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临床试验/NCT04879238
NCT04879238已完成不适用

Tailoring a Mindful Intervention to Enhance Opioid Treatment Outcomes in a Community Program

University of Connecticut1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2021年4月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
43
试验地点
1
主要终点
Acceptability

研究概览

简要总结

The main aim of this study is to better understand whether yoga can be blended with mindfulness as an additional intervention for people receiving medication assisted treatment at a Hartford-based community agency. If this program is acceptable to participants, then additional studies can allow us to determine its impact on stress and cravings. This intervention, developed by the researchers, is called BEING.

详细描述

This study is a micro-trial of our mindful yoga intervention, BEING, tailored to the MAT clients. This study adapts an existing manualized program of yoga and mindfulness intervention (BEING) for MAT participants. Particularly important is addressing potential challenges and concerns regarding acceptability and feasibility of implementation in vulnerable males with substance dependence. We are enlisting the support of a mindful yoga expert with experience in related populations (i.e., previously incarcerated male veterans with mental health issues) in the adaptation process. This study is designed primarily to test the feasibility of the implementation of the intervention. We cannot draw statistically valid conclusions about the impact the intervention on outcomes, given the overall study design. We plan to collect participant feedback on whether or not the intervention is acceptable. We also want to evaluate the availability, accessibility, acceptability and feasibility of collecting certain measures that would be collected in a subsequent adequately powered treatment study.

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Receiving Medication Assisted Treatment 18 years or older Released from incarceration within the past year Currently receiving services from the partnering community agency English speaking

排除标准

  • •Under 18 years old Non-English Speaking Current incarcerated Not receiving Medication Assisted Treatment Not receiving services from the partnering community agency

研究组 & 干预措施

Yoga-Mindfulness Intervention

Experimental

Completing single session of yoga blended with mindfulness.

干预措施: BEING (Behavioral)

结局指标

主要结局

Acceptability

时间窗: 3 months following pre-test

Responses to questions about how acceptable participants found the intervention. The questions are indicated below: All questions can be responded to with one of the following answers: Completely disagree; disagree; neither agree nor disagree; agree; completely agree. I approve of the yoga and mindfulness training. I find the yoga and mindfulness training interesting. I like the yoga and mindfulness training. I welcome the yoga and mindfulness training. The training seems appropriate. The training applies to me. The training seems right for me. The training seems like a good match for me. The training seems easy to carry out. The training seems possible. The training seems doable. The training seems easy to use.

Adherence (self report)

时间窗: 3 months following pre-test

Adherence to MAT per client self report-Response to question on whether they are still on MAT.

Adherence (record review)

时间窗: 3 months following intervention

Review of client chart to see if the client is still on MAT and taking as prescribed.

次要结局

未报告次要终点

研究者

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

Michael Fendrich

Associate Dean for Research

University of Connecticut

研究点 (1)

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