PsychosisNCT04060498
Mindfulness Intervention and Relapse in Psychosis
A study testing Mindfulness intervention and Psychoeducation intervention in people with Psychosis, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Practicing mindfulness is popular and well-accepted for its benefits in improving mental and physical health. In particular, its benefits in promoting resilience to stress and well-being have been shown in studies involving different psychiatric conditions, as well as preventing relapse in patients with depressive… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Psychosis
- What is being tested?
- Mindfulness intervention and Psychoeducation intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 152 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jun 2019to 1 Oct 2023
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- aged 18 to 55 years
- in full symptomatic remission for at least 6 months
- have been ill for no more than 3 years following first episode psychosis
- have sufficient proficiency in Chinese to understand verbal instructions and to give informed consent.
Who cannot join
- known diagnosis of intellectual disability
- organic brain disorder
- current or previous use of illicit drugs
- substance-induced psychosis or alcohol intake in excess of 5 standard units per day
- people who practice mindfulness and meditation exercise for more than twice a week over the past 1 month.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Mindfulness Intervention in Prevention of Relapse in Psychosis
Practicing mindfulness is popular and well-accepted for its benefits in improving mental and physical health. In particular, its benefits in promoting resilience to stress and well-being have been shown in studies involving different psychiatric conditions, as well as preventing relapse in patients with depressive disorders. However, its role in relapse prevention among patients with psychosis has not been tested.
The investigators therefore propose a multi-site, single-blind, 12-month randomized controlled trial in Hong Kong to examine the effectiveness of mindfulness intervention in prevention of relapse among 152 remitted psychosis patients.
Read the detailed description
Objectives and hypotheses
- Primary objective:
- To examine if mindfulness-based intervention can reduce rates of relapse at 1 year in remitted patients with psychosis.
- Secondary objectives:
- To test whether mindfulness-based intervention can reduce stress, depressive symptoms, and improve functioning and quality of life at 1 year in remitted patients with psychosis.
Participants Patients will be recruited from the Early Assessment Service for Young people with psychosis (EASY). This service provides specialized psychiatric care for the first three years for young persons with first episode psychosis and covers the entire population of Hong Kong of approximately seven million people. The sample will consist of 152 fully remitted patients diagnosed with schizophrenia or non-affective psychosis (schizophreniform disorder, schizoaffective disorder, brief psychotic disorder, or psychotic disorder not otherwise specified)
Study design This is a single-blind, 12-month, multi-site, randomized controlled trial (RCT) of the effect of mindfulness intervention in preventing relapse in remitted psychosis. Patients will be randomized into either having 7-week mindfulness-based intervention or 7-week psychoeducation groups. The study consists of the following time points: baseline (before the start of intervention), at 7-week after the intervention, and then monthly for the remaining 12 months following end of the intervention. Relapse will be assessed monthly during the 1-year follow-up period. Patients will be terminated from the study if relapse occurs during the follow up. The study will be carried out in accordance with Good Clinical Practice and with the Declaration of Helsinki. The study have sought for approval from the Institutional Review Boards at each site. All participants will be required to provide written informed consent. Patients will be individually randomized to one of the two parallel groups: 7-week mindfulness intervention or 7-week psychoeducation.
Procedures
Mindfulness intervention group All patients in the mindfulness group will receive EASY service and 7 weekly-session mindfulness-based intervention for psychosis (MBI-p). It is a protocol-based, low intensity mindfulness developed to help patients to achieve greater sense of peace and calmness, and facilitate participants in handling everyday stress and conflicts. MBI-p consists of seven 1.5-hour group sessions, and each group will have 2-6 participants. Each MBI-p session has the following components: engagement and introduction, mindfulness practices, daily life application and consolidation of learning. Facilitators in conducting the MBI-p will be trained by experienced investigators.
Psychoeducation group All patients in the psychoeducation group will receive EASY service and 7 weekly-session psychoeducation. Each psychoeducation will last for 1.5 hours, including topics on the signs and symptoms of psychosis, aetiology of psychosis and medication usage.
Assessments The primary outcome of relapse will be assessed using the Positive and Negative Syndrome Scale (PANSS) and the Clinical Global Impressions (CGI) Scale (Guy, 1976). Relapse will be assessed before (baseline) and after intervention, and then monthly for 12 months. When patients experience a psychotic relapse at any point during this 12-month period, their participation will be terminated.
- Conditions
- Psychosis
- Being tested
- Mindfulness intervention, Psychoeducation intervention
- Keywords
- Mindfulness, Prevention, Relapse, Psychosis, Schizophrenia, Psychotic Disorders, Mental Disorders, Schizophrenia and Disorders with Psychotic Features
- Medical subject headings
- Psychotic Disorders, Recurrence, Schizophrenia, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness interventionBehavioural
MBI-p focuses on simplicity, for both facilitators and patients; and use acceptance and embracing attitude for fear and sadness. The ultimate aims are to help patients achieve a greater sense of peace and calmness, and facilitate participants in handling everyday stress and conflicts.
