Mindful Moms in Recovery (MMORE)

Trustees of Dartmouth College

Status: Completed

Conditions: Opioid-use Disorder

Treatments: Behavioral: Mindful Moms Yoga Mindfulness Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04584502

R33AT010117 (U.S. NIH Grant/Contract)

STUDY00031364

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years of age or older.
• English-speaking.
• Singleton pregnancy.
• Receiving comprehensive medication treatment for opioid use disorder as part of prenatal care at a partner maternity care practice.

Exclusion criteria

• Cognitive or psychiatric impairments that prohibit being able to provide informed consent.
• Any physical conditions that prohibit activity such as gentle yoga.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

4 participants in 2 patient groups

Intervention as adjunct to Treatment as Usual

Experimental group

Description:

Participants will attend via Zoom an 8-session group-based yoga-mindfulness intervention offered over the course of approximately 10 consecutive weeks. Participants will also be asked to use a mobile companion app once a week during the intervention period. All intervention participants also receive treatment as usual for OUD at the partner practice, which includes medication for OUD, individual and/or group counseling, and case management.

Treatment:

Behavioral: Mindful Moms Yoga Mindfulness Intervention

Treatment as Usual

No Intervention group

Description:

Participants receive treatment as usual for OUD at the partner practice, which includes medication for OUD, individual and/or group counseling, and case management.