Mindfulness Psychoeducation Program for Schizophrenia

Study Overview
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Brief Summary
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The study is the first pilot randomised controlled trial (RCT) to explore the feasibility and efficacy of Mindfulness-based psychoeducation in emotion regulation and related depressive and anxiety symptoms in people with schizophrenia.

Detailed Description
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There is increasing evidence to demonstrate the safety and effectiveness of mindfulness-based psychoeducation programme (MBPP) for Chinese people with schizophrenia. A single-blind, multi-site, pragmatic randomised controlled trial conducted in Hong Kong, mainland China, and Taiwan with 300 participants consistently demonstrated significant improvement in regard to insight of illness, functioning, mental state and the length of re-hospitalisations when compared with conventional psychoeducation and Treatment As Usual (TAU) groups (Chien, 2017). The study hypothesises that: Participants receiving MBPP will decrease their use of rumination and expressive suppression, and increase the use of cognitive reappraisal compared to a control group after completion of the intervention. Participants receiving MBPP attain a reduction in depressive/anxiety symptoms compared to a control group after completion of the intervention. These effects are expected to be maintained through 3-month follow up with regular self-practice.

Official Title
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The Effectiveness of a Mindfulness Psychoeducation Program on Emotional Regulation for People With Schizophrenia: A Pilot Randomized Control Trial

Conditions
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Schizophreniform Disorders

Intervention / Treatment
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* Behavioral: Mindfulness psychoeducation Programme


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 years to 65 years old Diagnosis with schizophrenia-spectrum disorders according to the criteria of the Diagnostic and Statistical Manual for Mental Disorders DSM-IV-TR (and the latest DSM-V) or International Classification of Diseases (ICD-10)-Classification of Mental Disorders Able to communicate in written and conversational Chinese/Cantonese Able to understand the concepts of the study and to give informed consent Exclusion Criteria: Comorbid organic brain disorders or substance abuse Participation in any forms of cognitive therapy Participation and/or practice of mindfulness (in the forms of Tai Chi, Qi Gong, etc.) more than twice a week during the previous three months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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 from a research assistant. Eligible participants will be randomly assigned to receive Mindfulness psychoeducation programme (MBPP) plus TAU or TAU.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness psychoeducation programme<br>A MBPP will be conducted for 2 hours for each session, one a week for ten weeks, with 13-15 participants per group. The protocol has been developed based on the model of mindfulness-based stress reduction proposed by Kabat-Zinn (1994) and Tong et al. (2015), and the psychoeducation programmes by Chien and Lee, and Lehman and colleagues (Chien & Lee, 2010; Kabat-Zinn et al., 1992; Lehman et al., 2004; Tong et al., 2015). | Behavioral: Mindfulness psychoeducation Programme<br>* A MBPP will be conducted for 2 hours for each session, one a week for eight weeks. The protocol has been developed based on the model of mindfulness-based stress reduction proposed by Kabat-Zinn (1994) and Tong et al. (2015), and the psychoeducation programmes by Chien and Lee, and Lehman and colleagues (Chien & Lee, 2010; Kabat-Zinn et al., 1992; Lehman et al., 2004; Tong et al., 2015). The programme will be integration of mindfulness and psychoeducation to cultivate the client's mindfulness attitude. The clients will learn to apply the mindfulness in illness management and daily difficulties.<br>|
| No Intervention: Treatment as usual<br>The usual care group will receive routine psychiatric outpatient services, including monthly psychiatric consultation and treatment by a psychiatrist, psychiatric nursing advice and brief education according to the patient's psychosocial needs. There will be community mental health services, social welfare or financial assistance supported by medical social workers, whenever necessary. Participants in this control may be aware that they are receiving no extra treatment which may result in negative expectancies and inflation of the treatment effect (Stoney & Johnson, 2012). To eliminate the time effect and artificially inflated intervention effect, patients in the control group will receive telephone contact once a week to discuss their disease process and daily issues. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Emotion regulation questionnaire (ERQ) | This is a self-report questionnaire that measures two different emotion regulation patterns: cognitive reappraisal and expressive suppression. The questionnaire has 10 items: six items reflect the reappraisal factor and four items reflect the suppressive factor. The 10 items are rated on a scale from 1 (strongly disagree) to 7 (strongly agree). | Clients will be followed up and assessed at baseline, immediately after 8 weeks of MBI intervention (post-intervention), and 3 months post-intervention by the assessor who will be blind to participant allocation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Short Ruminative Response Scale (SRRS) | It comprises 10 items that are symptom-focused, self-focused, or focused on the possible causes and consequences of the depressive mood. Participants will be asked to rate on a four-point Likert scale, resulting in a possible range of scores from 22 to 88, with a higher score implying a higher level of rumination. | Clients will be followed up and assessed at baseline, immediately after 8 weeks of MBI intervention (post-intervention), and 3 months post-intervention by the assessor who will be blind to participant allocation | 
| Change in Depression Anxiety Stress Scale (DASS-21) | This instrument comprises three subscales including Depression, Anxiety, and Stress. The Depression scale assesses dysphoria, hopelessness, devaluation of life, self-deprecation, lack of interest or involvement, anhedonia and inertia. The Anxiety scale assesses autonomic arousal, skeletal muscle effects, situational anxiety and subjective experience of anxious affect. The stress scale is sensitive to levels of chronic non-specific arousal. Each subscale consists of seven items. The severity ratings are made on a series of 4-point (0 to 3) scales (0 = did not apply to me at all, 3 = applied to me very much, or most of the time). The higher the subscale scores the more severe the symptoms. | Clients will be followed up and assessed at baseline, immediately after 8 weeks of MBI intervention (post-intervention), and 3 months post-intervention by the assessor who will be blind to participant allocation | 
| Change in The Chinese version of the Psychotic Symptom Rating Scale (C-PSYRATS) | C-PSYRATS consists of 17 items assessing the specific dimensions of hallucinations and delusions, with each item being rated on a 5-point scale from 0 (Absent) to 4 (Severe/Often/Extreme). There are two subscales including the auditory hallucinations subscale (AHS) consisting of 11 items, and the delusions subscale (DS) composed six items. The scale measures the subjective characteristics of AHS and DS including their nature, persistence, amount, distress, disruption and controllability toward the symptoms. | Clients will be followed up and assessed at baseline, immediately after 8 weeks of MBI intervention (post-intervention), and 3 months post-intervention by the assessor who will be blind to participant allocation | 
| Change in Social and Occupational Functioning Assessment Scale (SOFAS) | It is a single-item scale ranging from 1 to 100, with higher scores indicating higher functioning. | Clients will be followed up and assessed at baseline, immediately after 8 weeks of MBI intervention (post-intervention), and 3 months post-intervention by the assessor who will be blind to participant allocation | 
| Change in Five Facet Mindfulness Questionnaire - Short form (FFMQ-SF) | The FFMQ-SF is a 20-item questionnaire that measures five facets of mindfulness including observing, describing, acting with awareness, nonjudging, and non-reacting (Baer, Smith, Hopkins, Krietemeyer, & Toney, 2006). Items are scored on a 5-point scale ranging from 1 (never/very rarely true) to 5 (very often/always true). Higher scores indicate greater levels of mindfulness. | Clients will be followed up and assessed at baseline, immediately after 8 weeks of MBI intervention (post-intervention), and 3 months post-intervention by the assessor who will be blind to participant allocation |