Clinical trial NCT06487195: Effects of a Peer-facilitated, Recovery-focused Self-illness Management Program for First-episode Psychosis
Official title: Effectiveness of a Peer-facilitated, Recovery-focused Self-illness Management Program (Peer-RESIM) for First-episode Psychosis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Psychotic Disorders
Keywords: First-episode psychosis
randomized controlled trial
peer facilitator
recovery
illness self-management
functioning
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Integrated Community Centers for Mental Wellness
First posted: 2024-07-05
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel assignment; repeated-measures, multi-centre 3-arm RCT
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed description: 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:

(1) the Peer-facilitated, Recovery-focused Self-Illness-Management program (Peer-RESIM) will yield significantly greater improvements than psychoeducation and/or routine-care only at 1-week, 9-month and/or 18-month follow-ups in patients' recovery and functioning (primary outcomes).

2. It also tests the hypothesis that the Peer-RESIM will yield significantly greater improvements than the other two groups at 1-week, 9-month and/or 18-month follow-ups in psychotic symptoms, problem-solving, re-hospitalization rates, and/or service satisfaction (secondary outcomes).

The trial examines whether the Peer-RESIM participants will indicate clinically significant changes/benefits in two primary outcomes at 1-week, 9-month and/or 18-month follow-ups.

In addition, focus-group interviews will be conducted to explore the perceived benefits, service satisfaction and strengths/limitations of the Peer-RESIM from peer-facilitators' and participants' perspectives.

Methods: A assessor-blinded, three-arm multi-centre RCT was conducted. A list of 198 Chinese adult patients with FEP randomly selected from four Community Centers for Mental Wellness in Hong Kong (in 2023) (i.e., 16-17 subjects/group from each center; a total of 66 participants per group) and randomly assigned into one of the three study groups (Peer-RESIM, psycho-education, or usual care only group) by matching with computerized random numbers.

After four-month interventions, the patient outcomes will be measured at immediately, 9 months, and 18 months post-intervention, and analysed on intention-to-treat basis. Clinical significant changes in the primary outcomes will be assessed within and between groups according to Jacobson and Traux's criteria to examine the clinical benefits to patients. Focus-group interviews will also be conducted to explore the perceived benefits, service satisfaction and strengths/limitations of the Peer-RESIM from peer-facilitators' and participants' perspectives.

Study outcomes and variables:

Socio-demographic and clinical data (e.g., gender, age, clinical diagnosis, illness duration, and medications) will be collected at baseline, and changes in medications will be recorded during the study.

Primary outcomes include: the Questionnaire about the Process of Recovery (QPR) and the 43-item Specific Level of Functioning Scale.

Secondary outcomes include: the 30-item Positive and Negative Syndrome Scale (PANSS); the Revised Social-Problem-Solving Inventory (C-SPSI-R:S); Frequency and length of time to rehospitalization(s); and the 8-item Client Satisfaction Questionnaire (CSQ-8). (Note: illness/treatment insight and drug attitude as appropriate).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Questionnaire about the Process of Recovery (QPR)
timeFrame: Total score self-reported at recruitment
measure: Questionnaire about the Process of Recovery (QPR)
timeFrame: Total score self-reported at 1 week post-intervention
measure: Questionnaire about the Process of Recovery (QPR)
timeFrame: Total score self-reported at 9 months post-intervention
measure: Questionnaire about the Process of Recovery (QPR)
timeFrame: Total score self-reported at 18 months post-intervention
measure: Specific Level of Functioning Scale (SLOF)
timeFrame: Total score self-reported at recruitment
measure: Specific Level of Functioning Scale (SLOF)
timeFrame: Total score self-reported at 1 week post-intervention
measure: Specific Level of Functioning Scale (SLOF)
timeFrame: Total score self-reported at 9 months post-intervention
measure: Specific Level of Functioning Scale (SLOF)
timeFrame: Total score self-reported at 18 months post-intervention
Secondary outcomes:
measure: Positive and Negative Syndrome Scale (PANSS)
timeFrame: Changes in mean scores from recruitment to 18 months follow-up
measure: Chinese version of the Revised Social-Problem-Solving Inventory (C-SPSI-R:S)
timeFrame: Changes in mean scores from recruitment to 18 months follow-up
measure: RE-hospitalisation rates
timeFrame: Changes in average rates from recruitment to 18 months follow-up
measure: 8-item Client Satisfaction Questionnaire (CSQ-8)
timeFrame: Changes in mean scores from recruitment to 18 months follow-up
Other outcomes:
measure: Perception and insight/attitude towards illness/treatment
timeFrame: Changes in mean scores from recruitment to 18 months follow-up
Locations:
city: Hong Kong
country: Hong Kong
facility: Integrated Community Centers for Mental Wellness
Study officials:
affiliation: Chinese University of Hong Kong
name: Wai Tong Chien, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chien WT, Bressington D. A randomized controlled clinical trial of a nurse-led structured psychosocial intervention program for people with first-onset mental illness in psychiatric outpatient clinics. Psychiatry Res. 2015 Sep 30;229(1-2):277-86. doi: 10.1016/j.psychres.2015.07.012. Epub 2015 Jul 10.
citation: Johnson S, Lamb D, Marston L, Osborn D, Mason O, Henderson C, Ambler G, Milton A, Davidson M, Christoforou M, Sullivan S, Hunter R, Hindle D, Paterson B, Leverton M, Piotrowski J, Forsyth R, Mosse L, Goater N, Kelly K, Lean M, Pilling S, Morant N, Lloyd-Evans B. Peer-supported self-management for people discharged from a mental health crisis team: a randomised controlled trial. Lancet. 2018 Aug 4;392(10145):409-418. doi: 10.1016/S0140-6736(18)31470-3.
citation: Craig TK, Garety P, Power P, Rahaman N, Colbert S, Fornells-Ambrojo M, Dunn G. The Lambeth Early Onset (LEO) Team: randomised controlled trial of the effectiveness of specialised care for early psychosis. BMJ. 2004 Nov 6;329(7474):1067. doi: 10.1136/bmj.38246.594873.7C. Epub 2004 Oct 14.
citation: D'Zurilla TJ, Nezu A,M. Problem-solving therapy : a positive approach to clinical intervention,3rd ed. New York, NY: Springer; 2007.