Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00624

2 Trial Registration Date

2018-09-12

i Registration Status

Prospective

3 Secondary IDs

2017-0070

4 Source(s) of Funding

The Hong Kong Jockey Club Charities Trust

5 Primary Sponsor

The Hong Kong Jockey Club Charities Trust

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

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

i Name

Amy CHAN

ii Address

Rm 326C, Department of Psychology,
3rd Floor, Wong Foo Yuan Building
Chung Chi College,
The Chinese University of Hong Kong
Shatin, N.T.

iii Phone

39433460

iv Email

atychan@cuhk.edu.hk

v Affiliation

Department of Psychology, 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

Rm 354, Department of Psychology,
The Chinese University of Hong Kong
Shatin, N.T.

iii Phone

3943-6577

iv Email

wwsmak@psy.cuhk.edu.hk

v Affiliation

Department of Psychology, The Chinese University of Hong Kong

vi Country

Hong Kong

9 Official Scientific Title of the Study

The Stepped-care Online Self-help and Support Service Project on Mental Health

10 Public Title

The Stepped-care Online Self-help and Support Service Project on Mental Health

i Public Title in Chinese 研究名稱

階梯式精神健康支援系統

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?

2018-05-29

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2018.169

14 Medical Condition Being Studied

Stepped-care mental health service implementation

15 Intervention

i Types of intervention

Other

Please specify

Stepped-care model

ii Description/ name of Intervention/article

In our stepped care system, we aim to offer an array of mental health tools and interventions to our participants so that they can access relevant mental health information and services through a one-stop centralized online platform. Individuals can register to the system through a simple sign-in procedure. They will then be directed to an online personal assessment (a.k.a. mental health check-up) where their well-being profile will be taken. Based on their scores on mental well-being (i.e. flourishing), anxiety, and depression, they will be recommended to services that are appropriate their current well-being profile.

iii Dosage form of the intervention

Online mental health trainings, offline mental health programs and services

iv Dosage of the intervention

Depending on participants' mental health needs

v Duration of the intervention

Depending on participants' mental health needs

vi Frequency of the intervention

Depending on participants' mental health needs

16 Comparative Treatments

i Description/ name of comparative treatments

Given the nature of an implementation research, there is no comparative treatment.

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

Adults aged 18 or above

Access to internet

ii Exclusion Criteria

Age 17 or below

iii Age Minimum

18

iv Age Maximum

999

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

3

Please specify

vi Study Objectives (Optional)

To evaluate the implementation of stepped-care model in mental health services provisioning

20 Anticipated trial start date

2018-09-21

21 Target Sample Size

120

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

i The Name of the outcome

Mental health

ii The metric or method of measurement used

Patient Health Questionnaire (PHQ-9), Generalized Anxiety Disorder (GAD-7), Flourishing Scale

iii The timepoint(s) of primary interest

Baseline, post-intervention, follow-up

24 Secondary Outcome

i The Name of the outcome

Service providers and service users' views toward the stepped-care services

ii The metric or method of measurement used

Normalization process theory framework

iii The timepoint(s) of primary interest

Baseline, post-intervention, 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

ChiCTR1800018536

28 Date of Registration in Primary Registry

2018-09-12

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Trial History Detail on 2018-12-05