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Trial History Detail on 2015-08-28

CUHK_CCT00267

2010-06-18

Prospective

Nil

Health and Health Service Research Fund, The Food and Health Bureau, Hong Kong SAR

Nil

Nil

Rebecca Wong

Room 426, School of Public Health, CUHK

2252 8741

tiffanyding@cuhk.edu.hk

Nil

Professor Samuel Yeung Shan WONG

4/F Division of Family Medicine and Primary Health Care, School of Public Health and Primary Care, CUHK

2252 8774

tiffanyding@cuhk.edu.hk

Nil

A randomized, controlled clinical trial: The effects of mindfulness-based cognitive therapy on generalized anxiety disorder and health service utilization in primary care

A randomized, controlled clinical trial: The effects of mindfulness-based cognitive therapy on generalized anxiety disorder and health service utilization in primary care

Nil

Hong Kong SAR

Yes

2009-09-11

generalized anxiety disorder

Other

cognitive

mindfulness-based cognitive therapy

8 weeks

Psycho-education group (PEG) based on cognitive behavioural therapy principles / usual care

1) being 21-65 years of age 2) having, at baseline assessment, a DSM-IV TR principal diagnosis of generalized anxiety disorder on SCID 14 and a score of 10 or above using the Chinese version of the Beck Anxiety Inventory. 3) can understand Cantonese. 4) are willing to attend the MBCT programme.

1) past participation in an MBSR or MBCT group, 2) illiterate subjects as they will not be able to complete the meditation diary, 3) psychiatric and medical comorbidities that are potentially life threatening (i.e. psychosis. Suicidal ideation, terminal medical illness) or those expected to severely limit patient participation or adherence (e.g. psychosis, current substance abuse, dementia, pregnancy) 4) those already seeing a psychiatrist, a cognitive behavioural therapist or psychotherapists/counselors, 5) commencement of psychotropic medication within 2 months.

21

65

Both Male and Female

Interventional

Randomized

Active

Single-blind

Parallel

2010-07-01

228

Complete

Anxiety symptoms will be measured using the Chinese version Beck Anxiety Inventory and the validated Chinese version Penn State Worry Questionnaire.

Depressive symptoms will be measured by the validated Chinese version of the Centre for Epidemiological Studies-Depression Scale (CES-D). Health related quality of life will be measured by the validated Chinese version Medical Outcomes Study Short-Form Health Survey (SF-12).
“Mindfulness” will be measured by the Five Facet Mindfulness Questionnaire.
Health management scales contain different scales adopted from Stanford patient education center will also be included. These scales include the 6-Item Chronic Disease Self-Efficacy scale, the fatigue visual numeric scale, the shortness of breath scale, the pain visual numeric scale, the health distress scale, the communication with physician scale, and the social/role activities limitations scale.
Functional gastrointestinal disorders screening and symptom questionnaire including the assessment to identify gastro-oesophageal reflux disease and functional dyspepsia and irritable bowel syndrome will also be obtained.
Health service utilization including visits to primary care doctors (both private and public) and hospitalizations will be recorded. The frequency and duration of practice of both MBCT and PEG in each group will be documented. Moreover, medication use including changes in medication will be monitored at 3 month interval. Response rate (enrollment of subjects), retention rate (number and proportion attended each class) of the MBCT and the psycho-education group will be documented.

No

2015-08-28

ChiCTR-TRC-10000907

2010-06-25


Yes

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