SchizophreniaNCT03246932
Peer-led Psycho-education for Schizophrenia
A study testing Peer-led psycho-education group, Profession-led psycho-education group and Routine psychiatric care in people with Schizophrenia, run by Chinese University of Hong Kong at 2 sites in 2 countries.
Trial summary
Profession-led psycho-education programs for people with schizophrenia are evidenced to improve patients' knowledge about the illness, mental state and relapse rate. Nevertheless, other benefits to patients, for example, their functioning and insight into illness or to be substantive in a longer term (>12 months) are… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Peer-led psycho-education group, Profession-led psycho-education group and Routine psychiatric care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 342 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Dec 2020to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- patients, aged 18+, attending one psychiatric outpatient clinic under study;
- diagnosed as schizophrenia and its subtypes according to the Diagnostic and Statistical Manual, 4th Text-Revised Edition, as ascertained by the Structured Clinical Interview (SCID-I);
- having onset of the illness for not >5 years; and
- able to communicate in Cantonese language.
Who cannot join
- mentally unstable and unfit for study participation at recruitment;
- with co-morbidity of other severe mental health problems such as depression and substance misuse; and
- have recently received or are receiving any structured psychosocial intervention.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: The Effectiveness of a Peer-led Psycho-education Group in Schizophrenia: A Multi-site Randomised Controlled Trial
Profession-led psycho-education programs for people with schizophrenia are evidenced to improve patients' knowledge about the illness, mental state and relapse rate. Nevertheless, other benefits to patients, for example, their functioning and insight into illness or to be substantive in a longer term (>12 months) are inconsistent and uncertain, especially in Asian populations. This single-blind multi-site randomized clinical trial was to test the effects of a peer-expert-led psycho-education group intervention (in addition to usual care) for adult patients with schizophrenia spectrum disorders over a 24-month follow-up, in comparison to a profession-led psycho-education group or treatment-as-usual only.
Read the detailed description
Objectives: This study is to test the effectiveness of a peer-expert-led psycho-education group programme for Chinese outpatients with schizophrenia spectrum disorders over an 24-month follow-up. The program is an integrated,psycho-education program that addresses patients' knowledge and self-management of schizophrenia and problem-solving skills. Methods: A single-blind, multi-site randomized controlled trial will be conducted with 342 Chinese patients with schizophrenia in Hong Kong, China and Taiwan. In each of three study sites, the participants will be randomly selected from the eligible patient list (i.e., 114 subjects from each study site) and after baseline measurement, be assigned to either the peer-led psycho-education program, profession-led psycho-education group, or usual psychiatric care. The patients' mental and psychosocial functioning, insights into illness, and their re-hospitalization rates will be measured at recruitment and at one week, and 6, 12 and 24 months after completing the interventions. Hypothesis: The patients in the peer-led psycho-education program will report significantly greater improvements in their symptoms and re-hospitalisation rates (primary outcomes) and other secondary outcomes (e.g., insight into illness and functioning) over the 24-month follow-up, when compared with those in profession-led psycho-education group and/or usual care. Conclusions: The findings will provide evidence whether the peer-led psycho-education group program can better improve Chinese schizophrenia sufferers' psychosocial functioning and reduce their illness relapse.
- Conditions
- Schizophrenia
- Being tested
- Peer-led psycho-education group, Profession-led psycho-education group, Routine psychiatric care
- Keywords
- peer expert or specialist, psycho-education, schizophrenia, outpatients
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer-led psycho-education groupBehavioural
A structured, researcher-designed peer-led psycho-education program (6 months), comprising of 12 bi-weekly, 2-hour group sessions.
Profession-led psycho-education groupBehavioural
A psychoeducation group program (12 sessions, bi-weekly).
Routine psychiatric careOther
Routine psychiatric outpatient care, or Treatment-as-usual (TAU).
| Study group | Role | What they receive |
|---|---|---|
| Peer-led psycho-education group | Experimental | A structured, researcher-designed peer expert-led psycho-education program (6 months), comprised of 12 bi-weekly, 2-hour group sessions (10-12 patients per group). The program was based on the psycho-education and self-help, problem-solving programs by Chien et al. (2010) and Lehman et al. (2004). Receives: Behavioral: Peer-led psycho-education group; Other: Routine psychiatric care |
| Routine psychiatric care | Other | Routine psychiatric outpatient care, including medication, psychiatric consultation in outpatient clinic, brief education by psychiatric nurses, financial and social welfare advices by social workers, and individual counseling by clinical psychologist. Receives: Other: Routine psychiatric care |
| Profession-led psycho-education group | Active comparator | A psycho-education group program (12 sessions, bi-weekly) based on Dr. Macpherson's Family Psychoeducation Program in 1996 and Chien and Bressington's one in 2014/15 will be used. Receives: Behavioral: Profession-led psycho-education group; Other: Routine psychiatric care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive and Negative Syndrome Scale
The Positive and Negative Syndrome Scale assesses the severity of psychotic symptoms on three subscales: positive symptoms (7 items), negative symptoms (7 items) and general psychopathology (16 items). will be assessed at recruitment and one week, 6 months, 12 months and 24 months after the interventions completed.
