NCT07812298

Brief Summary

Globally, approximately one-third of people with severe mental illness report self-stigma. Self-stigma negatively affects recovery by lowering quality of life, self-esteem, and self-efficacy, and reducing treatment adherence, which can lead individuals to refuse psychiatric medication, experience increased psychiatric symptoms, and relapse. Multi-component interventions, which combine several single interventions, have been found to produce better outcomes than single interventions alone, but few studies have been conducted in this area. To address this research gap, this study aimed to develop and evaluate the longer-term impact of a 12-session Expanded Coming Out Proud (ECOP) group delivered by a social worker and a peer support worker, with skills in empowerment and transforming negative self-stigmatising beliefs, to reduce self-stigma in people with severe mental illness in Hong Kong. This study was a multicentre, randomised controlled trial with 6-month follow-up. The intervention group received ECOP in addition to treatment as usual (TAU), which included interest classes and recreational activities, while the control group received TAU.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 20, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 4, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 10, 2026

Completed
Last Updated

September 10, 2026

Status Verified

September 1, 2026

Enrollment Period

1.7 years

First QC Date

September 4, 2026

Last Update Submit

September 4, 2026

Conditions

Keywords

Expanded Coming Out Proud groupSelf-stimgaEmpowermentCognitive Behavioural TherapyHonest Open and ProudDepression

Outcome Measures

Primary Outcomes (1)

  • Chinese Internalised Stigma of Mental Illness (ISMI)

    The Chinese Internalised Stigma of Mental Illness is a 24-item self-report scale measuring changes in self-stigma, with good validity and reliability (α = 0.93; Young et al., 2016). The ISMI has been used in research studies on self-stigma (Lamarca et al., 2024). Each item (e.g., "I am disappointed in myself for having a mental illness") is rated on a 4-point scale, ranging from strongly agree (1) to strongly disagree (4). Item scores are averaged, with higher scores indicating greater self-stigma. As suggested by previous studies (Brohan et al., 2010), an ISMI score of 2.50 or above is regarded as high self-stigma, while a score below 2.50 is regarded as low self-stigma; this classification was adopted in this study.

    From enrollment to the end of the treatment at 12 weeks, 3-month follow-up and 6-month follow-up.

Secondary Outcomes (3)

  • Chinese Beck Depression Inventory (BDI)

    From enrollment to the end of the treatment at 12 weeks, 3-month follow-up and 6-month follow-up

  • Chinese Rosenberg Self-Esteem Scale (RSES)

    From enrollment to the end of the treatment at 12 weeks, 3-month follow-up and 6-month follow-up.

  • Personal Empowerment Self-Assessment Scale (PESAS)

    From enrollment to the end of the treatment at 12 weeks, 3-month follow-up and 6-month follow-up.

Study Arms (2)

Expanded Coming Out Proud group (ECOP)

EXPERIMENTAL

In addition to Treatment as usual (TAU), the ECOP was conducted in collaborating community mental health centres over a 12-week intervention period, with one session per week, each lasting about 1.5 hours.

Behavioral: Expanded Coming Out Proud group

Control group

OTHER

Participants in the control group received TAU, including interest classes and leisure activities provided by collaborating community mental health centres, which were the same as those received by the intervention group

Behavioral: control group

Interventions

control groupBEHAVIORAL

Participants in the control group received TAU, including interest classes and leisure activities provided by collaborating community mental health centres, which were the same as those received by the intervention group

Control group

The ECOP consisted of 12 sessions, covering the following topics: sharing the experience of stigma (session 1); challenging social stigmatized beliefs (session 2); transforming self-stigmatized beliefs with CBT skill, e.g. guided discovery, pie-chart, behavioural experiment, (session 3-6); relaxation and social skill training on facing social stigma situations (session 7-8); reflecting the risks and benefits of secrecy and disclosure of mental illness (session 9); exploring the five levels of disclosure, which range from the lowest level of maintaining secrecy to the highest level of broadcasting one's experience with mental illness (session 10); learning to share own story with a mental illness (session learning to share own story with a mental illness (session 11); summary (session 12).

