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Mechanisms of Action and Outcome (Peer Support)

Primary Purpose

Mental Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
recovery oriented mental health peer support group
recovery-oriented mental health clinician-led group
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Mental Disorders focused on measuring mental health, group processes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • VA Connecticut Health Care System (West Haven)
  • VA New England Health Care System

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Peer-led Groups

Clinician-led Groups

Treatment as Usual

Arm Description

Arm 1 is a 3-month recovery-focused mental health education and support group led by peer facilitators

Arm 2 is a 3-month recovery-focused mental health education and support group led by a mental health clinician

Arm 3 is treatment as usual (no intervention)

Outcomes

Primary Outcome Measures

Patient Activation
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
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
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
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)
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.

Secondary Outcome Measures

Full Information

First Posted
November 6, 2007
Last Updated
June 22, 2015
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00555568
Brief Title
Mechanisms of Action and Outcome
Acronym
Peer Support
Official Title
Mechanisms of Action and Outcome in Peer Support Groups
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Disorders
Keywords
mental health, group processes

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
298 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Peer-led Groups
Arm Type
Experimental
Arm Description
Arm 1 is a 3-month recovery-focused mental health education and support group led by peer facilitators
Arm Title
Clinician-led Groups
Arm Type
Experimental
Arm Description
Arm 2 is a 3-month recovery-focused mental health education and support group led by a mental health clinician
Arm Title
Treatment as Usual
Arm Type
No Intervention
Arm Description
Arm 3 is treatment as usual (no intervention)
Intervention Type
Behavioral
Intervention Name(s)
recovery oriented mental health peer support group
Intervention Description
This is a recovery-focused mental health education and support group led by peer facilitators
Intervention Type
Behavioral
Intervention Name(s)
recovery-oriented mental health clinician-led group
Intervention Description
This is a recovery-focused mental health education and support group led by a mental health clinician
Primary Outcome Measure Information:
Title
Patient Activation
Description
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.
Time Frame
3 months
Title
Empowerment
Description
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.
Time Frame
3 months
Title
Social Support
Description
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
Time Frame
3 months
Title
VR-12 MCS
Description
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;
Time Frame
3 months
Title
Overall Mental Health (BASIS-24 Summary Score)
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan V. Eisen, PhD BA
Organizational Affiliation
VA New England Health Care System
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jack A Clark, PhD
Organizational Affiliation
VA New England Health Care System
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Connecticut Health Care System (West Haven)
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States
Facility Name
VA New England Health Care System
City
Bedford
State/Province
Massachusetts
ZIP/Postal Code
01730
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23203360
Citation
Eisen SV, Schultz MR, Mueller LN, Degenhart C, Clark JA, Resnick SG, Christiansen CL, Armstrong M, Bottonari KA, Rosenheck RA, Sadow D. Outcome of a randomized study of a mental health peer education and support group in the VA. Psychiatr Serv. 2012 Dec;63(12):1243-6. doi: 10.1176/appi.ps.201100348.
Results Reference
result
PubMed Identifier
24660950
Citation
Beehler S, Clark JA, Eisen SV. Participant experiences in peer- and clinician-facilitated mental health recovery groups for veterans. Psychiatr Rehabil J. 2014 Mar;37(1):43-50. doi: 10.1037/prj0000048.
Results Reference
result
Citation
Bottonari KA, Schultz MR, Resnick SG, Mueller L, Clark J, Sadow DC, Eisen SV. Peer-led vs. Clinician-led Recovery-Oriented Groups: What Predicts Attendance by Veterans? International Journal of Psychosocial Rehabilitation. 2012 Jan 1; 16(2):96-113
Results Reference
result

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Mechanisms of Action and Outcome

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