Addressing Loneliness as a Therapy Target Among Individuals Using Opioids
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Mean change in loneliness
研究概览
简要总结
This study aims to enroll 300 participants who will be assigned to one of three 3 groups. Each group will receive an intervention lasting 6, weekly sessions of 40-60 minutes. Eligibility include having an opioid use disorder and reporting loneliness or feeling alone or disconnected.
详细描述
Individuals (n = 300) with an opioid use disorder reporting loneliness will be randomized to either (1) therapist-delivered cognitive-behavioral therapy for perceived social isolation, (2) therapist-delivered Health Education, or (3) self-guided Health Education. Loneliness, opioid and other substance use, the amount of social interactions, social support, and mental and physical health factors prior to starting the treatment, after completing the treatment, and 1, 3, and 6 months following the treatment will be assessed to see how well they work compared to each other.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be 18+
- •understand English -have internet access-
- •screen positive for an opioid use disorder
- •screen positive for elevated loneliness
排除标准
- •does not understand consent
- •does not have consistent access to a phone and internet
结局指标
主要结局
Mean change in loneliness
时间窗: Baseline to 6 months
Loneliness will be measured using the UCLA Loneliness Scale. A 20-item scale designed to measure one's subjective feelings of loneliness as well as feelings of social isolation. Participants rate each item as 1 (never), 2 (rarely), 3 (sometimes) or 4 (often). The scores range from 20-80 with higher scores indicating worse outcome.
Mean change in number of days of opioid use
时间窗: Baseline to 6 months
Participants will complete a calendar indicating the type and frequency of drug use.
次要结局
- mean change in social interactions(Baseline to 6 months)
- Mean change in depression(Baseline to 6 months)
- Mean change in anxiety(Baseline to 6 months)
研究者
Lisham Ashrafioun
Assistant Professor
University of Rochester