Psychoeducation interventionBehavioural
Psychoeducation focuses on disseminating information about common mental disorders, psychosis (its causes, risk factors and trajectory), and methods of treatment for psychosis.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness intervention | Experimental | This arm consists of seven weekly-session mindfulness-based intervention for psychosis (MBI-p). The MBI-p is a protocol-based, low intensity intervention developed to help patients achieve a greater sense of peace and calmness, and facilitates participants in handling everyday stress and conflicts. Receives: Behavioral: Mindfulness intervention |
| Psychoeducation intervention | Placebo comparator | This arm consists of seven weekly-sessions of psychoeducation. Topics to be discussed in the sessions include the signs and symptoms of psychosis, aetiology of psychosis, as well as pharmacological and non-pharmacological interventions. Receives: Behavioral: Psychoeducation intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with psychotic relapse(s)
Psychotic relapse is defined as an increase in at least one of the following PANSS (Kay et al., 1987) items: delusion and/or hallucinatory behavior to a score of 3 or above; conceptual disorganization or unusual thought content to a score of 4 or above; and suspiciousness to a score of 5 or above.
Measured: 12 months post-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 2019
- Study start1 Jun 2019
- Primary completion1 Oct 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PsychosisStudies of the same condition, open and under way.
- More trials run by The 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- University Grants Committee, Hong Kong
- Responsible party
- Sponsor
- Investigators
- Christy Lai-ming Hui, Dr, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04060498
- Sponsor's protocol ID
- 17110918
- Status last verified
- Jan 2022
- First submitted
- 16 Aug 2019
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guy W (1976). Clinical global impression scale (CGI). In Guy W. editors. ECDEU assessment manual for psychopharmacology, Revised. Rockville MD: US Dept of Health, Education and Welfare, National Institute of Mental Health. Page 217-222.
Kay SR, Fiszbein A, Opler LA. The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophr Bull. 1987;13(2):261-76. doi: 10.1093/schbul/13.2.261.
PubMed 3616518Hui CLM, Wong CCL, Lui ECY, Chiu TC, Tao TJ, Chan EWT, Lin J, Tong ACY, Suen YN, Chan CWH, Yeung WS, Lee EHM, Chan SKW, Chang WC, Chen EYH. Effects of mindfulness-based intervention in preventing relapse in patients with remitted psychosis: a randomized controlled trial. Schizophrenia (Heidelb). 2024 Dec 20;10(1):120. doi: 10.1038/s41537-024-00539-0.
PubMed 39702769
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Mindfulness Intervention in Prevention of Relapse in Psychosis
- ClinicalTrials.gov ID
- NCT04060498
- Acronym / sponsor ID
- 17110918
- Conditions
- Psychosis
- Keywords
- Mindfulness, Prevention, Relapse, Psychosis, Schizophrenia, Psychotic Disorders, Mental Disorders, Schizophrenia and Disorders with Psychotic Features
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- University Grants Committee, Hong Kong
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 19 Aug 2019 (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.
Practicing mindfulness is popular and well-accepted for its benefits in improving mental and physical health. In particular, its benefits in promoting resilience to stress and well-being have been shown in studies involving different psychiatric conditions, as well as preventing relapse in patients with depressive disorders. However, its role in relapse prevention among patients with psychosis has not been tested.
The investigators therefore propose a multi-site, single-blind, 12-month randomized controlled trial in Hong Kong to examine the effectiveness of mindfulness intervention in prevention of relapse among 152 remitted psychosis patients.
Detailed description
Objectives and hypotheses
- Primary objective:
- To examine if mindfulness-based intervention can reduce rates of relapse at 1 year in remitted patients with psychosis.
- Secondary objectives:
- To test whether mindfulness-based intervention can reduce stress, depressive symptoms, and improve functioning and quality of life at 1 year in remitted patients with psychosis.
Participants Patients will be recruited from the Early Assessment Service for Young people with psychosis (EASY). This service provides specialized psychiatric care for the first three years for young persons with first episode psychosis and covers the entire population of Hong Kong of approximately seven million people. The sample will consist of 152 fully remitted patients diagnosed with schizophrenia or non-affective psychosis (schizophreniform disorder, schizoaffective disorder, brief psychotic disorder, or psychotic disorder not otherwise specified)
Study design This is a single-blind, 12-month, multi-site, randomized controlled trial (RCT) of the effect of mindfulness intervention in preventing relapse in remitted psychosis. Patients will be randomized into either having 7-week mindfulness-based intervention or 7-week psychoeducation groups. The study consists of the following time points: baseline (before the start of intervention), at 7-week after the intervention, and then monthly for the remaining 12 months following end of the intervention. Relapse will be assessed monthly during the 1-year follow-up period. Patients will be terminated from the study if relapse occurs during the follow up. The study will be carried out in accordance with Good Clinical Practice and with the Declaration of Helsinki. The study have sought for approval from the Institutional Review Boards at each site. All participants will be required to provide written informed consent. Patients will be individually randomized to one of the two parallel groups: 7-week mindfulness intervention or 7-week psychoeducation.
