Tailoring a Mindful Intervention to Enhance Opioid Treatment

NCT ID: NCT04879238

Last Updated: 2022-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-27

Study Completion Date

2022-08-31

Brief Summary

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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

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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.

Conditions

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Opioid-use Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Yoga and Mindfulness intervention
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Yoga-Mindfulness Intervention

Completing single session of yoga blended with mindfulness.

Group Type EXPERIMENTAL

BEING

Intervention Type BEHAVIORAL

60 minute yoga session that blends mindfulness techniques

Interventions

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BEING

60 minute yoga session that blends mindfulness techniques

Intervention Type BEHAVIORAL

Other Intervention Names

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Yoga-Mindfulness

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Connecticut

OTHER

Sponsor Role lead

Responsible Party

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Michael Fendrich

Associate Dean for Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael Fendrich, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Connecticut

Locations

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Community Renewal Team

Hartford, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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H20-0111

Identifier Type: -

Identifier Source: org_study_id

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