Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00593

2 Trial Registration Date

2018-03-09

i Registration Status

Prospective

3 Secondary IDs

14151961

4 Source(s) of Funding

Health and Medical Research Fund

5 Primary Sponsor

Food and Health Bureau, HKSAR

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

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

i Name

Larry AUYEUNG

ii Address

Rm 326C, Department of Psychology,
3rd Floor, Wong Foo Yuan Building
Chung Chi College,
The Chinese University of Hong Kong
Shatin, N.T.

iii Phone

3943 3463

iv Email

larryauyeung@cuhk.edu.hk

v Affiliation

Department of Psychology, The Chinese University of Hong Kong

vi Country

Hong Kong

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

i Name

Winnie W. S. Mak

ii Address

Rm 354, Department of Psychology,
The Chinese University of Hong Kong
Shatin, N.T.

iii Phone

3943-6577

iv Email

wwsmak@psy.cuhk.edu.hk

v Affiliation

Department of Psychology, The Chinese University of Hong Kong

vi Country

Hong Kong

9 Official Scientific Title of the Study

Efficacy and economic evaluation of Iinternet-based mindfulness and cognitive behavioural therapy as treatment for anxiety and depression: A randomised controlled trial

10 Public Title

"Mindwork" -An investigation on Mental Health Self-help Course

i Public Title in Chinese 研究名稱

「心造Mindwork」-心理健康自學課程研究計劃

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?

2017-01-10

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2015.388-T

14 Medical Condition Being Studied

Depression

Anxiety

15 Intervention

i Types of intervention

Other

Please specify

Internet-based Cognitive Behavioral Therapy

ii Description/ name of Intervention/article

An Internet based cognitive behavioral therapy (iCBT) will be used as intervention in this trial. The intervention consists of 6 sessions, participants can move forward sequentially one after the other within 8 weeks in guided self-help format. The session topics in iCBT are as follows:
1. Introduction of symptoms, prevalence, and treatment of depression and anxiety; basic principles of CBT
2. Guidelines on managing repetitive negative thinking, and physical symptoms through de-arousal
3. Guidelines on behavioral activation and behavioral experiment
4. Guidelines on structured problem solving and managing worry
5. Guidelines on challenging dysfunctional beliefs
6. Learning plans towards relapse prevention

iii Dosage form of the intervention

Internet-based guided self-help

iv Dosage of the intervention

Not applicable

v Duration of the intervention

Six to Eight weeks

vi Frequency of the intervention

One session per week

16 Comparative Treatments

i Description/ name of comparative treatments

An Internet based Psycho-education course will be used as comparative treatment. The course consists of 6 sessions, participants can move forward sequentially one after the other within 8 weeks in guided self-help format. The session topics in Psycho-education course are as follows:

1. Introduction to Psychology
2. Personality
3. Culture and Behavior
4. Conformity and obedience
5. Memory
6. Consciousnesses

ii Dosage form of the comparative treatments

Internet-based self-help

iii Dosage of the comparative treatments

Not applicable

iv Duration of the comparative treatments

Six to Eight weeks

v Frequency of the comparative treatments

One session per week

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

1) 9 item Patient Health Questionnaire (PHQ-9) and 7-item Generalized Anxiety Disorder (GAD-7) score ≥ 5

2) a DSM-5 diagnosis of current major depressive disorder or any anxiety disorders (except the one listed in the exclusion criteria)

3) at least 18 of age

4) able to read and understand Chinese and spoken Cantonese

ii Exclusion Criteria

1) a DSM-5 diagnosis of current manic episodes, post-traumatic stress disorder (PTSD), substance use disorders, and psychotic disorders

2) actively suicidal (as measured by Question 9 of the PHQ-9 with score > 2)

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

Block randomization

ii Nature of control

Active

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

Trial subjects

iv Group Assignment

Not Applicable

v Study Phase

3

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2018-05-01

21 Target Sample Size

527

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

i The Name of the outcome

Depression and anxiety

ii The metric or method of measurement used

9 item Patient Health Questionnaire (PHQ-9) and 7-item Generalized Anxiety Disorder (GAD-7)

iii The timepoint(s) of primary interest

Pre-intervention, Post-intervention, and 6 months follow-up

24 Secondary Outcome

i The Name of the outcome

Quality of life

ii The metric or method of measurement used

Short-Form Six- Dimension (SF-6D) health utility measures

iii The timepoint(s) of primary interest

Pre-intervention, Post-intervention, and 6 months follow-up

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2020-03-06

27 Primary Registry and Trial Identifying Number

ChiCTR1800015149

28 Date of Registration in Primary Registry

2018-03-10

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Trial History Detail on 2018-03-22