Procedures
Mindfulness intervention group All patients in the mindfulness group will receive EASY service and 7 weekly-session mindfulness-based intervention for psychosis (MBI-p). It is a protocol-based, low intensity mindfulness developed to help patients to achieve greater sense of peace and calmness, and facilitate participants in handling everyday stress and conflicts. MBI-p consists of seven 1.5-hour group sessions, and each group will have 2-6 participants. Each MBI-p session has the following components: engagement and introduction, mindfulness practices, daily life application and consolidation of learning. Facilitators in conducting the MBI-p will be trained by experienced investigators.
Psychoeducation group All patients in the psychoeducation group will receive EASY service and 7 weekly-session psychoeducation. Each psychoeducation will last for 1.5 hours, including topics on the signs and symptoms of psychosis, aetiology of psychosis and medication usage.
Assessments The primary outcome of relapse will be assessed using the Positive and Negative Syndrome Scale (PANSS) and the Clinical Global Impressions (CGI) Scale (Guy, 1976). Relapse will be assessed before (baseline) and after intervention, and then monthly for 12 months. When patients experience a psychotic relapse at any point during this 12-month period, their participation will be terminated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness intervention | Experimental | Behavioral: Mindfulness interventionThis arm consists of seven weekly-session mindfulness-based intervention for psychosis (MBI-p). The MBI-p is a protocol-based, low intensity intervention developed to help patients achieve a greater sense of peace and calmness, and facilitates participants in handling everyday stress and conflicts. |
| Psychoeducation intervention | Placebo comparator | Behavioral: Psychoeducation interventionThis arm consists of seven weekly-sessions of psychoeducation. Topics to be discussed in the sessions include the signs and symptoms of psychosis, aetiology of psychosis, as well as pharmacological and non-pharmacological interventions. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- aged 18 to 55 years
- in full symptomatic remission for at least 6 months
- have been ill for no more than 3 years following first episode psychosis
- have sufficient proficiency in Chinese to understand verbal instructions and to give informed consent.
Key exclusion criteria (5 listed)
- known diagnosis of intellectual disability
- organic brain disorder
- current or previous use of illicit drugs
- substance-induced psychosis or alcohol intake in excess of 5 standard units per day
- people who practice mindfulness and meditation exercise for more than twice a week over the past 1 month.
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 |
|---|---|---|
| Mindfulness interventionMBI-p focuses on simplicity, for both facilitators and patients; and use acceptance and embracing attitude for fear and sadness. The ultimate aims are to help patients achieve a greater sense of peace and calmness, and facilitate participants in handling everyday stress and conflicts. | Behavioural | Mindfulness intervention |
| Psychoeducation interventionPsychoeducation focuses on disseminating information about common mental disorders, psychosis (its causes, risk factors and trajectory), and methods of treatment for psychosis. | Behavioural | Psychoeducation intervention |
Primary outcome
Number of participants with psychotic relapse(s)
Time frame: 12 months post-intervention
Psychotic relapse is defined as an increase in at least one of the following PANSS (Kay et al., 1987) items: delusion and/or hallucinatory behavior to a score of 3 or above; conceptual disorganization or unusual thought content to a score of 4 or above; and suspiciousness to a score of 5 or above.
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 18 May 2026.
- BackgroundGuy W (1976). Clinical global impression scale (CGI). In Guy W. editors. ECDEU assessment manual for psychopharmacology, Revised. Rockville MD: US Dept of Health, Education and Welfare, National Institute of Mental Health. Page 217-222.
- Background: PubMed 3616518Kay SR, Fiszbein A, Opler LA. The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophr Bull. 1987;13(2):261-76. doi: 10.1093/schbul/13.2.261.
- Results publication: PubMed 39702769Hui CLM, Wong CCL, Lui ECY, Chiu TC, Tao TJ, Chan EWT, Lin J, Tong ACY, Suen YN, Chan CWH, Yeung WS, Lee EHM, Chan SKW, Chang WC, Chen EYH. Effects of mindfulness-based intervention in preventing relapse in patients with remitted psychosis: a randomized controlled trial. Schizophrenia (Heidelb). 2024 Dec 20;10(1):120. doi: 10.1038/s41537-024-00539-0.
- 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.
Christy Lai-ming Hui, Dr principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness intervention and Psychoeducation intervention in people with Psychosis, run by The University of Hong Kong at 1 site in Hong Kong.
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 5 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 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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. Some participants in this study may receive a placebo. 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?
Number of participants with psychotic relapse(s) (time frame: 12 months post-intervention). 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 NCT04060498, which also lists 3 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 18 May 2026.