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Mindfulness-based Illness Management Program for Schizophrenia (MBPP)

Primary Purpose

Schizophrenia

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Routine Care
Mindfulness-based program
Psychoeducation group
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring mindfulness-based program, Psychoeducation, schizophrenia, Chinese, outpatients

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Jilin Medical College
  • KH/LKS Specialty OPD
  • TM Psy Centre
  • Taipei Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Other

Active Comparator

Arm Label

Mindfulness-based program

Routine Care

Psychoeducation group

Arm Description

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).

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 15, 2012
Last Updated
December 16, 2019
Sponsor
The Hong Kong Polytechnic University
Collaborators
Hospital Authority, Hong Kong, Jilin Medical College, China, Taipei Medical University, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT01667601
Brief Title
Mindfulness-based Illness Management Program for Schizophrenia
Acronym
MBPP
Official Title
The Effectiveness of a Mindfulness-based Illness Management Program for Chinese Patients With Schizophrenia: An Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University
Collaborators
Hospital Authority, Hong Kong, Jilin Medical College, China, Taipei Medical University, Taiwan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
mindfulness-based program, Psychoeducation, schizophrenia, Chinese, outpatients

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
449 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness-based program
Arm Type
Experimental
Arm Description
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).
Arm Title
Routine Care
Arm Type
Other
Arm Description
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.
Arm Title
Psychoeducation group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Routine Care
Other Intervention Name(s)
Routine Psychiatric Care
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-based program
Other Intervention Name(s)
Mindfulness-based illness management program, Mindfulness-based care for schizophrenia program
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducation group
Other Intervention Name(s)
Conventional psychoeducation group, Psychoeducation group intervention
Intervention Description
A 5-month patient psychoeducation group program (12 sessions) led by the research team will be provided.
Primary Outcome Measure Information:
Title
Rehospitalization rates
Description
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.
Time Frame
from recruitment to 24-month follow-up
Title
Positive and Negative Syndrome Scale
Description
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.
Time Frame
from recruitment to 24-month follow-up
Secondary Outcome Measure Information:
Title
insights to illness and treatment
Description
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.
Time Frame
from recruitment to 24-month follow-up
Other Pre-specified Outcome Measures:
Title
Specific Level of Functioning Scale
Description
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.
Time Frame
from recruitment to 24-month follow-up
Title
Six-item Social Support Questionnaire
Description
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.
Time Frame
from recruitment to 24-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chien WT, PhD
Organizational Affiliation
The HK Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jilin Medical College
City
Jilin
State/Province
Jilin
ZIP/Postal Code
0432
Country
China
Facility Name
KH/LKS Specialty OPD
City
Shatin
State/Province
NT
Country
Hong Kong
Facility Name
TM Psy Centre
City
Tuen Mun
State/Province
NT
Country
Hong Kong
Facility Name
Taipei Medical University
City
Taipei
State/Province
Xinyi
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23412024
Citation
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.
Results Reference
background
PubMed Identifier
24809397
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
28374661
Citation
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. Erratum In: Psychol Med. 2023 Apr;53(6):2720.
Results Reference
result

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Mindfulness-based Illness Management Program for Schizophrenia

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