Centre For Clinical Research And Biostatistics (CCRB)

Back History

1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00431

2 Trial Registration Date

2014-08-25

i Registration Status

Prospective

3 Secondary IDs

2014.382-T

4 Source(s) of Funding

Department of Psychiatry, Chinese University of Hong Kong

5 Primary Sponsor

Prof. Chan, Sau Man Sandra

6 Secondary Sponsor

Dr. Chau Wai Ho

Function

Take on all the responsibilities of sponsorship jointly with the primary sponsor

Please specify

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

i Name

Dr. Chau Wai Ho

ii Address

Department of Psychiatry, 1/F, Tai Po Hospital

iii Phone

26076965

iv Email

stevenwhchau@gmail.com

v Affiliation

Tai Po Hospital

vi Country

Hong Kong SAR

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

i Name

Dr. Chau Wai Ho

ii Address

Department of Psychiatry, 1/F, Tai Po Hospital

iii Phone

26076965

iv Email

stevenwhchau@gmail.com

v Affiliation

Tai Po Hospital

vi Country

Hong Kong SAR

9 Official Scientific Title of the Study

A randomized controlled study on the clinical efficacy of brief attentional bias modification training (ABMT) in adults with generalized anxiety disorder

10 Public Title

A randomized controlled study on the clinical efficacy of brief attentional bias modification training (ABMT) in adults with generalized anxiety disorder

i Public Title in Chinese 研究名稱

簡短的”注意偏誤修正訓練”的臨床效果- -應用於廣泛焦慮症病人的隨機分組對照研究

11 Short Title (Optional)

Brief attentional bias modification training for GAD

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?

2014-07-11

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2014.382-T

14 Medical Condition Being Studied

Generalized Anxiety Disorder

15 Intervention

i Types of intervention

Behavior

Please specify

ii Description/ name of Intervention/article

computerised attentional bias modification training (ABMT)

iii Dosage form of the intervention

Not applicable

iv Dosage of the intervention

Not applicable

v Duration of the intervention

4 weekly sessions

vi Frequency of the intervention

weekly

16 Comparative Treatments

i Description/ name of comparative treatments

sham attentional bias modification training

ii Dosage form of the comparative treatments

Not applicable

iii Dosage of the comparative treatments

Not applicable

iv Duration of the comparative treatments

4 weekly sessions

v Frequency of the comparative treatments

weekly

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

a) aged 18-64 years and meeting diagnostic criteria of GAD of the Structured Clinical Interview for the DSM-IV(SCID); b) no emergent suicide risk; c) no change in dosage of antidepressant or benzodaizepine in the past 8 weeks.

ii Exclusion Criteria

a) history of any psychotic disorders, bipolar affective disorder or organic mental disorders b)alcohol or other substance abuse c) unable to read traditional written Chinese d) currently receiving structured psychotherapy

iii Age Minimum

18

iv Age Maximum

64

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

Block randomization

ii Nature of control

Placebo

iii Degree of masking

Double-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Other

Please specify

Not applicable

vi Study Objectives (Optional)

20 Anticipated trial start date

2014-09-03

21 Target Sample Size

48

22 Recruitment Status

Complete

23 Primary Outcome

difference in Anxiety symptoms between pre-intervention 1 month post-intervention

24 Secondary Outcome

differences in attentional bias score, depressive symptoms, level of worry and rumination, and quality of life between pre-intervention and 1 month post-intervention

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2015-09-09

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-14005205

28 Date of Registration in Primary Registry

2014-09-10

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Trial Detail