Clinical trial NCT04166019: Effect of a Peer-led Self-management Program for Recent-onset Psychosis
Official title: Effectiveness of a Peer-led Self-Management Program for People With Recent-onset Psychosis: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Early Psychosis
Psychotic Disorders
Keywords: first-onset psychosis
randomized controlled trial
peer support
self management
recovery
re-hospitalization
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Integrated Community Centers for Mental Wellness
First posted: 2019-11-18
Enrollment: 180
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 3-arm randomized controlled trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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:

1. Improvement in patients' level of recovery at 1-2 weeks post-intervention (Primary hypothesis and outcome);
2. 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
3. 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.

Subjects: 180 people with recent-onset psychosis (not more than 3 years onset) randomly selected from 6 Integrated Community Centers for Mental Wellness and randomly assigned into 3 arms.

Instruments/Measures: Level of self-reported recovery (QPS, primary outcome); occurrence and frequency of and time to psychiatric hospitalization over past 6 or 18 months; symptom severity (PANSS); problem solving ability (C-SPSI-R:S); illness insight (ITAQ); functioning (SLOF), and service satisfaction (CSQ-8).

Focus group interviews will be conducted to collect views on benefits and weaknesses of PLSMI.

Data analyses: Comparing the mean value changes of outcomes between-groups across time on intention-to-treat basis, using MANOVA/Mixed Modeling/Generalized Estimation Equations test and comparing the occurrence of and time to hospitalization between groups using survival analysis and Cox regression test; content analysis of qualitative data from focus-group interviews and intervention sessions.

Expected results: The findings provide evidence of the effectiveness of peer-support self-management program for early-stage psychosis in community mental health healthcare on improving patients' recovery and other important patient outcomes, as well as service satisfaction.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Questionnaire about the Process of Recovery (QPR)
timeFrame: At recruitment
measure: Questionnaire about the Process of Recovery (QPR)
timeFrame: At 1-2 weeks post-intervention
measure: Questionnaire about the Process of Recovery (QPR)
timeFrame: At 6 months post-intervention
measure: Questionnaire about the Process of Recovery (QPR)
timeFrame: At 12 months post-intervention
measure: Questionnaire about the Process of Recovery (QPR)
timeFrame: At 18 months post-intervention
Secondary outcomes:
measure: Re-hospitalization rate
timeFrame: Change from recruitment to 18 months follow-up
measure: Positive and Negative Syndrome Scale (PANSS)
timeFrame: Change from recruitment to 18 months follow-up
measure: Specific Level of Functioning Scale (SLOF)
timeFrame: Change from recruitment to 18 months follow-up
measure: Revised Social-Problem-Solving Inventory (C-SPSI-R:S)
timeFrame: Change from recruitment to 18 months follow-up
measure: Insight and Treatment Attitude Questionnaire (ITAQ)
timeFrame: Change from recruitment to 18 months follow-up
measure: Client Satisfaction Questionnaire (CSQ-8)
timeFrame: Change from recruitment to 18 months follow-up
Other outcomes:
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: 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: Chien WT, Bressington D, Chan S, Lubman DI. Effects of peer-support illness-management program for people with recent-onset psychosis (Oral presentation, Proceeding p. 14). THE IRES - 627TH INTERNATIONAL CONFERENCES ON ECONOMICS AND SOCIAL SCIENCES (ICESS; June 2019). Thailand: Bangkok.