Effects of a Peer-facilitated, Recovery-focused Self-illness Management Program for First-episode Psychosis
NCT Number: NCT06487195
Acronym: Peer-RESIM
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Psychotic Disorders
Interventions: BEHAVIORAL: Peer-facilitated, Recovery-based Self-illness-management programme|BEHAVIORAL: Psycho-education group|BEHAVIORAL: Treatment-as-usual only
Sponsor: Chinese University of Hong Kong
Collaborators: Integrated Community Centers for Mental Wellness
Sex: ALL
Age: ADULT
Enrollment: 198
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2023-02-01
Completion Date: 2025-06-30
Locations: Integrated Community Centers for Mental Wellness, Hong Kong, Hong Kong

Summary:
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.

Primary Outcome Measures: Questionnaire about the Process of Recovery (QPR), 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)., Total score self-reported at recruitment|Questionnaire about the Process of Recovery (QPR), 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)., Total score self-reported at 1 week post-intervention|Questionnaire about the Process of Recovery (QPR), 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)., Total score self-reported at 9 months post-intervention|Questionnaire about the Process of Recovery (QPR), 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)., Total score self-reported at 18 months post-intervention|Specific Level of Functioning Scale (SLOF), 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")., Total score self-reported at recruitment|Specific Level of Functioning Scale (SLOF), 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")., Total score self-reported at 1 week post-intervention|Specific Level of Functioning Scale (SLOF), 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")., Total score self-reported at 9 months post-intervention|Specific Level of Functioning Scale (SLOF), 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")., Total score self-reported at 18 months post-intervention
Secondary Outcome Measures: Positive and Negative Syndrome Scale (PANSS), The 30-item Positive and Negative Syndrome Scale (PANSS) developed by Kay et al. (1987) will evaluate on three subscales: positive symptoms, negative symptoms and general psychopathology. Items will be rated on an 8-point scale (0-"absent" to 7-"extreme")., Changes in mean scores from recruitment to 18 months follow-up|Chinese version of the Revised Social-Problem-Solving Inventory (C-SPSI-R:S), The 25-item C-SPSI-R:S comprises two domains: problem-solving style (rational/impulsive; careless/avoidance) and orientation (positive/negative), being rated on a 5-point Likert-scale (0-"not-at-all true" to 4-"extremely true")., Changes in mean scores from recruitment to 18 months follow-up|RE-hospitalisation rates, Occurrence and time to hospitalisation, and frequency of re-hospitalisations over the past 5-6 months, Changes in average rates from recruitment to 18 months follow-up|8-item Client Satisfaction Questionnaire (CSQ-8), The 8-item CSQ-8 developed by Attkisson and Zwick (1982) is a well-accepted questionnaire used to evaluate service users' opinions/comments about services received. Items are rated on a 4-point Likert scale (1-"very dissatisfied" to 4-"very satisfied")., Changes in mean scores from recruitment to 18 months follow-up
Other Outcome Measures: Perception and insight/attitude towards illness/treatment, perception and insight/attitude towards the illness and treatment, as appropriate, using valid questionnaires or qualitative interviews, Changes in mean scores from recruitment to 18 months follow-up