Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00438

2 Trial Registration Date

2014-11-10

i Registration Status

Prospective

3 Secondary IDs

2014.473-T

4 Source(s) of Funding

Chen Wai Wai Vivien Foundation Ltd

5 Primary Sponsor

Chen Wai Wai Vivien Foundation Therapeutic Physical Mental Exercise Centre, Department of Psychiatry, The Chinese University of Hong Kong

6 Secondary Sponsor

N/A

Function

Please specify

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

i Name

Ms Harriet W Y Tang 鄧穎瑜

ii Address

Room 3A, Block E, Staff Quarters, Prince of Wales Hospital, 46 Ngan Shing Street, Shatin

iii Phone

852-28314305

iv Email

harriet@cuhk.edu.hk

v Affiliation

Department of Psychiatry, The Chinese University of Hong Kong

vi Country

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

i Name

Prof. Linda CW Lam 林翠華

ii Address

Department of Psychiatry, G/F Multi-Centre, Tai Po Hospital, Tai Po. NT, Hong Kong

iii Phone

852-26076027

iv Email

cwlam@cuhk.edu.hk

v Affiliation

Department of Psychiatry, the Chinese University of Hong Kong

vi Country

9 Official Scientific Title of the Study

Aerobic and mind body exercise interventions for adults with anxiety and depressive disorders under primary care settings in Hong Kong – a randomized control trial.

10 Public Title

Aerobic and mind body exercise interventions for adults with anxiety and depressive disorders under primary care settings in Hong Kong – a randomized control trial.

i Public Title in Chinese 研究名稱

個人化身心運動治療對抑鬱症及焦慮症之隨機對照臨床試驗效果研究

11 Short Title (Optional)

A study on the effects of mind body exercise on depression and anxiety

12 Countries of Recruitment

Hong Kong SAR, China

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2014-10-22

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Major Depressive Episode or Generalized Anxiety Disorder

15 Intervention

i Types of intervention

Behavior

Please specify

ii Description/ name of Intervention/article

Aerobic and mind body exercise interventions

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

6 weeks intervention

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

6 week intervention of either mind body exercise intervention or educational health talk

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. Subject from 18 to 60 years old
2. Clinical Diagnosis of Major Depressive Episode or Generalized Anxiety Disorder
3. Currently undergoing treatment for the mood disorder in a priamry care setting

ii Exclusion Criteria

1. Other comorbid psychiatric diagnosis
2. Physically unfit to exercise as assessed by physiotherapist.
3. Pregnant

iii Age Minimum

18

iv Age Maximum

60

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Placebo

iii Degree of masking

Single-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

2014-11-22

21 Target Sample Size

80

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

Primary outcome measure will be the Hospital Anxiety Depression Scale (HADS). Assesment and records of adverse events will be conducted at baseline, 6th week and 12th weeks.

24 Secondary Outcome

Secondary outcomes include the Sheehan Disability Scale, Pittsburgh Sleep Quality Index, 12 item Short Form Health Survey and Fitbit Flex wristband monitor for mobilizaiton pattern. Assesment and records of adverse events will be conducted at baseline, 6th week and 12th weeks.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2015-12-10

27 Primary Registry and Trial Identifying Number

ChiCTR-IOR-14005463

28 Date of Registration in Primary Registry

2014-11-10

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

N/A

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Trial History Detail on 2014-11-10