Measured: from recruitment to 24-month follow-up
Specific Level of Functioning Scale
Patients' levels of psychosocial functioning will be assessed with the Specific Level of Functioning Scale at baseline and one week, 6 months, 12 months and 24 months follow-up.
Measured: from recruitment to 24-month follow-up
Secondary outcomes (2)
Re-hospitalization rate
Average amount (number) and length of hospital stay of the patients over previous six months will be assessed at recruitment and one week, 6 months, 12 months and 24 months after the interventions completed.
Measured: from recruitment to 24-month follow-up
Six-item Social Support Questionnaire
Patients' perceived social support will be assessed with the Six-item Social Support Questionnaire at baseline and one week, 6 months, 12 months and 24 months follow-up.
Measured: from recruitment to 24-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2017
- Study start1 Dec 2020
- Primary completion31 May 2025
- Study completion30 Sep 2025
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 SchizophreniaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 342 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Authority, Hong Kong, Jilin University Medical Science Division, Taipei Medical University
- Responsible party
- Principal investigator, Prof. Wai Tong CHIEN, Chinese University of Hong Kong
- Investigators
- WT Chien, PhD, Principal investigator, CUHK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03246932
- Sponsor's protocol ID
- CWai-Tong
- Status last verified
- Aug 2025
- First submitted
- 8 Aug 2017
- Last updated
- 19 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chien WT, Norman I. The effectiveness and active ingredients of mutual support groups for family caregivers of people with psychotic disorders: a literature review. Int J Nurs Stud. 2009 Dec;46(12):1604-23. doi: 10.1016/j.ijnurstu.2009.04.003. Epub 2009 May 28.
PubMed 19481205Chien WT, Leung SF, Yeung FK, Wong WK. Current approaches to treatments for schizophrenia spectrum disorders, part II: psychosocial interventions and patient-focused perspectives in psychiatric care. Neuropsychiatr Dis Treat. 2013;9:1463-81. doi: 10.2147/NDT.S49263. Epub 2013 Sep 25.
PubMed 24109184Chien WT, Clifton AV, Zhao S, Lui S. Peer support for people with schizophrenia or other serious mental illness. Cochrane Database Syst Rev. 2019 Apr 4;4(4):CD010880. doi: 10.1002/14651858.CD010880.pub2.
PubMed 30946482Chien 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 26193827
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a Peer-led Psycho-education Group in Schizophrenia: A Multi-site Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03246932
- Acronym / sponsor ID
- CWai-Tong
- Conditions
- Schizophrenia
- Keywords
- peer expert or specialist, psycho-education, schizophrenia, outpatients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 342 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- Hospital Authority, Hong Kong, Jilin University Medical Science Division, Taipei Medical University
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 11 Aug 2017 (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.
Profession-led psycho-education programs for people with schizophrenia are evidenced to improve patients' knowledge about the illness, mental state and relapse rate. Nevertheless, other benefits to patients, for example, their functioning and insight into illness or to be substantive in a longer term (>12 months) are inconsistent and uncertain, especially in Asian populations. This single-blind multi-site randomized clinical trial was to test the effects of a peer-expert-led psycho-education group intervention (in addition to usual care) for adult patients with schizophrenia spectrum disorders over a 24-month follow-up, in comparison to a profession-led psycho-education group or treatment-as-usual only.
