Mechanisms of Action and Outcome

Mechanisms of Action and Outcome in Peer Support Groups

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00555568

Acronym

Peer Support

Enrollment

298

Registered

2007-11-08

Start date

2007-01-31

Completion date

2010-06-30

Last updated

2015-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mental Disorders

Keywords

mental health, group processes

Brief summary

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.

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.

Interventions

BEHAVIORALrecovery oriented mental health peer support group

This is a recovery-focused mental health education and support group led by peer facilitators

BEHAVIORALrecovery-oriented mental health clinician-led group

This is a recovery-focused mental health education and support group led by a mental health clinician

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Patient Activation	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	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	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	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)	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.

Countries

United States

Participant flow

Recruitment details

Three cohorts of veterans were recruited from each of two sites. Those assigned to a peer-led group participated in the Vet-to-Vet program. Those assigned to a clinician-led group participated in a recovery-oriented group led by a clinician. Those assigned to 'treatment-as-usual' continued with their usual treatment.

Participants by arm

Arm	Count
Arm 1: Peer-Led Group Arm 1 is a 3-month recovery-focused mental health education and support group led by peer facilitators recovery oriented mental health peer support group: This is a recovery-focused mental health education and support group led by peer facilitators	100
Arm 2: Clinician-Led Group Arm 2 is a 3-month recovery-focused mental health education and support group led by a mental health clinician recovery-oriented mental health clinician-led group: This is a recovery-focused mental health education and support group led by a mental health clinician	98
Arm 3: Treatment as Usual Arm 3 is treatment as usual (no intervention)	100
Total	298

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Lost to Follow-up	26	16	16

Baseline characteristics

Characteristic	Total	Arm 1: Peer-Led Group	Arm 2: Clinician-Led Group	Arm 3: Treatment as Usual
Age, Customized 35-50 years	93 participants	31 participants	38 participants	24 participants
Age, Customized < 35 years	18 participants	7 participants	8 participants	3 participants
Age, Customized 51-60 years	132 participants	44 participants	36 participants	52 participants
Age, Customized >60 years	55 participants	18 participants	16 participants	21 participants
Ethnicity (NIH/OMB) Hispanic or Latino	28 Participants	12 Participants	8 Participants	8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	270 Participants	88 Participants	90 Participants	92 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	77 Participants	22 Participants	32 Participants	23 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	31 Participants	12 Participants	8 Participants	11 Participants
Race (NIH/OMB) White	190 Participants	66 Participants	58 Participants	66 Participants
Region of Enrollment United States	298 participants	100 participants	98 participants	100 participants
Sex: Female, Male Female	22 Participants	5 Participants	10 Participants	7 Participants
Sex: Female, Male Male	276 Participants	95 Participants	88 Participants	93 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —
other Total, other adverse events	0 / 100	0 / 98	0 / 100
serious Total, serious adverse events	0 / 100	0 / 98	0 / 100

Arm	Measure	Value (MEAN)	Dispersion
Arm 1: Peer-led Group	VR-12 MCS	47.16 units on a scale	Standard Deviation 12.41
Arm 2: Clinician-led Group	VR-12 MCS	44.57 units on a scale	Standard Deviation 13.3
Arm 3: Treatment as Usual	VR-12 MCS	47.18 units on a scale	Standard Deviation 12.8

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026