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NCT Number: NCT07129369

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

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.

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Key information

Conditions

Psychotic Disorders Mental Disorders Recent-Onset Psychosis Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Integrated Community Centers for Mental Wellness, Hong Kong, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Usual-Care-only

Behavioral

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

Primary outcomes

  1. Patient functioning

    Time frame: Baseline

    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.

  2. Patient functioning

    Time frame: Change from baseline to 1-week post-intervention

    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.

  3. Patient functioning

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

    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.

  4. Patient functioning

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

    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.

Secondary outcomes

  1. Problem-solving ability

    Time frame: Baseline

    Problem-solving ability will be measured a 25-item Chinese version of Revised (Short) Social Problem-Solving Inventory. It comprises 2 domains: problem-solving style (rational, impulsive/careless and avoidance) and orientation (positive/negative). Items are rated on a 5-point Likert scale (0=not at all true to 4=extremely true; total score range= 0-100). A higher total score indicates better problem solving ability.

  2. Problem-solving ability

    Time frame: Change from baseline to 1-week post-intervention

    Problem-solving ability will be measured a 25-item Chinese version of Revised (Short) Social Problem-Solving Inventory. It comprises 2 domains: problem-solving style (rational, impulsive/careless and avoidance) and orientation (positive/negative). Items are rated on a 5-point Likert scale (0=not at all true to 4=extremely true; total score range= 0-100). A higher total score indicates better problem solving ability.

  3. Problem-solving ability

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

    Problem-solving ability will be measured a 25-item Chinese version of Revised (Short) Social Problem-Solving Inventory. It comprises 2 domains: problem-solving style (rational, impulsive/careless and avoidance) and orientation (positive/negative). Items are rated on a 5-point Likert scale (0=not at all true to 4=extremely true; total score range= 0-100). A higher total score indicates better problem solving ability.

  4. Problem-solving ability

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

    Problem-solving ability will be measured a 25-item Chinese version of Revised (Short) Social Problem-Solving Inventory. It comprises 2 domains: problem-solving style (rational, impulsive/careless and avoidance) and orientation (positive/negative). Items are rated on a 5-point Likert scale (0=not at all true to 4=extremely true; total score range= 0-100). A higher total score indicates better problem solving ability.

  5. Psychotic symptoms

    Time frame: Baseline

    Psychotic symptoms will be assessed by a trained researcher using the 30-item Positive and Negative Syndrome Scale. It contains three subscales: positive symptoms, negative symptoms, and general psychopathology. Items will be rated on an 8-point scale (1= absent to 7= extreme; total score range= 30-210). A higher total score indicates more severe psychotic symptoms.

  6. Psychotic symptoms

    Time frame: Change from baseline to 1-week post-intervention

    Psychotic symptoms will be assessed by a trained researcher using the 30-item Positive and Negative Syndrome Scale. It contains three subscales: positive symptoms, negative symptoms, and general psychopathology. Items will be rated on an 8-point scale (1= absent to 7= extreme; total score range= 30-210). A higher total score indicates more severe psychotic symptoms.

  7. Psychotic symptoms

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

    Psychotic symptoms will be assessed by a trained researcher using the 30-item Positive and Negative Syndrome Scale. It contains three subscales: positive symptoms, negative symptoms, and general psychopathology. Items will be rated on an 8-point scale (1= absent to 7= extreme; total score range= 30-210). A higher total score indicates more severe psychotic symptoms.

  8. Psychotic symptoms

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

    Psychotic symptoms will be assessed by a trained researcher using the 30-item Positive and Negative Syndrome Scale. It contains three subscales: positive symptoms, negative symptoms, and general psychopathology. Items will be rated on an 8-point scale (1= absent to 7= extreme; total score range= 30-210). A higher total score indicates more severe psychotic symptoms.

  9. Insight into illness/treatment

    Time frame: Baseline

    Insight into illness/treatment will be assessed with the 11-item Insight and Treatment Attitude Questionnaire. 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.

  10. Insight into illness/treatment

    Time frame: Change from baseline to 1-week post-intervention

    Insight into illness/treatment will be assessed with the 11-item Insight and Treatment Attitude Questionnaire. 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.

  11. Insight into illness/treatment

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

    Insight into illness/treatment will be assessed with the 11-item Insight and Treatment Attitude Questionnaire. 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.

  12. Insight into illness/treatment

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

    Insight into illness/treatment will be assessed with the 11-item Insight and Treatment Attitude Questionnaire. 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.

  13. Rehospitalization rate

    Time frame: Baseline

    Rehospitalization rate will be calculated using the frequency and duration of and time to rehospitalizations over the past 5-6 months.

  14. Rehospitalization rate

    Time frame: At 1-week post-intervention

    Rehospitalization rate will be calculated using the frequency and duration of and time to rehospitalizations over the past 5-6 months.

  15. Rehospitalization rate

    Time frame: At 9-month follow-up after the intervention

    Rehospitalization rate will be calculated using the frequency and duration of and time to rehospitalizations over the past 5-6 months.

  16. Rehospitalization rate

    Time frame: At 18-month follow-up after the intervention

    Rehospitalization rate will be calculated using the frequency and duration of and time to rehospitalizations over the past 5-6 months.

  17. Service satisfaction

    Time frame: Baseline

    Service satisfaction will be assessed with the 8-item Client Satisfaction Questionnaire. 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.

  18. Service satisfaction

    Time frame: Change from baseline to 1-week post-intervention

    Service satisfaction will be assessed with the 8-item Client Satisfaction Questionnaire. 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.

  19. Service satisfaction

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

    Service satisfaction will be assessed with the 8-item Client Satisfaction Questionnaire. 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.

  20. Service satisfaction

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

    Service satisfaction will be assessed with the 8-item Client Satisfaction Questionnaire. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Wai Tong Chien, PhD

CONTACT

[email protected]

93518670

Yongfeng Chen, PhD

CONTACT

[email protected]

93518670

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Collaborators

  • Integrated Community Centers for Mental Wellness
  • Psychiatric outpatient clinics

Registry information

Official study title

Evaluating the Effects of a Peer-facilitated, Acceptance-based Self-learning for Illness Management (PASIM) Program for Adults With Recent-onset Psychosis: A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 19, 2025
Registry last updated
Aug 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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