Clinical trial NCT04060498: Mindfulness Intervention and Relapse in Psychosis
Official title: Effectiveness of Mindfulness Intervention in Prevention of Relapse in Psychosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Psychosis
Keywords: Mindfulness, Prevention, Relapse, Psychosis, Schizophrenia, Psychotic Disorders, Mental Disorders, Schizophrenia and Disorders with Psychotic Features
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: University Grants Committee, Hong Kong
First posted: 2019-08-19
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with psychotic relapse(s)
timeFrame: 12 months post-intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: The University of Hong Kong
name: Christy Lai-ming Hui, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.