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Bipolar Disorder (BD)NCT06878937

'Thriving With Bipolar Disorder': Co-design and Evaluation of a Peer-Led Education Program Focused on Quality of Life

A study testing Peer Delivered Psychoeducation Program in people with Bipolar Disorder (BD) and Quality of Life (QOL), run by University of British Columbia at 1 site in Canada.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Self-management strategies can be used by individuals with bipolar disorder (BD) to cope with symptoms and improve quality of life (QoL). Peer-facilitated education programs have the potential to diversify delivery of self-management information by capitalizing on the expertise of individuals who live well with BD. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bipolar Disorder (BD), Quality of Life (QOL)
What is being tested?
Peer Delivered Psychoeducation Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteCanada
Study dates
Jun 2025to Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • Program facilitators
  • aged 18 or older
  • a self-reported diagnosis of a mood disorder
  • sufficient access to an internet-enabled computer or smartphone device to access the Zoom teleconferencing platform
  • ability to understand, read and write English
  • at least one year of prior experience leading peer support groups or recovery programs through Hope+Me
Show all 14Show fewer
  • previously received training through Hope+Me
  • completed a Criminal Records Check
  • Program participants
  • aged 18 or older
  • residing in Canada
  • a self-reported diagnosis of BD
  • ability to understand, read and write English
  • sufficient access to an internet-enabled computer or smartphone device to access the Zoom teleconferencing platform

Who cannot join

  • inability to communicate in written and verbal English to a sufficient level to allow participation in the program and research activities

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Erin Michalak contact

604-827-3393

erin.michalak@ubc.ca

Emma Morton contact

emma.morton@monash.edu

Canada1 site

  • University of British Columbia

    Vancouver, British Columbia, V6T1Z3

    CREST.BD, 604-827-3393, crest.bd@ubc.ca

    Erin Michalak

Other trials in Canada

About this study

Official title: 'Thriving With Bipolar Disorder': Co-design and Pilot Evaluation of a Peer-Delivered, Quality of Life Focused Group Psychoeducation Program

Self-management strategies can be used by individuals with bipolar disorder (BD) to cope with symptoms and improve quality of life (QoL). Peer-facilitated education programs have the potential to diversify delivery of self-management information by capitalizing on the expertise of individuals who live well with BD. We have co-designed a novel, peer-facilitated, QoL-focused, group education program for people living with BD. This project will involve administration of the program and an evaluation of the feasibility, acceptability, and efficacy of this program for self-management of BD.

Read the detailed description

Background and Purpose:

Peer support (where individuals with shared lived experience of a mental health condition provide each other with informational, emotional, and social support) may be an acceptable way to disseminate information on self-management strategies, capitalizing on the expertise and knowledge of people who live well with BD.

Peer-facilitated group psychoeducation includes the benefits of evidence-based self-management information and tools, with the added advantage of providing role models for recovery and modelling of self-management skills. Unfortunately, there is a dearth of BD-specific peer-facilitated self-management psychoeducation programs, and corresponding evaluations of their efficacy.

To capitalize on the potential of peer support to enhance the delivery of BD self-management information, content from two, web-based, self-directed psychoeducational interventions was adapted to create a peer-facilitated psychoeducation program using a community-based participatory research (CBPR) framework. The resulting program contains eight, weekly, two-hour sessions. Each session focuses on a topic related to QoL in BD (including Mood, Sleep, Physical Health, Relationships, Money, Self-esteem, and Independence), and contains a combination of education, opportunities for peer-to-peer knowledge exchange, and activities that facilitate practice of self-management strategies. A facilitator and attendee manual have been created for use in this program.

Methods:

The project will be implemented across two phases:

In the first phase, which we have already completed, we have applied CBPR principles to develop a peer-facilitated, QoL-focused group psychoeducation program for individuals with BD. The resulting program, entitled 'Thriving with bipolar disorder' will be delivered in eight, weekly, two-hour sessions that will be co-facilitated by two peer facilitators with lived experience of BD.

In the second phase, we will conduct a pilot evaluation of the feasibility, acceptability, and preliminary efficacy of the program. The program will be delivered through Hope+Me, an Ontario-based charity that supports people living with mood and anxiety disorders through education, advocacy, training, and support services. Four peer facilitators will be recruited through Hope+Me and will attend a ~5.5 hour training session prior to commencing the program. We will aim to recruit 32-40 program participants (8-10 per group) given previous research summarizing the ideal group size.

