Centre For Clinical Research And Biostatistics (CCRB)

Back

1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00631

2 Trial Registration Date

2018-11-05

i Registration Status

Prospective

3 Secondary IDs

NTEC-2018-0365

4 Source(s) of Funding

n/a

5 Primary Sponsor

The Chinese University of Hong Kong

6 Secondary Sponsor

New Life Psychiatric Rehabilitation Association

Function

Take on all the responsibilities of sponsorship jointly with the primary sponsor

Please specify

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

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

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

vi Country

Hong Kong

9 Official Scientific Title of the Study

Honest Open Proud: a randomized control trial on its effectiveness in reducing self-stigma among people with mental illness in Hong Kong

10 Public Title

Honest Open Proud: a randomized control trial on its effectiveness in reducing self-stigma among people with mental illness in Hong Kong

i Public Title in Chinese 研究名稱

「我故事。我話事。告別十五十六時」：對減低有精神健康挑戰親歷經驗的香港人的自我污名之成效的隨機對照試驗研究

11 Short Title (Optional)

Honest Open Proud: a randomized control trial on its effectiveness in reducing self-stigma among people with mental illness in Hong Kong

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?

2018-10-08

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2018.349

14 Medical Condition Being Studied

Disclosure of one's mental health challenges

15 Intervention

i Types of intervention

Other

Please specify

Psychological

ii Description/ name of Intervention/article

Honest, Open, Proud Program

iii Dosage form of the intervention

n/a

iv Dosage of the intervention

n/a

v Duration of the intervention

Each session lasts about 1.5 to 2 hours

vi Frequency of the intervention

6 sessions

16 Comparative Treatments

i Description/ name of comparative treatments

Wait-list 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

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Participants who are identified themselves as a person with lived experience of mental illness

Aged 18 or above at the time of inclusion

Able to read and write Chinese

Participants with at least a moderate level of self-reported disclosure stress (≥4 for “In general, how distressed or worried are you in terms of secrecy or disclosure of your mental illness to others?”, rated from 1/not at all to 7/very much)

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

Randomized

Please specify

Subjects are assigned to intervention group or waitlist control group by randomization

ii Nature of control

Not Applicable

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

1

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2018-11-15

21 Target Sample Size

203

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

i The Name of the outcome

Self-Stigma, Disclosure stress, Stigma stress, Secrecy, Self-stigmatizing thinking’s automaticity and repetition, Concealment motivation

ii The metric or method of measurement used

Questionnaire

iii The timepoint(s) of primary interest

Pre-intervention, post-intervention, one-month follow-up

24 Secondary Outcome

i The Name of the outcome

Depressive symptoms, Recovery, Hopelessness, Empowerment

ii The metric or method of measurement used

Questionnaire

iii The timepoint(s) of primary interest

Pre-intervention, post-intervention, one-month follow-up

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

ChiCTR1900021011

28 Date of Registration in Primary Registry

2018-11-15

Back

Trial History Detail on 2019-01-29