Effects of a Peer-facilitated, Acceptance-based Self-learning for Illness Management (PASIM) Program

NCT ID: NCT07129369

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 186 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-02
• Study Completion Date: 2028-10-31

Brief Summary

Psychosis is a very disabling mental illness with a wide range of dysregulations and disruptions in cognition, emotions, and behaviors, resulting in poor functioning and frequent relapses, especially in the first five years of the illness. There is a knowledge gap about whether Peer-facilitated, Acceptance-based Self-learning for Illness Management (PASIM) can have longer-term and more significant benefits than current professional-led psychoeducation in diverse health outcomes of these psychotic patients such as functioning, problem-solving, and recovery. This multi-center randomized controlled trial with repeated measures, 3-arm design is proposed to test and compare the effects between two alternative interventions (PASIM and Psychoeducation Group program) and a usual-care-only group over an 18-month follow-up.

Detailed Description

Objectives:

To test the primary hypothesis that the PASIM program can produce significantly greater improvements than psychoeducation and/or usual-care only groups at 1-week, 9-month, and/or 18-month follow-ups on patients' functioning; To test the hypothesis that the PASIM program will produce significantly greater improvements than psychoeducation and usual-care-only over the 18-month follow-ups in patients' psychotic symptoms, problem-solving, illness insight, rehospitalization rates, and/or service satisfaction (secondary outcomes); To explore the strengths, weaknesses and areas for improvements of and satisfaction with the PASIM program, from participants' and peer facilitators' perspectives, using individual semi-structured interviews.

Design: A multi-center randomized controlled trial with repeated measures, 3-arm design will be conducted with both outcome and process evaluation.

Subjects: 186 adults with recent-onset psychosis and randomly assigned into three study groups.

Data collection procedure: After explaining the study and ethical issues to participants, written consent and then baseline measurement will be obtained. During interventions, participants' attendance, workbook completion and attritions will be monitored. At 1-week (Posttest-1), and 9- (Posttest-2) and 18-month (Posttest-3) post-intervention, outcome measurements will be evaluated. In addition, individual semi-structured interviews will be conducted after Posttest-1.

Data analysis: Generalized Estimating Equation test will be used to compare mean-value changes in individual outcomes, and Kaplan-Meier survival-analysis used to analyze the relative risks of re-hospitalizations, between groups over follow-ups. Content analysis will be conducted for qualitative interview data.

Expected results: The PASIM is the first peer-supported self-help for illness management intervention for early-stage psychosis, particularly in Chinese population. It can be a useful and potential cost-saving intervention in community mental healthcare service, providing accessible, self-learned illness self-management training facilitated by peer-support workers (persons recovered from psychosis) in views of limited healthcare resources and mental health professionals in locally and internationally.

Conditions

Psychotic Disorders; Recent-Onset Psychosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

PASIM group

Participants in the PASIM program will study and complete the self-learning manual (printed and online versions available) with 5 modules for ROP patients (translated, refined and validated by research team) and participate in 4 group sessions facilitated by a peer-support worker over 5 months.

Group Type: EXPERIMENTAL

PASIM program

Intervention Type: BEHAVIORAL

The program consists of 5 modules for ROP patients (translated, refined and validated by research team) and 4 group sessions (1.5 hours per session; 8-10 members/group; in-between completion of the 5 modules) facilitated by a peer-support worker over 5 months. The 5 modules include: Module 1-Patient's well-being; Module 2-Getting the best out of support services; Module 3-Acceptance and insight toward psychosis and long-term self-care; Module 4-Dealing with psychosocial effects of the illness- I; and Module 5-Dealing with physical/mental health effects of the illness- II. The 4 group sessions will be conducted at the orientation and after reading the 1st, 3rd and 5th module to introduce the program, encourage to complete the module per month, performing value clarifying and acceptance (psychological flexibility) exercises, and clarify and discuss self-care learning and and challenges.

Usual-Care-only

Intervention Type: BEHAVIORAL

Participants receive usual community mental healthcare services provided by POPCs and ICCMWs.

Psychoeducation group

The psychoeducation group (12 two-hour sessions, 5 subgroups with 12-14 patients per group) will be led by one trained psychiatric nurse experienced in psychiatric rehabilitation and psychoeducation group.

Group Type: EXPERIMENTAL

Psychoeducation

Intervention Type: BEHAVIORAL

The psychoeducation group (5 subgroups with 12-14 patients per group) will be led by one trained psychiatric nurse experienced in psychiatric rehabilitation and psychoeducation group. The program consists of 12 two-hour sessions held weekly or biweekly (similar to the PASIM) over 5 months with four key components, including introduction and goal setting; an education workshop on psychosis care and community service; learning effective coping and self-care skills with rehearsals/reviews; and skills practices and preparing for future life.

Usual-Care-only

Intervention Type: BEHAVIORAL

Participants receive usual community mental healthcare services provided by POPCs and ICCMWs.

Usual-care-only group

This control group (and 2 intervention groups) will receive usual community mental healthcare services provided by POPCs and ICCMWs. Patients in ICCMWs and POPCs may receive services in commons, including occupational/living skills training, education on psychosis care, recreational services, and individual and/or family counseling and referrals to social and health care services as needed. The control group will also receive an information booklet about illness self-care to minimize the Hawthorne effect from the PASIM manual reading.

