AzTrials
AzTrials

Expanded Coming Out Proud GroupNCT07812298

Expanded-Coming-Out-Proud Group on Reducing Self-stigma for People With a Severe Mental Illness- A Randomized Control Trial With Six-month Follow-up

A study testing Expanded Coming Out Proud group in people with Expanded Coming Out Proud Group and Control Group, run by City University of Hong Kong at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Expanded Coming Out Proud group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteHong Kong
Study dates
20 Jul 2022to 31 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site
  • City University of Hong Kong

    Kowloon Tong, Hong Kong

Other trials in Hong Kong

About this study

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.

Read the detailed description

This study was a multicentre randomized controlled trial. Participants were recruited from four community-based mental health centres in Hong Kong through open recruitment via promotional activities and referrals from these centres. Those who consented to participate were randomly assigned to either the treatment or control group using computer software administered by a research team member who was not involved in data collection or implementation of the ECOP group. Block randomisation was used to ensure equal numbers in the treatment and control groups. The control group received treatment as usual (TAU) provided by a community mental health centre, including interest classes and recreational activities. In addition to TAU, the intervention group received an ECOP group led by an experienced social worker and a peer social worker from a community mental health centre. A research assistant who was blinded to the randomized allocation of participants conducted data collection and outcome assessment with standardized assessment tools at baseline, post-treatment, and at 3-month and 6-month follow-ups

The ECOP incorporated the advantages of both cognitive behavioural therapy and the Coming Out Proud. On one hand, the ECOP, based on the cognitive behavioural therapy, helped participants learn skills to transform self-stigmatising beliefs to reduce self-stigma. On the other hand, the ECOP, adapted from the Coming Out Proud, empowered them to face social stigma effectively by disclosing their mental illness to appropriate social systems, such as peers, support groups, and the media, with an appropriate level of self-disclosure. The ECOP consisted of 12 group sessions, one per week, each lasting one and a half hours, led by an experienced social worker and a peer support worker.

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.

For all analyses, two-tailed p values of < 0.05 is considered statistically significant. Data analyses will be performed using SPSS 29.0 (IBM Corporation, 2024). For hypotheses (1) and (2), within group intervention effects on all outcome assessment scores were investigated by using repeated measures of analysis of variance (ANOVA), while between group intervention effects were investigated by using group x time repeated measures of ANOVA. Effect sizes were calculated using partial η2, with values of 0.01, 0.06 and 0.14 considered small, moderate and large effects, respectively (Cohen, 1988). For hypothesis (3), the predictive power of the improved ISMI and PESAS scores from pre-intervention to post-intervention on the improved BDI and RSE score were investigated and compared using multiple linear regression analysis, using stepwise selection procedure to investigate the relative predictive power of the improved ISMI score and PESAS score.

Being tested
Expanded Coming Out Proud group, control group
Keywords
Expanded Coming Out Proud group, Self-stimga, Empowerment, Cognitive Behavioural Therapy, Honest Open and Proud, Depression
Medical subject headings
Empowerment, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Expanded Coming Out Proud groupBehavioural

    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).

  • control groupBehavioural

    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

Study groups in NCT07812298
Study groupRoleWhat they receive
Expanded Coming Out Proud group (ECOP)ExperimentalIn 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.
Receives: Behavioral: Expanded Coming Out Proud group
Control groupOtherParticipants 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
Receives: Behavioral: control group

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (3)
  1. Chinese Beck Depression Inventory (BDI)

    The Chinese Beck Depression Inventory (BDI; Byrne et al., 2004) is a 21-item self-reported scale to measure participants' self-reported depressive symptoms with good validity and reliability (α = 0.91). Each item (e.g., Past failure) is rated on a 4-point scale with scores ranging from "0" to "3". The scores are summed over the items with higher scores indicating a higher severity of symptoms.

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

  2. Chinese Rosenberg Self-Esteem Scale (RSES)

    The Chinese Rosenberg Self-Esteem Scale (RSES; Peng et al., 2024) is a 10-item scale to assess participants' self-reported self-esteem with good validity and reliability (Cronbach's α = 0.63). Each item (e.g., I feel that I have a number of good qualities) is rated on a 4-point scale with scores ranging from "1" (strongly agree) to "4" (strongly disagree). The scores are summed over the items with higher scores indicating better self-esteem.

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

  3. Personal Empowerment Self-Assessment Scale (PESAS)

    The Personal Empowerment Self-Assessment Scale (PESAS; Authors, 2013a) is a 10-item scale to measure an individual's perception of their own empowerment. The PESAS was developed as part of the Coming Out Proud with satisfactory reliability and validity (Authors, 2013a). In this study, the reliability of PESAS was found to be very good (α = 0.84). Each item (e.g., Having a mental illness doesn't mean I'm a bad person) is rated on a 5-point scale with scores ranging from 1 "strongly disagree" to 5 "strongly agree".

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2026
  2. Study start20 Jul 2022
  3. Primary completion31 Mar 2024
  4. Study completion31 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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
Masking
Single blind
Who is masked
Investigator
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07812298
Sponsor's protocol ID
12609519
Status last verified
Sep 2026
First submitted
4 Sep 2026
Last updated
10 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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

  • 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

  • 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.

    PubMed 33459793
  • 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.

    PubMed 32361335
  • 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.

    PubMed 39549598
  • 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.

    PubMed 30505939
  • 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.

    PubMed 23488488
  • 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.

    PubMed 39654814
  • 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.

    PubMed 26582785
  • 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

Questions about this trial

What is this clinical trial studying?

A study testing Expanded Coming Out Proud group in people with Expanded Coming Out Proud Group and Control Group, run by City University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Chinese Internalised Stigma of Mental Illness (ISMI) (time frame: From enrollment to the end of the treatment at 12 weeks, 3-month follow-up and 6-month follow-up.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07812298, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in