Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00560

2 Trial Registration Date

2017-07-18

i Registration Status

Prospective

3 Secondary IDs

CREC Ref. No.:2017.282

4 Source(s) of Funding

Department of Psychiatry, CUHK

5 Primary Sponsor

Department of Psychiatry

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

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

i Name

Lisa Ma

ii Address

Unit L, 19/F, Kings Wing Plaza 1,
3 On Kwan Street,
Shek Mun, Shatin, N.T.

iii Phone

28314305

iv Email

lisama@link.cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

Hong Kong

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

i Name

MA Duan Yang

ii Address

Unit L, 19/F, Kings Wing Plaza 1,
3 On Kwan Street,
Shek Mun, Shatin, N.T.

iii Phone

28314305

iv Email

lisama@link.cuhk.edu.hk

v Affiliation

Department of Psychiatry, The Chinese University of Hong Kong

vi Country

Hong Kong

9 Official Scientific Title of the Study

Mindfulness-based cognitive therapy for community-dwelling adults with anxiety symptoms: An exploration of efficacy and cognitive mechanism

10 Public Title

Mindfulness-based cognitive therapy for community-dwelling adults with anxiety symptoms: An exploration of efficacy and cognitive mechanism

i Public Title in Chinese 研究名稱

静觀認知療法對社區人士之焦慮徵狀的功效研究

11 Short Title (Optional)

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2017-05-09

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2017.282

14 Medical Condition Being Studied

Anxiety symptoms

15 Intervention

i Types of intervention

Behavior

Please specify

ii Description/ name of Intervention/article

Mindfulness-based cognitive therapy

iii Dosage form of the intervention

N/A

iv Dosage of the intervention

N/A

v Duration of the intervention

8 weeks

vi Frequency of the intervention

One lesson per week

16 Comparative Treatments

i Description/ name of comparative treatments

Psychoeducation program

ii Dosage form of the comparative treatments

N/A

iii Dosage of the comparative treatments

N/A

iv Duration of the comparative treatments

8 weeks

v Frequency of the comparative treatments

One lesson per week

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Scoring 10 points or more in Beck Anxiety Inventory

Consent to attend the 8-week intervention program and complete the assessments

ii Exclusion Criteria

Currently experiencing depressive episode

History of psychotic experience

Currently receiving psychotherapy or counseling more than once a month

Inability to complete assessments through difficulty with Cantonese or written Chinese, visual impairment, or cognitive difficulties

iii Age Minimum

18

iv Age Maximum

60

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

Participants will be randomized into either the MBCT group or the PE group in blocks of 4

ii Nature of control

Active

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

Investigator/research team

iv Group Assignment

Parallel

v Study Phase

Other

Please specify

Non-drug trial

vi Study Objectives (Optional)

20 Anticipated trial start date

2017-08-01

21 Target Sample Size

38

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

i The Name of the outcome

Anxiety symptoms

ii The metric or method of measurement used

Beck Anxiety Inventory

iii The timepoint(s) of primary interest

Before intervention, immediately after intervention, 8 weeks after intervention

24 Secondary Outcome

i The Name of the outcome

Other symptom scores and level of mindfulness

ii The metric or method of measurement used

C-CIS-R, HADS, MAAS

iii The timepoint(s) of primary interest

Before intervention, immediately after intervention, 8 weeks after intervention

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2018-08-31

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

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Trial History Detail on 2017-07-18