Adaptation and Validation of a Social-contact-based Intervention for Stigma Against Opioid Use Disorder
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1. To adapt and validate an information-dissemination and social contact-based intervention to reduce public stigma in opioid use disorder.
研究概览
简要总结
Opioids are one of the world’s largest used substances, just behind alcohol and cannabis. In India, approximately 2.1% of individuals (three times the global average) are known to be suffering from an opioid use disorder (OUD), and 0.7% are known to be “problem users†(using opioids in a harmful or dependent pattern). Stigma is defined by a mark of disgrace connected to a quality of an individual, which often leads to social exclusion and adversely impacts mental and physical health. Stigma not only affects the individual but also families, communities, and societies. The literature describes four types of stigmas: self-stigma, affiliate stigma, public stigma, and structural stigma. Historically, substance use disorders (SUDs) are stigmatized more than other mental illnesses. This study aims to determine a social contact-based intervention’s feasibility and acceptability to reduce public stigma in OUD. In the first phase of the study, the content of the social-contact-based intervention will be adapted and then validated by the Delphi consensus method. A set of slides and a one-page information booklet aimed at improving participants’ knowledge and potentially changing attitudes towards people who use drugs and alcohol will be made. The second phase of the study will be an open-label study. Thirty participants will be recruited, who will receive information and in-person social contact from a person with lived experience (PWLE). The format of delivery will be group based, and the content will be delivered in a single session. Baseline assessment will include the administration of a questionnaire for the assessment of public stigma. This assessment will be repeated post- intervention (within 48 hours of receiving the intervention) and after 12 ± 2 weeks of the intervention. We will assess direct and indirect acceptability/feasibility outcomes. A questionnaire will assess direct outcomes comprising eight questions regarding the intervention- overall experience, effort required, understandability, if it is worth their time, if it matches their value system, if it will change their beliefs and attitudes, and if they will recommend it to family and friends. Indirect outcome measures will be based on trial phases, i.e., recruitment, participation, and completion rates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Has never lived in the same household (for more than 1 year) as a family member who has been diagnosed with opioid use disorder as per DSM-5 Able to read Hindi/English Able to provide written informed consent.
排除标准
- •Those unwilling to participate in the study.
结局指标
主要结局
1. To adapt and validate an information-dissemination and social contact-based intervention to reduce public stigma in opioid use disorder.
时间窗: 48 hours and 12 ± 2 weeks
2. To test the acceptability and feasibility of this intervention.
时间窗: 48 hours and 12 ± 2 weeks
次要结局
- 1. To measure the change in stigma score after the intervention.(48 hours and 12 ± 2 weeks)
研究者
Arshia Sood
Post Graduate Institute of Medical Education and Research, Chandigarh
