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Набор скоро начнётся NCT06878937

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

Без фазы С лечением Bipolar Disorder (BD) Quality of Life (QOL)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Peer Delivered Psychoeducation Program.
Кому может быть актуально
Состояния в реестре: Bipolar Disorder (BD), Quality of Life (QOL). Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Канада
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое Peer Delivered Psychoeducation Program
    The peer delivered psychoeducation program is the only intervention being tested in this pilot evaluation study.

Первичные конечные точки

  • Feasibility (Session Attendance) [Срок оценки: Every week, from enrollment to the end of the intervention at 8 weeks.]
Вторичные конечные точки (11)
  • Patient Health Questionnaire 8 (PHQ-8) [Срок оценки: 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 [Срок оценки: At enrollment, immediately after the intervention at 8 weeks, and a follow-up 4 weeks after the intervention.]
  • Altman Self-Rating Mania Scale [Срок оценки: At enrollment, immediately after the intervention at 8 weeks, and a follow-up 4 weeks after the intervention.]
  • Bipolar Recovery Questionnaire [Срок оценки: 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 [Срок оценки: At enrollment, immediately after the intervention at 8 weeks, and a follow-up 4 weeks after the intervention.]
  • Self-Compassion Scale-Short Form [Срок оценки: At enrollment, immediately after the intervention at 8 weeks, and a follow-up 4 weeks after the intervention.]
  • Internalised Stigma of Mental Illness Scale Brief Version [Срок оценки: At enrollment, immediately after the intervention at 8 weeks, and a follow-up 4 weeks after the intervention.]
  • Social Provisions Scale Short Form [Срок оценки: At enrollment, immediately after the intervention at 8 weeks, and a follow-up 4 weeks after the intervention.]
  • Client Satisfaction Questionnaire-8 [Срок оценки: Immediately after the intervention at 8 weeks.]
  • Group Climate Questionnaire Short Form [Срок оценки: Every week, from enrollment to the end of the intervention at 8 weeks.]
  • Feasibility (Fidelity) [Срок оценки: Every week, from enrollment to the end of the intervention at 8 weeks.]

Критерии участия

Критерии включения

  • 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

Канада · 1 центр
  • University of British Columbia — Vancouver

Публикации

  • 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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 PMID 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. PMID 18752852

Идентификаторы

NCT: NCT06878937 · H24-03489

Первоисточники (государственные реестры)

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