The evaluation will be conducted as a single-arm, uncontrolled, pilot feasibility trial. An explanatory sequential mixed-methods design will be used. The following data will be collected:

  • Participants will provide baseline demographic and clinical information in a survey as part of their consent.
  • Participants will complete surveys for efficacy measures at baseline, immediately after completing the program and 1 month after completing the program.
  • Program feedback will be collected from participants immediately after completing the program through a Qualtrics survey.
  • Peer facilitators will complete a brief, post-session Qualtrics survey each week, recording attendance, fidelity, and session feedback.

At the end of the intervention period, a subset of consenting participants (~n=12) and peer facilitators (~n=4) will be invited to participate in a one-hour qualitative individual interview over Zoom.

Study Population:

Four peer facilitators will be recruited through Hope+Me. We hope to recruit ~fourty program participants. Inclusion and exclusion criteria are specified in the 'Eligibility' section.

Being tested
Peer Delivered Psychoeducation Program
Keywords
Psychoeducation, Peer-Support, Bipolar Disorder, Quality of Life, Self-Management
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 Delivered Psychoeducation ProgramBehavioural

    The peer delivered psychoeducation program is the only intervention being tested in this pilot evaluation study.

Study groups in NCT06878937
Study groupRoleWhat they receive
Peer-Delivered Psychoeducation ProgramExperimentalIndividuals in this arm will complete the peer-delivered psychoeducation program.
Receives: Behavioral: Peer Delivered Psychoeducation Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility (Session Attendance)

    Feasibility will be assessed using program attendance rates. After each session, peer facilitators will complete a brief questionnaire to record the number of participants who attended each session. Feasibility is defined as the proportion of participants achieving the minimum attendance of 62.5% (i.e., five out of eight sessions), based on the median therapeutic dose in a review of group therapy program evaluations.

    Measured: Every week, from enrollment to the end of the intervention at 8 weeks.

Secondary outcomes (11)

  1. Patient Health Questionnaire 8 (PHQ-8)

    Self-reported depressive symptoms will be assessed by the Patient Health Questionnaire-8 (PHQ-8), which evaluates 8 of the 9 criteria for depression from the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV). The eight Likert-type items ask about the frequency of depressive symptoms experienced in the past two weeks (0 = "Not at all" to 3 = "Nearly every day"). Responses are summed to create a total score (range: 0-24); higher scores indicate greater depression severity. The PHQ-8 performs comparably with clinician assessments; internal reliability has been demonstrated in population studies (Cronbach α=0.87).

    The PHQ-8 has comparable performance to the original nine item version (PHQ-9), which assesses all DSM-IV criteria, including current suicidal ideation. The PHQ-8 is chosen for this evaluation because this program doesn't incorporate formal psychiatric evaluation and supports, data collected is self-reported, and immediate follow-up isn't possible.

    Measured: At enrollment, immediately after the intervention at 8 weeks, and a follow-up 4 weeks after the intervention.

  2. Quality of Life in Bipolar Disorder (QoL.BD) Scale

    The Quality of Life in Bipolar Disorder (QoL.BD) Scale will be used to assess aspects of QoL specifically impacted by or relevant to BD. This scale assesses 12 core aspects of QoL (mood, sleep, physical health, cognition, household management, leisure, finances, relationships, self-esteem, spirituality, identity, and independence). Each domain contains four Likert-type items that assess satisfaction with that area (1 = Strongly Disagree to 5 = Strongly Agree). An overall score can be calculated by summing responses to the 48 items (range: 48-240), with higher scores indicating greater life satisfaction.

    During psychometric testing, the factor structure of the QoL.BD has been supported, and the scale has demonstrated excellent internal reliability (Cronbach α>0.8) and appropriate test-retest reliability. Construct validity has been supported through positive correlations with generic QoL instruments and negative correlations with depressive symptoms.

    Measured: At enrollment, immediately after the intervention at 8 weeks, and a follow-up 4 weeks after the intervention.

