Mindfulness Intervention for People With Psychosis

The Hong Kong Polytechnic University108 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

108

Conditions

Recent-onset Psychosis

Interventions

Mindfulness-based cognitive therapy (psychosis)BEHAVIORAL

A small group intervention is based on a structured and validated protocol that will include mindfulness practice, cognitive skills

Psychoeducation (psychosis)BEHAVIORAL

A small group intervention will be focusing on understanding of psychosis, treatment, relapse prevention and useful information and resources.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

The Fourth People's Hospital

Chengdu, China

The Society of Rehabilitation and Crime Prevention

Hong Kong, Hong Kong

Outcomes

Primary Outcomes

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).

Time frame: Changes will be assessed pre-study; at one week, 3-month and 6-month post-intervention

Secondary Outcomes

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).

Time frame: 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.

Time frame: 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).

Time frame: Changes will be assessed pre-study; at one week, 3-month and 6-month post-intervention

Acceptance and Action Scale (AAQII)

Data from ClinicalTrials.gov

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