NCT02404246

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

December 31, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 31, 2015

Completed
Last Updated

October 13, 2017

Status Verified

October 1, 2017

Enrollment Period

3.8 years

First QC Date

December 31, 2014

Last Update Submit

October 11, 2017

Conditions

Keywords

BipolarPeersDBSA

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (2)

  • Mean number of weeks with depression during follow-ups.

    up to 9 months

  • Mean number of weeks using mania PSR scores during follow-ups.

    up to 9 months

Study Arms (2)

Intervention Arm

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

Usual Care

Interventions

Intervention Arm

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • Children under age 18.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Group Health Research Institute

Seattle, Washington, 98101, United States

Location

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Study Officials

  • Gregory Simon, MD, MPH

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 31, 2014

First Posted

March 31, 2015

Study Start

December 1, 2005

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

October 13, 2017

Record last verified: 2017-10

Locations