Sustaining Recovery for People on Opioid Agonist Treatment With Conversational Agents
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of participants that stay engaged in buprenorphine treatment
研究概览
简要总结
This study aims to improve retention in buprenorphine treatment, a medication used for opioid use disorder, through the use of a smartphone-delivered recovery support intervention. The intervention involves an Embodied Conversational Agent (ECA), a virtual, animated computer agent designed to simulate natural face-to-face conversations. ECAs have been shown to help individuals manage their healthcare in other settings, and this study seeks to evaluate their potential in supporting patients on medication for opioid use disorder (MOUD).
详细描述
One hundred participants will be enrolled in the study from the Office-Based Addiction Treatment (OBAT) clinic at Boston Medical Center (BMC). The participants will be randomly assigned to one of two groups. In the intervention group, participants will engage in ECA use and will receive (1) technical support, (2) text message reminders, and (3) monetary incentives. Alternatively, participants will be randomized to the treatment as usual group where they do not access the ECA application. Assessments will be conducted in person at baseline and over the phone at 6 months and 12 months. At 3 and 9 months, research staff will make brief telephone contacts to confirm or update participant contact information. The primary outcome is retention in buprenorphine treatment over 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Diagnosis of Opioid Use Disorder (OUD)
- •Within 30 days of intake at recruitment site (BMC OBAT)
- •Possession of a smartphone that has minimum requirements
- •English-speaking and reading
- •Willing to release electronic health record (EHR) data
- •Able to provide at least two alternate contacts who usually know how to get in touch with them
- •Currently prescribed buprenorphine from an outpatient clinic
排除标准
- •Incarceration anticipated within 12 months of enrollment
- •Inability to comprehend the study protocol, defined as failing three times to answer correctly a set of questions during the consent process
- •Inability to use the ECA app (i.e., due to markedly limited visual or auditory acuity or motor function required to interact with the ECA)
研究组 & 干预措施
ECA, technical support, additional ECA messages, and incentives
Participants randomized into the intervention arm will be engaged in ECA use, technical support, additional ECA messages reminding the use of the ECA app on behalf of OBAT clinical staff, and monetary incentives.
干预措施: Embodied conversational agent (ECA) (Other)
ECA, technical support, additional ECA messages, and incentives
Participants randomized into the intervention arm will be engaged in ECA use, technical support, additional ECA messages reminding the use of the ECA app on behalf of OBAT clinical staff, and monetary incentives.
干预措施: Technical support (Other)
ECA, technical support, additional ECA messages, and incentives
Participants randomized into the intervention arm will be engaged in ECA use, technical support, additional ECA messages reminding the use of the ECA app on behalf of OBAT clinical staff, and monetary incentives.
干预措施: Additional ECA messages (Other)
ECA, technical support, additional ECA messages, and incentives
Participants randomized into the intervention arm will be engaged in ECA use, technical support, additional ECA messages reminding the use of the ECA app on behalf of OBAT clinical staff, and monetary incentives.
干预措施: Additional incentives (Other)
Treatment as usual group
Participants randomized into this arm will receive treatment as usual
结局指标
主要结局
Number of participants that stay engaged in buprenorphine treatment
时间窗: 12 months
Engaged in buprenorphine treatment or treatment retention is defined as a participant's treatment period of at least 365 days, including those with multiple disengagement and reengagement periods, as long as any gap in active prescriptions or receipt of injections is less than 60 days.
次要结局
- Treatment retention at 6 months(6 months)
- Treatment duration(6 months. 12 months)
- Opioid use(6 months)
- Changes in stigma based on the Substance Use Stigma Mechanism Scale (SU-SMS)(Baseline, 6 months)
- Changes in stigma based on the Buprenorphine Treatment Stigma Mechanism Scale (BT-SMS)(Baseline, 6 months)
- Changes in recovery capital(Baseline, 6 months)
- Frequency of interaction with the ECA app(6 months, 12 months)
- User attitude and satisfaction toward the ECA(6 months)