Mindful Moms in Recovery

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Opioid-use Disorder

Intervention / Treatment
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* Behavioral: Mindful Moms Yoga Mindfulness Intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Intervention as adjunct to usual care.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention as adjunct to Treatment as Usual<br>Participants will attend 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<br>* MMORE is an 8-session yoga-mindfulness intervention protocol, offered 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.<br>* Other names: MMORE;|
| No Intervention: Treatment as Usual<br>Participants receive treatment as usual for OUD at the partner practice, which includes medication for OUD, individual and/or group counseling, and case management. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy, Mindfulness, Yoga, Substance Use Disorder