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

NCT06878937 | Not Yet Recruiting

• 1 other identifier: H24-03489
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Bipolar Disorder (BD); Quality of Life (QOL)

Keywords

Psychoeducation; Peer-Support; Bipolar Disorder; Quality of Life; Self-Management

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (11)

• Patient Health Questionnaire 8 (PHQ-8)

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

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

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

• Altman Self-Rating Mania Scale

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

• Bipolar Recovery Questionnaire

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

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

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

Other Outcomes (2)

• Program and Facilitator Feedback

  Immediately after the intervention at 8 weeks.

• Qualitative Feedback

  Immediately after the intervention at 8 weeks.

Study Arms (1)

Peer-Delivered Psychoeducation Program

EXPERIMENTAL

Individuals in this arm will complete the peer-delivered psychoeducation program.

Behavioral: Peer Delivered Psychoeducation Program

Interventions

Peer Delivered Psychoeducation Program BEHAVIORAL

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

Peer-Delivered Psychoeducation Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of British Columbia: lead
• Mood Disorders Association of Ontario: collaborator

Study Sites (1)

University of British Columbia

Vancouver, British Columbia, V6T1Z3, Canada

Location

Related Publications (14)

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  PMID: 11556941 BACKGROUND

• 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.

  PMID: 10259963 BACKGROUND

• 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.

  PMID: 31996259 BACKGROUND

• 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.

  PMID: 31771532 BACKGROUND

• 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.

  PMID: 22858215 BACKGROUND

• 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.

  PMID: 31042692 BACKGROUND

• 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.

  PMID: 31298180 BACKGROUND

• 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.

  PMID: 18752852 BACKGROUND

• 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.

  PMID: 32949871 BACKGROUND

• 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.

  PMID: 32338620 BACKGROUND

• 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.

  PMID: 21040290 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 10245370 BACKGROUND

• 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.

  PMID: 41406148 DERIVED

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Central Study Contacts

Erin Michalak

CONTACT

604-827-3393; erin.michalak@ubc.ca

Emma Morton

CONTACT

emma.morton@monash.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Psychiatry, Faculty of Medicine

Model Details: 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).

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 17, 2025
• Study Start: June 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 3 months and ending 3 years after article publication.
• Access Criteria: Researchers interested in using the data must provide a methodologically sound proposal. All requests should be directed to emma.morton@monash.edu. If a request is approved, the requesting party will need to secure behavioural research ethics board approval from their institution and sign a Clinical Study Data Transfer Agreement. Data will be shared using a secure file transfer service approved by the university (Microsoft OneDrive). The research team reserves the right to deny incomplete/inaccurate proposals, if there is a perceived conflict of interest, or if researchers cannot ensure sufficient measures are in place to maintain the security and privacy of the data.

Locations

CA (1)