Mindfulness Intervention and Relapse in Psychosis

May 14, 2026 updated by: The University of Hong Kong

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Objectives and hypotheses

  1. Primary objective:

    • To examine if mindfulness-based intervention can reduce rates of relapse at 1 year in remitted patients with psychosis.

  2. 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
152

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Christy Lai-ming Hui, Dr
  • Phone Number: +852 2255 3064
  • Email: christy@lmhui.com

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Department of Psychiatry, Queen Mary Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 51 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Mindfulness intervention
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.
Behavioral: Mindfulness intervention
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.
Placebo Comparator: Psychoeducation intervention
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.
Behavioral: Psychoeducation intervention
Psychoeducation focuses on disseminating information about common mental disorders, psychosis (its causes, risk factors and trajectory), and methods of treatment for psychosis.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
12 months post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Hong Kong

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University Grants Committee, Hong Kong

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Christy Lai-ming Hui, Dr, The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 16, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 16, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 19, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 17110918

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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