Mindful Moms in Recovery

NCT04584502 | Completed Results DMC

• 2 other identifiers: STUDY00031364R33AT010117
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Opioid-use Disorder

Keywords

Pregnancy; Mindfulness; Yoga; Substance Use Disorder

Outcome Measures

Primary Outcomes (2)

• Number of Participants Who Self-reported Retention in Medication Treatment for Opioid Use Disorder

  We were not able to obtain clinical record data from partner settings due to high staff demand and considerable stress at partner settings due to the impact of COVID-19 pandemic. Data regarding retention in medication treatment was obtained via self-report in assessment surveys.

  baseline-3-months postpartum

• Number of Participants Who Self Reported Opioid Use

  We were not able to collect urine toxicology data so measured by way of self-report (frequency of use past 3 months). Scored as 0=No; 1=Yes

  baseline to 3-months postpartum

Secondary Outcomes (5)

• Participant Report of Other Substance Use

  Baseline to 3-months postpartum

• Depression Symptoms

  Baseline to 3 months postpartum

• Anxiety Symptoms

  Baseline to 3-months postpartum

• Perceived Stress

  Baseline to 3-months postpartum

• Mindfulness

  Baseline to 3-months postpartum

Other Outcomes (1)

• Self-reported Quality of Life

  Baseline to 3-months postpartum

Study Arms (2)

Intervention as adjunct to Treatment as Usual

EXPERIMENTAL

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.

Behavioral: Mindful Moms Yoga Mindfulness Intervention

Treatment as Usual

NO INTERVENTION

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

Interventions

Mindful Moms Yoga Mindfulness Intervention BEHAVIORAL

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.

Also known as: MMORE

Intervention as adjunct to Treatment as Usual

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Trustees of Dartmouth College: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Sarah Lord, Ph.D.
• Organization: Geisel School of Medicine

sarah.e.lord@dartmouth.edu

6036467089

Study Officials

• Sarah E Lord, PhD

  Geisel School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study will be blind to the Principal Investigators, the statistician, and to those on the team responsible for participant data collection. The study team will work to try to blind clinicians delivering treatment as usual to participant assignment but there is a chance that patients will reveal their condition to clinicians despite our best efforts. To achieve blindness, treatment assignment will done by the Project Manager, who will not be directly involved in evaluation data collection. Data collection will be conducted by the study Research Assistant who will be blinded to participant treatment assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Dissemination and Implementation Science Core

Model Details: Intervention as adjunct to usual care.

Study Record Dates

• First Submitted: October 6, 2020
• First Posted: October 14, 2020
• Study Start: May 1, 2022
• Primary Completion: July 31, 2023
• Study Completion: September 30, 2023
• Last Updated: July 31, 2025
• Results First Posted: July 31, 2025

Record last verified: 2025-07

Locations

US (1)