Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00267

2 Trial Registration Date

2010-06-18

i Registration Status

Prospective

3 Secondary IDs

Nil

4 Source(s) of Funding

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

5 Primary Sponsor

Nil

6 Secondary Sponsor

Nil

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Rebecca Wong

ii Address

Room 426, School of Public Health, CUHK

iii Phone

2252 8741

iv Email

tiffanyding@cuhk.edu.hk

v Affiliation

Nil

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Professor Samuel Yeung Shan WONG

ii Address

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

iii Phone

2252 8774

iv Email

tiffanyding@cuhk.edu.hk

v Affiliation

Nil

vi Country

9 Official Scientific Title of the Study

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

10 Public Title

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

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

Nil

12 Countries of Recruitment

Hong Kong SAR

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2009-09-11

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

generalized anxiety disorder

15 Intervention

i Types of intervention

Other

Please specify

cognitive

ii Description/ name of Intervention/article

mindfulness-based cognitive therapy

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

8 weeks

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

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

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

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.

ii Exclusion Criteria

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.

iii Age Minimum

21

iv Age Maximum

65

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Active

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2010-07-01

21 Target Sample Size

228

22 Recruitment Status

Complete

23 Primary Outcome

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

24 Secondary Outcome

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.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2015-08-28

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-10000907

28 Date of Registration in Primary Registry

2010-06-25

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

Nil

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Trial History Detail on 2015-08-28