  3. Altman Self-Rating Mania Scale

    Self-reported mania will be assessed using the Altman Self-Rating Mania Scale. This instrument measures behaviours and feelings during the past week using five items; a total score (range: 5-25) can be calculated by summing responses, with higher scores indicating more severe manic symptoms.

    Responses have been found to correlate strongly with clinician-rated mania; internal reliability is acceptable (Cronbach α>0.65).

    Measured: At enrollment, immediately after the intervention at 8 weeks, and a follow-up 4 weeks after the intervention.

  4. Bipolar Recovery Questionnaire

    Personal recovery will be measured using the Bipolar Recovery Questionnaire. Items are informed by qualitative interviews regarding experiences of personal (as opposed to clinical) recovery in BD. This scale contains 36 visual analogue scales (range: 0-100); responses are summed to create an overall score (range: 0-3600). Higher scores are indicative of better self-appraised recovery.

    This instrument has been found to be internally consistent (Cronbach α=0.875) and reliable over a month-long test-retest period.

    Measured: At enrollment, immediately after the intervention at 8 weeks, and a follow-up 4 weeks after the intervention.

  5. Stanford's Chronic Disease Self-Efficacy 'Manage Disease in General' Subscale

    Self-efficacy will be measured using the 5-item Manage Disease in General subscale of Stanford's Chronic Disease Self-Efficacy Scale. The score on this subscale is the mean of 5 Likert-type items (1 = not at all confident to 10 = totally confident). Higher scores on this subscale (range: 1-10) indicate greater confidence in managing the symptoms and impacts of a chronic health condition.

    Measured: At enrollment, immediately after the intervention at 8 weeks, and a follow-up 4 weeks after the intervention.

  6. Self-Compassion Scale-Short Form

    Self-compassion will be measured using the Self-Compassion Scale-Short Form (61, 62), which contains 12 Likert-type items (1=Almost Never, 5 = Almost Always) used to assess 6 dimensions of self-compassion: self-kindness, self-judgement, common humanity, isolation, mindfulness, and overidentification. Subscales are calculated by averaging relevant items. To calculate an overall score (range: 1-5), negative subscales are reverse-coded. Higher overall scores indicate more frequent self-compassionate behaviours and attitudes.

    Internal consistency has been demonstrated (Cronbach α=0.86); confirmatory factor analysis supports both the 6 subscales and a single higher-order factor of self-compassion.

    Measured: At enrollment, immediately after the intervention at 8 weeks, and a follow-up 4 weeks after the intervention.

  7. Internalised Stigma of Mental Illness Scale Brief Version

    Self-stigma will be measured using the Internalised Stigma of Mental Illness Scale Brief Version. This instrument contains 9 Likert-type items (1= Strongly Disagree, 4 = Strongly Agree); two are reverse-coded. Item responses are averaged for an overall score (range: 1-4); higher scores indicate more internalized stigmatizing attitudes towards mental illness.

    Internal consistency has been demonstrated (Cronbach α=0.86); confirmatory factor analysis supports a unidimensional factor structure.

    Measured: At enrollment, immediately after the intervention at 8 weeks, and a follow-up 4 weeks after the intervention.

  8. Social Provisions Scale Short Form

    Perceived social support will be measured using the Social Provisions Scale Short Form. This instrument contains 10 Likert-type items (1= Strongly Disagree, 4 = Strongly Agree) which evaluate an individual's perceptions of the availability of social support. An overall score (range: 10-40) and five subscales can be calculated by summing relevant items; subscales include guidance (receipt of information or advice), reliable alliance (practical help and support), reassurance of worth (feeling valued by others), attachment (emotional bonds), and social integration (sense of belonging to a group with shared interests and attitudes).

    Internal consistency of the scale has been supported (Cronbach α>0.80).

    Measured: At enrollment, immediately after the intervention at 8 weeks, and a follow-up 4 weeks after the intervention.

  9. Client Satisfaction Questionnaire-8

    The Client Satisfaction Questionnaire-8 will be used to assess attendees' satisfaction with the 'Thriving with Bipolar Disorder' program post-intervention.

    This instrument has high internal consistency (Cronbach α=0.91); higher scores have been associated with greater attendance of services and improved clinical outcomes

    Measured: Immediately after the intervention at 8 weeks.

