Pilot Study of reSET-O to Treatment-as-usual in Acute Care Settings
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Acceptability as assessed by the System Usability Scale
研究概览
简要总结
This randomized controlled pilot study will evaluate feasibility, acceptability, and potential efficacy of an app, reSET-O, for patients being started on buprenorphine in acute care settings.
详细描述
This randomized controlled pilot study will enroll 60 participants, who will be randomly assigned to a treatment as usual (TAU) group or a reSET-O+TAU group after being started on buprenorphine in acute care settings (e.g., emergency department) and referred to community treatment. Study enrollment will last for 3 months after discharge from the acute care setting. Participants in the reSET-O+TAU group will be provided with the reSET-O app and will be encouraged to engage with the app for the 3 months following discharge from the acute care unit. The app works as an extension of cognitive behavioral therapy, providing psychoeducation related to opioid use disorder. All participants will be assessed at study intake and every month during the 3-month intervention.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-65 years old
- •Opioid use disorder
- •Eligible for buprenorphine treatment
- •Has reSET-O compatible mobile device
排除标准
- •Pregnancy
- •Significant psychiatric comorbidity
结局指标
主要结局
Acceptability as assessed by the System Usability Scale
时间窗: 3 months
Participant responses to the System Usability Scale.
Percentage of approached patients who are eligible for and interested in participation
时间窗: 3 months
Percentage of approached patients who are eligible for and interested in participation will be used to assess feasibility.
Acceptability as assessed by the Treatment Acceptability Questionnaire
时间窗: 3 months
Participant responses to the Treatment Acceptability Questionnaire.
次要结局
- Percentage of drug-negative urine samples during the 3-month intervention(3 months)
- Attendance at follow-up appointment for on-going buprenorphine treatment within 30 days of discharge(30 days)