Mindful Moms in Recovery
- Conditions
- Opioid-use Disorder
- Interventions
- Behavioral: Mindful Moms Yoga Mindfulness Intervention
- Registration Number
- NCT04584502
- Lead Sponsor
- Dartmouth-Hitchcock Medical Center
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 4
- 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.
- Cognitive or psychiatric impairments that prohibit being able to provide informed consent.
- Any physical conditions that prohibit activity such as gentle yoga.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention as adjunct to Treatment as Usual Mindful Moms Yoga Mindfulness Intervention 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.
- Primary Outcome Measures
Name Time Method 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. baseline to 3-months postpartum Data collected through review of clinical record review of consented participants.
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. baseline to 3-months postpartum Data collected through review of clinical record of consented participants.
- Secondary Outcome Measures
Name Time Method Change in post-traumatic stress from baseline, as assessed with the abbreviated Post-Traumatic Stress Disorder (PTSD) Checklist screening instrument. Baseline, 8 weeks, and 3-months postpartum 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.
Change in depression from baseline, as assessed with the Edinburgh Prenatal and Postnatal Depression Scale. Baseline, 8 weeks, and 3-months postpartum The Edinburgh Prenatal and Postnatal Depression Scale contains 10 questions with scores ranging from 10 to 40 with higher scores indicating greater depression symptoms.
Change in anxiety from baseline, as assessed with the Generalized Anxiety Disorder Scale (GAD) Baseline, 8 weeks, and 3-months postpartum The Generalized Anxiety Disorder Scale contains 7 questions with scores ranging from 0 to 21, with higher scores indicating greater anxiety symptoms.
Change in stress from baseline, as assessed with the Perceived Stress Scale Baseline, 8 weeks, and 3-months postpartum The Perceived Stress Scale contains 10 questions with scores ranging from 0 to 40 with higher scores indicating greater stress.
Change in mindfulness from baseline, as assessed with the Mindful Attention Awareness Scale (MAAS) Baseline, 8 weeks, and 3-months postpartum The Mindful Attention Awareness Scale contains 15 questions with scores ranging between 1 and 6 with higher scores indicating greater mindfulness.
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. Baseline, 8 weeks, and 3-months postpartum 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.
Trial Locations
- Locations (1)
Dartmouth Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States