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Mechanisms of Action and Outcome (Peer Support)
This study is currently recruiting participants.
Verified by Department of Veterans Affairs, October 2008
Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00555568
  Purpose

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.


Condition Intervention
Mental Disorders
Behavioral: recovery oriented mental health peer support group
Behavioral: recovery-oriented mental health clinician-led group

MedlinePlus related topics: Mental Health
U.S. FDA Resources
Study Type: Interventional
Study Design: Health Services Research, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Mechanisms of Action and Outcome in Peer Support Groups

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • BASIS-24, SF-12, Recovery Assessment Scale [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • empowerment scale, MOS social support scale, Hope Scale, Patient Activation Measure (PAM), Patient Satisfaction [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: January 2007
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
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
2: Experimental
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
3: No Intervention
Arm 3 is treatment as usual (no intervention)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00555568

Contacts
Contact: Patrick D Furlong, BA (781) 687-6714 patrick.furlong@va.gov
Contact: Nicole DelVecchio (781) 687-3162 nicole.delvecchio@va.gov

Locations
United States, Connecticut
VA Connecticut Health Care System (West Haven) Recruiting
West Haven, Connecticut, United States, 06516
Contact: Susan Crowley, MD     203-932-5711 ext 3950     susan.crowley@va.gov    
United States, Massachusetts
VA New England Health Care System Recruiting
Bedford, Massachusetts, United States, 01730
Contact: Susan V Eisen, PhD BA     781-687-2858     susan.eisen@va.gov    
Contact: Nicole DelVecchio     (781) 687-3162     nicole.delvecchio@va.gov    
Sub-Investigator: Jack A Clark, PhD            
Sub-Investigator: Cindy L Christiansen, PhD            
Principal Investigator: Susan V. Eisen, PhD BA            
Sponsors and Collaborators
Investigators
Principal Investigator: Susan V. Eisen, PhD BA VA New England Health Care System
  More Information

Responsible Party: Department of Veterans Affairs ( Eisen, Susan - Principal Investigator )
Study ID Numbers: D4464R
Study First Received: November 6, 2007
Last Updated: October 6, 2008
ClinicalTrials.gov Identifier: NCT00555568  
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
mental health
group processes

Study placed in the following topic categories:
Mental Disorders

ClinicalTrials.gov processed this record on January 15, 2009