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临床试验/NCT02751229
NCT02751229已完成2 期

Adaptation and Evaluation of the Honest Open Proud Program for Adolescents With Mental Illness

University of Ulm6 个研究点 分布在 2 个国家目标入组 100 人开始时间: 2016年5月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
100
试验地点
6
主要终点
Stigma Stress Scale, 8 items (Rüsch, Corrigan, Wassel et al., 2009; Rüsch, Corrigan, Powell et al., 2009)

研究概览

简要总结

The purpose of the study is to evaluate the efficacy of the group-based intervention 'Honest Open Proud' among adolescents with mental illness.

详细描述

Both due to fear of public stigma and due to self-stigma or shame, people with mental illness may decide to keep their condition a secret or even to withdraw from other people altogether in order to minimise the risk of being labelled. Secrecy can help on the short term to protect individuals from public stigma, but often it has negative long-term consequences such as social isolation, distress and unemployment. Disclosure, on the other hand, carries the risk to be discriminated by others, but can reduce the burden of secrecy, lead to support by others and reduce public stigma. In this study investigators aim to evaluate whether a group program run both by people with mental illness (peers) and professionals helps to reduce self-stigma and makes it easier for adolescents to handle the necessary choices related to secrecy versus disclosure.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
13 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • At least one self-reported current axis I or axis II disorder according to DSM-5 (American Psychiatric Association, 2013), which is not restricted to only substance-related disorder(s)
  • Age 13 to 18
  • Ability to provide written informed consent
  • Fluid in German (needed for self-report measures)
  • At least a moderate level of self-reported disclosure-related distress/difficulty (score 4 or higher on the screening item '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)

排除标准

  • Self-reported diagnosis of only a substance- or alcohol-related disorder, without non-substance related current psychiatric comorbidity. We will exclude people who only have a substance-/alcohol-related disorder because the disclosure of these disorders is not the topic of the HOP intervention
  • Intellectual disability
  • Organic disorders

结局指标

主要结局

Stigma Stress Scale, 8 items (Rüsch, Corrigan, Wassel et al., 2009; Rüsch, Corrigan, Powell et al., 2009)

时间窗: 3 weeks (T1)

Health-Related Quality of Life Questionnaire KIDSCREEN-10 Index, 10 items (Deighton et al., 2014; Ravens-Sieberer et al., 2010)

时间窗: 6 weeks (T2)

次要结局

  • Satisfaction with intervention questionnaire (according to Keller, Konopka, Fegert, & Naumann, 2003; own development)(3 weeks)
  • Empowerment Scale, Subscales 'self-esteem' and 'control over the future', 13 items (Rogers, Chamberlin, Ellison, & Crean, 1997)(baseline, 3 and 6 weeks)
  • Attitudes to disclosure, 2 items (Rüsch, Evans-Lacko, Henderson, Flach, & Thornicroft, 2011)(baseline, 3 and 6 weeks)
  • Disclosure Distress, 1 item ("In general, how distressed or worried are you in terms of secrecy or disclosure of your mental illness to others?', from 1, not at all, to 7, very much) (Rüsch et al., 2014a)(baseline, 3 and 6 weeks)
  • Shame about having a mental illness, 1 item ("Do you feel ashamed about having a mental illness?"; from 1, not at all, to 7, very much) (Rüsch et al., 2014b)(baseline, 3 and 6 weeks)
  • General Help-Seeking Questionnaire, 1 item (Wilson et al., 2005)(baseline, 3 and 6 weeks)
  • Beck Hopelessness Scale (BHS), 4-item short version (Yip, Paul S F & Cheung, 2006)(baseline, 3 and 6 weeks)
  • Self-Stigma of Mental Illness Scale (SSMIS), Subscale 'self-concurrence', 5 items (Corrigan et al., 2012; Rüsch et al., 2006)(baseline, 3 and 6 weeks)
  • Self-Identified Stage of Recovery (SISR), 5 items (Andresen, Caputi, & Oades, 2010)(baseline, 3 and 6 weeks)
  • Internalised Stigma of Mental Illness Inventory (ISMI), 10-item short version (Boyd, Otilingam, & Deforge, 2014)(baseline, 3 and 6 weeks)
  • Social withdrawal and secrecy, 12 item-short version (Link et al., 2009)(baseline, 3 and 6 weeks)

研究者

发起方
University of Ulm
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nicolas Rüsch

Professor

University of Ulm

研究点 (6)

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