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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

4 settembre 2026 aggiornato da: Daniel Young, City University of Hong Kong

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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

80

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Hong Kong
      • Kowloon Tong, Hong Kong, Hong Kong
        • City University of Hong Kong

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  1. aged 18 years or older;
  2. 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
  3. receiving community mental health services provided by collaborative local non-governmental organisations

Exclusion Criteria:

  1. having suicidal risk;
  2. unstable mental state;
  3. were unable to participate independently in group activities; and
  4. exhibited disruptive behaviour

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Expanded Coming Out Proud group (ECOP)
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.
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).
Altro: Control group
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
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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Chinese Internalised Stigma of Mental Illness (ISMI)
Lasso di tempo: From enrollment to the end of the treatment at 12 weeks, 3-month follow-up and 6-month follow-up.
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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Chinese Beck Depression Inventory (BDI)
Lasso di tempo: From enrollment to the end of the treatment at 12 weeks, 3-month follow-up and 6-month follow-up
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.
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)
Lasso di tempo: From enrollment to the end of the treatment at 12 weeks, 3-month follow-up and 6-month follow-up.
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.
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)
Lasso di tempo: From enrollment to the end of the treatment at 12 weeks, 3-month follow-up and 6-month follow-up.
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".
From enrollment to the end of the treatment at 12 weeks, 3-month follow-up and 6-month follow-up.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

20 luglio 2022

Completamento primario (Effettivo)

31 marzo 2024

Completamento dello studio (Effettivo)

31 dicembre 2024

Date di iscrizione allo studio

Primo inviato

4 settembre 2026

Primo inviato che soddisfa i criteri di controllo qualità

4 settembre 2026

Primo Inserito (Effettivo)

10 settembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

10 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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