Mindful Moms in Recovery

Opioid-use Disorder Clinical Trial

— MMORE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04584502
• Other study ID #: STUDY00031364
• Secondary ID: R33AT010117
• Status: Completed
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: September 30, 2023

Study information

• Verified date: February 2024
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: September 30, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Opioid-Related Disorders
• Opioid-use Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (3)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	National Center for Complementary and Integrative Health (NCCIH), Trustees of Dartmouth College

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in pain perception from baseline, as measured by the visual analog scale (VAS)	The Visual Analog Scale is a scale ranging from 0 (no pain) to 10 (worst possible pain) and anchored with descriptive faces.	Baseline, 8 weeks, and 3-months postpartum
Other	Change from baseline in quality of life measured by the World Health Organization (WHO) Quality of Life Brief.	The World Health Organization Quality of Life - Brief instrument contains 26 questions to assess a quality of life profile based on four domains: physical health, psychological health, social relationships, and environment. Each domain ranges in score from 0 to 100 where higher scores denote higher quality of life.	Baseline, 8 weeks, and 3-months postpartum
Primary	Retention in medication treatment for opioid use disorder as assessed by number of weeks buprenorphine or methadone present in urine toxicology screening in clinical record conducted as part of treatment as usual.	Data collected through review of clinical record review of consented participants.	baseline to 3-months postpartum
Primary	Change in opioid abstinence from baseline as assessed by number of weeks consistently abstinent from opioids as determined by weekly point of care urine toxicology screening conducted as part of treatment as usual.	Data collected through review of clinical record of consented participants.	baseline to 3-months postpartum
Secondary	Change in opioid and other substance use from baseline, as assessed with the World Health Organization (WHO) Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) V3.0.	The Alcohol, Smoking and Substance Involvement Screening Test contains 7 questions and asks about past and current substance use and addiction to various substances. Each substance ranges in scores between 0 to 27+ with higher scores indicating greater risk level of addiction and dependence. Opioid addiction severity will be measured by 11 "yes or no" response items aligned with the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria with more "yes" responses indicating higher opioid addiction severity.	Baseline, 8 weeks, and 3-months postpartum
Secondary	Change in depression from baseline, as assessed with the Edinburgh Prenatal and Postnatal Depression Scale.	The Edinburgh Prenatal and Postnatal Depression Scale contains 10 questions with scores ranging from 10 to 40 with higher scores indicating greater depression symptoms.	Baseline, 8 weeks, and 3-months postpartum
Secondary	Change in anxiety from baseline, as assessed with the Generalized Anxiety Disorder Scale (GAD)	The Generalized Anxiety Disorder Scale contains 7 questions with scores ranging from 0 to 21, with higher scores indicating greater anxiety symptoms.	Baseline, 8 weeks, and 3-months postpartum
Secondary	Change in stress from baseline, as assessed with the Perceived Stress Scale	The Perceived Stress Scale contains 10 questions with scores ranging from 0 to 40 with higher scores indicating greater stress.	Baseline, 8 weeks, and 3-months postpartum
Secondary	Change in post-traumatic stress from baseline, as assessed with the abbreviated Post-Traumatic Stress Disorder (PTSD) Checklist screening instrument.	The abbreviated Post-Traumatic Stress Disorder Checklist screening instrument contains 20 questions with scores ranging from 0 to 80 with higher scores indicating greater PTSD symptoms.	Baseline, 8 weeks, and 3-months postpartum
Secondary	Change in mindfulness from baseline, as assessed with the Mindful Attention Awareness Scale (MAAS)	The Mindful Attention Awareness Scale contains 15 questions with scores ranging between 1 and 6 with higher scores indicating greater mindfulness.	Baseline, 8 weeks, and 3-months postpartum