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
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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Hong Kong
-
Kowloon Tong、Hong Kong、香港
- City University of Hong Kong
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- 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
Exclusion Criteria:
- having suicidal risk;
- unstable mental state;
- were unable to participate independently in group activities; and
- exhibited disruptive behaviour
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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).
|
|
他の：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
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Chinese Internalised Stigma of Mental Illness (ISMI)
時間枠：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.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Chinese Beck Depression Inventory (BDI)
時間枠：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)
時間枠：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)
時間枠：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.
|
協力者と研究者
出版物と役立つリンク
一般刊行物
- 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.
- 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
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 12609519
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。