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临床试验/NCT03826966
NCT03826966已完成不适用

Comprehensive CBT (Cognitive Behavioral Therapy) Via Reset for a Hub and Spoke MAT (Medication Assisted Treatment) System of Care

Milton S. Hershey Medical Center1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2019年3月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
1
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 research is being done to find out whether an app based cognitive behavior therapy called reSET improves the adherence to and outcome of buprenorphine treatment for opioid use disorder (OUD) in the setting of a Hub and Spoke implementation system.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

盲法说明

N/A at this time. This trial is a pilot study seeking an N of 15 participants. All participants will be assigned the "treatment," which is accessing an mobile app, re-SET, for cognitive behavioral therapy extension that is to be used with MAT (Buprenorphine only at this time).

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

  • •18 years of age or older
  • •Starting outpatient treatment for OUD within the PACMAT Hub and Spoke system (either the Hub or one of the Spokes)
  • •Planning maintenance treatment with buprenorphine
  • •Willing to participate in the study
  • •Can read, write and comprehend English

排除标准

  • •Planning an outpatient detoxification, or treatment other than buprenorphine maintenance (e.g. methadone maintenance, Vivitrol, or counseling with no medication)
  • •Judged by the evaluating physician or allied clinician to need a higher level of care (e.g. residential or inpatient treatment)
  • •Unwilling to participate in the study
  • •Under the age of 18
  • •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 is a mobile app designed to provide extended cognitive behavioral therapy for patients initiating medication assisted treatment (MAT) for opioid use disorder (OUD). This pilot trial is evaluating the acceptability and feasibility of the app, reSET. 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)
  • Opioid and other substance abuse as assessed through participant self-report(6 months)
  • Health status as assessed by the EuroQol(6 months)
  • Overall mental health symptoms related to depression and anxiety as assessed by the K-10(6 months)
  • HIV Risk as assessed by the SERBAS(6 months)
  • Cravings to use drugs as assessed by the reSET app(6 months)
  • Coping strategies as assessed by the CSS(6 months)
  • Satisfaction of using reSET as a form of treatment as measured by a qualitative interview(6 months)
  • Mental health symptoms specific to depression as assessed by the PHQ-9(6 months)
  • Mental health symptoms related to PTSD as assessed by the PCL-C(6 months)
  • Social Connectedness as assessed by the SCS(6 months)
  • Effectiveness of the reSET app content as measured by the IAFF(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sarah Kawasaki

Assistant Professor

Milton S. Hershey Medical Center

研究点 (1)

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