Mindfulness-based Illness Management Program for Schizophrenia (MBPP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by The Hong Kong Polytechnic University
Sponsor:
Collaborator:
Hospital Authority, Hong Kong
Information provided by (Responsible Party):
Chien Wai-Tong, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier:
NCT01667601
First received: August 15, 2012
Last updated: August 19, 2014
Last verified: August 2014
  Purpose

Only a few intervention studies have also focused on changing patients' negative thoughts and feelings towards the illness and their relationship to the suffering caused by those thoughts, which is evidenced to empower psychosocial functioning and control of distressing thoughts in severe depression and psychotic disorders by using the Mindfulness-Based Stress Reduction program. This controlled trial is designed to test the effects of a mindfulness-based Illness management program (MBPP) for Chinese patients with schizophrenia on their symptom severity, illness insight and psychosocial functioning.


Condition Intervention Phase
Schizophrenia
Other: Routine Care
Behavioral: Mindfulness-based program
Behavioral: Psychoeducation group
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effectiveness of a Mindfulness-based Illness Management Program for Chinese Patients With Schizophrenia: An Randomised Controlled Trial

Resource links provided by NLM:


Further study details as provided by The Hong Kong Polytechnic University:

Primary Outcome Measures:
  • Rehospitalization rate [ Time Frame: from recruitment to 18-month follow-up ] [ Designated as safety issue: No ]
    Average amount (number) and length of hospital stay of the patients over previous six months will be assessed at recruitment and one week, 9 months and 18 months after the interventions completed.


Secondary Outcome Measures:
  • insights to illness and treatment [ Time Frame: from recruitment to 18-month follow-up ] [ Designated as safety issue: No ]
    Patients' insight and attitudes to illness and treatment will be measured with the Insight and Treatment Attitudes Questionnaire at recruitment and one week, 9 months and 18 months after yhr interventions completed.


Other Outcome Measures:
  • symptom severity [ Time Frame: from recruitment to 18-month follow-up ] [ Designated as safety issue: No ]
    Patients' mental state will be assessed with the Brief Psychiatric Rating Scale at baseline and one week, 9 months and 18 months follow-up.


Estimated Enrollment: 108
Study Start Date: May 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mindfulness-based program
A structured, researcher-designed mindfulness-based schizophrenia care program (5 months), comprised of 12 bi- or tri-weekly, 2-hour group sessions (5-6 patients per group). The program was based on the psychoeducation programs by Chien et al. (2010) and Lehman et al. (2004), as well as the 8-session Mindfulness-Based Stress Reduction Program by Kabat-Zinn (1990).
Behavioral: Mindfulness-based program
The program was based on the psychoeducation programs by Chien et al and Lehman et al, as well as the 8-session Mindfulness-Based Stress Reduction Program by Kabat-Zinn(1990).
Other Names:
  • Mindfulness-based illness management program
  • Mindfulness-based care for schizophrenia program
Routine Care
Routine psychiatric outpatient care, including medication, psychiatric consultation in outpatient clinic, brief education by psychiatric nurses, financial and social welfare advices by social workers, and individual counseling by clinical psychologist.
Other: Routine Care
Psychiatric outpatient care provided by the outpatient departments, e.g., medical consultation, brief education by psychiatric nurses and financial advices or referrals by social workers.
Other Name: Routine Psychiatric Care
Behavioral: Mindfulness-based program
The program was based on the psychoeducation programs by Chien et al and Lehman et al, as well as the 8-session Mindfulness-Based Stress Reduction Program by Kabat-Zinn(1990).
Other Names:
  • Mindfulness-based illness management program
  • Mindfulness-based care for schizophrenia program
Behavioral: Psychoeducation group
A 5-month patient psychoeducation group program (12 sessions) led by the research team will be provided.
Other Names:
  • Conventional psychoeducation group
  • Psychoeducation group intervention
Active Comparator: Psychoeducation group

A psychoeducation group program (12 sessions, bi- or tri-weekly) based on Dr. McFarlane's Family Psychoeducation Program in 2002 will be used.

Reference: McFarlane, W.R. (2002). Multiple family groups in the treatment of severe psychiatric disorders. New York: Guilford Press.

Behavioral: Psychoeducation group
A 5-month patient psychoeducation group program (12 sessions) led by the research team will be provided.
Other Names:
  • Conventional psychoeducation group
  • Psychoeducation group intervention

Detailed Description:

Objectives: This study is to test the effectiveness of a mindfulness-based illness management program for Chinese outpatients with schizophrenia over an 18-month follow-up. The program is an integrated, insight-inducing educational program that addresses patients' awareness and knowledge of schizophrenia and skills of illness management.

Methods: A multisite controlled trial will be conducted with 108 Chinese patients with schizophrenia in Hong Kong. They will be randomly assigned to either the mindfulness-based illness management program, conventional psychoeducation group, or usual psychiatric care. The patients' mental and psychosocial functioning, insights into illness, and their re-hospitalization rates will be measured at recruitment and at one week and 9 months and 18 months after the interventions.

Hypothesis: The patients in the psychoeducation program will report significantly greater improvements in their illness insights, symptom severity and length of re-hospitalizations over the 18-month follow-up, compared with those in psychoeducation group or usual care.

Conclusions: The findings will provide evidence whether the mindfulness-based illness management program can improve Chinese schizophrenia sufferers' psychosocial functioning and reduce their illness relapse.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • outpatients;
  • aged 18+; and
  • diagnosed as schizophrenic (<5 years) according to the Diagnostic and Statistical Manual, 4th edition.

Exclusion Criteria:

  • not able to understand the psychoeducation content;
  • mentally unstable at recruitment; and
  • with co-morbidity of other severe mental health problems such as depression and substance misuse.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01667601

Contacts
Contact: Chien WT, PhD 852-27665648 chinwaton@gmail.com
Contact: Chan Alan, MSc 852-27664146 rsalanc@polyu.edu.hk

Locations
Hong Kong
KH/LKS Specialty OPD Enrolling by invitation
Shatin/Mongkok, NT/Kln, Hong Kong
TM Psy Centre Recruiting
Tuen Mun, NT, Hong Kong
Contact: WT Chien, PhD    852-27665648    wai.tong.chien@polyu.edu.hk   
Principal Investigator: WT Chien, PhD         
Sponsors and Collaborators
The Hong Kong Polytechnic University
Hospital Authority, Hong Kong
Investigators
Principal Investigator: Chien WT, PhD The HK Polytechnic University
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chien Wai-Tong, Professor, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT01667601     History of Changes
Other Study ID Numbers: D50888
Study First Received: August 15, 2012
Last Updated: August 19, 2014
Health Authority: Hong Kong: The Hong Kong Polytechnic University

Keywords provided by The Hong Kong Polytechnic University:
mindfulness-based program
Psychoeducation
schizophrenia
Chinese
outpatients

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014