  10. Group Climate Questionnaire Short Form

    To describe the acceptability of the group climate, we will use the Group Climate Questionnaire short form. This is the most widely used measure of group therapy cohesion, and can be completed by a group member, facilitator, or observer; here, to minimize response burden on attendees, weekly feedback will be provided by facilitators. It contains 12 items describing specific behaviours that are rated on a 7-point Likert scale (where 0 indicates "not at all" and 7 indicates "extremely"), three subscales can be calculated based on the mean score of relevant items. These subscales are Engaged (which describes a positive working group atmosphere), Avoiding (which describes avoidance of responsibility for group dynamics), and Conflict (which describes tension and anger between group members).

    Measured: Every week, from enrollment to the end of the intervention at 8 weeks.

  11. Feasibility (Fidelity)

    To evaluate fidelity, facilitators will self-report adherence to the manual using four self-report Likert-type items, asking them to report the degree to which they reviewed information as described in the manual, shared their own lived experiences, and facilitated group involvement in discussions and activities. This method of fidelity assessment was selected given that the use of external observers may impact participant willingness to participate in group discussions and activities. Similar self-reported fidelity assessments have previously been used in evaluations of peer-led programs.

    Measured: Every week, from enrollment to the end of the intervention at 8 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2025
  2. Study startJun 2025 (estimated)
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

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
Supportive care
Allocation
Not applicable
Intervention model
Single group
Model description
Evaluation of the psychoeducation program will be conducted as a single-arm, uncontrolled, pilot feasibility trial. An explanatory sequential mixed-methods design will be used (Creswell \& Clark, 2011).
Masking
None (open label)
Enrolment
44 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06878937
Sponsor's protocol ID
H24-03489
Status last verified
Jun 2025
First submitted
4 Mar 2025
Last updated
17 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data that underlie the results reported in any published articles after deidentification. Qualitative data will not be shared to protect privacy and confidentiality due to the potential risk of participant re-identification.

Publications

  • Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

    PubMed 11556941

  • Attkisson CC, Zwick R. The client satisfaction questionnaire. Psychometric properties and correlations with service utilization and psychotherapy outcome. Eval Program Plann. 1982;5(3):233-7. doi: 10.1016/0149-7189(82)90074-x.

    PubMed 10259963

  • Biggs K, Hind D, Gossage-Worrall R, Sprange K, White D, Wright J, Chatters R, Berry K, Papaioannou D, Bradburn M, Walters SJ, Cooper C. Challenges in the design, planning and implementation of trials evaluating group interventions. Trials. 2020 Jan 29;21(1):116. doi: 10.1186/s13063-019-3807-4.

    PubMed 31996259

  • Tse S, Yuen WWY, Murray G, Davidson L, Lai Q, Kan A. Combining technical and expert-by-experience knowledge in the quest for personal recovery from bipolar disorder: a qualitative study. BMC Psychiatry. 2019 Nov 26;19(1):368. doi: 10.1186/s12888-019-2357-3.

    PubMed 31771532

  • Proudfoot J, Parker G, Manicavasagar V, Hadzi-Pavlovic D, Whitton A, Nicholas J, Smith M, Burckhardt R. Effects of adjunctive peer support on perceptions of illness control and understanding in an online psychoeducation program for bipolar disorder: a randomised controlled trial. J Affect Disord. 2012 Dec 15;142(1-3):98-105. doi: 10.1016/j.jad.2012.04.007. Epub 2012 Aug 2.

    PubMed 22858215

  • Shin C, Lee SH, Han KM, Yoon HK, Han C. Comparison of the Usefulness of the PHQ-8 and PHQ-9 for Screening for Major Depressive Disorder: Analysis of Psychiatric Outpatient Data. Psychiatry Investig. 2019 Apr;16(4):300-305. doi: 10.30773/pi.2019.02.01. Epub 2019 Apr 24.

