline to end represent reductions in depression. Negative values for change from baseline to end represent increases in depression.'}, {'measure': 'Client Satisfaction Questionnaire', 'timeFrame': 'at study end (6 weeks)', 'description': 'The Client Satisfaction Questionnaire (CSQ) is a standardized, widely-used measure of customer satisfaction with health services and programs. Total scores on the 7-items we used range from 7 to 28. Higher scores represent greater satisfaction.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Problem-solving', 'Stigma reduction', 'Peer support', 'Online mental health program'], 'conditions': ['Problem-solving', 'Well-being', 'Peer Support', 'Online Mental Health Program']}, 'referencesModule': {'references': [{'pmid': '35023846', 'type': 'DERIVED', 'citation': 'Possemato K, Wu J, Greene C, MacQueen R, Blonigen D, Wade M, Owen J, Keane T, Brief D, Lindley S, Prins A, Mackintosh MA, Carlson E. Web-Based Problem-solving Training With and Without Peer Support in Veterans With Unmet Mental Health Needs: Pilot Study of Feasibility, User Acceptability, and Participant Engagement. J Med Internet Res. 2022 Jan 13;24(1):e29559. doi: 10.2196/29559.'}], 'seeAlsoLinks': [{'url': 'https://studypages.com/s/are-you-are-a-veteran-facing-challenging-problems-upgrade-your-problem-solving-skills-with-an-online-course-made-for-veterans-405563/', 'label': 'Social media marketing ad with link to join the study'}, {'url': 'https://is.gd/MovingForwardCourse', 'label': 'Link to REDCap eligibility screening questions'}]}, 'descriptionModule': {'briefSummary': 'Many Veterans with mental health care needs go without care due to stigma, practical problems with getting services, and a high value on self-sufficiency. VHA has developed online programs aimed at fostering MH that are easy to access and may be more acceptable than psychotherapy. The purpose of this study is to learn whether peer-supported use of an online problem-solving course is acceptable and helpful and whether the study data can be collected online. Results of this pilot study would inform a larger study of the impact on problem-solving and mental health of a non-stigmatizing, online program - with and without peer support. If effective, peer supported online programs would improve the quality of care to Veterans with unmet mental health needs.', 'detailedDescription': 'Approval will be obtained from VA primary care staff leaders at Palo Alto Division and VA Palo Alto Community Based Outpatient Clinics (CBOCs) to mail notes and a study information card to patients who do not have stop codes for mental health or integrated care in their EMR records for the past six months. The study information cards will describe the study, how to enroll, and will direct the Veteran to REDCap eligibility screening questions. When eligibility is confirmed, REDCap will automatically alert research assistant to enroll participant and randomize.\n\nPrimary Care Mental Health Integration staff at each clinic may also refer patients to the study by entering referral information directly into secure, encrypted REDCap files or by handing the patient a study information card.\n\nCommunity veterans will be invited via social media marketing. Ads will link to a study web site. Study web site will link potential participants to REDCap eligibility screening questions. When eligibility is confirmed, REDCap will automatically alert research assistant to enroll participant and randomize.\n\nVeterans who decide to be in the study will be assigned by chance to one of three groups: An On Your Own group, a Peer Support group, or a Wait group. Veterans assigned to take the Moving Forward course with peer support or on their own will complete the course online and practice the problem-solving skills they learned for six weeks. Finishing the Moving Forward course takes a total of about four hours. Veterans in the peer support group will speak with a Veteran who is experienced with the course on the phone for 15 to 20 minutes once a week during the study about using the ideas and exercises in the course to solve problems. Veterans assigned to the wait group will answer questions online about problem-solving skills and their well-being at the start and after six weeks). They will be able to take the course if they would like to after the six weeks have passed. Veterans in the On Your Own and Peer Support groups will answer questions online at the beginning, middle, and end of the study about problem-solving skills, their opinions about the course and about peer support (if they got it), and their well-being. This will take 10 to 15 minutes each time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A Veteran of one of the U.S. military services, including National Guard and Reserves.\n* Positive screen (score of 1 or more) on the PHQ-2 or GAD-2.\n* Access to a phone and to a desktop or laptop computer with internet access.\n* Willingness to be randomized to one of three conditions.\n* Willingness to work with a Peer Support Specialist.\n\nExclusion Criteria:\n\n* An active suicide plan.\n* Changes in psychoactive medications in the past month.\n* MH treatment in the past 6 months, including treatment from a PC-MHI team member.'}, 'identificationModule': {'nctId': 'NCT03555435', 'acronym': 'PS-OPS', 'briefTitle': 'Pilot Study of Peer-Supported Online Problem-Solving Program', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Pilot Study of Standalone and Peer Supported Online Problem Solving Program in Veterans With Untreated Mental Health Problems', 'orgStudyIdInfo': {'id': 'PPO 16-323'}, 'secondaryIdInfos': [{'id': 'HX-002361-01', 'type': 'OTHER_GRANT', 'domain': 'VA Health Services R & D'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'On Your Own', 'description': 'Participants in this group will use the online program on their own for 6 weeks.', 'interventionNames': ['Other: Moving Forward On Your Own']}, {'type': 'EXPERIMENTAL', 'label': 'Peer Support', 'description': 'Participants in this group will use the online program on their own for 6 weeks with the support of a peer coach. Peer coaching sessions will consist of 6 15-20 minute sessions one time per week. Sessions will be guided by a Moving Forward Peer Support Manual.', 'interventionNames': ['Behavioral: Moving Forward with Peer Support']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Wait', 'description': 'Participants in this group will wait 6 weeks.', 'interventionNames': ['Behavioral: Wait']}], 'interventions': [{'name': 'Moving Forward On Your Own', 'type': 'OTHER', 'description': 'Participants in this group will use the online program on their own for 6 weeks.', 'armGroupLabels': ['On Your Own']}, {'name': 'Moving Forward with Peer Support', 'type': 'BEHAVIORAL', 'description': 'Participants in this group will use the online program on their own for 6 weeks with the support of a peer coach. Peer coaching sessions will consist of 6 15-20 minute sessions one time per week. Sessions will be guided by a Moving Forward Peer Support Manual.', 'armGroupLabels': ['Peer Support']}, {'name': 'Wait', 'type': 'BEHAVIORAL', 'description': 'Participants in this group will wait 6 weeks.', 'armGroupLabels': ['Wait']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304-1207', '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}}], 'overallOfficials': [{'name': 'Eve Bernstein Carlson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Palo Alto Health Care System, Palo Alto, CA'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Datasets will be made available within 1 year of publication.', 'ipdSharing': 'YES', 'description': 'A de-identified, anonymized dataset containing IPD reported in a publication will be created and shared. Datasets meeting VA standards for disclosure to the public will be made available within 1 year of publication. Prior to distribution, a local privacy officer will certify that all datasets contains no PHI. Final data sets will be maintained locally until enterprise-level resources become available for long-term storage and access.', 'accessCriteria': 'Guidance on request and distribution processes will be provided by ORD. Those requesting data will be asked to sign a Letter of Agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}