Bipolar DisorderNCT02404246
Pilot Trial of Peer Support for Bipolar Disorder
A study testing Peer support program in people with Bipolar Disorder, run by Kaiser Permanente at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Peer support program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2005to Sep 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Children under age 18.
Trial locations and contacts
1 site in 1 country.
United States1 site
Group Health Research Institute
Seattle, Washington, 98101
About this study
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).
Read the 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.
- Conditions
- Bipolar Disorder
- Being tested
- Peer support program
- Keywords
- Bipolar, Peers, DBSA
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer support programBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Peer support program |
| Usual Care | No intervention | Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean differences in depression scores using the Structured Clinical Interview for DSM Disorders (SCID) for current depression and LIFE measure and timeline for depression
Measured: 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
Measured: 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
Measured: up to 9 months
Secondary outcomes (2)
Mean number of weeks with depression during follow-ups.
Measured: up to 9 months
Mean number of weeks using mania PSR scores during follow-ups.
Measured: up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2015 (estimated)
- Study startDec 2005
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gregory Simon, MD, MPH, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02404246
- Sponsor's protocol ID
- 1R34MH073605-01
- Status last verified
- Oct 2017
- First submitted
- 31 Dec 2014
- Last updated
- 13 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial of Peer Support for Bipolar Disorder
- ClinicalTrials.gov ID
- NCT02404246
- Acronym / sponsor ID
- 1R34MH073605-01
- Conditions
- Bipolar Disorder
- Keywords
- Bipolar, Peers, DBSA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- Dec 2005
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 31 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: Peer support programIntervention 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). |
| Usual Care | No intervention | –Usual Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Children under age 18.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer support program | Behavioural | Intervention Arm |
Primary outcome
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
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
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
2 secondary outcomes
Mean number of weeks with depression during follow-ups.
Time frame: up to 9 months
Mean number of weeks using mania PSR scores during follow-ups.
Time frame: up to 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory Simon, MD, MPH principal investigator
Kaiser Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer support program in people with Bipolar Disorder, run by Kaiser Permanente at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: up to 9 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2017.