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

NCT07129369 | Not Yet Recruiting DMC

• 1 other identifier: 14608525
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 2

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.

Conditions

Psychotic Disorders; Recent-Onset Psychosis

Keywords

Randomized controlled trial; Acceptance-based intervention; Peer support; Self help; Recent-onset psychosis

Outcome Measures

Primary Outcomes (4)

• Patient functioning

  The 43-item Specific Level of Functioning Scale is used to measure patient functioning across four domains: self-maintenance, social functioning, activities, and community-living skills. Each item is evaluated using a 5-point Likert scale (1=highly dependent/typical/always to 5=fully self-sufficient/never; total score range= 43-215). A higher total score indicates a higher level of functioning.

  Baseline

• Patient functioning

  The 43-item Specific Level of Functioning Scale is used to measure patient functioning across four domains: self-maintenance, social functioning, activities, and community-living skills. Each item is evaluated using a 5-point Likert scale (1=highly dependent/typical/always to 5=fully self-sufficient/never; total score range= 43-215). A higher total score indicates a higher level of functioning.

  Change from baseline to 1-week post-intervention

• Patient functioning

  The 43-item Specific Level of Functioning Scale is used to measure patient functioning across four domains: self-maintenance, social functioning, activities, and community-living skills. Each item is evaluated using a 5-point Likert scale (1=highly dependent/typical/always to 5=fully self-sufficient/never; total score range= 43-215). A higher total score indicates a higher level of functioning.

  Change from baseline to 9-month follow-up after the intervention

• Patient functioning

  The 43-item Specific Level of Functioning Scale is used to measure patient functioning across four domains: self-maintenance, social functioning, activities, and community-living skills. Each item is evaluated using a 5-point Likert scale (1=highly dependent/typical/always to 5=fully self-sufficient/never; total score range= 43-215). A higher total score indicates a higher level of functioning.

  Change from baseline to 18-month follow-up after the intervention

Secondary Outcomes (20)

• Problem-solving ability

  Baseline

• Problem-solving ability

  Change from baseline to 1-week post-intervention

• Problem-solving ability

  Change from baseline to the 9-month follow-up after the intervention

• Problem-solving ability

  Change from baseline to 18-month follow-up after the intervention

• Psychotic symptoms

  Baseline

Study Arms (3)

PASIM group

EXPERIMENTAL

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.

Behavioral: PASIM program; Behavioral: Usual-Care-only

Psychoeducation group

EXPERIMENTAL

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.

Behavioral: Psychoeducation; Behavioral: Usual-Care-only

Usual-care-only group

OTHER

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.

Behavioral: Usual-Care-only

Interventions

PASIM program 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.

PASIM group

Psychoeducation 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.

Psychoeducation group

Usual-Care-only BEHAVIORAL

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

PASIM group; Psychoeducation group; Usual-care-only group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• Integrated Community Centers for Mental Wellness: collaborator
• Psychiatric outpatient clinics: collaborator

Study Sites (2)

Integrated Community Centers for Mental Wellness

Hong Kong, Hong Kong, China

Location

Psychiatric outpatient clinics in one hospital cluster of Hospital Authority

Hong Kong, Hong Kong, China

Location

Related Publications (4)

• 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.

  PMID: 38908265 BACKGROUND

• 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.

  PMID: 33327452 BACKGROUND

• 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.

  PMID: 26193827 BACKGROUND

• 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.

  PMID: 31416744 BACKGROUND

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Wai Tong Chien, PhD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wai Tong Chien, PhD

CONTACT

93518670; 1155184102@link.cuhk.edu.hk

Yongfeng Chen, PhD

CONTACT

93518670; 1155184102@link.cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Center / Clinical staff
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: August 19, 2025
• Study Start: January 2, 2026
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): October 31, 2028
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)