An interventional study of Mindful Moms Yoga Mindfulness Intervention in Opioid-use Disorder, sponsored by Trustees of Dartmouth College. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-31.
Sponsored by Trustees of Dartmouth College · Not applicable, Interventional, and Treatment
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.
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.
1,411 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.
This study's enrollment of 4 is below the median of 63 across 1,123 interventional studies indexed under Opioid-Related Disorders.
Browse Opioid-Related Disorders studies →Trustees of Dartmouth College is the lead sponsor of 38 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: Mindful Moms Yoga Mindfulness Intervention
Participants receive treatment as usual for OUD at the partner practice, which includes medication for OUD, individual and/or group counseling, and case management.
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.
Also known as: MMORE
Number of Participants Who Self-reported Retention in Medication Treatment for Opioid Use Disorder
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.
Time frame: baseline-3-months postpartum
Number of Participants Who Self Reported Opioid Use
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
Time frame: baseline to 3-months postpartum
Participant Report of Other Substance Use
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.
Time frame: Baseline to 3-months postpartum
Depression Symptoms
The Edinburgh Postnatal Depression Scale contains 10 questions. Total scores range from 0 to 30 with higher scores indicating greater depression symptoms.
Time frame: Baseline to 3 months postpartum
Anxiety Symptoms
The Generalized Anxiety Disorder Scale contains 7 questions with scores ranging from 0 to 21, with higher scores indicating greater anxiety symptoms.
Time frame: Baseline to 3-months postpartum
Perceived Stress
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.
Time frame: Baseline to 3-months postpartum
Mindfulness
The Mindful Attention Awareness Scale consists of 15 questions with scores ranging between 1 and 6 with higher mean scores indicating greater mindfulness.
Time frame: Baseline to 3-months postpartum
Self-reported Quality of Life
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.
Time frame: Baseline to 3-months postpartum
Significant recruitment challenges due to narrow eligibility (buprenorphine received in maternity care setting) and COVID restrictions. Recruitment ran from April 2022 to July 2023, after institutional and funder approvals were finally obtained for the revised protocol to use a virtual intervention delivery format. Recruitment occurred through partner maternity care settings primarily with flyers placed in high patient traffic areas and clinician distribution of study materials to patients.
| Milestone | Intervention as Adjunct to Treatment as Usual | Treatment as Usual |
|---|---|---|
| Started | 3 | 0 |
| Completed | 3 | 0 |
| Not completed | 0 | 0 |
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.
| participants who reported 'yes' to MOUD | Intervention as Adjunct to Treatment as Usual | Treatment as Usual |
|---|---|---|
| Number of Participants Who Self-reported Retention in Medication Treatment for Opioid Use Disorder | 2 | — |
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
| Participants | Intervention as Adjunct to Treatment as Usual | Treatment as Usual |
|---|---|---|
| Number of Participants Who Self Reported Opioid Use | 3 | — |
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.
| Participants | Intervention as Adjunct to Treatment as Usual | Treatment as Usual |
|---|---|---|
| Participant Report of Other Substance Use | 0 | — |
The Edinburgh Postnatal Depression Scale contains 10 questions. Total scores range from 0 to 30 with higher scores indicating greater depression symptoms.
| score on a scale | Intervention as Adjunct to Treatment as Usual | Treatment as Usual |
|---|---|---|
| Depression Symptoms | 9.0 ± 4.6 | — |
The Generalized Anxiety Disorder Scale contains 7 questions with scores ranging from 0 to 21, with higher scores indicating greater anxiety symptoms.
| score on a scale | Intervention as Adjunct to Treatment as Usual | Treatment as Usual |
|---|---|---|
| Anxiety Symptoms | 4.33 ± 4.16 | — |
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.
| score on a scale | Intervention as Adjunct to Treatment as Usual | Treatment as Usual |
|---|---|---|
| Perceived Stress | 5.67 ± 4.16 | — |
The Mindful Attention Awareness Scale consists of 15 questions with scores ranging between 1 and 6 with higher mean scores indicating greater mindfulness.
| score on a scale | Intervention as Adjunct to Treatment as Usual | Treatment as Usual |
|---|---|---|
| Mindfulness | 4.09 ± 1.37 | — |
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.
| score on a scale | Intervention as Adjunct to Treatment as Usual | Treatment as Usual |
|---|---|---|
| Self-reported Quality of Life | 70.8 ± 20.2 | — |
Collected over Baseline (pregnancy) to 3 months postpartum)(e.g., approximately 6 months).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention as Adjunct to Treatment as Usual | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
| Treatment as Usual | — | — | — |
All of the participants that completed Baseline were randomized into the Treatment condition. One participant that completed enrollment did not complete Baseline due to loss of contact (e.g., did not respond to repeated outreach by study team).
| Age, Categorical(Participants) | Intervention as Adjunct to Treatment as Usual | Treatment as Usual | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 3 | 0 | 3 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Intervention as Adjunct to Treatment as Usual | Treatment as Usual | Total |
|---|---|---|---|
| Female | 3 | 0 | 3 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Intervention as Adjunct to Treatment as Usual | Treatment as Usual | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 3 | 0 | 3 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Intervention as Adjunct to Treatment as Usual | Treatment as Usual | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 3 | 0 | 3 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Intervention as Adjunct to Treatment as Usual | Treatment as Usual | Total |
|---|---|---|---|
| United States | 3 | — | 3 |
| Number of Participants who Self-Reported Medication Treatment for Opioid Use(Participants) | Intervention as Adjunct to Treatment as Usual | Treatment as Usual | Total |
|---|---|---|---|
| Count of participants | 3 | 0 | 3 |
| Number of Participants Who Self-Reported Opioid and Other Substance use(Participants) | Intervention as Adjunct to Treatment as Usual | Treatment as Usual | Total |
|---|---|---|---|
| Count of participants | 3 | — | 3 |
| Depression Symptoms(units on a scale) | Intervention as Adjunct to Treatment as Usual | Treatment as Usual | Total |
|---|---|---|---|
| Mean | 13.0 ± 1.0 | — | 13 ± 1.0 |
5 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Trustees of Dartmouth College