跳至主要内容
临床试验/NCT06487195
NCT06487195进行中(未招募)不适用

Effectiveness of a Peer-facilitated, Recovery-focused Self-illness Management Program (Peer-RESIM) for First-episode Psychosis

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 198 人开始时间: 2023年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
198
试验地点
1
主要终点
Questionnaire about the Process of Recovery (QPR)

研究概览

简要总结

Psychosis is a major disabling and disruptive mental illness characterized by a wide variety of disturbances in cognition and emotions, resulting in poor psychosocial functioning and frequent relapses. Despite convincing evidence of short-term symptom control and functional recovery, there has been a limited amount of data generated over the past two decades on the long-term outcomes of early interventions for psychotic patients (especially, first-episode psychosis, FEP). We propose a controlled trial with an adequate study power to examine the longer-term effects (18 months) of a Peer-facilitated, Recovery-focused Self-Illness-Management program (Peer-RESIM) for adults with FEP. Specifically, the proposed study will assess the effects of better-prepared PSWs, and a culturally adapted intervention protocol designed by our multidisciplinary research team, on improving patients' self-care and recovery.

详细描述

People with first-episode psychosis (FEP) are often anxious/stressed and unprepared to manage the illness and associated disturbances of daily living and functioning. Due to this unpreparedness for illness management and diverse adverse health effects in FEP, different approaches to psychosocial interventions provide significant benefits in improving patients' symptom management and preventing relapses. However, similar to early interventions, inconsistent/inconclusive results have been reported for most psychosocial health outcomes, particularly over a long-term follow-up.

There is increasing evidence showing that recovery-focused care is an effective approach to community-based psychiatric rehabilitation and mental health practice. Using this approach, empowered self-help and hope cultivation can help patients develop a sense of purpose and meaning in life and optimism for the future. Peer support can be provided by ex-/co-patients with similar illness experience who have been trained to provide voluntary/in-job mental health services. Consequently, they are well-placed to model and encourage active and autonomous recovery in their peers (fellow-patients). This innovative method of supporting recovery-focused mental healthcare is increasingly popular among those developing mental healthcare services and policies.[9] However, there few high-quality trials have assessed this strategy, and there is little evidence of its positive effects on functional and clinical recovery, symptoms and hospitalizations and service satisfaction, especially in Asian countries. Structured self-help (and/or peer-supported) training and practices may have the advantage of empowering and facilitating FEP patients to meet their (co-patients') real-life personal and illness care goals; they also minimize professional input, which may enhance the feasibility, accessibility, and/or user-friendliness of an intervention and keep its cost of delivery low.

Milton and our (1st-)Co-I conducted a multi-center randomized controlled trial of peer-facilitated recovery from severe mental illness intervention in England, using the Crisis- Resolution-Team Optimisation and RElapse Prevention(CORE) program. In their trial, significantly fewer participants in the treatment group (n=120) were admitted to inpatient care (29%vs.38%), time-to-readmission was longer (112vs.86 days), and service satisfaction was higher (78%vs.41%) than the usual care only group, over a 1-year follow-up period. A similar service is required in Hong Kong, and this peer-facilitated, self-management model/approach can be adopted/tested.

Mental healthcare should maximize the self-management of individual first-episode psychosis patients' mental wellbeing, peer support, and experience-sharing for patients to improve their illness self-care and recovery. Based on the findings of Milton's and our Co-I's randomized trial of CORE program, a similar peer-facilitated, recovery-based self-illness-management program can be adopted/tested in Hong Kong, with cultural adaptations to match local service development strategies/needs.

This proposed randomized controlled trial tests two main hypotheses that:

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
Triple (Care Provider, Investigator, Outcomes Assessor)

盲法说明

Outcome assessors, researchers and clinical staff are blind to the group and intervention assignment; they are also concealed to the participant lists.

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Hong Kong Chinese residents, aged 18-60;
  • clinically and primarily diagnosed with a first-episode psychosis according to the DSM-V criteria (American Psychiatric Association 2013), and within 3 years onset of illness;
  • able to understand Cantonese/Mandarin; and
  • having Global Assessment of Functioning scores ≥51, indicating mild-to-moderate symptoms and challenges in maintaining work/school/family roles, but mentally stable and comprehendible to the training and education offered

排除标准

  • recently received/are currently receiving another psychosocial or psychoeducation intervention;
  • having a comorbidity of learning/cognitive/personality disorder, and/or clinically significant medical disease; or
  • having a visual/language/communication difficulty/disorder.

结局指标

主要结局

Questionnaire about the Process of Recovery (QPR)

时间窗: Total score self-reported at 18 months post-intervention

Level of recovery from illness will be measured with the Questionnaire about the Process of Recovery (QPR) developed by Neil et al. (2009). It consists of 22 items and three subscales (self-empowerment, 10 items; effective interpersonal relationships, 6 items; and rebuilding life, 6 items). Items will be rated on a 5-point Likert scale (0, "disagree strongly" to 4, "agree strongly"; total score range, 0-88).

Specific Level of Functioning Scale (SLOF)

时间窗: Total score self-reported at 18 months post-intervention

Patient functioning will be measured with the 43-item Specific Level of Functioning Scale by Schneider and Struening (1983), consisting of 4 domains:- self-maintenance (12 items), social functioning (14 items), activities (11 items), and community-living skills (6 items), assessed using a 5-point Likert scale (1-"highly dependent/typical/always' to 5-"fully self-sufficient/ typical/never").

次要结局

  • Chinese version of the Revised Social-Problem-Solving Inventory (C-SPSI-R:S)(Changes in mean scores from recruitment to 18 months follow-up)
  • RE-hospitalisation rates(Changes in average rates from recruitment to 18 months follow-up)
  • 8-item Client Satisfaction Questionnaire (CSQ-8)(Changes in mean scores from recruitment to 18 months follow-up)
  • Positive and Negative Syndrome Scale (PANSS)(Changes in mean scores from recruitment to 18 months follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Wai Tong CHIEN

Professor

Chinese University of Hong Kong

研究点 (1)

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