NCT00555568

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
298

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 6, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 8, 2007

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
5.1 years until next milestone

Results Posted

Study results publicly available

June 23, 2015

Completed
Last Updated

June 23, 2015

Status Verified

June 1, 2015

Enrollment Period

3 years

First QC Date

November 6, 2007

Results QC Date

February 20, 2015

Last Update Submit

June 22, 2015

Conditions

Keywords

mental healthgroup processes

Outcome Measures

Primary Outcomes (5)

  • 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.

    3 months

  • 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.

    3 months

  • 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

    3 months

  • 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;

    3 months

  • 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.

    3 months

Study Arms (3)

Peer-led Groups

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

Clinician-led Groups

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

Treatment as Usual

NO INTERVENTION

Arm 3 is treatment as usual (no intervention)

Interventions

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

Peer-led Groups

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

Clinician-led Groups

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • veteran in treatment for a psychiatric disorder at a participating study site

You may not qualify if:

  • currently participating in a recovery group that constitutes an intervention arm of this research study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

VA Connecticut Health Care System (West Haven)

West Haven, Connecticut, 06516, United States

Location

VA New England Health Care System

Bedford, Massachusetts, 01730, United States

Location

Related Publications (3)

  • 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.

  • 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.

  • 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

    RESULT

MeSH Terms

Conditions

Mental DisordersPsychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Results Point of Contact

Title
Susan V. Eisen
Organization
CHOIR (Center for Healthcare Organization & Implementation Research

Study Officials

  • Susan V. Eisen, PhD BA

    VA New England Health Care System

    PRINCIPAL INVESTIGATOR
  • Jack A Clark, PhD

    VA New England Health Care System

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2007

First Posted

November 8, 2007

Study Start

January 1, 2007

Primary Completion

January 1, 2010

Study Completion

June 1, 2010

Last Updated

June 23, 2015

Results First Posted

June 23, 2015

Record last verified: 2015-06

Locations