A Randomized Clinical Trial of Comprehensive Cognitive Behavioral Therapy (CBT) Via reSET-O for a Hub and Spoke Medication Assisted Treatment (MAT) System of Care.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Retention in Treatment on MAT for 6 Months After Enrolling in the Study
研究概览
简要总结
This randomized controlled trial research study will be evaluating an app, reSET-O, owned by Pear Therapeutics, Inc., to evaluate treatment retention rates in individuals with opioid use disorder after initiating medication assisted treatment.
详细描述
This randomized controlled trial research study will enroll 200 subjects, where half will be randomly assigned to treatment as usual (TAU) and the app, reSET-O (n = 100), and half will be assigned to TAU only (n = 100), in order to evaluate treatment retention rates in individuals with opioid use disorder after initiating medication assisted treatment. All subjects will participate in the study for a total of six months, and all subjects will attend five research appointments across the six months. Participants assigned to TAU + reSET-O will be expected to engage with the app, reSET-O, for the full six months. The app works as an extension of cognitive behavioral therapy as it provides psychoeducation related to opioid dependence and use, and is designed as an adjunctive treatment with medication assisted treatment for opioid use disorder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Diagnosis of opioid use disorder (OUD) as determined through routine clinical care
- •Recently starting outpatient treatment for OUD within the Penn State Health Hub and Spoke System of Care
- •Initiating MAT with buprenorphine-naloxone (suboxone), buprenorphine (Subutex), or methadone. Since buprenorphine (Subutex) is an FDA approved MAT for pregnant women with OUD, pregnant women are eligible to participate in the research study, assuming they meet all other eligibility requirements.
- •Prison inmates are eligible to participate in the study
- •Ability to read, write, and comprehend English
排除标准
- •Initiating maintenance treatment that does not include MAT or switching to a maintenance treatment that does not include MAT (i.e.: detoxification and counseling treatment only without MAT).
- •Planning an outpatient detoxification
- •Judged by the evaluating physician or allied clinician to need a higher level of care (i.e.: residential or inpatient treatment)
- •Less than 18 years of age
- •Unable to read, write, and comprehend English
结局指标
主要结局
Retention in Treatment on MAT for 6 Months After Enrolling in the Study
时间窗: 6 months
reSET-O is a mobile app designed to provide extended cognitive behavioral therapy for patients initiating medication assisted treatment (MAT) for opioid use disorder (OUD). The first outcome being measure is treatment retention. We want to examine if participants enrolled in the study will maintain on MAT for 6 months after enrollment. This will be evaluated based on the number of appointments attended by the research participants. Data mining through our systems electronic medical record (EMR) will be conducted in order to count the number of attended appointments for study participants to gauge their treatment retention.
次要结局
- Opioid and Other Substance Abuse as Assessed Through Biological Specimen(6 months)
- Overall Mental Health Symptoms Related to Depression and Anxiety as Assessed by the K-10(6 months)
- Mental Health Symptoms Specific to Depression as Assessed by the PHQ-9(6 months)
- Opioid and Other Substance Abuse as Assessed Through Participant Self-report(6 months)
- Mental Health Symptoms Related to PTSD as Assessed by the PCL-C(6 months)
研究者
Sarah Kawasaki
Associate Professor of Pennsylvania Psychiatric Institute
Milton S. Hershey Medical Center