Trials / Completed
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
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Mindful Moms Yoga Mindfulness Intervention | MMORE 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.