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Clinical Trials/NCT03632278
NCT03632278
Unknown
Not Applicable

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

The Hong Kong Polytechnic University1 site in 1 country58 target enrollmentJune 3, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Schizophreniform Disorders
Sponsor
The Hong Kong Polytechnic University
Enrollment
58
Locations
1
Primary Endpoint
Change in Emotion regulation questionnaire (ERQ)
Last Updated
7 years ago

Overview

Brief Summary

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

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: 1. 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. 2. Participants receiving MBPP attain a reduction in depressive/anxiety symptoms compared to a control group after completion of the intervention. 3. These effects are expected to be maintained through 3-month follow up with regular self-practice.

Registry
clinicaltrials.gov
Start Date
June 3, 2018
End Date
December 31, 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

LAM Ho Yan

Principal investigator

The Hong Kong Polytechnic University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in Emotion regulation questionnaire (ERQ)

Time Frame: 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

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).

Secondary Outcomes

  • Change in Short Ruminative Response Scale (SRRS)(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)(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)(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)(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)(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)

Study Sites (1)

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