Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00341

2 Trial Registration Date

2012-10-11

i Registration Status

Prospective

3 Secondary IDs

Nil

4 Source(s) of Funding

Health and Health Services Research Fund, Food and Health Bureau, HKSAR Government

5 Primary Sponsor

Prof. Winnie Wing Sze MAK, Department of Psychology, The Chinese University of Hong Kong

6 Secondary Sponsor

Ms. Wacy W. S. LUI, Corporate Clinical Psychology Services, Hospital Authority
Ms. Amy T. Y. CHAN, Department of Psychology, The Chinese University of Hong Kong
Prof. Joseph T. F. LAU, School of Public Health and Primary Care, The Chinese University of Hong Kong

Function

Please specify

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

i Name

Mr Ip Man Ho Amen

ii Address

Room 304D, Wong Foo Yuan Building, The Chinese University of Hong Kong

iii Phone

3943 4189

iv Email

amhip@psy.cuhk.edu.hk

v Affiliation

Research Assistant, Department of Psychology, The Chinese University of Hong Kong

vi Country

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

i Name

Prof. Winnie Wing Sze MAK

ii Address

Rm 354, Sino Building, The Chinese University of Hong Kong

iii Phone

3943 6577

iv Email

wwsmak@psy.cuhk.edu.hk

v Affiliation

Associate Professor, Department of Psychology, The Chinese University of Hong Kong

vi Country

9 Official Scientific Title of the Study

Internet-based mindfulness programme for the promotion of public mental health: Randomised controlled trial

10 Public Title

Wiseliving – an Internet-based mental health program

i Public Title in Chinese 研究名稱

智慧生活─網上心理健康計劃

11 Short Title (Optional)

Online mindfulness program

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?

2013-03-21

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

General public’s mental health

15 Intervention

i Types of intervention

Other

Please specify

Online program

ii Description/ name of Intervention/article

A mindfulness program: The program teaches participants to cultivate mindfulness (paying attention nonjudgmentally to the present moment) by using various exercises that are adapted from the Mindfulness-based Stress Reduction Program (MBSR), and Mindfulness-based Cognitive Therapy (MBCT).

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

8 weeks

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

A psychoeducation program: The program focuses on enhancing mental health literacy through the provision of basic facts and information about mental health. Contents of this program are based on MacDonald and O’Hara’s ‘10 elements of mental health promotion and demotion’, which is adopted by the UK and Victorian government as a reference for formulating mental health policies.

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) At least 18 of age
(2) Read and understand Chinese
(3) Computer literate
(4) Have consistent access to the internet

ii Exclusion Criteria

(1) Severe to extremely severe depression or anxiety scores on the DASS-21 based on the cut-off scores recommended by the DASS21
(2) Scoring 1-3 on items 16, 21 or 28 of Mental Health Inventory (MHI-38) indicating possible suicidal ideation
(3) Currently receiving professional mental health services
(4) Currently taking psychotropic medication

iii Age Minimum

18

iv Age Maximum

Nil

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

Open label

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

2013-07-02

21 Target Sample Size

632

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

(1)Well-being: The WHO 5-item Well-Being Index (WBI) will be used to measure overall psychological well-being at pre-test, each week before browsing the program, post-test and 3-month follow-up.
Besides, the following aspects will be assessed at pre-test, post-test and 3-month follow-up.
(2)Mental health: Participants will complete the 18-item Mental Health Inventory (MHI) to assess their mental health. Domains of mental health measured include anxiety, depression, behavioural control and positive affect.
(3)Life satisfaction: Life satisfaction will be assessed by the 5-item Satisfaction with Life Scale (LS).
(4)Pain: Average level of pain will be measured by the Visual Analogue Scale-Pain (VAS-P). Participants are asked to rate their average daily pain on a line from 0 (no pain) to 100 (very severe pain).
(5)Energy: Average level of energy will be measured by VAS-Energy (VAS-E). Participants are asked to rate their average daily energy level on a 100mm long line from 0 (no energy) to 100 (a lot of energy).
(6)Sleep: The 4-item sleep disturbance subscale of the Medical Outcomes Study Sleep Measure (MOS-Sleep) will be used to assess how well participants sleep without tapping into other sleep-related medical conditions.
(7) Work absenteeism and productivity: The 7-item absenteeism and productivity questions of the WHO Health and Work Performance Questionnaire will also be administered to participants being employed.

24 Secondary Outcome

(1)Mindfulness: The shortened 20-item version of Five Facets Mindfulness Questionnaire (FFMQ) is administered in the study to examine the changes in the mindfulness. It will be measured at pre-test, week 3, week 5, week 7 of the program, post-test and 3-month follow-up.
(2)General self-efficacy: The 10-item General Self-efficacy Scale (GSES) will be used to measure participants’ perceived self-efficacy to cope with stressful situations or problems. It will be measured at pre-test, week 3, week 5, week 7 of the program, post-test and 3-month follow-up.
(3) Self-compassion: The shortened 8-item Self-Other Four Immeasurable (SOFI) scale will be used to measure self-compassion. It will be measured at pre-test, week 3, week 5, week 7 of the program, post-test and 3-month follow-up.
(4)Users’ expected creditability of the program: At pre-test, the participants will be asked to complete the 6-item Credibility/Expectancy Questionnaire (CEQ), which aims to examine if expectancies or perception of treatment credibility are related to outcomes.
(5)Users’ satisfaction: The 8-item Client Satisfaction Questionnaire (CSQ) will be used to measure participants’ attitude towards and satisfaction with the internet-based interventions at post-test.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2015-07-30

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-12002623

28 Date of Registration in Primary Registry

2012-10-26

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

Nil

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Trial History Detail on 2013-06-27