Clinical trial NCT06878937: 'Thriving With Bipolar Disorder': Co-design and Evaluation of a Peer-Led Education Program Focused on Quality of Life
Official title: 'Thriving With Bipolar Disorder': Co-design and Pilot Evaluation of a Peer-Delivered, Quality of Life Focused Group Psychoeducation Program
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Bipolar Disorder (BD)
Quality of Life (QOL)
Keywords: Psychoeducation
Peer-Support
Bipolar Disorder
Quality of Life
Self-Management
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Mood Disorders Association of Ontario
First posted: 2025-03-17
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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).
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: Inclusion Criteria:

1. 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
2. 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

Exclusion Criteria:

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

Primary outcomes:
measure: Feasibility (Session Attendance)
timeFrame: Every week, from enrollment to the end of the intervention at 8 weeks.
Secondary outcomes:
measure: Patient Health Questionnaire 8 (PHQ-8)
timeFrame: At enrollment, immediately after the intervention at 8 weeks, and a follow-up 4 weeks after the intervention.
measure: Quality of Life in Bipolar Disorder (QoL.BD) Scale
timeFrame: At enrollment, immediately after the intervention at 8 weeks, and a follow-up 4 weeks after the intervention.
measure: Altman Self-Rating Mania Scale
timeFrame: At enrollment, immediately after the intervention at 8 weeks, and a follow-up 4 weeks after the intervention.
measure: Bipolar Recovery Questionnaire
timeFrame: At enrollment, immediately after the intervention at 8 weeks, and a follow-up 4 weeks after the intervention.
measure: Stanford's Chronic Disease Self-Efficacy 'Manage Disease in General' Subscale
timeFrame: At enrollment, immediately after the intervention at 8 weeks, and a follow-up 4 weeks after the intervention.
measure: Self-Compassion Scale-Short Form
timeFrame: At enrollment, immediately after the intervention at 8 weeks, and a follow-up 4 weeks after the intervention.
measure: Internalised Stigma of Mental Illness Scale Brief Version
timeFrame: At enrollment, immediately after the intervention at 8 weeks, and a follow-up 4 weeks after the intervention.
measure: Social Provisions Scale Short Form
timeFrame: At enrollment, immediately after the intervention at 8 weeks, and a follow-up 4 weeks after the intervention.
measure: Client Satisfaction Questionnaire-8
timeFrame: Immediately after the intervention at 8 weeks.
measure: Group Climate Questionnaire Short Form
timeFrame: Every week, from enrollment to the end of the intervention at 8 weeks.
measure: Feasibility (Fidelity)
timeFrame: Every week, from enrollment to the end of the intervention at 8 weeks.
Other outcomes:
measure: Program and Facilitator Feedback
timeFrame: Immediately after the intervention at 8 weeks.
measure: Qualitative Feedback
timeFrame: Immediately after the intervention at 8 weeks.
Locations:
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.