Mindful Moms in Recovery

Not Applicable

Completed

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

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 Outcome Measures

Name	Time	Method
Number of Participants Who Self-reported Retention in Medication Treatment for Opioid Use Disorder	baseline-3-months postpartum	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.
Number of Participants Who Self Reported Opioid Use	baseline to 3-months postpartum	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

Secondary Outcome Measures

Name	Time	Method
Participant Report of Other Substance Use	Baseline to 3-months postpartum	The Alcohol, Smoking and Substance Involvement Screening Test includes items to assess past and current substance use: tobacco, alcohol, marijuana, cocaine, heroin/fentanyl) frequency of use (past 3 months; not at all/once or twice/once a month/once or twice a month/once a week/daily or almost daily). Scored as: 0 (not at all/once or twice); 1=more than once or twice (composite of marijuana and cocaine use). Reported as # of participants that scored 1.
Depression Symptoms	Baseline to 3 months postpartum	The Edinburgh Postnatal Depression Scale contains 10 questions. Total scores range from 0 to 30 with higher scores indicating greater depression symptoms.
Anxiety Symptoms	Baseline to 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.
Perceived Stress	Baseline to 3-months postpartum	The Perceived Stress Scale includes 4 questions on 5-point Likert (0-4). Total scores ranging from 0 to 16 with higher scores indicating greater stress.
Mindfulness	Baseline to 3-months postpartum	The Mindful Attention Awareness Scale consists of 15 questions with scores ranging between 1 and 6 with higher mean scores indicating greater mindfulness.

Locations (1): Dartmouth Hitchcock Medical Center
🇺🇸
Lebanon, New Hampshire, United States
Dartmouth Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States