Group Type: OTHER

Usual-Care-only

Intervention Type: BEHAVIORAL

Participants receive usual community mental healthcare services provided by POPCs and ICCMWs.

Interventions

PASIM program

The program consists of 5 modules for ROP patients (translated, refined and validated by research team) and 4 group sessions (1.5 hours per session; 8-10 members/group; in-between completion of the 5 modules) facilitated by a peer-support worker over 5 months. The 5 modules include: Module 1-Patient's well-being; Module 2-Getting the best out of support services; Module 3-Acceptance and insight toward psychosis and long-term self-care; Module 4-Dealing with psychosocial effects of the illness- I; and Module 5-Dealing with physical/mental health effects of the illness- II. The 4 group sessions will be conducted at the orientation and after reading the 1st, 3rd and 5th module to introduce the program, encourage to complete the module per month, performing value clarifying and acceptance (psychological flexibility) exercises, and clarify and discuss self-care learning and and challenges.

Intervention Type: BEHAVIORAL

Psychoeducation

The psychoeducation group (5 subgroups with 12-14 patients per group) will be led by one trained psychiatric nurse experienced in psychiatric rehabilitation and psychoeducation group. The program consists of 12 two-hour sessions held weekly or biweekly (similar to the PASIM) over 5 months with four key components, including introduction and goal setting; an education workshop on psychosis care and community service; learning effective coping and self-care skills with rehearsals/reviews; and skills practices and preparing for future life.

Intervention Type: BEHAVIORAL

Usual-Care-only

Participants receive usual community mental healthcare services provided by POPCs and ICCMWs.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Primarily diagnosed with psychosis (or ROP with <5 years of illness as defined in recent literature), including brief, first-episode and other psychotic disorders according to the criteria of the DSM-5 [American Psychiatric Association 2013];
• H.K. Chinese residents, aged 18-64 years;
• Global Assessment of Functioning scores ≥51, indicating mild to moderate symptoms and difficulties in psychosocial/occupational functioning [American Psychiatric Association 2013], being mentally stable to comprehend APSI or psychoeducation and outcome measures;
• Able to read and understand Cantonese/ Mandarin.

Exclusion Criteria

• Have received or are receiving other psychotherapies;
• Comorbidity with other mental (learning disability, cognitive, or personality disorder) or significant medical disease(s);
• And/or communication, visual or hearing difficulty.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Integrated Community Centers for Mental Wellness

UNKNOWN

Sponsor Role: collaborator

Psychiatric outpatient clinics

UNKNOWN

Sponsor Role: collaborator

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Prof. Wai Tong CHIEN

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wai Tong Chien, PhD

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

Integrated Community Centers for Mental Wellness

Hong Kong, Hong Kong, China

Psychiatric outpatient clinics in one hospital cluster of Hospital Authority

Hong Kong, Hong Kong, China

Countries

China

Central Contacts

Wai Tong Chien, PhD

Role: CONTACT

1155184102@link.cuhk.edu.hk

93518670

Yongfeng Chen, PhD

Role: CONTACT

1155184102@link.cuhk.edu.hk

93518670

Facility Contacts

Wai Tong Chien

Role: primary

wtchien@cuhk.edu.hk

+85239438172

Wai Tong Chien

Role: primary

wtchien@cuhk.edu.hk

+85239438172

References

Chien WT, Chong YY, Bressington D, McMaster CW. A randomized controlled trial of an acceptance-based, insight-inducing medication adherence therapy (AIM-AT) for adults with early-stage psychosis. Psychiatry Res. 2024 Sep;339:116046. doi: 10.1016/j.psychres.2024.116046. Epub 2024 Jun 17.

Reference Type: BACKGROUND

PMID: 38908265 (View on PubMed)

Chien WT, Bressington D, Lubman DI, Karatzias T. A Randomised Controlled Trial of a Caregiver-Facilitated Problem-Solving Based Self-Learning Program for Family Carers of People with Early Psychosis. Int J Environ Res Public Health. 2020 Dec 14;17(24):9343. doi: 10.3390/ijerph17249343.

Reference Type: BACKGROUND

PMID: 33327452 (View on PubMed)

Chien WT, Bressington D. A randomized controlled clinical trial of a nurse-led structured psychosocial intervention program for people with first-onset mental illness in psychiatric outpatient clinics. Psychiatry Res. 2015 Sep 30;229(1-2):277-86. doi: 10.1016/j.psychres.2015.07.012. Epub 2015 Jul 10.

Reference Type: BACKGROUND

PMID: 26193827 (View on PubMed)

Chien WT, Cheng HY, McMaster TW, Yip ALK, Wong JCL. Effectiveness of a mindfulness-based psychoeducation group programme for early-stage schizophrenia: An 18-month randomised controlled trial. Schizophr Res. 2019 Oct;212:140-149. doi: 10.1016/j.schres.2019.07.053. Epub 2019 Aug 12.

Reference Type: BACKGROUND

PMID: 31416744 (View on PubMed)

Other Identifiers

14608525

Identifier Type: -

Identifier Source: org_study_id