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

Primary Purpose

Early Psychosis, Psychotic Disorders

Status
Active
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Peer-led self-management program
Psycho-education group
Usual care
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Early Psychosis focused on measuring first-onset psychosis, randomized controlled trial, peer support, self management, recovery, re-hospitalization

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Integrated Community Centers for Mental Wellness

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Other

Arm Label

Peer-led self-management program

Psycho-education group

Usual care only

Arm Description

Peer-led self-management program (PLSMI) consists of 10 weekly/biweekly, 1.5-hour sessions (4 months), based on the modified Crisis-resolution-team Optimization and Relapse Prevention (CORE) program workbook/manual and psycho-education programs developed by the research team. 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. Participants work through the workbook at their own pace, with the support from the peer support worker, to facilitate/support their recovery. They will meet in group with a trained peer support worker on 10 sessions, usually at 7-12 days intervals over 4 months.

Psycho-education groups (12-18 members/group; 10 two-hour sessions, weekly/biweekly), 4-month duration similar to the PLSMI, will be led by one trained advanced practice psychiatric nurse in each center experienced in psychiatric rehabilitation, and are guided by a validated group-intervention protocol based on the research team's and McFarlane et al.'s psycho-education programs for psychosis.

Usual care (control) participants (and treatment groups) will receive routine psychiatric outpatient and community mental healthcare services.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.

Secondary Outcome Measures

Re-hospitalization rate
Occurrence of and time to hospitalization, and frequency of re-hospitalizations over past 5-6 months
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.
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.
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.
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.
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.

Full Information

First Posted
November 13, 2019
Last Updated
August 28, 2023
Sponsor
Chinese University of Hong Kong
Collaborators
Integrated Community Centers for Mental Wellness
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1. Study Identification

Unique Protocol Identification Number
NCT04166019
Brief Title
Effect of a Peer-led Self-management Program for Recent-onset Psychosis
Acronym
PLSMI
Official Title
Effectiveness of a Peer-led Self-Management Program for People With Recent-onset Psychosis: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
March 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
Collaborators
Integrated Community Centers for Mental Wellness

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Psychosis, Psychotic Disorders
Keywords
first-onset psychosis, randomized controlled trial, peer support, self management, recovery, re-hospitalization

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment; repeated-measures 3-arm randomized controlled trial
Masking
InvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Peer-led self-management program
Arm Type
Experimental
Arm Description
Peer-led self-management program (PLSMI) consists of 10 weekly/biweekly, 1.5-hour sessions (4 months), based on the modified Crisis-resolution-team Optimization and Relapse Prevention (CORE) program workbook/manual and psycho-education programs developed by the research team. 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. Participants work through the workbook at their own pace, with the support from the peer support worker, to facilitate/support their recovery. They will meet in group with a trained peer support worker on 10 sessions, usually at 7-12 days intervals over 4 months.
Arm Title
Psycho-education group
Arm Type
Active Comparator
Arm Description
Psycho-education groups (12-18 members/group; 10 two-hour sessions, weekly/biweekly), 4-month duration similar to the PLSMI, will be led by one trained advanced practice psychiatric nurse in each center experienced in psychiatric rehabilitation, and are guided by a validated group-intervention protocol based on the research team's and McFarlane et al.'s psycho-education programs for psychosis.
Arm Title
Usual care only
Arm Type
Other
Arm Description
Usual care (control) participants (and treatment groups) will receive routine psychiatric outpatient and community mental healthcare services.
Intervention Type
Behavioral
Intervention Name(s)
Peer-led self-management program
Other Intervention Name(s)
PLSMI
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Psycho-education group
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Usual care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Questionnaire about the Process of Recovery (QPR)
Description
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.
Time Frame
At recruitment
Title
Questionnaire about the Process of Recovery (QPR)
Description
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.
Time Frame
At 1-2 weeks post-intervention
Title
Questionnaire about the Process of Recovery (QPR)
Description
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.
Time Frame
At 6 months post-intervention
Title
Questionnaire about the Process of Recovery (QPR)
Description
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.
Time Frame
At 12 months post-intervention
Title
Questionnaire about the Process of Recovery (QPR)
Description
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.
Time Frame
At 18 months post-intervention
Secondary Outcome Measure Information:
Title
Re-hospitalization rate
Description
Occurrence of and time to hospitalization, and frequency of re-hospitalizations over past 5-6 months
Time Frame
Change from recruitment to 18 months follow-up
Title
Positive and Negative Syndrome Scale (PANSS)
Description
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.
Time Frame
Change from recruitment to 18 months follow-up
Title
Specific Level of Functioning Scale (SLOF)
Description
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.
Time Frame
Change from recruitment to 18 months follow-up
Title
Revised Social-Problem-Solving Inventory (C-SPSI-R:S)
Description
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.
Time Frame
Change from recruitment to 18 months follow-up
Title
Insight and Treatment Attitude Questionnaire (ITAQ)
Description
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.
Time Frame
Change from recruitment to 18 months follow-up
Title
Client Satisfaction Questionnaire (CSQ-8)
Description
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.
Time Frame
Change from recruitment to 18 months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wai Tong Chien, PhD
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Integrated Community Centers for Mental Wellness
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The name and email of the researchers can be shared openly for communication and collaboration.
Citations:
PubMed Identifier
30102174
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.
Results Reference
background
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.
Results Reference
background

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

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