Tailoring a Mindful Intervention to Enhance Opioid Treatment

Not Applicable

Completed

• Conditions: Opioid-use Disorder
• Interventions: Behavioral: BEING

• Registration Number: NCT04879238
• Lead Sponsor: University of Connecticut

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2021-04-27
• Study First Submitted: 2021-05-05
• Study First Submitted QC: 2021-05-05
• Study First Posted: 2021-05-10
• Primary Completion: 2022-07-30
• Study Completion: 2022-08-31
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-04
• Last Update Posted: 2022-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

• 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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Yoga-Mindfulness Intervention	BEING	Completing single session of yoga blended with mindfulness.

Primary Outcome Measures

Name	Time	Method
Acceptability	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)	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)	3 months following intervention	Review of client chart to see if the client is still on MAT and taking as prescribed.

Trial Locations

Locations (1)

Community Renewal Team; 🇺🇸 Hartford, Connecticut, United States