Psychotic DisordersNCT07129369
Effects of a Peer-facilitated, Acceptance-based Self-learning for Illness Management (PASIM) Program
A study testing PASIM program, Psychoeducation and Usual-Care-only in people with Psychotic Disorders and Recent-Onset Psychosis, run by Chinese University of Hong Kong at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Psychotic Disorders, Recent-Onset Psychosis
- What is being tested?
- PASIM program, Psychoeducation and Usual-Care-only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 2 sitesChina
- Study dates
- 2 Jan 2026to 31 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Integrated Community Centers for Mental Wellness
Hong Kong, Hong Kong
Wai Tong Chien, +85239438172, wtchien@cuhk.edu.hk
Psychiatric outpatient clinics in one hospital cluster of Hospital Authority
Hong Kong, Hong Kong
Wai Tong Chien, +85239438172, wtchien@cuhk.edu.hk
About this study
Official 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
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.
Read the 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
- Being tested
- PASIM program, Psychoeducation, Usual-Care-only
- Keywords
- Randomized controlled trial, Acceptance-based intervention, Peer support, Self help, Recent-onset psychosis
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PASIM programBehavioural
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.
PsychoeducationBehavioural
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-onlyBehavioural
Participants receive usual community mental healthcare services provided by POPCs and ICCMWs.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Usual-Care-only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from baseline to 18-month follow-up after the intervention
Secondary outcomes (20)
Problem-solving ability
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.
Measured: Baseline
Problem-solving ability
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.
Measured: Change from baseline to 1-week post-intervention
Problem-solving ability
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.
Measured: Change from baseline to the 9-month follow-up after the intervention
Problem-solving ability
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.
Measured: Change from baseline to 18-month follow-up after the intervention
Psychotic symptoms
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.
Measured: Baseline
Psychotic symptoms
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.
Measured: Change from baseline to 1-week post-intervention
Psychotic symptoms
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.
Measured: Change from baseline to 9-month follow-up after the intervention
Psychotic symptoms
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.
Measured: Change from baseline to 18-month follow-up after the intervention
Insight into illness/treatment
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.
Measured: Baseline
Insight into illness/treatment
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.
Measured: Change from baseline to 1-week post-intervention
Insight into illness/treatment
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.
Measured: Change from baseline to 9-month follow-up after the intervention
Insight into illness/treatment
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.
Measured: Change from baseline to 18-month follow-up after the intervention
Rehospitalization rate
Rehospitalization rate will be calculated using the frequency and duration of and time to rehospitalizations over the past 5-6 months.
Measured: Baseline
Rehospitalization rate
Rehospitalization rate will be calculated using the frequency and duration of and time to rehospitalizations over the past 5-6 months.
Measured: At 1-week post-intervention
Rehospitalization rate
Rehospitalization rate will be calculated using the frequency and duration of and time to rehospitalizations over the past 5-6 months.
Measured: At 9-month follow-up after the intervention
Rehospitalization rate
Rehospitalization rate will be calculated using the frequency and duration of and time to rehospitalizations over the past 5-6 months.
Measured: At 18-month follow-up after the intervention
Service satisfaction
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.
Measured: Baseline
Service satisfaction
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.
Measured: Change from baseline to 1-week post-intervention
Service satisfaction
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.
Measured: Change from baseline to 9- month follow-up after the intervention
Service satisfaction
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.
Measured: Change from baseline to the 18-month follow-up after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start2 Jan 2026 (estimated)
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Psychotic DisordersStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Integrated Community Centers for Mental Wellness, Hong Kong, Psychiatric outpatient clinics
- Responsible party
- Principal investigator, Prof. Wai Tong CHIEN, Chinese University of Hong Kong
- Investigators
- Wai Tong Chien, PhD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07129369
- Sponsor's protocol ID
- 14608525
- Status last verified
- Aug 2025
- First submitted
- 6 Aug 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The name and email of the researchers can be shared openly for communication and collaboration.
Publications
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.
PubMed 38908265Chien 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.
PubMed 33327452Chien 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.
PubMed 26193827Chien 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.
PubMed 31416744
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07129369
- Acronym / sponsor ID
- 14608525
- Conditions
- Psychotic Disorders, Recent-Onset Psychosis
- Keywords
- Randomized controlled trial, Acceptance-based intervention, Peer support, Self help, Recent-onset psychosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- Integrated Community Centers for Mental Wellness, Hong Kong, Psychiatric outpatient clinics
- Study start
- 2 Jan 2026 (estimated)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 19 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PASIM group | Experimental | Behavioral: PASIM program, Behavioral: Usual-Care-onlyParticipants 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. |
| Psychoeducation group | Experimental | Behavioral: Psychoeducation, Behavioral: Usual-Care-onlyThe 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. |
| Usual-care-only group | Other | Behavioral: Usual-Care-onlyThis 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PASIM programThe 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. | Behavioural | PASIM group |
| PsychoeducationThe 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. | Behavioural | Psychoeducation group |
| Usual-Care-onlyParticipants receive usual community mental healthcare services provided by POPCs and ICCMWs. | Behavioural | PASIM group, Psychoeducation group, Usual-care-only group |
Primary outcome
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.
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.
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.
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.
20 secondary outcomes
Problem-solving ability
Time frame: Baseline
Problem-solving ability
Time frame: Change from baseline to 1-week post-intervention
Problem-solving ability
Time frame: Change from baseline to the 9-month follow-up after the intervention
Problem-solving ability
Time frame: Change from baseline to 18-month follow-up after the intervention
Psychotic symptoms
Time frame: Baseline
Psychotic symptoms
Time frame: Change from baseline to 1-week post-intervention
Psychotic symptoms
Time frame: Change from baseline to 9-month follow-up after the intervention
Psychotic symptoms
Time frame: Change from baseline to 18-month follow-up after the intervention
Insight into illness/treatment
Time frame: Baseline
Insight into illness/treatment
Time frame: Change from baseline to 1-week post-intervention
Insight into illness/treatment
Time frame: Change from baseline to 9-month follow-up after the intervention
Insight into illness/treatment
Time frame: Change from baseline to 18-month follow-up after the intervention
Rehospitalization rate
Time frame: Baseline
Rehospitalization rate
Time frame: At 1-week post-intervention
Rehospitalization rate
Time frame: At 9-month follow-up after the intervention
Rehospitalization rate
Time frame: At 18-month follow-up after the intervention
Service satisfaction
Time frame: Baseline
Service satisfaction
Time frame: Change from baseline to 1-week post-intervention
Service satisfaction
Time frame: Change from baseline to 9- month follow-up after the intervention
Service satisfaction
Time frame: Change from baseline to the 18-month follow-up after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Background: PubMed 38908265Chien 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.
- Background: PubMed 33327452Chien 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.
- Background: PubMed 26193827Chien 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.
- Background: PubMed 31416744Chien 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.
- Individual participant dataSharing planned: No. The name and email of the researchers can be shared openly for communication and collaboration.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wai Tong Chien, PhD principal investigator
Chinese University of Hong Kong
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PASIM program, Psychoeducation and Usual-Care-only in people with Psychotic Disorders and Recent-Onset Psychosis, run by Chinese University of Hong Kong at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wai Tong Chien, PhD (93518670, 1155184102@link.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient functioning (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07129369, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.