Centre For Clinical Research And Biostatistics (CCRB)

Back History

1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00377

2 Trial Registration Date

2013-08-13

i Registration Status

Prospective

3 Secondary IDs

CRE-2012.515

4 Source(s) of Funding

Health and Medical Research Fund of Food and Health Bureau

5 Primary Sponsor

Health and Medical Research Fund of Food and Health Bureau

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

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

i Name

Miss Winnie Cheng

ii Address

Department of Psychology, The Chinese University of Hong Kong, Shatin, Hong Kong

iii Phone

39434189

iv Email

wwlcheng@psy.cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

Hong Kong

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

i Name

Prof. Winnie W. S. Mak

ii Address

Department of Psychology, The Chinese University of Hong Kong, Shatin, Hong Kong

iii Phone

39436577

iv Email

wwsmak@psy.cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

Hong Kong

9 Official Scientific Title of the Study

Self-determination theory-based exercise programmes for the enhancement of exercise adherence and well-being among people with depression: Randomised controlled trial

10 Public Title

Self-determination theory-based exercise programmes for the enhancement of exercise adherence and well-being among people with depression: Randomised controlled trial

i Public Title in Chinese 研究名稱

抑鬱症康復者的運動堅持度與安康之增量效度

11 Short Title (Optional)

Self-determination theory-based exercise programmes

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?

2013-03-07

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2012.515

14 Medical Condition Being Studied

Depression

15 Intervention

i Types of intervention

Behavior

Please specify

ii Description/ name of Intervention/article

Self-determination theory-based exercise programmes

iii Dosage form of the intervention

Fitness Class

iv Dosage of the intervention

N/A

v Duration of the intervention

8 weeks

vi Frequency of the intervention

Twice a week

16 Comparative Treatments

i Description/ name of comparative treatments

Participants will be randomly assigned to one of the following conditions: (1) Self-Determination Theory-based Exercise (SDTE) program and (2) standard exercise (SE) programme. All participants will attend two 1-hour exercise sessions every week for 8 weeks. The SDTE provides an interpersonal climate promoting the fulfillment of psychological needs of autonomy, competence, and interpersonal relatedness, whereas the SE will not be facilitative of psychological need support.

ii Dosage form of the comparative treatments

Fitness Class

iii Dosage of the comparative treatments

N/A

iv Duration of the comparative treatments

8 weeks

v Frequency of the comparative treatments

Twice a week

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

(1) aged above 18 years; (2) Cantonese speaking; (3) a primary diagnosis of DSM-IV-TR major depressive disorder; (4) no change in psychotropic medication for at least 3 months

ii Exclusion Criteria

(1) presence of current or past DSM-IV-TR diagnosis of schizophrenia-spectrum disorder, bipolar disorder, or eating disorder; (2) presence of psychoactive substance (including alcohol) harmful use and dependence in the past 3 months; (3) being clinically judged to have high risk of suicidal behaviour; (4) have a known history of intellectual disability; (5) pregnancy; (6) knee and/or back pain or other physical conditions deemed not appropriate for exercise; and (7) have a regular exercise routine based on the WHO guideline of having 150 minutes/week of moderate physical activity or 75 minutes/week of vigorous physical activity in the past 3 months. Participants who change their medication during the programme will be allowed to stay, but their data will be removed from analysis

iii Age Minimum

18

iv Age Maximum

65

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

RCT

ii Nature of control

Placebo

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Not Applicable

v Study Phase

2

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2014-04-01

21 Target Sample Size

160

22 Recruitment Status

Recruiting

23 Primary Outcome

Program attendance during the program; physical activity at baseline, post-program, 3-month follow-up

24 Secondary Outcome

Psychological well-being (depression, positive well-being) at baseline, post-program, 3-month follow-up; Health-related physical fitness (aerobic fitness and body composition) at baseline, post-program, 3-month follow-up; intrinsic motivation at baseline, post-program, 3-month follow-up

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2016-09-09

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-13003472

28 Date of Registration in Primary Registry

2013-08-17

Back History

Trial Detail