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Trial History Detail on 2020-03-05

CUHK_CCRB00593

2018-03-09

Prospective

14151961

Health and Medical Research Fund

Food and Health Bureau, HKSAR

N/A

Not Applicable

Joey Chan

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

3943 3463

choyijoeychan@cuhk.edu.hk

Department of Psychology, The Chinese University of Hong Kong

Hong Kong

Winnie W. S. Mak

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

3943-6577

wwsmak@psy.cuhk.edu.hk

Department of Psychology, The Chinese University of Hong Kong

Hong Kong

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

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

「心造Mindwork」-心理健康自學課程研究計劃

Hong Kong

Yes

2017-01-10

Joint CUHK-NTEC Clinical Research Ethics Committee

2015.388-T

Depression

Anxiety

Other

Internet-based Cognitive Behavioral Therapy

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 10 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

Internet-based guided self-help

Not applicable

Six to Eight weeks

One session per week

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 10 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

Internet-based self-help

Not applicable

Six to Eight weeks

One session per week

1) 9 item Patient Health Questionnaire (PHQ-9) and 7-item Generalized Anxiety Disorder (GAD-7) score ≥10

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

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 P4 suicidality screener )

18

999

Both Male and Female

Interventional

Randomized

Block randomization

Active

Single-blind

Trial subjects

Not Applicable

3

2018-05-01

527

Recruiting

Depression and anxiety

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

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

Quality of life

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

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

Adaptive behaviours and cognitions

FATS

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

Intolerance of uncertainty

IU

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

Perseverative Thinking

PTQ

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

Flourishing

FS

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

Productivity cost

iMTA productivity cost questionnaire (IPCQ)

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

Acceptance and use of technology

UTAUT

Pre-intervention

No

2020-03-06

ChiCTR1800015149

2018-03-10

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