Effect of a Peer-led Self-management Program for Recent-onset Psychosis
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Early Psychosis
- Psychotic Disorders
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Parallel Assignment; repeated-measures 3-arm randomized controlled trialMasking: Double (Investigator, Outcomes Assessor)Masking Description: Outcome assessors and researchers (and center staff) are blind to the group assignment and intervention undertaken and concealed to the participant list.Primary Purpose: Health Services Research
Participation Requirements
- Age
- Between 18 years and 60 years
- Gender
- Both males and females
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-e...
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: Improvement in patients' level of recovery at 1-2 weeks post-intervention (Primary hypothesis and outcome); 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 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.
Tracking Information
- NCT #
- NCT04166019
- Collaborators
- Integrated Community Centers for Mental Wellness
- Investigators
- Principal Investigator: Wai Tong Chien, PhD Chinese University of Hong Kong