Ignite Creation Date:
2025-12-24 @ 5:51 PM
Ignite Modification Date:
2026-02-23 @ 8:56 PM
Study NCT ID:
NCT00555568
Status:
COMPLETED
Last Update Posted:
2015-06-23
First Post:
2007-11-06
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Mechanisms of Action and Outcome
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'susan.eisen@va.gov', 'phone': '781-687-2858', 'title': 'Susan V. Eisen', 'organization': 'CHOIR (Center for Healthcare Organization & Implementation Research'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'from enrollment to completion of 3-month follow-up', 'eventGroups': [{'id': 'EG000', 'title': 'Arm 1: Peer-led Group', 'description': 'Arm 1 is a 3-month recovery-focused mental health education and support group led by peer facilitators', 'otherNumAtRisk': 100, 'otherNumAffected': 0, 'seriousNumAtRisk': 100, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Arm 2: Clinician-led Group', 'description': 'Arm 2 is a 3-month recovery-focused mental health education and support group led by a mental health clinician', 'otherNumAtRisk': 98, 'otherNumAffected': 0, 'seriousNumAtRisk': 98, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Arm 3: Treatment as Usual', 'description': 'Arm 3 is treatment as usual (no intervention)', 'otherNumAtRisk': 100, 'otherNumAffected': 0, 'seriousNumAtRisk': 100, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Patient Activation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Peer-led Group', 'description': 'Arm 1 is a 3-month recovery-focused mental health education and support group led by peer facilitators'}, {'id': 'OG001', 'title': 'Arm 2: Clinician-led Group', 'description': 'Arm 2 is a 3-month recovery-focused mental health education and support group led by a mental health clinician'}, {'id': 'OG002', 'title': 'Arm 3: Treatment as Usual', 'description': 'Arm 3 is treatment as usual (no intervention)'}], 'classes': [{'categories': [{'measurements': [{'value': '29.12', 'spread': '5.91', 'groupId': 'OG000'}, {'value': '28.82', 'spread': '6.48', 'groupId': 'OG001'}, {'value': '29.21', 'spread': '5.80', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'Patient activation refers to patient knowledge skill and confidence for self-management.\n\nFull name of the scale is Patient Activation Measure (PAM). Scale response options range from 1-4 and scores can range from 13-52. Higher values indicate greater activation. No subscales are used.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Empowerment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Peer-led Group', 'description': 'Arm 1 is a 3-month recovery-focused mental health education and support group led by peer facilitators'}, {'id': 'OG001', 'title': 'Arm 2: Clinician-led Group', 'description': 'Arm 2 is a 3-month recovery-focused mental health education and support group led by a mental health clinician'}, {'id': 'OG002', 'title': 'Arm 3: Treatment as Usual', 'description': 'Arm 3 is treatment as usual (no intervention)'}], 'classes': [{'categories': [{'measurements': [{'value': '80.20', 'spread': '6.66', 'groupId': 'OG000'}, {'value': '80.85', 'spread': '8.00', 'groupId': 'OG001'}, {'value': '81.15', 'spread': '8.37', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'Empowerment is measured by the "Making Decisions" instrument. Response options range from 1-4 and scores can range from 28-112. Higher scores indicate more empowerment.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Social Support', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Peer-led Group', 'description': 'Arm 1 is a 3-month recovery-focused mental health education and support group led by peer facilitators'}, {'id': 'OG001', 'title': 'Arm 2: Clinician-led Group', 'description': 'Arm 2 is a 3-month recovery-focused mental health education and support group led by a mental health clinician'}, {'id': 'OG002', 'title': 'Arm 3: Treatment as Usual', 'description': 'Arm 3 is treatment as usual (no intervention)'}], 'classes': [{'categories': [{'measurements': [{'value': '63.18', 'spread': '16.59', 'groupId': 'OG000'}, {'value': '58.21', 'spread': '19.00', 'groupId': 'OG001'}, {'value': '64.30', 'spread': '16.31', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'Social Support was assessed by the Medical Outcomes Study Social Support Survey. Response options range from 1-5 and scores range from 19-95. Higher scores indicate greater social support', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'VR-12 MCS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Peer-led Group', 'description': 'Arm 1 is a 3-month recovery-focused mental health education and support group led by peer facilitators'}, {'id': 'OG001', 'title': 'Arm 2: Clinician-led Group', 'description': 'Arm 2 is a 3-month recovery-focused mental health education and support group led by a mental health