Schizophrenia Clinical Trial
Official title:
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.
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.
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