Expanded Coming Out Proud group (ECOP)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged 18 years or older;
  • diagnosed with a mental illness by their medical officers according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition, Text Revision) (American Psychiatric Association, 2022); and
  • receiving community mental health services provided by collaborative local non-governmental organisations

You may not qualify if:

  • having suicidal risk;
  • unstable mental state;
  • were unable to participate independently in group activities; and
  • exhibited disruptive behaviour

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

City University of Hong Kong

Kowloon Tong, Hong Kong, Hong Kong

Location

Related Publications (10)

  • Ng, P. Y.-N., Chiu, R., Young, K.-W. D., Chen, Q.-R. J., & Corrigan, P. (2026). Randomized Controlled Trial of Expanded Coming Out Group on Reducing Self-Stigma of Schizophrenia People. Research on Social Work Practice, 36(1), 59-72

    RESULT
  • Byrne, B. M., Stewart, S. M., & Lee, P. W. H. (2004). Validating the Beck Depression Inventory-II for Hong Kong Community Adolescents. International Journal of Testing, 4(3), 199-216

    RESULT
  • Dubreucq J, Plasse J, Franck N. Self-stigma in Serious Mental Illness: A Systematic Review of Frequency, Correlates, and Consequences. Schizophr Bull. 2021 Aug 21;47(5):1261-1287. doi: 10.1093/schbul/sbaa181.

  • Yanos PT, DeLuca JS, Roe D, Lysaker PH. The impact of illness identity on recovery from severe mental illness: A review of the evidence. Psychiatry Res. 2020 Jun;288:112950. doi: 10.1016/j.psychres.2020.112950. Epub 2020 Apr 5.

  • Lamarca M, Espinosa V, Acuna V, Vila-Badia R, Balsells-Mejia S, Moritz S, Berna F, Konig C, Gaweda L, Group P, Barajas A, Ochoa S. Reducing self-stigma in psychosis: A systematic review and meta-analysis of psychological interventions. Psychiatry Res. 2024 Dec;342:116262. doi: 10.1016/j.psychres.2024.116262. Epub 2024 Nov 16.

  • Fox AB, Earnshaw VA, Taverna EC, Vogt D. Conceptualizing and Measuring Mental Illness Stigma: The Mental Illness Stigma Framework and Critical Review of Measures. Stigma Health. 2018 Nov;3(4):348-376. doi: 10.1037/sah0000104. Epub 2017 Sep 21.

  • Corrigan PW, Kosyluk KA, Rusch N. Reducing self-stigma by coming out proud. Am J Public Health. 2013 May;103(5):794-800. doi: 10.2105/AJPH.2012.301037. Epub 2013 Mar 14.

  • Peng W, Zhou Y, Chu J, Liu Z, Zheng K, Yao S, Yi J. Factorial and Criterion Validities of the Chinese Version of Rosenberg Self-Esteem Scale Among Undergraduate Students. Psychol Res Behav Manag. 2024 Dec 5;17:4135-4144. doi: 10.2147/PRBM.S494452. eCollection 2024.

  • Young DK, Ng PY. The prevalence and predictors of self-stigma of individuals with mental health illness in two Chinese cities. Int J Soc Psychiatry. 2016 Mar;62(2):176-85. doi: 10.1177/0020764015614596. Epub 2015 Nov 18.

  • Young, D. K.-W., Ng, P. Y. N., Pan, J.-Y., & Cheng, D. (2017). Validity and reliability of Internalized Stigma of Mental Illness (Cantonese). Research on Social Work Practice, 27(1), 103-110

    RESULT

MeSH Terms

Conditions

EmpowermentDepression

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Social BehaviorBehaviorBehavioral Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
A research assistant who was blinded to the randomised allocation of participants conducted data collection and outcome assessment with standardized assessment tools
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The ECOP was conducted in collaborating community mental health centres over a 12-week intervention period, with one session per week, each lasting about 1.5 hours. A program manual with standardized and detailed guidelines were designed and written by the research team. In this study, the ECOP consisted of 12 sessions, covering the following topics: sharing the experience of stigma (session 1); challenging social stigmatized beliefs (session 2); transforming self-stigmatized beliefs with CBT skill, e.g. guided discovery, pie-chart, behavioural experiment, (session 3-6); relaxation and social skill training on facing social stigma situations (session 7-8); reflecting the risks and benefits of secrecy and disclosure of mental illness (session 9); exploring the five levels of disclosure, which range from the lowest level of maintaining secrecy to the highest level of broadcasting one's experience with mental illness (session 10); learning to share own story with a mental illness (session
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 4, 2026

First Posted

September 10, 2026

Study Start

July 20, 2022

Primary Completion

March 31, 2024

Study Completion

December 31, 2024

Last Updated

September 10, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

The data that support the findings of this study are available only from the corresponding author upon reasonable request and with the permission of the Research Ethics Committee of Hong Kong Baptist University.

Locations