Tailoring a Mindful Intervention to Enhance Opioid Treatment (BEING)
Primary Purpose
Opioid-use Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BEING
Sponsored by
About this trial
This is an interventional treatment trial for Opioid-use Disorder focused on measuring Medication Assisted Treatment
Eligibility Criteria
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
Sites / Locations
- Community Renewal Team
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Yoga-Mindfulness Intervention
Arm Description
Completing single session of yoga blended with mindfulness.
Outcomes
Primary Outcome Measures
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.
Adherence (self report)
Adherence to MAT per client self report-Response to question on whether they are still on MAT.
Adherence (record review)
Review of client chart to see if the client is still on MAT and taking as prescribed.
Secondary Outcome Measures
Full Information
NCT ID
NCT04879238
First Posted
May 5, 2021
Last Updated
November 4, 2022
Sponsor
University of Connecticut
1. Study Identification
Unique Protocol Identification Number
NCT04879238
Brief Title
Tailoring a Mindful Intervention to Enhance Opioid Treatment
Acronym
BEING
Official Title
Tailoring a Mindful Intervention to Enhance Opioid Treatment Outcomes in a Community Program
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
April 27, 2021 (Actual)
Primary Completion Date
July 30, 2022 (Actual)
Study Completion Date
August 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Connecticut
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-use Disorder
Keywords
Medication Assisted Treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Yoga and Mindfulness intervention
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Yoga-Mindfulness Intervention
Arm Type
Experimental
Arm Description
Completing single session of yoga blended with mindfulness.
Intervention Type
Behavioral
Intervention Name(s)
BEING
Other Intervention Name(s)
Yoga-Mindfulness
Intervention Description
60 minute yoga session that blends mindfulness techniques
Primary Outcome Measure Information:
Title
Acceptability
Description
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.
Time Frame
3 months following pre-test
Title
Adherence (self report)
Description
Adherence to MAT per client self report-Response to question on whether they are still on MAT.
Time Frame
3 months following pre-test
Title
Adherence (record review)
Description
Review of client chart to see if the client is still on MAT and taking as prescribed.
Time Frame
3 months following intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Fendrich, PhD
Organizational Affiliation
University of Connecticut
Official's Role
Principal Investigator
Facility Information:
Facility Name
Community Renewal Team
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06120
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Requests for participant data will be considered on an individual basis.
Learn more about this trial
Tailoring a Mindful Intervention to Enhance Opioid Treatment
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