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Clinical Trials/NCT04166019
NCT04166019
Completed
Not Applicable

Effectiveness of a Peer-led Self-Management Program for People With Recent-onset Psychosis: A Randomized Controlled Trial

Chinese University of Hong Kong1 site in 1 country180 target enrollmentDecember 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Early Psychosis
Sponsor
Chinese University of Hong Kong
Enrollment
180
Locations
1
Primary Endpoint
Questionnaire about the Process of Recovery (QPR)
Status
Completed
Last Updated
8 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2020
End Date
July 31, 2025
Last Updated
8 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Prof. Wai Tong CHIEN

Principal Investigator

Chinese University of Hong Kong

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

Outcomes

Primary Outcomes

Questionnaire about the Process of Recovery (QPR)

Time Frame: 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.

Secondary Outcomes

  • 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)

Study Sites (1)

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