Detailed description
Objectives: This study is to test the effectiveness of a peer-expert-led psycho-education group programme for Chinese outpatients with schizophrenia spectrum disorders over an 24-month follow-up. The program is an integrated,psycho-education program that addresses patients' knowledge and self-management of schizophrenia and problem-solving skills. Methods: A single-blind, multi-site randomized controlled trial will be conducted with 342 Chinese patients with schizophrenia in Hong Kong, China and Taiwan. In each of three study sites, the participants will be randomly selected from the eligible patient list (i.e., 114 subjects from each study site) and after baseline measurement, be assigned to either the peer-led psycho-education program, profession-led psycho-education group, or usual psychiatric care. The patients' mental and psychosocial functioning, insights into illness, and their re-hospitalization rates will be measured at recruitment and at one week, and 6, 12 and 24 months after completing the interventions. Hypothesis: The patients in the peer-led psycho-education program will report significantly greater improvements in their symptoms and re-hospitalisation rates (primary outcomes) and other secondary outcomes (e.g., insight into illness and functioning) over the 24-month follow-up, when compared with those in profession-led psycho-education group and/or usual care. Conclusions: The findings will provide evidence whether the peer-led psycho-education group program can better improve Chinese schizophrenia sufferers' psychosocial functioning and reduce their illness relapse.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Peer-led psycho-education group | Experimental | Behavioral: Peer-led psycho-education group, Other: Routine psychiatric careA structured, researcher-designed peer expert-led psycho-education program (6 months), comprised of 12 bi-weekly, 2-hour group sessions (10-12 patients per group). The program was based on the psycho-education and self-help, problem-solving programs by Chien et al. (2010) and Lehman et al. (2004). |
| Routine psychiatric care | Other | Other: Routine psychiatric careRoutine psychiatric outpatient care, including medication, psychiatric consultation in outpatient clinic, brief education by psychiatric nurses, financial and social welfare advices by social workers, and individual counseling by clinical psychologist. |
| Profession-led psycho-education group | Active comparator | Behavioral: Profession-led psycho-education group, Other: Routine psychiatric careA psycho-education group program (12 sessions, bi-weekly) based on Dr. Macpherson's Family Psychoeducation Program in 1996 and Chien and Bressington's one in 2014/15 will be used. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- patients, aged 18+, attending one psychiatric outpatient clinic under study;
- diagnosed as schizophrenia and its subtypes according to the Diagnostic and Statistical Manual, 4th Text-Revised Edition, as ascertained by the Structured Clinical Interview (SCID-I);
- having onset of the illness for not >5 years; and
- able to communicate in Cantonese language.
Key exclusion criteria (3 listed)
- mentally unstable and unfit for study participation at recruitment;
- with co-morbidity of other severe mental health problems such as depression and substance misuse; and
- have recently received or are receiving any structured psychosocial intervention.
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 |
|---|---|---|
| Peer-led psycho-education groupA structured, researcher-designed peer-led psycho-education program (6 months), comprising of 12 bi-weekly, 2-hour group sessions. | Behavioural | Peer-led psycho-education group |
| Profession-led psycho-education groupA psychoeducation group program (12 sessions, bi-weekly). | Behavioural | Profession-led psycho-education group |
| Routine psychiatric careRoutine psychiatric outpatient care, or Treatment-as-usual (TAU). | Other | Peer-led psycho-education group, Profession-led psycho-education group, Routine psychiatric care |
Primary outcome
Positive and Negative Syndrome Scale
Time frame: from recruitment to 24-month follow-up
The Positive and Negative Syndrome Scale assesses the severity of psychotic symptoms on three subscales: positive symptoms (7 items), negative symptoms (7 items) and general psychopathology (16 items). will be assessed at recruitment and one week, 6 months, 12 months and 24 months after the interventions completed.
Specific Level of Functioning Scale
Time frame: from recruitment to 24-month follow-up
Patients' levels of psychosocial functioning will be assessed with the Specific Level of Functioning Scale at baseline and one week, 6 months, 12 months and 24 months follow-up.
2 secondary outcomes
Re-hospitalization rate
Time frame: from recruitment to 24-month follow-up
Six-item Social Support Questionnaire
Time frame: from recruitment to 24-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Background: PubMed 19481205Chien WT, Norman I. The effectiveness and active ingredients of mutual support groups for family caregivers of people with psychotic disorders: a literature review. Int J Nurs Stud. 2009 Dec;46(12):1604-23. doi: 10.1016/j.ijnurstu.2009.04.003. Epub 2009 May 28.
- Background: PubMed 24109184Chien WT, Leung SF, Yeung FK, Wong WK. Current approaches to treatments for schizophrenia spectrum disorders, part II: psychosocial interventions and patient-focused perspectives in psychiatric care. Neuropsychiatr Dis Treat. 2013;9:1463-81. doi: 10.2147/NDT.S49263. Epub 2013 Sep 25.
- Background: PubMed 30946482Chien WT, Clifton AV, Zhao S, Lui S. Peer support for people with schizophrenia or other serious mental illness. Cochrane Database Syst Rev. 2019 Apr 4;4(4):CD010880. doi: 10.1002/14651858.CD010880.pub2.
- 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.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
WT Chien, PhD principal investigator
CUHK
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer-led psycho-education group, Profession-led psycho-education group and Routine psychiatric care in people with Schizophrenia, run by Chinese University of Hong Kong at 2 sites in 2 countries.
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: finished, as of the sponsor's last update on 19 Mar 2026. 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, Hong Kong. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive and Negative Syndrome Scale (time frame: from recruitment to 24-month follow-up). The study lists 2 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 NCT03246932, 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 Mar 2026; AzTrials last refreshed its copy on 29 Oct 2026.