Centre For Clinical Research And Biostatistics (CCRB)

Back History

1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00509

2 Trial Registration Date

2016-05-03

iRegistration Status

Prospective

3 Secondary IDs

2016.073-T

4 Source(s) of Funding

The Chinese University of Hong Kong

5 Primary Sponsor

The Chinese University of Hong Kong

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

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

i Name

Henry Wong Cheuk Yin

ii Address

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

iii Phone

66031174

iv Email

1155073628@link.cuhk.edu.hk

v Affiliation

CUHK

vi Country

Hong Kong

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

i Name

Henry Wong Cheuk Yin

ii Address

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

iii Phone

66031174

iv Email

1155073628@link.cuhk.edu.hk

v Affiliation

The Department of Psychology, The Chinese University of Hong Kong

vi Country

Hong Kong

9 Official Scientific Title of the Study

Effect of Wellness Recovery Action Plan on mental wellbeing among college students who are at risk for depression or anxiety: A randomized controlled trial

10 Public Title

Effect of Wellness Recovery Action Plan on mental wellbeing among college students who are at risk for depression or anxiety: A randomized controlled trial

i Public Title in Chinese 研究名稱

身心健康行動計劃研究

11 Short Title (Optional)

12 Countries of Recruitment

Hong Kong

13Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2016-03-21

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2016.073-T

14 Medical Condition Being Studied

Depression

Anxiety

15Intervention

i Types of intervention

Other

Please specify

Workshop

ii Description/ name of Intervention/article

Wellness Recovery Action Plan (WRAP) is an evidence-based program focusing on self-care and self-management of one's wellness, in improving overall well-being and in reducing depression/anxiety symptoms among high-risk students. WRAP's efficacy is well supported by literatures in the western countries, and has been included on the Substance Abuse and Mental Health Services Administration (SAMHSA) National Registry as an Evidence-Based Program and Practice (Cook et al., 2009; Cook et al., 2014; Fukui et al., 2011).

iii Dosage form of the intervention

Workshop

iv Dosage of the intervention

4 sessions, 2 hours per session

v Duration of the intervention

2 weeks

vi Frequency of the intervention

Twice per week

16Comparative Treatments

i Description/ name of comparative treatments

Waitlist control.

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

17Key Inclusion and Exclusion Criteria

i Inclusion Criteria

College student

Score “mild” or above on either measure of severity of depressive symptoms (≥ 5 on PHQ-9) or anxiety symptoms (≥ 5 on GAD-7)

18 years old or above

Read and understand Chinese and spoken Cantonese

ii Exclusion Criteria

Having taken WRAP previously

Currently receiving professional psychiatric services

Actively suicidal

iii Age Minimum

18 years old

iv Age Maximum

60 years old

v Gender

Both Male and Female

18 Study Type

Interventional

19Study Design

i Randomization

Randomized

Please specify

Based on computer-generated random digits

ii Nature of control

Active

iii Degree of masking

Not Applicable

If Single-blind, who will be masked?

iv Group Assignment

Single group

v Study Phase

3

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2016-05-10

21 Target Sample Size

124

22 Recruitment Status

Not Yet Recruiting

23Primary Outcome

iThe Name of the outcome

Severity of depression

iiThe metric or method of measurement used

Self-rating questionnaire

iiiThe timepoint(s) of primary interest

Pre-test, post-test, 3-month follow-up

Primary Outcome

iThe Name of the outcome

Severity of anxiety

iiThe metric or method of measurement used

Self-rating questionnaire

iiiThe timepoint(s) of primary interest

Pre-test, post-test, 3-month follow-up

24Secondary Outcome

iThe Name of the outcome

Hopefulness

iiThe metric or method of measurement used

Self-rating questionnaire

iiiThe timepoint(s) of primary interest

Pre-test, post-test, 3-month follow-up

Secondary Outcome

iThe Name of the outcome

Mental wellbeing

iiThe metric or method of measurement used

Self-rating questionnaire

iiiThe timepoint(s) of primary interest

Pre-test, post-test, 3-month follow-up

Secondary Outcome

iThe Name of the outcome

Mental health recovery

iiThe metric or method of measurement used

Self-rating questionnaire

iiiThe timepoint(s) of primary interest

Pre-test, post-test, 3-month follow-up

Secondary Outcome

iThe Name of the outcome

Empowerment

iiThe metric or method of measurement used

Self-rating questionnaire

iiiThe timepoint(s) of primary interest

Pre-test, post-test, 3-month follow-up

Secondary Outcome

iThe Name of the outcome

Perceived stress

iiThe metric or method of measurement used

Self-rating questionnaire

iiiThe timepoint(s) of primary interest

Pre-test, post-test, 3-month follow-up

25Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26Last Update Date

2016-09-02

27 Primary Registry and Trial Identifying Number

ChiCTR-IOR-16008434

28 Date of Registration in Primary Registry

2016-05-03

Back History

Trial Detail