Effectiveness of a Peer-led Self-Management Program for People With Recent-onset Psychosis: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Questionnaire about the Process of Recovery (QPR)
研究概览
简要总结
This randomized controlled trial is to test the effectiveness of a peer-led self-management program (PLSMI) for people with recent-onset psychosis in the community over 18-month follow-up, compared with a conventional psychoeducation group and routine community mental healthcare.
详细描述
Objectives: to investigate the effectiveness of a peer-led self-management intervention (PLSMI) for recent-onset psychosis on patient outcomes over 18-months follow-up, compared with a conventional psycho-education group and routine care only group.
Hypotheses: When compared with those in a psycho-education group and routine care, the PLSMI participants will indicate significantly greater:
- Improvement in patients' level of recovery at 1-2 weeks post-intervention (Primary hypothesis and outcome);
- Reduction of their re-hospitalization rates and symptom severity, and/or improvement in functioning, satisfaction with service, problem-solving, and insight into illness at 1-2 weeks post-intervention; and/or
- Improvements in the above outcomes (hypotheses 1) at 6-, 12- and/or 18-month follow-ups.
Primary outcome is patients' level of recovery. Qualitative interviews with purposely selected PLSMI participants and all peer support workers (agreed for interview) will enhance understanding about their perceived benefits, service satisfaction, strengths, and limitations of the intervention undertaken from peer-workers' and participants' perspectives.
Study Design: A multi-center randomized controlled trial with repeated-measures, three-group design on a community-based PLSMI will be conducted with both outcome and process evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Outcome assessors and researchers (and center staff) are blind to the group assignment and intervention undertaken and concealed to the participant list.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hong Kong Chinese residents, aged 18-60 years;
- •Having Global Assessment of Functioning scores ≥ 51, indicating mild to moderate symptoms and difficulty in psychosocial/occupational functioning and thus mentally stable to comprehend the self-care training and education provided; and
- •Able to understand Cantonese/Mandarin
排除标准
- •Participated in or having been receiving other psycho-education/psychotherapies;
- •Having co-morbidity of another mental illness (learning disability and cognitive and personality disorders) or any clinically significant medical diseases; and
- •Having visual/language/communication difficulty
研究组 & 干预措施
Peer-led self-management program
Peer-led self-management program (PLSMI) consists of 10 weekly/biweekly, 1.5-hour sessions (4 months), based on the modified Crisis-resolution-team Optimization and Relapse Prevention (CORE) program workbook/manual and psycho-education programs developed by the research team. The program based on completion of a self-management workbook, consisting of the main components: personal recovery goals, plans to re-establish community functioning and support networks following a crisis, identifying early warning signs and creating a relapse prevention plan, and strategies and coping resources to problem-solving and maintain well-being. Participants work through the workbook at their own pace, with the support from the peer support worker, to facilitate/support their recovery. They will meet in group with a trained peer support worker on 10 sessions, usually at 7-12 days intervals over 4 months.
干预措施: Peer-led self-management program (Behavioral)
Peer-led self-management program
Peer-led self-management program (PLSMI) consists of 10 weekly/biweekly, 1.5-hour sessions (4 months), based on the modified Crisis-resolution-team Optimization and Relapse Prevention (CORE) program workbook/manual and psycho-education programs developed by the research team. The program based on completion of a self-management workbook, consisting of the main components: personal recovery goals, plans to re-establish community functioning and support networks following a crisis, identifying early warning signs and creating a relapse prevention plan, and strategies and coping resources to problem-solving and maintain well-being. Participants work through the workbook at their own pace, with the support from the peer support worker, to facilitate/support their recovery. They will meet in group with a trained peer support worker on 10 sessions, usually at 7-12 days intervals over 4 months.
干预措施: Usual care (Behavioral)
Psycho-education group
Psycho-education groups (12-18 members/group; 10 two-hour sessions, weekly/biweekly), 4-month duration similar to the PLSMI, will be led by one trained advanced practice psychiatric nurse in each center experienced in psychiatric rehabilitation, and are guided by a validated group-intervention protocol based on the research team's and McFarlane et al.'s psycho-education programs for psychosis.
干预措施: Psycho-education group (Behavioral)
Psycho-education group
Psycho-education groups (12-18 members/group; 10 two-hour sessions, weekly/biweekly), 4-month duration similar to the PLSMI, will be led by one trained advanced practice psychiatric nurse in each center experienced in psychiatric rehabilitation, and are guided by a validated group-intervention protocol based on the research team's and McFarlane et al.'s psycho-education programs for psychosis.
干预措施: Usual care (Behavioral)
Usual care only
Usual care (control) participants (and treatment groups) will receive routine psychiatric outpatient and community mental healthcare services.
干预措施: Usual care (Behavioral)
结局指标
主要结局
Questionnaire about the Process of Recovery (QPR)
时间窗: At 18 months post-intervention
Level of recovery from illness is measured with the Questionnaire about the Process of Recovery (QPR) developed by Neil et al. (2009). Items are rated on a 5-point Likert scale (0=disagree strongly to 4=agree strongly); the higher total score indicates a higher of recovery progress.
Questionnaire about the Process of Recovery (QPR)
时间窗: At recruitment
Level of recovery from illness is measured with the Questionnaire about the Process of Recovery (QPR) developed by Neil et al. (2009). Items are rated on a 5-point Likert scale (0=disagree strongly to 4=agree strongly; score range= 0-88); the higher total score indicates a higher of recovery progress.
Questionnaire about the Process of Recovery (QPR)
时间窗: At 1-2 weeks post-intervention
Level of recovery from illness is measured with the Questionnaire about the Process of Recovery (QPR) developed by Neil et al. (2009). Items are rated on a 5-point Likert scale (0=disagree strongly to 4=agree strongly); the higher total score indicates a higher of recovery progress.
Questionnaire about the Process of Recovery (QPR)
时间窗: At 6 months post-intervention
Level of recovery from illness is measured with the Questionnaire about the Process of Recovery (QPR) developed by Neil et al. (2009). Items are rated on a 5-point Likert scale (0=disagree strongly to 4=agree strongly); the higher total score indicates a higher of recovery progress.
Questionnaire about the Process of Recovery (QPR)
时间窗: At 12 months post-intervention
Level of recovery from illness is measured with the Questionnaire about the Process of Recovery (QPR) developed by Neil et al. (2009). Items are rated on a 5-point Likert scale (0=disagree strongly to 4=agree strongly); the higher total score indicates a higher of recovery progress.
次要结局
- Positive and Negative Syndrome Scale (PANSS)(Change from recruitment to 18 months follow-up)
- Specific Level of Functioning Scale (SLOF)(Change from recruitment to 18 months follow-up)
- Re-hospitalization rate(Change from recruitment to 18 months follow-up)
- Revised Social-Problem-Solving Inventory (C-SPSI-R:S)(Change from recruitment to 18 months follow-up)
- Insight and Treatment Attitude Questionnaire (ITAQ)(Change from recruitment to 18 months follow-up)
- Client Satisfaction Questionnaire (CSQ-8)(Change from recruitment to 18 months follow-up)
研究者
Prof. Wai Tong CHIEN
Principal Investigator
Chinese University of Hong Kong