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Logo of bmcpsycBioMed Centralsearchsubmit a manuscriptregisterthis articleBMC Psychiatry
 
BMC Psychiatry. 2011; 11: 187.
Published online Nov 29, 2011. doi:  10.1186/1471-244X-11-187
PMCID: PMC3247186
A randomized, controlled clinical trial: the effect of mindfulness-based cognitive therapy on generalized anxiety disorder among Chinese community patients: protocol for a randomized trial
Samuel YS Wong,corresponding author1 Winnie WS Mak,2 Eliza YL Cheung,1 Candy YM Ling,3 Wacy WS Lui,4 WK Tang,5 Rebecca LP Wong,1 Herman HM Lo,6 Stewart Mercer,7 and Helen SW Ma8
1Division of Family Medicine and Primary Health Care, School of Public Health and Primary Care, The Chinese University of Hong Kong, Hong Kong, China
2Department of Psychology, The Chinese University of Hong Kong, Hong Kong, China
3New Life Psychiatric Rehabilitation Association, Hong Kong, China
4Hospital Authority, Hong Kong, China
5Department of Psychiatry, The Chinese University of Hong Kong, Hong Kong, China
6Department of Social Work and Social Administration, The University of Hong Kong, Hong Kong, China
7Section of General Practice and Primary Care, University of Glasgow, Glasgow, UK
8Centre of Buddhist Studies, The University of Hong Kong, Hong Kong, China
corresponding authorCorresponding author.
Samuel YS Wong: yeungshanwong/at/cuhk.edu.hk; Winnie WS Mak: wwsmak/at/psy.cuhk.edu.hk; Eliza YL Cheung: eliza.cheung/at/cuhk.edu.hk; Candy YM Ling: candy.ymling/at/gmail.com; Wacy WS Lui: wacylui/at/yahoo.com; WK Tang: tangwk/at/cuhk.edu.hk; Rebecca LP Wong: rebeccawong/at/cuhk.edu.hk; Herman HM Lo: hkfws_hlo/at/yahoo.com.hk; Stewart Mercer: Stewart.Mercer/at/glasgow.ac.uk; Helen SW Ma: shelenma/at/hku.hk
Received May 24, 2011; Accepted November 29, 2011.
Abstract
Background
Research suggests that an eight-week Mindfulness-Based Cognitive Therapy (MBCT) program may be effective in the treatment of generalized anxiety disorders. Our objective is to compare the clinical effectiveness of the MBCT program with a psycho-education programme and usual care in reducing anxiety symptoms in people suffering from generalized anxiety disorder.
Methods
A three armed randomized, controlled clinical trial including 9-month post-treatment follow-up is proposed. Participants screened positive using the Structure Clinical Interview for DSM-IV (SCID) for general anxiety disorder will be recruited from community-based clinics. 228 participants will be randomly allocated to the MBCT program plus usual care, psycho-education program plus usual care or the usual care group. Validated Chinese version of instruments measuring anxiety and worry symptoms, depression, quality of life and health service utilization will be used. Our primary end point is the change of anxiety and worry score (Beck Anxiety Inventory and Penn State Worry Scale) from baseline to the end of intervention. For primary analyses, treatment outcomes will be assessed by ANCOVA, with change in anxiety score as the baseline variable, while the baseline anxiety score and other baseline characteristics that significantly differ between groups will serve as covariates.
Conclusions
This is a first randomized controlled trial that compare the effectiveness of MBCT with an active control, findings will advance current knowledge in the management of GAD and the way that group intervention can be delivered and inform future research.
Unique Trail Number (assigned by Centre for Clinical Trails, Clinical Trials registry, The Chinese University of Hong Kong): CUHK_CCT00267
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