Pilot Trial of Peer Support for Bipolar Disorder

October 11, 2017 updated by: Kaiser Permanente
This pilot effectiveness trial will evaluate the feasibility, acceptability, and effectiveness of a structured peer support program based on the Certified Peer Specialist Program of the Depression and Bipolar Support Alliance (DBSA).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Bipolar disorder is a chronic and often disabling illness affecting 1-2% of US adults. Peer support programs are an innovative and promising model to reverse demoralization, activate consumers to seek more effective care, develop consumers' self-management skills, and restore participation in work and other social roles. Peer-led programs can address key barriers to dissemination of effective psychosocial treatment. This pilot effectiveness trial will evaluate the feasibility, acceptability, and effectiveness of a structured peer support program based on the Certified Peer Specialist Program of the Depression and Bipolar Support Alliance (DBSA). Following the philosophy of recovery, the intervention focuses on:

  • Motivating consumers to develop an expectation of recovery
  • Encouraging regular self-monitoring of mood symptoms
  • Training consumers to develop self-management skills for symptom control and problem solving
  • Activating consumers to be more informed partners in care and more effective self-advocates
  • Motivating and assisting consumers to reclaim work and other rewarding social roles

The investigators will use a rigorous research design to evaluate how structured peer support promotes core values of mental health recovery. Impact of the intervention will be judged across a range of outcomes:

  • Long-term control of mood disorder symptoms
  • Optimal participation in work and other rewarding social roles
  • Consumers' perceptions of autonomy and full participation in the treatment process Findings from this pilot study will inform the development of a full-scale effectiveness trial to include a broader range of participants and health care settings.

Study Type

Interventional

Enrollment (Actual)

88

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

  • United States
    • Washington
      • Seattle, Washington, United States, 98101
        • Group Health Research Institute

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:

  • GHC members aged 18 and over with Bipolar Disorder Type 1 or Type 2 and at least 6 weeks during the past 3 months with a depression or mania/hypomania Psychiatric Status Rating of 3 or greater (indicating significant symptoms at least half of the time). Potential participants will not be excluded because of medical, psychiatric, or substance use comorbidity.

Exclusion Criteria:

  • Children under age 18.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual Care
Experimental: Intervention Arm
Intervention evaluated the feasibility, acceptability, and effectiveness of a structured peer support intervention based on the Certified Peer Specialist Program of the Depression and Bipolar Support Alliance (DBSA).
Behavioral: Peer support program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean differences in depression scores using the Structured Clinical Interview for DSM Disorders (SCID) for current depression and LIFE measure and timeline for depression
Time Frame: up to 9 months
up to 9 months
Mania PSR scores using the Structured Clinical Interview for DSM Disorders (SCID) for mania/Hypo-mania and LIFE measure and timeline for mania
Time Frame: up to 9 months
up to 9 months
Intervention program effects on consumer's perceptions of care across follow-ups using self-efficacy tool, POPP Empowerment ("Well-Being Module") and Health Care Climate questionnaire
Time Frame: up to 9 months
up to 9 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean number of weeks with depression during follow-ups.
Time Frame: up to 9 months
up to 9 months
Mean number of weeks using mania PSR scores during follow-ups.
Time Frame: up to 9 months
up to 9 months

Collaborators and Investigators

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

Sponsor

Kaiser Permanente

Investigators

  • Principal Investigator: Gregory Simon, MD, MPH, Kaiser Permanente

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

December 1, 2005

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

December 31, 2014

First Submitted That Met QC Criteria

March 26, 2015

First Posted (Estimate)

March 31, 2015

Study Record Updates

Last Update Posted (Actual)

October 13, 2017

Last Update Submitted That Met QC Criteria

October 11, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R34MH073605-01 (U.S. NIH Grant/Contract)

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.

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