clinician'}, {'id': 'OG002', 'title': 'Arm 3: Treatment as Usual', 'description': 'Arm 3 is treatment as usual (no intervention)'}], 'classes': [{'categories': [{'measurements': [{'value': '47.16', 'spread': '12.41', 'groupId': 'OG000'}, {'value': '44.57', 'spread': '13.30', 'groupId': 'OG001'}, {'value': '47.18', 'spread': '12.80', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'VR-12 MCS refers to the Mental Health Component of the SF-12. The rating scale varies depending on the item. Scores range from 0-100; higher values indicate better mental health;', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Overall Mental Health (BASIS-24 Summary Score)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Peer-led Group', 'description': 'Arm 1 is a 3-month recovery-focused mental health education and support group led by peer facilitators'}, {'id': 'OG001', 'title': 'Arm 2: Clinician-led Group', 'description': 'Arm 2 is a 3-month recovery-focused mental health education and support group led by a mental health clinician'}, {'id': 'OG002', 'title': 'Arm 3: Treatment as Usual', 'description': 'Arm 3 is treatment as usual (no intervention)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.09', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '1.24', 'spread': '0.66', 'groupId': 'OG001'}, {'value': '1.08', 'spread': '0.65', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'BASIS-24 refers to the 24-item Behavior and Symptom Identification Scale. Responses range from 0-4; scores range from 0-4; higher values indicate greater symptom severity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm 1: Peer-led Group', 'description': 'Arm 1 is a 3-month recovery-focused mental health education and support group led by peer facilitators'}, {'id': 'FG001', 'title': 'Arm 2: Clinician Led Group', 'description': 'Arm 2 is a 3-month recovery-focused mental health education and support group led by a mental health clinician'}, {'id': 'FG002', 'title': 'Arm 3: Treatment as Usual', 'description': 'Arm 3 is treatment as usual (no intervention)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}, {'groupId': 'FG001', 'numSubjects': '98'}, {'groupId': 'FG002', 'numSubjects': '100'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '74'}, {'groupId': 'FG001', 'numSubjects': '82'}, {'groupId': 'FG002', 'numSubjects': '84'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '16'}]}]}], 'recruitmentDetails': "Three cohorts of veterans were recruited from each of two sites. Those assigned to a peer-led group participated in the Vet-to-Vet program. Those assigned to a clinician-led group participated in a recovery-oriented group led by a clinician. Those assigned to 'treatment-as-usual' continued with their usual treatment."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}, {'value': '298', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm 1: Peer-Led Group', 'description': 'Arm 1 is a 3-month recovery-focused mental health education and support group led by peer facilitators\n\nrecovery oriented mental health peer support group: This is a recovery-focused mental health education and support group led by peer facilitators'}, {'id': 'BG001', 'title': 'Arm 2: Clinician-Led Group', 'description': 'Arm 2 is a 3-month recovery-focused mental health education and support group led by a mental health clinician\n\nrecovery-oriented mental health clinician-led group: This is a recovery-focused mental health education and support group led by a mental health clinician'}, {'id': 'BG002', 'title': 'Arm 3: Treatment as Usual', 'description': 'Arm 3 is treatment as usual (no intervention)'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '< 35 years', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}]}, {'title': '35-50 years', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '93', 'groupId': 'BG003'}]}]}, {'title': '51-60 years', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}, {'value': '132', 'groupId': 'BG003'}]}]}, {'title': '>60 years', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '55', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '95', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}, {'value': '276', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}, {'value': '270', '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': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', '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': '22', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '77', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '190', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}, {'value': '298', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'veterans treated for a mental health condition at one of 2 VA medical centers'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 298}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-22', 'studyFirstSubmitDate': '2007-11-06', 'resultsFirstSubmitDate': '2015-02-20', 'studyFirstSubmitQcDate': '2007-11-07', 'lastUpdatePostDateStruct': {'date': '2015-06-23', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-06-22', 'studyFirstPostDateStruct': {'date': '2007-11-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-06-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Activation', 'timeFrame': '3 months', 'description': 'Patient activation refers to patient knowledge skill and confidence for self-management.