Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00410

2 Trial Registration Date

2014-04-28

iRegistration Status

Prospective

3 Secondary IDs

CRE-2012.583

4 Source(s) of Funding

HMRF

5 Primary Sponsor

CUHK

6 Secondary Sponsor

N/A

Function

Please specify

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

i Name

Yuying SUN

ii Address

4/F, School of Public Health, Prince of Wales Hospital, Shatin, N.T., HK

iii Phone

2252 8797

iv Email

yuyingsun@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

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

i Name

Prof. Samuel Yeung Shan WONG

ii Address

4/F, School of Public Health, Prince of Wales Hospital, Shatin, N.T., HK

iii Phone

2252 8774

iv Email

yeungshanwong@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

9 Official Scientific Title of the Study

The effectiveness of group behavioural activation in the treatment of subthreshold depression in primary care in Hong Kong

10 Public Title

The effectiveness of group behavioural activation in the treatment of subthreshold depression in primary care in Hong Kong

i Public Title in Chinese 研究名稱

行為激活對輕微抑鬱的療效研究

11 Short Title (Optional)

BA

12 Countries of Recruitment

Hong Kong

13Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2013-02-22

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Subthreshold depression

15Intervention

i Types of intervention

Behavior

Please specify

ii Description/ name of Intervention/article

Behavioural activation

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

8 weeks, 8 training sessions, 1 per week

vi Frequency of the intervention

16Comparative Treatments

i Description/ name of comparative treatments

The BA intervention will be compared with care as usual (CAU) using a single blinded randomized design. Assessments with the outcome measures described below will take place at baseline, two, five months (3 months after intervention) and 1 year. The BA intervention will consist of weekly one and half hour session for 8 weeks. Participants assigned to the CAU will receive their medical care from the doctors who work in the general outpatient clinics. They are not referred to mental health intervention but receive active monitoring or regular minimal counselling from the primary care doctors.

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

17Key Inclusion and Exclusion Criteria

i Inclusion Criteria

1) Aged 18 years or above;
2) Score 5-9 by Patient Health Questionnaire depression scale (PHQ-9).

ii Exclusion Criteria

1)major depression within the past 6 months; 2)lifetime history of other psychiatric disorders including generalized anxiety disorder, psychosis, schizophrenia and bipolar affective disorder, alcohol or substance abuse, presence of serious suicidal risk and medical illness with a prognosis of less than 6 months to live; 3)patients who are receiving current treatment (taking antidepressants or other psychotropic medications or enrolled in any form of psychological interventions) for any depressive disorders or symptoms.

iii Age Minimum

18

iv Age Maximum

999

v Gender

Both Male and Female

18 Study Type

Interventional

19Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Not Applicable

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

2014-06-01

21 Target Sample Size

230

22 Recruitment Status

Recruiting

23 Primary Outcome

Reduction of self-reported depressive symptoms measured by the validated the Chinese version Beck Depression Inventory-II (BDI-II).

24 Secondary Outcome

Incidence of DSM-IV major depression in patients after 12 months as compared to usual care evaluated using the SCID (Structured Clinical Interview for DSM-IV).

25Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26Last Update Date

2016-06-13

27 Primary Registry and Trial Identifying Number

ChiCTR-TCS-14004601

28 Date of Registration in Primary Registry

2014-05-05

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

NA

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Trial History Detail on 2015-06-15