Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00266

2 Trial Registration Date

2010-06-18

i Registration Status

Prospective

3 Secondary IDs

Nil

4 Source(s) of Funding

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

Ting GAO

ii Address

Room 426, School of Public Health, CUHK

iii Phone

2252 8768

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

yeungshanwong@cuhk.edu.hk

v Affiliation

Nil

vi Country

9 Official Scientific Title of the Study

Prevention of anxiety and depression in Chinese: a randomized clinical trial testing the feasibility and effectiveness of a generic stepped care programme in primary care

10 Public Title

Prevention of anxiety and depression in Chinese: a randomized clinical trial testing the feasibility and effectiveness of a generic stepped care programme 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?

2010-05-06

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

sub-threshold depression and anxiety

15 Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

Stepped care programme, including watchful waiting, telephone counseling, problem solving treatment, family doctor treatment.

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

1 year

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

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) aged 18 years or above 2) Having a score of 16 or higher on the Epidemiological Studies Depression (CES-D) score of 16 or higher or Hospital Anxiety and Depression Scale (HADS) Anxiety Score (AS) of 3 or more.

ii Exclusion Criteria

1) Meeting criteria for DSM IV criteria for major depression or/and clinical anxiety disorders (they will be referred directly to the Family Medicine Training Centre for treatment for ethical reasons) 2) insufficient mastery of Chinese language 3) unwilling or unable to give informed consent

iii Age Minimum

18

iv Age Maximum

Nil

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

Double-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

240

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

Incidence of DSM depressive and/or anxiety disorders (panic disorder, agoraphobia, social phobia and generalized anxiety) in patients after 12 months as compared to usual care evaluated using the SCID (Structured Clinical Interview for DSM-IV) conducted by blinded trained health professional.

24 Secondary Outcome

1) Depressive and Anxiety Symptoms
Reduction of self-reported anxiety and depressive symptoms measured by the validated Chinese Hospital Anxiety Depression Scale, the validated Chinese version of the Centre for Epidemiological Studies-Depression Scale and the Chinese version of Beck Anxiety and De4pression Inventory at every 3-month interval.
2) Quality of Life
Improvement in quality of life will be measured by the validated Chinese version of Medical Outcomes Study Short-Form Health Survey at every 6-month interval.
3) Health Service Utilization, Medication Use
Utilization of health services including visits to primary care doctors (both private and public) and hospitalizations and the number of days of absence from work will be recorded at monthly intervals by the trained research assistant using telephone. All medications associated with an intention to improve mood or mood related symptoms will be recorded at the same time and will include anticonvulsants, antidepressants, anxiolytics including benzodiazepines at every 3-month interval.
4) Satisfaction with Delivered Care
This will be measured with a question adopted from CAHPS 2.0 Adult Questionnaire at every 3-month interval.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2011-06-30

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-10000908

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 2011-02-08