Centre For Clinical Research And Biostatistics (CCRB)

Back History

1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00410

2 Trial Registration Date

2014-04-28

i Registration Status

Prospective

3 Secondary IDs

CRE-2012.583

4 Source(s) of Funding

Health and Medical Research Fund

5 Primary Sponsor

The Jockey Club School of Public Health and Primary Care

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

7 Responsible 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 8794

iv Email

yuyingsun@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

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

Hong Kong

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

13 Research 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

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

CRE-2012.583

14 Medical Condition Being Studied

Subthreshold depression

15 Intervention

i Types of intervention

Behavior

Please specify

ii Description/ name of Intervention/article

Behavioural activation (BA): The Martell and Colleagues 2010 protocol will be used for the content of group BA intervention due to its established efficacy. The objective of the BA intervention is to identify, promote and reinforce activities and circumstances that are consistent with each participant’s long term goals. Specific content of the group BA will include psychoeducation with respect to well-being, setting both short and long term goals, the self-monitoring of activity and mood using activity logs to recognize the association between specific activities and mood, scheduling daily activities and the identification of avoidance and its impact using the Trigger Response Avoidance Pattern model to allow participants to be more aware of their decision making with respect to their behaviors and to explore alternative behaviors with the aim to achieve goals.

iii Dosage form of the intervention

Weekly two hour/session for 8 weeks

iv Dosage of the intervention

Two hour/session/week

v Duration of the intervention

8 weeks

vi Frequency of the intervention

Once per week

16 Comparative Treatments

i Description/ name of comparative treatments

Care As Usual (CAU): 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. All participants will be informed that their health care utilization, including their visits and use of medications will be recorded using the electronic patient record systems.

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

N/A

17 Key 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

19 Study Design

i Randomization

Randomized

Please specify

randomized two-armed intervention study

ii Nature of control

Not Applicable

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

Investigator/research team

iv Group Assignment

Parallel

v Study Phase

4

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2014-06-01

21 Target Sample Size

230

22 Recruitment Status

Complete

23 Primary Outcome

Reduction of self-reported depressive symptoms measured by the validated Chinese version Beck Depression Inventory-II (BDI-II). Assessments with the outcome measures will take place at baseline, two, five months (3 months after intervention) and 1 year.

24 Secondary Outcome

Incidence of DSM-IV major depression in patients will be evaluated using the SCID (Structured Clinical Interview for DSM-IV) at 1 year.
The other outcomes are all measured at baseline, two, five months (3 months after intervention) and 1 year.
Improvement in quality of life will be measured by the validated Chinese version Medical Outcomes Study Short-Form Health Survey (SF-12).
Utilization of health services including visits to primary care doctors (both private and public) or accident and emergency units, visits to any specialist outpatient clinics, use of other psychiatric services such as psychologists, social workers or occupational therapists, and hospitalizations and the number of days of absence from work will be recorded at all patient visits.
The 8-item Activity and Circumstances Change Questionnaire will be used to assess the extent to which participants experience both activity change and circumstantial change.
The Sheehan Disability Scale will also be used for patients to rate their impairment in 3 life domains including work, social and family/home management.
Anxiety symptoms will be measured using the State Trait Anxiety Inventory.
Satisfaction with delivered care will be measured with a question adopted from CAHPS 2.0 Adult Questionnaire.
Quality-adjusted life years will be measured by EuroQol-five dimension-five level (EQ-5D-5L).

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last 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

Back History

Trial Detail