Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00559

2 Trial Registration Date

2017-07-05

i Registration Status

Prospective

3 Secondary IDs

2017.203-T

4 Source(s) of Funding

nil

5 Primary Sponsor

nil

6 Secondary Sponsor

nil

Function

Not Applicable

Please specify

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

i Name

Wong Kwok Leung

ii Address

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

iii Phone

98451270

iv Email

1155089270@link.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

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

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

A randomized control trial of Internet-based mindfulness intervention on promoting health-related outcomes

10 Public Title

21 day mindfulness navigation intervention

i Public Title in Chinese 研究名稱

21日靜觀導航計劃

11 Short Title (Optional)

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?

2017-04-27

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2017.203-T

14 Medical Condition Being Studied

Insomnia

Pain

Healthy Diet

15 Intervention

i Types of intervention

Behavior

Please specify

ii Description/ name of Intervention/article

Whatsapp-based mindfulness intervention

iii Dosage form of the intervention

online messenger platform - whatsapp

iv Dosage of the intervention

10-15 mindfulness exercises

v Duration of the intervention

21 days

vi Frequency of the intervention

daily

16 Comparative Treatments

i Description/ name of comparative treatments

Wait list control

ii Dosage form of the comparative treatments

nil

iii Dosage of the comparative treatments

nil

iv Duration of the comparative treatments

nil

v Frequency of the comparative treatments

nil

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

aged above 18

being able to understand Chinese and give consent

have adequate computer literacy to follow the online intervention

ii Exclusion Criteria

Officially diagnosed with Psychiatric disorder

Actively suicidal

iii Age Minimum

18

iv Age Maximum

None

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

Participants will be randomized to treatment or waitlist control conditions based on random digit

ii Nature of control

Placebo

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

3

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2017-07-17

21 Target Sample Size

600

22 Recruitment Status

Recruiting

23 Primary Outcome

i The Name of the outcome

pain

ii The metric or method of measurement used

self-report questionnaire

iii The timepoint(s) of primary interest

pre, post, 1-month follow-up, and 3-month follow-up

Primary Outcome

i The Name of the outcome

insomnia

ii The metric or method of measurement used

self-report questionnaire

iii The timepoint(s) of primary interest

pre, post, 1-month follow-up, and 3-month follow-up

Primary Outcome

i The Name of the outcome

eating behavior

ii The metric or method of measurement used

self-report questionnaire

iii The timepoint(s) of primary interest

pre, post, 1-month follow-up, and 3-month follow-up

24 Secondary Outcome

i The Name of the outcome

Chronic Pain Acceptance

ii The metric or method of measurement used

self-report questionnaire

iii The timepoint(s) of primary interest

pre, post, 1-month follow-up, and 3-month follow-up

Secondary Outcome

i The Name of the outcome

Pain Catastrophizing thoughts

ii The metric or method of measurement used

self-report questionnaire

iii The timepoint(s) of primary interest

pre, post, 1-month follow-up, and 3-month follow-up

Secondary Outcome

i The Name of the outcome

Pre-Sleep Arousal

ii The metric or method of measurement used

self-report questionnaire

iii The timepoint(s) of primary interest

pre, post, 1-month follow-up, and 3-month follow-up

Secondary Outcome

i The Name of the outcome

Dysfunctional Beliefs and Attitudes about Sleep

ii The metric or method of measurement used

self-report questionnaire

iii The timepoint(s) of primary interest

pre, post, 1-month follow-up, and 3-month follow-up

Secondary Outcome

i The Name of the outcome

self-control on eating behavior

ii The metric or method of measurement used

self-report questionnaire

iii The timepoint(s) of primary interest

pre, post, 1-month follow-up, and 3-month follow-up

Secondary Outcome

i The Name of the outcome

Mindfulness

ii The metric or method of measurement used

self-report questionnaire

iii The timepoint(s) of primary interest

pre, post, 1-month follow-up, and 3-month follow-up

Secondary Outcome

i The Name of the outcome

Depression

ii The metric or method of measurement used

self-report questionnaire

iii The timepoint(s) of primary interest

pre, post, 1-month follow-up, and 3-month follow-up

Secondary Outcome

i The Name of the outcome

Anxiety

ii The metric or method of measurement used

self-report questionnaire

iii The timepoint(s) of primary interest

pre, post, 1-month follow-up, and 3-month follow-up

Secondary Outcome

i The Name of the outcome

Well-being

ii The metric or method of measurement used

self-report questionnaire

iii The timepoint(s) of primary interest

pre, post, 1-month follow-up, 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

2019-03-06

27 Primary Registry and Trial Identifying Number

ChiCTR-INR-17011880

28 Date of Registration in Primary Registry

2017-07-05

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Trial History Detail on 2018-03-05