Clinical trial NCT01667601: Mindfulness-based Illness Management Program for Schizophrenia
Official title: The Effectiveness of a Mindfulness-based Illness Management Program for Chinese Patients With Schizophrenia: An Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: mindfulness-based program
Psychoeducation
schizophrenia
Chinese
outpatients
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: Hospital Authority, Hong Kong
name: Jilin Medical College, China
name: Taipei Medical University, Taiwan
First posted: 2012-08-17
Enrollment: 449
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Rehospitalization rates
timeFrame: from recruitment to 24-month follow-up
measure: Positive and Negative Syndrome Scale
timeFrame: from recruitment to 24-month follow-up
Secondary outcomes:
measure: insights to illness and treatment
timeFrame: from recruitment to 24-month follow-up
Other outcomes:
measure: Specific Level of Functioning Scale
timeFrame: from recruitment to 24-month follow-up
measure: Six-item Social Support Questionnaire
timeFrame: from recruitment to 24-month follow-up
Locations:
city: Jilin
country: China
facility: Jilin Medical College
state: Jilin
city: Shatin
country: Hong Kong
facility: KH/LKS Specialty OPD
state: NT
city: Tuen Mun
country: Hong Kong
facility: TM Psy Centre
state: NT
city: Taipei
country: Taiwan
facility: Taipei Medical University
state: Xinyi
Study officials:
affiliation: The HK Polytechnic University
name: Chien WT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.