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OpenTrials
Completed

NCT Number: NCT04879238

Tailoring a Mindful Intervention to Enhance Opioid Treatment

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.

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Key information

Conditions

Opioid-use Disorder Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Community Renewal Team

Hartford, Connecticut, 06120, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BEING

Behavioral

60 minute yoga session that blends mindfulness techniques

Other names: Yoga-Mindfulness

Primary outcomes

  1. Acceptability

    Time frame: 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.

  2. Adherence (self report)

    Time frame: 3 months following pre-test

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

  3. Adherence (record review)

    Time frame: 3 months following intervention

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

Sponsors and collaborators

Lead sponsor

University of Connecticut

Other

Registry information

Official study title

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

Acronym: BEING

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 10, 2021
Registry last updated
Nov 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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