Pilot Trial of Peer Support for Bipolar Disorder

Bipolar Disorder Clinical Trial

Official title:

Pilot Trial of Peer Support for Bipolar Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02404246
• Other study ID #: 1R34MH073605-01
• Status: Completed
• Phase: N/A
• First received: December 31, 2014
• Last updated: October 11, 2017
• Start date: December 2005
• Est. completion date: September 2009

Study information

• Verified date: October 2017
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bipolar Disorder
• Disease

Intervention

Behavioral:
• Peer support program

Locations

Country	Name	City	State
United States	Group Health Research Institute	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Kaiser Permanente

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean differences in depression scores using the Structured Clinical Interview for DSM Disorders (SCID) for current depression and LIFE measure and timeline for depression		up to 9 months
Primary	Mania PSR scores using the Structured Clinical Interview for DSM Disorders (SCID) for mania/Hypo-mania and LIFE measure and timeline for mania		up to 9 months
Primary	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		up to 9 months
Secondary	Mean number of weeks with depression during follow-ups.		up to 9 months
Secondary	Mean number of weeks using mania PSR scores during follow-ups.		up to 9 months