    PubMed 31042692

  • Wu Y, Levis B, Riehm KE, Saadat N, Levis AW, Azar M, Rice DB, Boruff J, Cuijpers P, Gilbody S, Ioannidis JPA, Kloda LA, McMillan D, Patten SB, Shrier I, Ziegelstein RC, Akena DH, Arroll B, Ayalon L, Baradaran HR, Baron M, Bombardier CH, Butterworth P, Carter G, Chagas MH, Chan JCN, Cholera R, Conwell Y, de Man-van Ginkel JM, Fann JR, Fischer FH, Fung D, Gelaye B, Goodyear-Smith F, Greeno CG, Hall BJ, Harrison PA, Harter M, Hegerl U, Hides L, Hobfoll SE, Hudson M, Hyphantis T, Inagaki M, Jette N, Khamseh ME, Kiely KM, Kwan Y, Lamers F, Liu SI, Lotrakul M, Loureiro SR, Lowe B, McGuire A, Mohd-Sidik S, Munhoz TN, Muramatsu K, Osorio FL, Patel V, Pence BW, Persoons P, Picardi A, Reuter K, Rooney AG, Santos IS, Shaaban J, Sidebottom A, Simning A, Stafford L, Sung S, Tan PLL, Turner A, van Weert HC, White J, Whooley MA, Winkley K, Yamada M, Benedetti A, Thombs BD. Equivalency of the diagnostic accuracy of the PHQ-8 and PHQ-9: a systematic review and individual participant data meta-analysis. Psychol Med. 2020 Jun;50(8):1368-1380. doi: 10.1017/S0033291719001314. Epub 2019 Jul 12.

    PubMed 31298180

  • Kroenke K, Strine TW, Spitzer RL, Williams JB, Berry JT, Mokdad AH. The PHQ-8 as a measure of current depression in the general population. J Affect Disord. 2009 Apr;114(1-3):163-73. doi: 10.1016/j.jad.2008.06.026. Epub 2008 Aug 27.

    PubMed 18752852

  • Morton E, Murray G, Yatham LN, Lam RW, Michalak EE. The Quality of Life in Bipolar Disorder (QoL.BD) questionnaire a decade on - A systematic review of the measurement of condition-specific aspects of quality of life in bipolar-disorder. J Affect Disord. 2021 Jan 1;278:33-45. doi: 10.1016/j.jad.2020.09.017. Epub 2020 Sep 7.

    PubMed 32949871

  • Morton E, Hou SH, Fogarty O, Murray G, Barnes S, Depp C; CREST.BD; Michalak E. A Web-Based Adaptation of the Quality of Life in Bipolar Disorder Questionnaire: Psychometric Evaluation Study. JMIR Ment Health. 2020 Apr 27;7(4):e17497. doi: 10.2196/17497.

    PubMed 32338620

  • Michalak EE, Murray G; Collaborative RESearch Team to Study Psychosocial Issues in Bipolar Disorder (CREST.BD). Development of the QoL.BD: a disorder-specific scale to assess quality of life in bipolar disorder. Bipolar Disord. 2010 Nov;12(7):727-40. doi: 10.1111/j.1399-5618.2010.00865.x.

    PubMed 21040290

  • MacKenzie, K. (1983). The clinical application of a group climate measure. In R.R. Dies & K.R. MacKenzie (Eds.), Advances in group psychotherapy: Integrating research and practice (pp. 159-170). International Universities Press.

  • Larsen DL, Attkisson CC, Hargreaves WA, Nguyen TD. Assessment of client/patient satisfaction: development of a general scale. Eval Program Plann. 1979;2(3):197-207. doi: 10.1016/0149-7189(79)90094-6. No abstract available.

    PubMed 10245370

  • Morton E, Kcomt A, Michalak EE. 'Thriving with bipolar disorder': The co-design of a peer-delivered group psychoeducation program and single-arm pilot feasibility evaluation protocol. PLoS One. 2025 Dec 17;20(12):e0338306. doi: 10.1371/journal.pone.0338306. eCollection 2025.

    PubMed 41406148

Questions about this trial

What is this clinical trial studying?

A study testing Peer Delivered Psychoeducation Program in people with Bipolar Disorder (BD) and Quality of Life (QOL), run by University of British Columbia at 1 site in Canada.

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 14 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: opening soon, as of the sponsor's last update on 17 Jun 2025. 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 Canada. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Erin Michalak (604-827-3393, erin.michalak@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility (Session Attendance) (time frame: Every week, from enrollment to the end of the intervention at 8 weeks.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06878937, which also lists 14 linked publications.

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 17 Jun 2025.

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