Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00378

2 Trial Registration Date

2013-08-15

i Registration Status

Prospective

3 Secondary IDs

CRE-2013.160-T

4 Source(s) of Funding

Health and Medical Research Fund

5 Primary Sponsor

Winnie W. S. Mak

6 Secondary Sponsor

N/A

Function

Please specify

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

i Name

Winnie W. S. Mak

ii Address

Department of Psychology, The Chinese University of Hong Kong, 3rd Floor, Sino Building, Shatin, N.T., Hong Kong

iii Phone

39436577

iv Email

wwsmak@psy.cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

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

i Name

Winnie W. S. Mak

ii Address

Department of Psychology, The Chinese University of Hong Kong, 3rd Floor, Sino Building, Shatin, N.T., Hong Kong

iii Phone

39436577

iv Email

wwsmak@psy.cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

9 Official Scientific Title of the Study

Mobile self-compassionate programme for the promotion of public mental health: Randomised controlled trial

10 Public Title

Mobile self-compassionate programme for the promotion of public mental health: Randomised controlled trial

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

Self-compassion apps for mental health promotion

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?

2013-04-12

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

mental health

15 Intervention

i Types of intervention

Other

Please specify

Psychological

ii Description/ name of Intervention/article

Mobile self-compassion programme

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

4 weeks, with 3-month follow-up

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Psychoeducation

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

18 (1) age over 18, (2) read and understand Chinese, (3) own a smartphone/ tablet device, and (4) have consistent access to the mobile internet.

ii Exclusion Criteria

(1) having a psychiatric diagnosis as reported by the participants (2) currently suicidal as scoring 1-3 on item 16, 21, or 28 of the Mental Health Inventory, (3) currently undergoing professional mental health services, and (4) currently taking psychotropic medication.

iii Age Minimum

18

iv Age Maximum

n/a

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Active

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

2014-10-01

21 Target Sample Size

250

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

To evaluate the effectiveness of the Self-Compassion Programme (SCP) in the enhancement of mental health compared with the Psychoeducation Programme (PP) at post-program and 3-month follow-up.

24 Secondary Outcome

To evaluate the effectiveness of Self-Compassion Programme (SCP) in the enhancement of self-compassion and emotion regulation compared with the Psychoeducation Programme (PP) at post-program and 3-month follow-up.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2016-01-04

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

* Legacy Fields

i Recruitment Information Available?

No

ii Link to Recruitment Information

n/a

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Trial History Detail on 2013-08-15