Mechanisms of Action and Outcome (Peer Support)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00555568
First received: November 6, 2007
Last updated: September 18, 2014
Last verified: September 2014
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Mechanisms of Action and Outcome in Peer Support Groups

Resource links provided by NLM:


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 ]

Enrollment: 299
Study Start Date: January 2007
Study Completion Date: June 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
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: Arm 2
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: Arm 3
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
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
Sponsors and Collaborators
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
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00555568     History of Changes
Other Study ID Numbers: D4464-R
Study First Received: November 6, 2007
Last Updated: September 18, 2014
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on October 20, 2014