\n\nFull name of the scale is Patient Activation Measure (PAM). Scale response options range from 1-4 and scores can range from 13-52. Higher values indicate greater activation. No subscales are used.'}, {'measure': 'Empowerment', 'timeFrame': '3 months', 'description': 'Empowerment is measured by the "Making Decisions" instrument. Response options range from 1-4 and scores can range from 28-112. Higher scores indicate more empowerment.'}, {'measure': 'Social Support', 'timeFrame': '3 months', 'description': 'Social Support was assessed by the Medical Outcomes Study Social Support Survey. Response options range from 1-5 and scores range from 19-95. Higher scores indicate greater social support'}, {'measure': 'VR-12 MCS', 'timeFrame': '3 months', 'description': 'VR-12 MCS refers to the Mental Health Component of the SF-12. The rating scale varies depending on the item. Scores range from 0-100; higher values indicate better mental health;'}, {'measure': 'Overall Mental Health (BASIS-24 Summary Score)', 'timeFrame': '3 months', 'description': 'BASIS-24 refers to the 24-item Behavior and Symptom Identification Scale. Responses range from 0-4; scores range from 0-4; higher values indicate greater symptom severity.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['mental health', 'group processes'], 'conditions': ['Mental Disorders']}, 'referencesModule': {'references': [{'pmid': '23203360', 'type': 'RESULT', 'citation': 'Eisen SV, Schultz MR, Mueller LN, Degenhart C, Clark JA, Resnick SG, Christiansen CL, Armstrong M, Bottonari KA, Rosenheck RA, Sadow D. Outcome of a randomized study of a mental health peer education and support group in the VA. Psychiatr Serv. 2012 Dec;63(12):1243-6. doi: 10.1176/appi.ps.201100348.'}, {'pmid': '24660950', 'type': 'RESULT', 'citation': 'Beehler S, Clark JA, Eisen SV. Participant experiences in peer- and clinician-facilitated mental health recovery groups for veterans. Psychiatr Rehabil J. 2014 Mar;37(1):43-50. doi: 10.1037/prj0000048.'}, {'type': 'RESULT', 'citation': 'Bottonari KA, Schultz MR, Resnick SG, Mueller L, Clark J, Sadow DC, Eisen SV. Peer-led vs. Clinician-led Recovery-Oriented Groups: What Predicts Attendance by Veterans? International Journal of Psychosocial Rehabilitation. 2012 Jan 1; 16(2):96-113'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to examine the mechanisms of action and outcome in mental health peer support groups. The study design is a randomized trial in which participants are assigned to one of three study arms: a recovery oriented mental health group led by peer facilitators (Vet-to-Vet), a recovery oriented group led by a clinician, or "treatment as usual." Qualitative and quantitative methods will be used to assess substantive content and process of the recovery groups, as well as mental health and recovery outcomes.', 'detailedDescription': 'Background: Rehabilitation and recovery services for individuals with psychiatric disorders are an important focus of the Veterans Health Administration. In FY 2004, 847,131 veterans (17.4% of VHA patients) received specialized VHA mental health services at a cost of almost $2 billion. In June 2004, Secretary Principi initiated a Mental Health Task Force to improve mental health care for veterans. The resulting comprehensive strategic plan, A Road Map for Transforming VA Mental Health Care" presented two central recommendations: 1) emphasize the recovery model at every medical center, and 2) develop and implement the full continuum of recovery-oriented mental health services. A recovery oriented mental health system is one that fosters self-determination, hope, and empowerment. Peer/consumer support groups, which provide a forum for mutual acceptance, empowerment, information, education, advocacy, skills training, and community reintegration are an important component of this plan, and have been implemented in a number of VHA centers.\n\nObjectives: The objectives of the proposed research are to assess the content and impact of VHA mental health peer support groups for recovery from mental illness. Specifically, we will: a) examine the structure, process and outcome of two models of recovery-oriented group treatment for mental health-peer/consumer support groups led by peer facilitators (Vet-to-Vet program), and recovery-oriented groups led by a clinician; b) assess and compare empowerment, social support, traditional outcomes (psychiatric and substance abuse symptoms, community functioning) and recovery-oriented outcomes (hope, strength/resiliency) in each type of program; and c) test a model in which recovery-oriented outcomes are mediated by empowerment and social support.