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CompletedNCT04584502

Mindful Moms in Recovery

Mindful Moms in Recovery: Yoga-based Mindfulness Relapse Prevention for Pregnant Women With Opioid Use Disorder

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
4 (actual)
Sponsor
Trustees of Dartmouth College · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to evaluate the initial efficacy of a yoga-mindfulness intervention to promote ongoing recovery for pregnant and parenting women with Opioid Use Disorder (OUD) receiving perinatal services and medication treatment for OUD from maternity care practices in New Hampshire.

Detailed description

In this R33 project, the study team will conduct a randomized controlled trial to evaluate the efficacy and implementation of the Mindful Moms intervention (MMORE) with a group of pregnant women with identified OUD receiving medication treatment for OUD at partner maternity care practices. The study team will evaluate the impact of Mindful Moms as an adjunct to treatment as usual on retention in medication for opioid use disorder (MOUD) treatment, substance use, and relapse-related risks. This study has three Specific Aims: Aim 1: Evaluate MMORE in a randomized controlled study with pregnant women as an adjunct to MOUD treatment as usual care for impact on treatment retention, opioid abstinence, and relapse risks. Aim 2: Examine mechanisms of effect of MMORE on outcomes. Aim 3: Evaluate barriers and facilitators to sustainable implementation of MMORE as an adjunct to MOUD for pregnant and parenting women.

Conditions

Interventions

TypeNameDescription
BEHAVIORALMindful Moms Yoga Mindfulness InterventionMMORE is an 8-session yoga-mindfulness intervention protocol, offered via Zoom over the course of 10 consecutive weeks at the partner maternity care practice or a nearby location. Each session will last approximately 60 minutes (8 - 10 participants per group). Intervention participants will also be asked to use a mobile companion app at least once each week of the intervention period.

Timeline

Start date
2022-05-01
Primary completion
2023-07-31
Completion
2023-09-30
First posted
2020-10-14
Last updated
2025-07-31
Results posted
2025-07-31

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04584502. Inclusion in this directory is not an endorsement.

Mindful Moms in Recovery (NCT04584502) · Clinical Trials Directory