Clinical trial NCT04584502: Mindful Moms in Recovery
Official title: Mindful Moms in Recovery: Yoga-based Mindfulness Relapse Prevention for Pregnant Women With Opioid Use Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-use Disorder
Keywords: Pregnancy
Mindfulness
Yoga
Substance Use Disorder
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
name: Trustees of Dartmouth College
First posted: 2020-10-14
Enrollment: 4
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention as adjunct to usual care.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: baseline to 3-months postpartum
measure: 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.
timeFrame: baseline to 3-months postpartum
Secondary outcomes:
measure: 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.
timeFrame: Baseline, 8 weeks, and 3-months postpartum
measure: Change in depression from baseline, as assessed with the Edinburgh Prenatal and Postnatal Depression Scale.
timeFrame: Baseline, 8 weeks, and 3-months postpartum
measure: Change in anxiety from baseline, as assessed with the Generalized Anxiety Disorder Scale (GAD)
timeFrame: Baseline, 8 weeks, and 3-months postpartum
measure: Change in stress from baseline, as assessed with the Perceived Stress Scale
timeFrame: Baseline, 8 weeks, and 3-months postpartum
measure: Change in post-traumatic stress from baseline, as assessed with the abbreviated Post-Traumatic Stress Disorder (PTSD) Checklist screening instrument.
timeFrame: Baseline, 8 weeks, and 3-months postpartum
measure: Change in mindfulness from baseline, as assessed with the Mindful Attention Awareness Scale (MAAS)
timeFrame: Baseline, 8 weeks, and 3-months postpartum
Other outcomes:
measure: Change in pain perception from baseline, as measured by the visual analog scale (VAS)
timeFrame: Baseline, 8 weeks, and 3-months postpartum
measure: Change from baseline in quality of life measured by the World Health Organization (WHO) Quality of Life Brief.
timeFrame: Baseline, 8 weeks, and 3-months postpartum
Locations:
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Geisel School of Medicine
name: Sarah E Lord, PhD
role: PRINCIPAL_INVESTIGATOR
References: