- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00555568
Mechanisms of Action and Outcome (Peer Support)
Mechanisms of Action and Outcome in Peer Support Groups
Study Overview
Status
Conditions
Detailed Description
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.
Objectives: 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.
Methods: 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.
Significance 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Connecticut
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West Haven, Connecticut, United States, 06516
- VA Connecticut Health Care System (West Haven)
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Massachusetts
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Bedford, Massachusetts, United States, 01730
- VA New England Health Care System
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- veteran in treatment for a psychiatric disorder at a participating study site
Exclusion Criteria:
- currently participating in a recovery group that constitutes an intervention arm of this research study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Peer-led Groups
Arm 1 is a 3-month recovery-focused mental health education and support group led by peer facilitators
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This is a recovery-focused mental health education and support group led by peer facilitators
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Experimental: Clinician-led Groups
Arm 2 is a 3-month recovery-focused mental health education and support group led by a mental health clinician
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This is a recovery-focused mental health education and support group led by a mental health clinician
|
|
No Intervention: Treatment as Usual
Arm 3 is treatment as usual (no intervention)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient Activation
Time Frame: 3 months
|
Patient activation refers to patient knowledge skill and confidence for self-management. Full 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. |
3 months
|
|
Empowerment
Time Frame: 3 months
|
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.
|
3 months
|
|
Social Support
Time Frame: 3 months
|
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
|
3 months
|
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VR-12 MCS
Time Frame: 3 months
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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;
|
3 months
|
|
Overall Mental Health (BASIS-24 Summary Score)
Time Frame: 3 months
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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.
|
3 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Susan V. Eisen, PhD BA, VA New England Health Care System
- Principal Investigator: Jack A Clark, PhD, VA New England Health Care System
Publications and helpful links
General Publications
- 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.
- 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.
- 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
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D4464-R
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