NCT04879238

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 27, 2021

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

May 5, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 10, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

November 9, 2022

Status Verified

November 1, 2022

Enrollment Period

1.3 years

First QC Date

May 5, 2021

Last Update Submit

November 4, 2022

Conditions

Keywords

Medication Assisted Treatment

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • Adherence (record review)

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

    3 months following intervention

Study Arms (1)

Yoga-Mindfulness Intervention

EXPERIMENTAL

Completing single session of yoga blended with mindfulness.

Behavioral: BEING

Interventions

BEINGBEHAVIORAL

60 minute yoga session that blends mindfulness techniques

Also known as: Yoga-Mindfulness
Yoga-Mindfulness Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Community Renewal Team

Hartford, Connecticut, 06120, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Michael Fendrich, PhD

    University of Connecticut

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Yoga and Mindfulness intervention
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Dean for Research

Study Record Dates

First Submitted

May 5, 2021

First Posted

May 10, 2021

Study Start

April 27, 2021

Primary Completion

July 30, 2022

Study Completion

August 31, 2022

Last Updated

November 9, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Requests for participant data will be considered on an individual basis.

Locations