Mindfulness-based Illness Management Program for Schizophrenia (MBPP)

The Effectiveness of a Mindfulness-based Illness Management Program for Chinese Patients With Schizophrenia: An Randomised Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Behavioral: Mindfulness-based program; Other: Routine Care; Behavioral: Psychoeducation group

Detailed Description

Objectives: This study is to test the effectiveness of a mindfulness-based illness management program for Chinese outpatients with schizophrenia over a 24-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 two-phase, single-blind, multi-site randomized controlled trial will be conducted with 449 Chinese patients with schizophrenia in Hong Kong, China and Taiwan. In the first phase, 107 participants will be randomly selected from the eligible patient lists of three outpatient clinics in Hong Kong only (i.e., 38 subjects from each clinic), and after baseline measurement, be assigned to either the mindfulness-based illness management program, conventional psycho-education group, or usual psychiatric care. For the second phase, the participants will be randomly selected from the eligible patient list in three study venues or countries (i.e., 114 subjects from each study site/ country) and after baseline measurement, be assigned similar to the first phase to one of the three study groups. The patients' mental and psychosocial functioning, insights into illness, and their re-hospitalization rates will be measured at recruitment and at one week, and 6, 12 and 24 months after completing the interventions.

Hypothesis: The patients in the mindfulness-based psycho-education program will report significantly greater improvements in their symptoms and re-hospitalization rates (primary outcomes) and other secondary outcomes (e.g., insight into illness and functioning) over the 24-month follow-up, when compared with those in psycho-education group or usual care.

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

• Study Type: Interventional
• Enrollment (Actual): 449
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jilin
    • Jilin, Jilin, China, 0432
      • Jilin Medical College
• Hong Kong
  • NT
    • Shatin, NT, Hong Kong
      • KH/LKS Specialty OPD
    • Tuen Mun, NT, Hong Kong
      • TM Psy Centre
• Taiwan
  • Xinyi
    • Taipei, Xinyi, Taiwan
      • Taipei Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• outpatients;
• aged 18+; and
• diagnosed as schizophrenia and other psychotic disorders (< or =5 years) according to the Diagnostic and Statistical Manual, 4th edition, as ascertained by the Structured Clinical Interview (SCID-I).

Exclusion Criteria:

• not able to understand the psycho-education content and Chinese;
• mentally unstable at recruitment; and
• with co-morbidity of other severe mental health problems such as depression and substance misuse.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Mindfulness-based program; A structured, researcher-designed mindfulness-based psycho-education program (6 months), comprised of 12 bi-weekly, 2-hour group sessions (10-12 patients per group). The program was based on the psycho-education 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
OTHER: 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.	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; 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 Names: Routine Psychiatric Care; 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-weekly) based on Dr. Macpherson's Family Psychoeducation Program in 1996 and Chien and Bressington's one in 2014/15 will be used. References: Chien WT, Bressington D. A randomized controlled trial of a nurse-led structured psychosocial intervention program for people with first-onset mental illness in psychiatric outpatient clinics. Psychiatry Res 2015;229:277-86. Macpherson R, Jerrom B, Hughes AA. controlled study of education about drug treatment in schizophrenia. Br J Psychiatry 1996;168:709-17.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rehospitalization rates	Average amount (number) and length of hospital stay of the patients over previous six months will be assessed at recruitment and one week, 6 months, 12 months and 24 months after the interventions completed.	from recruitment to 24-month follow-up
Positive and Negative Syndrome Scale	The Positive and Negative Syndrome Scale assesses the severity of psychotic symptoms on three subscales: positive symptoms (7 items), negative symptoms (7 items) and general psychopathology (16 items). will be assessed at recruitment and one week, 6 months, 12 months and 24 months after the interventions completed. Symptom remission rate over the follow-up periods are also assessed. Complete remission was defined as 4-month simultaneous ratings of all individual items in PANSS as score ≤3.	from recruitment to 24-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
insights to illness and treatment	Patients' insight and attitudes to illness and treatment will be measured with the Insight and Treatment Attitudes Questionnaire at recruitment and one week, 6 months, 12 months and 24 months after the interventions completed.	from recruitment to 24-month follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Specific Level of Functioning Scale	Patients' levels of psychosocial functioning will be assessed with the Specific Level of Functioning Scale at baseline and one week, 6 months, 12 months and 24 months follow-up.	from recruitment to 24-month follow-up
Six-item Social Support Questionnaire	Patients' perceived social support will be assessed with the Six-item Social Support Questionnaire at baseline and one week, 6 months, 12 months and 24 months follow-up.	from recruitment to 24-month follow-up

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Collaborators: Hospital Authority, Hong Kong; Jilin Medical College, China; Taipei Medical University, Taiwan
• Investigators: Principal Investigator: Chien WT, PhD, The HK Polytechnic University

Publications and helpful links

General Publications

• Chien WT, Lee IY. The mindfulness-based psychoeducation program for Chinese patients with schizophrenia. Psychiatr Serv. 2013 Apr 1;64(4):376-9. doi: 10.1176/appi.ps.002092012.
• Chien WT, Thompson DR. Effects of a mindfulness-based psychoeducation programme for Chinese patients with schizophrenia: 2-year follow-up. Br J Psychiatry. 2014 Jul;205(1):52-9. doi: 10.1192/bjp.bp.113.134635. Epub 2014 May 8.
• Lam, A.H.Y., & Chien, W.T. (2016). The effectiveness of mindfulness-based intervention for people with schizophrenia: A systematic review. Neuropsychiatry (London), 6(5), 208-222.
• Chien WT, Bressington D, Yip A, Karatzias T. An international multi-site, randomized controlled trial of a mindfulness-based psychoeducation group programme for people with schizophrenia. Psychol Med. 2017 Sep;47(12):2081-2096. doi: 10.1017/S0033291717000526. Epub 2017 Apr 4.

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (ACTUAL): June 1, 2016
• Study Completion (ACTUAL): April 1, 2017

Study Registration Dates

• First Submitted: August 15, 2012
• First Submitted That Met QC Criteria: August 16, 2012
• First Posted (ESTIMATE): August 17, 2012

Study Record Updates

• Last Update Posted (ACTUAL): December 18, 2019
• Last Update Submitted That Met QC Criteria: December 16, 2019
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Chinese; schizophrenia; Psychoeducation; outpatients; mindfulness-based program
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: HSEARS20121211001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO