Tailoring a Mindful Intervention to Enhance Opioid Treatment

Opioid-use Disorder Clinical Trial

— BEING  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04879238
• Other study ID #: H20-0111
• Status: Completed
• Phase: N/A
• Start date: April 27, 2021
• Est. completion date: August 31, 2022

Study information

• Verified date: November 2022
• Source: University of Connecticut
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: August 31, 2022
• Est. primary completion date: July 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Opioid-Related Disorders
• Opioid-use Disorder

Intervention

Behavioral:
• BEING
60 minute yoga session that blends mindfulness techniques

Locations

Country	Name	City	State
United States	Community Renewal Team	Hartford	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
University of Connecticut

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability	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.	3 months following pre-test
Primary	Adherence (self report)	Adherence to MAT per client self report-Response to question on whether they are still on MAT.	3 months following pre-test
Primary	Adherence (record review)	Review of client chart to see if the client is still on MAT and taking as prescribed.	3 months following intervention