Clinical trial NCT02404246: Pilot Trial of Peer Support for Bipolar Disorder
Official title: Pilot Trial of Peer Support for Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar Disorder
Keywords: Bipolar
Peers
DBSA
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2015-03-31
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mean differences in depression scores using the Structured Clinical Interview for DSM Disorders (SCID) for current depression and LIFE measure and timeline for depression
timeFrame: up to 9 months
measure: Mania PSR scores using the Structured Clinical Interview for DSM Disorders (SCID) for mania/Hypo-mania and LIFE measure and timeline for mania
timeFrame: up to 9 months
measure: 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
timeFrame: up to 9 months
Secondary outcomes:
measure: Mean number of weeks with depression during follow-ups.
timeFrame: up to 9 months
measure: Mean number of weeks using mania PSR scores during follow-ups.
timeFrame: up to 9 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Group Health Research Institute
state: Washington
Study officials:
affiliation: Kaiser Permanente
name: Gregory Simon, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: