Mindfulness-based Illness Management Program for Schizophrenia
NCT ID: NCT01667601
Last Updated: 2019-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
449 participants
INTERVENTIONAL
2010-08-31
2017-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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).
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).
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.
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.
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).
Psychoeducation group
A 5-month patient psychoeducation group program (12 sessions) led by the research team will be provided.
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.
Psychoeducation group
A 5-month patient psychoeducation group program (12 sessions) led by the research team will be provided.
Interventions
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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.
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).
Psychoeducation group
A 5-month patient psychoeducation group program (12 sessions) led by the research team will be provided.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* mentally unstable at recruitment; and
* with co-morbidity of other severe mental health problems such as depression and substance misuse.
18 Years
64 Years
ALL
No
Sponsors
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Hospital Authority, Hong Kong
OTHER_GOV
Jilin Medical College, China
UNKNOWN
Taipei Medical University, Taiwan
UNKNOWN
The Hong Kong Polytechnic University
OTHER
Responsible Party
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Wai-Tong Chien
Professor
Principal Investigators
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Chien WT, PhD
Role: PRINCIPAL_INVESTIGATOR
The HK Polytechnic University
Locations
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Jilin Medical College
Jilin, Jilin, China
KH/LKS Specialty OPD
Shatin, NT, Hong Kong
TM Psy Centre
Tuenmen, NT, Hong Kong
Taipei Medical University
Taipei, Xinyi, Taiwan
Countries
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References
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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.
Other Identifiers
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HSEARS20121211001
Identifier Type: -
Identifier Source: org_study_id