Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00634

2 Trial Registration Date

2018-11-09

i Registration Status

Prospective

3 Secondary IDs

2017.569

4 Source(s) of Funding

Health and Medical Research Fund - Health Care and Promotion Scheme

5 Primary Sponsor

The Chinese University of Hong Kong

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

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

i Name

Sarah S. Y. Ku

ii Address

326C Sino Building
The Chinese University of Hong Kong

iii Phone

3943 4378

iv Email

sarahku@cuhk.edu.hk

v Affiliation

Department of Psychology

vi Country

Hong Kong

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

i Name

Winnie W. S. Mak

ii Address

354 Sino Building
The Chinese University of Hong Kong

iii Phone

3943-6577

iv Email

wwsmak@psy.cuhk.edu.hk

v Affiliation

Department of Psychology

vi Country

Hong Kong

9 Official Scientific Title of the Study

Mindful Flourishing-Promoting college students’ mental well-being through cultivation of mindfulness with online and offline approaches

10 Public Title

Mindful Flourishing-Promoting college students’ mental well-being through cultivation of mindfulness with online and offline approaches

i Public Title in Chinese 研究名稱

《日常心活》靜觀網上訓練研究

11 Short Title (Optional)

Mindful Flourishing

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?

2017-11-10

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2017.569

14 Medical Condition Being Studied

Psychological well-being

15 Intervention

i Types of intervention

Other

Please specify

Psychological

ii Description/ name of Intervention/article

Participants are invited to download the EMI mobile application so they can apply what they have learned in their daily lives. The EMI will be accompanied by mindfulness audios that guide participants to practice mindfulness.
This mindfulness mobile application utilizing EMI could provide mindfulness intervention in an environment that is natural to the participants, and help users understand the relations between their mindfulness, mood and stressors at different time and place during their daily lives. Real-time interventions will be provided to users according to their specific needs at that moment to facilitate their stress regulation, enhance their well-being, and integrate new adaptive thinking and behavioral patterns into their daily lives.

iii Dosage form of the intervention

N/A

iv Dosage of the intervention

N/A

v Duration of the intervention

N/A

vi Frequency of the intervention

N/A

16 Comparative Treatments

i Description/ name of comparative treatments

Propensity score matching (PSM) will be used to attain reasonable estimation of the intervention effect. Participants who have used the app will be matched a respective control group through PSM.
Specifically, a pool of college students who did not use the app will be recruited, and they will be invited to fill out the same sets of questionnaire. The propensity score of each app user and college students recruited for the potential control group will be calculated based on basic demographic information and baseline outcome variable scores. Each app user will then be matched with a student in the control group who shows the most similar neighbor propensity score. Hence, the propensity score matched pairs will be obtained for post-test and follow-up evaluation.

ii Dosage form of the comparative treatments

N/A

iii Dosage of the comparative treatments

N/A

iv Duration of the comparative treatments

N/A

v Frequency of the comparative treatments

N/A

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

At least 18 of age or University students

read and understand Chinese and spoken Cantonese

possess a mobile gadget

have consistent access to the Internet

ii Exclusion Criteria

N/A

iii Age Minimum

16

iv Age Maximum

40

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Non-randomized

Please specify

ii Nature of control

Not Applicable

iii Degree of masking

Not Applicable

If Single-blind, who will be masked?

iv Group Assignment

Not Applicable

v Study Phase

0

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2018-12-01

21 Target Sample Size

459

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

i The Name of the outcome

Depression

ii The metric or method of measurement used

PHQ-9

iii The timepoint(s) of primary interest

4

Primary Outcome

i The Name of the outcome

Anxiety

ii The metric or method of measurement used

GAD-7

iii The timepoint(s) of primary interest

4

Primary Outcome

i The Name of the outcome

Stress

ii The metric or method of measurement used

Perceived Stress Scale

iii The timepoint(s) of primary interest

4

24 Secondary Outcome

i The Name of the outcome

Mindfulness

ii The metric or method of measurement used

Five Facets Mindfulness Questionnaire (FFMQ) Non-attachment Scale (NAS)

iii The timepoint(s) of primary interest

4

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2021-03-08

27 Primary Registry and Trial Identifying Number

ChiCTR1900021016

28 Date of Registration in Primary Registry

2018-11-09

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Trial History Detail on 2019-01-29