Mechanisms of Action and Outcome (Peer Support)

June 22, 2015 updated by: US Department of Veterans Affairs

Mechanisms of Action and Outcome in Peer Support Groups

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.

Study Overview

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

Interventional

Enrollment (Actual)

298

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Connecticut
      • West Haven, Connecticut, United States, 06516
        • VA Connecticut Health Care System (West Haven)
    • Massachusetts
      • Bedford, Massachusetts, United States, 01730
        • VA New England Health Care System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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
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)

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
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;
3 months
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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

November 6, 2007

First Submitted That Met QC Criteria

November 7, 2007

First Posted (Estimate)

November 8, 2007

Study Record Updates

Last Update Posted (Estimate)

June 23, 2015

Last Update Submitted That Met QC Criteria

June 22, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D4464-R

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe