Mindful Moms in Recovery

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.

• Mindful Moms Yoga Mindfulness Intervention (Behavioral), also known as MMORE: 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.

Primary outcomes

• 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 outcomes

• 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.

Other outcomes

• Self-reported Quality of Life [Baseline to 3-months postpartum]: The World Health Organization Quality of Life-10 contains 10 questions to assess a quality of life profile based on four domains: physical health, psychological health, social relationships, and environment. Total score ranges from 0 to 100 where higher scores denote higher quality of life.

Sex: Female, ages: 18 Years to any

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.

Participant flow

Outcome results

• Number of Participants Who Self-reported Retention in Medication Treatment for Opioid Use Disorder (Primary), Number, participants who reported 'yes' to MOUD: Intervention as Adjunct to Treatment as Usual 2; Treatment as Usual
• Number of Participants Who Self Reported Opioid Use (Primary), Count of participants, Participants: Intervention as Adjunct to Treatment as Usual 3; Treatment as Usual
• Participant Report of Other Substance Use (Secondary), Count of participants, Participants: Intervention as Adjunct to Treatment as Usual 0; Treatment as Usual
• Depression Symptoms (Secondary), Mean, score on a scale: Intervention as Adjunct to Treatment as Usual 9.0 +/- 4.6; Treatment as Usual
• Anxiety Symptoms (Secondary), Mean, score on a scale: Intervention as Adjunct to Treatment as Usual 4.33 +/- 4.16; Treatment as Usual
• Perceived Stress (Secondary), Mean, score on a scale: Intervention as Adjunct to Treatment as Usual 5.67 +/- 4.16; Treatment as Usual
• Mindfulness (Secondary), Mean, score on a scale: Intervention as Adjunct to Treatment as Usual 4.09 +/- 1.37; Treatment as Usual
• Self-reported Quality of Life (Other pre specified), Mean, score on a scale: Intervention as Adjunct to Treatment as Usual 70.8 +/- 20.2; Treatment as Usual

Adverse events

Time frame: Baseline (pregnancy) to 3 months postpartum)(e.g., approximately 6 months).

• Study Protocol and Statistical Analysis Plan (PDF, 2022-04-07)

• Sarah E Lord, PhD, Principal investigator, Geisel School of Medicine

NIH grants: R33AT010117