Mindfulness Intervention for People With Psychosis

Mindfulness-based Interventions for People With Recent-onset Psychosis: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Recent-onset Psychosis
• Intervention / Treatment: Behavioral: Mindfulness-based cognitive therapy (psychosis); Behavioral: Psychoeducation (psychosis)

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 Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Chengdu, China
    • The Fourth People's Hospital
• Hong Kong
  • Hong Kong, Hong Kong
    • The Society of Rehabilitation and Crime Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness-based intervention; Intervention: a twelve 1.5 weekly program on mindfulness-based cognitive therapy (psychosis)	Behavioral: Mindfulness-based cognitive therapy (psychosis); A small group intervention is based on a structured and validated protocol that will include mindfulness practice, cognitive skills
Active Comparator: Psychoeducation; Intervention: a twelve 1.5 hours weekly program on psychoeducation (psychosis)	Behavioral: Psychoeducation (psychosis); A small group intervention will be focusing on understanding of psychosis, treatment, relapse prevention and useful information and resources.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Depression Anxiety Stress Scale - short form (DASS-21)	). 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).	Changes will be assessed pre-study; at one week, 3-month and 6-month post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Emotion Regulation Questionnaire (ERQ)	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).	Changes will be assessed pre-study; at one week, 3-month and 6-month post-intervention
The WHOQOL-100	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.	Changes will be assessed pre-study; at one week, 3-month and 6-month post-intervention
Positive and Negative Syndrome Scale (PANSS)	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).	Changes will be assessed pre-study; at one week, 3-month and 6-month post-intervention
Acceptance and Action Scale (AAQII)	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).	Changes will be assessed pre-study; at one week, 3-month and 6-month post-intervention
Five Facet Mindfulness Questionnaire (FFMQ)	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).	Changes will be assessed pre-study; at one week, 3-month and 6-month post-intervention
The number of re-hospitalization	To collect information from both the case files and self-reporting	It will be measured 6-month post-intervention
The length of re-hospitalization	To collect information from both the case files and self-reporting	It will be measured 6-month post-intervention

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Collaborators: Edinburgh Napier University
• Investigators: Study Director: Thanos Karatzias, Edinburgh Napier University

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2017
• Primary Completion (Actual): July 31, 2021
• Study Completion (Actual): July 31, 2021

Study Registration Dates

• First Submitted: March 9, 2018
• First Submitted That Met QC Criteria: April 10, 2018
• First Posted (Actual): April 18, 2018

Study Record Updates

• Last Update Posted (Actual): September 27, 2021
• Last Update Submitted That Met QC Criteria: September 20, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Mindfulness; Cognitive therapy
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Psychotic Disorders; Mental Disorders
• Other Study ID Numbers: HSEARS20170811001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD that underlie results in a publication
• IPD Sharing Time Frame: 3-months after publication
• IPD Sharing Access Criteria: Request by sending email
• IPD Sharing Supporting Information Type: SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No