Mechanisms of Action and Outcome (Peer Support)
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|ClinicalTrials.gov Identifier: NCT00555568|
Recruitment Status : Completed
First Posted : November 8, 2007
Results First Posted : June 23, 2015
Last Update Posted : June 23, 2015
|Condition or disease||Intervention/treatment||Phase|
|Mental Disorders||Behavioral: recovery oriented mental health peer support group Behavioral: recovery-oriented mental health clinician-led group||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||298 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Mechanisms of Action and Outcome in Peer Support Groups|
|Study Start Date :||January 2007|
|Actual Primary Completion Date :||January 2010|
|Actual Study Completion Date :||June 2010|
Experimental: Peer-led Groups
Arm 1 is a 3-month recovery-focused mental health education and support group led by peer facilitators
Behavioral: recovery oriented mental health peer support group
This is a recovery-focused mental health education and support group led by peer facilitators
Experimental: Clinician-led Groups
Arm 2 is a 3-month recovery-focused mental health education and support group led by a mental health clinician
Behavioral: recovery-oriented mental health clinician-led group
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)
- 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.
- 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.
- 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
- VR-12 MCS [ Time Frame: 3 months ]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;
- Overall Mental Health (BASIS-24 Summary Score) [ Time Frame: 3 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00555568
|United States, Connecticut|
|VA Connecticut Health Care System (West Haven)|
|West Haven, Connecticut, United States, 06516|
|United States, Massachusetts|
|VA New England Health Care System|
|Bedford, Massachusetts, United States, 01730|
|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|