Effect of a Peer-led Self-management Program for Recent-onset Psychosis

Psychotic Disorders Clinical Trial

— PLSMI  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04166019
• Other study ID #: 19101314
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: June 30, 2024

Study information

• Verified date: August 2023
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 180
• Est. completion date: June 30, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Early Psychosis
• Mental Disorders
• Psychotic Disorders

Intervention

Behavioral:
• Peer-led self-management program
The program based on completion of a self-management workbook, consisting of the main components: personal recovery goals, plans to re-establish community functioning and support networks following a crisis, identifying early warning signs and creating a relapse prevention plan, and strategies and coping resources to problem-solving and maintain well-being.
• Psycho-education group
The psycho-education group program is comprised of six components: introduction and goal-setting; basic understanding of psychosis and symptom and emotion self-care; education workshop of psychosis care, treatment and community support services; learning about self-care skills; establishing social support and effective coping skills; and skills practices, review and future plan.
• Usual care
Routine care services consist of monthly psychiatric consultation and treatments prescribed by psychiatrist, nursing advice on community care, brief education (1-2 hourly sessions) about mental illness/treatments by psychiatric nurses, home visits by case managers, and/or referrals to community/welfare services.

Locations

Country	Name	City	State
Hong Kong	Integrated Community Centers for Mental Wellness	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
Chinese University of Hong Kong	Integrated Community Centers for Mental Wellness

Country where clinical trial is conducted

Hong Kong, 

References & Publications (2)

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.

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Questionnaire about the Process of Recovery (QPR)	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; score range= 0-88); the higher total score indicates a higher of recovery progress.	At recruitment
Primary	Questionnaire about the Process of Recovery (QPR)	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.	At 1-2 weeks post-intervention
Primary	Questionnaire about the Process of Recovery (QPR)	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.	At 6 months post-intervention
Primary	Questionnaire about the Process of Recovery (QPR)	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.	At 12 months post-intervention
Primary	Questionnaire about the Process of Recovery (QPR)	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.	At 18 months post-intervention
Secondary	Re-hospitalization rate	Occurrence of and time to hospitalization, and frequency of re-hospitalizations over past 5-6 months	Change from recruitment to 18 months follow-up
Secondary	Positive and Negative Syndrome Scale (PANSS)	Symptom severity is assessed with the 30-item Positive and Negative Syndrome Scale (PANSS) developed by Kay (1987) across three sub-scales: positive symptoms, negative symptoms and general psychopathology. Items are rated on a 7-point Likert scale (1= absent to 7= extreme; total score range= 7-210); a higher total score indicates more severe psychotic symptoms.	Change from recruitment to 18 months follow-up
Secondary	Specific Level of Functioning Scale (SLOF)	Patient functioning is measured by the 43-item Specific Level of Functioning Scale (SLOF) developed by Schneider and Struening (1983) in terms of three domains: physical functioning/personal care, social functioning and community living skills. Items are rated on a 5-point Likert scale (1=very poor to 5=very well; total score range= 43-215); a higher total score indicates a higher level of functioning.	Change from recruitment to 18 months follow-up
Secondary	Revised Social-Problem-Solving Inventory (C-SPSI-R:S)	Problem-solving ability will be assessed with a 25-item Chinese version of Revised Social-Problem-Solving Inventory (C-SPSI-R:S), comprising 2 domains: problem-solving style (rational/impulsive; careless/avoidance) and orientation (positive/negative). Items are rated on a 5-point Likert scale (1=not at all true to 4=extremely true; total score range= 0-100); a higher total score indicates better problem solving ability.	Change from recruitment to 18 months follow-up
Secondary	Insight and Treatment Attitude Questionnaire (ITAQ)	Insight into illness and treatment is measured by the 11-item Treatment Attitude Questionnaire (ITAQ) developed by McEvoy et al. (1989) measuring patients' insights and recognition of their illness and attitudes towards the need for treatments. Items are rated on a 3-point Likert scale (0=not necessary to receive treatment to 2=treatment should be required/continued regularly; total score range= 0-22; a higher total score indicates better insight into the illness/treatment.	Change from recruitment to 18 months follow-up
Secondary	Client Satisfaction Questionnaire (CSQ-8)	Patient satisfaction with service is measured by the 8-item Client Satisfaction Questionnaire (CSQ-8) developed by Attkisson and Zwick (1982). Items are rated on a 4-point Likert scale (1= very dissatisfied to 4= very satisfied; total score range= 8-32); a higher total score indicates a better satisfaction with the services received/receiving.	Change from recruitment to 18 months follow-up