Mindfulness Intervention for People With Psychosis

Not Applicable

Completed

• Conditions: Recent-onset Psychosis
• Interventions: Behavioral: Mindfulness-based cognitive therapy (psychosis); Behavioral: Psychoeducation (psychosis)

• Registration Number: NCT03501862
• Lead Sponsor: The Hong Kong Polytechnic University

Brief Summary

People with psychosis demonstrated a tendency to use maladaptive cognitive emotion regulation strategies as compared with healthy control groups.

The present study is the first randomized controlled trial of group mindfulness-based intervention for psychosis. Half group will join the mindfulness-based cognitive intervention while another half will participate in psychoeducation to examine whether mindfulness will have a positive impact on emotion regulation and distress.

Detailed Description

Concurrently with positive and negative symptoms, affective symptoms and full affective disorder episodes are common in psychotic disorders particularly in the acute phase of illness.

Affective symptoms are a significant risk factor accounting for approximately 5-6% of suicide rates which remain or becomes higher shortly after a psychotic episode or hospital discharge (American Psychiatric Association, 2013). It has been proved that the emotion management and cognitive reappraisal were negatively associated with schizophrenia.

In the study, it is hypothesized that the intervention will have a positive impact on psychotic symptoms, general symptoms such as affective symptoms, psychological flexibility, mindfulness skills, quality of life and re-hospitalization by facilitating strategies on emotion regulation.

Study Timeline

• Study Start: 2017-01-15
• Study First Submitted: 2018-03-09
• Study First Submitted QC: 2018-04-10
• Study First Posted: 2018-04-18
• Primary Completion: 2021-07-31
• Study Completion: 2021-07-31
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-20
• Last Update Posted: 2021-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

• Must be Chinese residents and aged above 18
• Have a primary diagnosis of psychosis (non-affective) and/or other psychotic disorders met the Diagnostic and Statistical Manual DSM-5
• Have been diagnosed equivalent to or less than 5 years
• Mentally stable as assessed by the researcher and a psychiatrist to comprehend the education and training provided (a pre-recruitment briefing session for potential participants will be conducted to verify their ability to follow instructions and understanding in participation, and case files will be reviewed to ensure a stable medication regime for at least 6 months) in order to ensure their ability to make a valid consent
• Able to read and understand Chinese

Exclusion Criteria

• Have recently participated in (less than 3 months) or are receiving other structured psycho-education and/or psychotherapies
• Have comorbidities (a) developmental impairment (b) learning disability, (c) personality disorders, and/or (d) any clinically significant medical diseases (by case-file review).
• Have organic psychosis or a primary drug or alcohol addiction

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindfulness-based intervention	Mindfulness-based cognitive therapy (psychosis)	Intervention: a twelve 1.5 weekly program on mindfulness-based cognitive therapy (psychosis)
Psychoeducation	Psychoeducation (psychosis)	Intervention: a twelve 1.5 hours weekly program on psychoeducation (psychosis)

Primary Outcome Measures

Name	Time	Method
The Depression Anxiety Stress Scale - short form (DASS-21)	Changes will be assessed pre-study; at one week, 3-month and 6-month post-intervention	). It is chosen as the primary outcome measurement because scales of anxiety and depression possess the capacity to differentiate from the related state of tension and stress linking with environmental demands and emotional and physical disturbance. It is a 21-item instrument that measures over the past week symptoms of depression, anxiety and stress rated by 4-point severity or frequency scale. The scale is from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time).

Secondary Outcome Measures

Name	Time	Method
Positive and Negative Syndrome Scale (PANSS)	Changes will be assessed pre-study; at one week, 3-month and 6-month post-intervention	It is a 30-item, 7-point scale measuring positive and negative syndrome, differentiation of clinical symptoms and severity of illness. The seven rating points represent increasing levels of psychopathology from 1 (absent) to 7 (extreme).
Five Facet Mindfulness Questionnaire (FFMQ)	Changes will be assessed pre-study; at one week, 3-month and 6-month post-intervention	It is a 39-item self-report questionnaire that measures five facets of mindfulness: observing; describing; acting with awareness; non-judging and non-reacting. Items are scored on a 5-point Likert scale ranging from 1 (never or very rarely true) to 5 (very often or always true).
The number of re-hospitalization	It will be measured 6-month post-intervention	To collect information from both the case files and self-reporting
The Emotion Regulation Questionnaire (ERQ)	Changes will be assessed pre-study; at one week, 3-month and 6-month post-intervention	It is a 10-item scale that was developed to measure participants' tendency to regulate their emotions in cognitive reappraisal and expressive suppression. Items are scored on a 7- point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree).
Acceptance and Action Scale (AAQII)	Changes will be assessed pre-study; at one week, 3-month and 6-month post-intervention	A seven-item questionnaire that is a commonly used self-report measure of experiential avoidance which also measures psychological inflexibility. The items are rated on a 7-point Likert scale from 1 (never true) to 7 (always true).
The length of re-hospitalization	It will be measured 6-month post-intervention	To collect information from both the case files and self-reporting
The WHOQOL-100	Changes will be assessed pre-study; at one week, 3-month and 6-month post-intervention	It is a self-administered questionnaire consisting of 100 items and among them, there are six domains: physical, psychological, level of independence, social relationship and environmental and spirituality.

Trial Locations

Locations (2)

The Fourth People's Hospital; 🇨🇳 Chengdu, China

The Society of Rehabilitation and Crime Prevention; 🇭🇰 Hong Kong, Hong Kong