Mindfulness Intervention for People With Psychosis

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Recent-onset Psychosis

Intervention / Treatment
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* Behavioral: Mindfulness-based cognitive therapy (psychosis)
* Behavioral: Psychoeducation (psychosis)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants referred to the study will be assessed at a screening examination to ensure eligibility and obtain written consent by a research assistant. Eligible participants will undertake a further interview on outcome measures prior to randomization within 3 weeks the commencement of intervention. Eligible participants will be randomly assigned to receive Mindfulness-based Cognitive Therapy for Psychosis (MBCTp) plus TAU or TAU plus Psychoeducation for Psychosis (PEp). Simple randomization will be used to ensure that participants will have equal opportunity to be included into the study (Altaman and Bland, 1999).
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive therapy, Mindfulness