\n\nMethods: The study will use a research design in which participants are randomly assigned to attend an existing peer facilitator-led support group, a clinician-led recovery-oriented group, or "treatment as usual". The sample will include 300 individuals receiving outpatient mental health services at one of two VA sites: Bedford, MA or West Haven, CT. Qualitative and quantitative methods will be used to address the research objectives. We will observe and tape record a sample of group meetings, and interview participants and group leaders (consumer-facilitators or clinicians) to analyze and understand the "ingredients" (structure and content) of these groups. We will use standardized measures of self-efficacy, empowerment and social support to determine effects of group type on participants\' feelings of empowerment and social support, and whether empowerment and social support result in better outcomes. We will assess recovery-oriented (hope, optimism, strength and resilience) and traditional (symptom and functioning) outcomes. Qualitative data from group observations and interviews will be used to explore what other factors might explain the effects of participation in peer-support and clinician-led groups. Quantitative measures will be analyzed using regression modeling in an "intent to treat" approach. Path analysis that entails a series of regression models will be used to test the hypothesized mediation effect.\n\nSignificance to VA: The VA has made a clear commitment to implementation of peer-support programs as part of a recovery-oriented transformation of its mental health service system. However, there is currently no published research reporting the processes or outcomes of these programs. This study will provide valuable information regarding if, why and how peer support groups, as well as clinician-led recovery-oriented groups, benefit veterans with mental illness. This information will be valuable in guiding implementation of such programs across the country.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* veteran in treatment for a psychiatric disorder at a participating study site\n\nExclusion Criteria:\n\n* currently participating in a recovery group that constitutes an intervention arm of this research study'}, 'identificationModule': {'nctId': 'NCT00555568', 'acronym': 'Peer Support', 'briefTitle': 'Mechanisms of Action and Outcome', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Mechanisms of Action and Outcome in Peer Support Groups', 'orgStudyIdInfo': {'id': 'D4464-R'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Peer-led Groups', 'description': 'Arm 1 is a 3-month recovery-focused mental health education and support group led by peer facilitators', 'interventionNames': ['Behavioral: recovery oriented mental health peer support group']}, {'type': 'EXPERIMENTAL', 'label': 'Clinician-led Groups', 'description': 'Arm 2 is a 3-month recovery-focused mental health education and support group led by a mental health clinician', 'interventionNames': ['Behavioral: recovery-oriented mental health clinician-led group']}, {'type': 'NO_INTERVENTION', 'label': 'Treatment as Usual', 'description': 'Arm 3 is treatment as usual (no intervention)'}], 'interventions': [{'name': 'recovery oriented mental health peer support group', 'type': 'BEHAVIORAL', 'description': 'This is a recovery-focused mental health education and support group led by peer facilitators', 'armGroupLabels': ['Peer-led Groups']}, {'name': 'recovery-oriented mental health clinician-led group', 'type': 'BEHAVIORAL', 'description': 'This is a recovery-focused mental health education and support group led by a mental health clinician', 'armGroupLabels': ['Clinician-led Groups']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06516', 'city': 'West Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'VA Connecticut Health Care System (West Haven)', 'geoPoint': {'lat': 41.27065, 'lon': -72.94705}}, {'zip': '01730', 'city': 'Bedford', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'VA New England Health Care System', 'geoPoint': {'lat': 42.49065, 'lon': -71.27617}}], 'overallOfficials': [{'name': 'Susan V. Eisen, PhD BA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA New England Health Care System'}, {'name': 'Jack A Clark, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA New England Health Care System'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'US Department of Veterans Affairs', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}