Mindfulness Psychoeducation Program for Schizophrenia

T

The Hong Kong Polytechnic University

Status

Unknown

Conditions

Schizophreniform Disorders

Treatments

Behavioral: Mindfulness psychoeducation Programme

Study type

Interventional

Funder types

Other

Identifiers

NCT03632278
HSEARS20180531001

Details and patient eligibility

About

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.

Full 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: 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.

Enrollment

58 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

58 participants in 2 patient groups

Mindfulness psychoeducation programme
Experimental group
Description:
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).
Treatment:
Behavioral: Mindfulness psychoeducation Programme
Treatment as usual
No Intervention group
Description:
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.

Trial contacts and locations

1

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Central trial contact

Ho Yan Lam

Data sourced from clinicaltrials.gov

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