Trial Outcomes & Findings for Mindful Moms in Recovery (NCT NCT04584502)
NCT ID: NCT04584502
Last Updated: 2025-07-31
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
4 participants
Primary outcome timeframe
baseline-3-months postpartum
Results posted on
2025-07-31
Participant Flow
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.
One participant enrolled but could not be contacted to complete baseline assessment.
Participant milestones
| Measure |
Intervention as Adjunct to Treatment as Usual
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.
Mindful Moms Yoga Mindfulness Intervention: 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.
|
Treatment as Usual
Participants receive treatment as usual for OUD at the partner practice, which includes medication for OUD, individual and/or group counseling, and case management.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
0
|
|
Overall Study
COMPLETED
|
3
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mindful Moms in Recovery
Baseline characteristics by cohort
| Measure |
Intervention as Adjunct to Treatment as Usual
n=3 Participants
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.
Mindful Moms Yoga Mindfulness Intervention: 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.
|
Treatment as Usual
Participants receive treatment as usual for OUD at the partner practice, which includes medication for OUD, individual and/or group counseling, and case management.
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=99 Participants
|
—
|
3 participants
n=206 Participants
|
|
Number of Participants who Self-Reported Medication Treatment for Opioid Use
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Number of Participants Who Self-Reported Opioid and Other Substance use
|
3 Participants
n=99 Participants
|
—
|
3 Participants
n=206 Participants
|
|
Depression Symptoms
|
13.0 units on a scale
STANDARD_DEVIATION 1.0 • n=99 Participants
|
—
|
13 units on a scale
STANDARD_DEVIATION 1.0 • n=206 Participants
|
|
Anxiety Symptoms
|
9.7 units on a scale
STANDARD_DEVIATION 4.7 • n=99 Participants
|
—
|
9.7 units on a scale
STANDARD_DEVIATION 4.7 • n=206 Participants
|
|
Perceived Stress
|
7.7 units on a scale
STANDARD_DEVIATION .58 • n=99 Participants
|
—
|
7.7 units on a scale
STANDARD_DEVIATION .58 • n=206 Participants
|
|
Mindfulness
|
3.6 units on a scale
STANDARD_DEVIATION .53 • n=99 Participants
|
—
|
3.6 units on a scale
STANDARD_DEVIATION .53 • n=206 Participants
|
|
Pain
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Quality of Life
|
57.5 units on a scale
STANDARD_DEVIATION 5.0 • n=99 Participants
|
—
|
57.5 units on a scale
STANDARD_DEVIATION 5.0 • n=206 Participants
|
PRIMARY outcome
Timeframe: baseline-3-months postpartumPopulation: All participants were randomly assigned to the Intervention arm.
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.
Outcome measures
| Measure |
Intervention as Adjunct to Treatment as Usual
n=3 Participants
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.
Mindful Moms Yoga Mindfulness Intervention: 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.
|
Treatment as Usual
Participants receive treatment as usual for OUD at the partner practice, which includes medication for OUD, individual and/or group counseling, and case management.
|
|---|---|---|
|
Number of Participants Who Self-reported Retention in Medication Treatment for Opioid Use Disorder
|
2 participants who reported 'yes' to MOUD
|
—
|
PRIMARY outcome
Timeframe: baseline to 3-months postpartumPopulation: participants who completed 3 month assessment.
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
Outcome measures
| Measure |
Intervention as Adjunct to Treatment as Usual
n=3 Participants
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.
Mindful Moms Yoga Mindfulness Intervention: 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.
|
Treatment as Usual
Participants receive treatment as usual for OUD at the partner practice, which includes medication for OUD, individual and/or group counseling, and case management.
|
|---|---|---|
|
Number of Participants Who Self Reported Opioid Use
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline to 3-months postpartumPopulation: participants that completed 3 month assessment.
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.
Outcome measures
| Measure |
Intervention as Adjunct to Treatment as Usual
n=3 Participants
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.
Mindful Moms Yoga Mindfulness Intervention: 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.
|
Treatment as Usual
Participants receive treatment as usual for OUD at the partner practice, which includes medication for OUD, individual and/or group counseling, and case management.
|
|---|---|---|
|
Participant Report of Other Substance Use
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline to 3 months postpartumPopulation: participants only randomized to intervention condition.
The Edinburgh Postnatal Depression Scale contains 10 questions. Total scores range from 0 to 30 with higher scores indicating greater depression symptoms.
Outcome measures
| Measure |
Intervention as Adjunct to Treatment as Usual
n=3 Participants
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.
Mindful Moms Yoga Mindfulness Intervention: 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.
|
Treatment as Usual
Participants receive treatment as usual for OUD at the partner practice, which includes medication for OUD, individual and/or group counseling, and case management.
|
|---|---|---|
|
Depression Symptoms
|
9.0 score on a scale
Standard Deviation 4.6
|
—
|
SECONDARY outcome
Timeframe: Baseline to 3-months postpartumPopulation: Participants all randomized to intervention condition.
The Generalized Anxiety Disorder Scale contains 7 questions with scores ranging from 0 to 21, with higher scores indicating greater anxiety symptoms.
Outcome measures
| Measure |
Intervention as Adjunct to Treatment as Usual
n=3 Participants
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.
Mindful Moms Yoga Mindfulness Intervention: 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.
|
Treatment as Usual
Participants receive treatment as usual for OUD at the partner practice, which includes medication for OUD, individual and/or group counseling, and case management.
|
|---|---|---|
|
Anxiety Symptoms
|
4.33 score on a scale
Standard Deviation 4.16
|
—
|
SECONDARY outcome
Timeframe: Baseline to 3-months postpartumPopulation: Participants all randomized to intervention condition.
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.
Outcome measures
| Measure |
Intervention as Adjunct to Treatment as Usual
n=3 Participants
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.
Mindful Moms Yoga Mindfulness Intervention: 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.
|
Treatment as Usual
Participants receive treatment as usual for OUD at the partner practice, which includes medication for OUD, individual and/or group counseling, and case management.
|
|---|---|---|
|
Perceived Stress
|
5.67 score on a scale
Standard Deviation 4.16
|
—
|
SECONDARY outcome
Timeframe: Baseline to 3-months postpartumPopulation: Participants all randomized to intervention condition.
The Mindful Attention Awareness Scale consists of 15 questions with scores ranging between 1 and 6 with higher mean scores indicating greater mindfulness.
Outcome measures
| Measure |
Intervention as Adjunct to Treatment as Usual
n=3 Participants
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.
Mindful Moms Yoga Mindfulness Intervention: 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.
|
Treatment as Usual
Participants receive treatment as usual for OUD at the partner practice, which includes medication for OUD, individual and/or group counseling, and case management.
|
|---|---|---|
|
Mindfulness
|
4.09 score on a scale
Standard Deviation 1.37
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to 3-months postpartumPopulation: Participants all randomized to intervention condition.
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.
Outcome measures
| Measure |
Intervention as Adjunct to Treatment as Usual
n=3 Participants
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.
Mindful Moms Yoga Mindfulness Intervention: 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.
|
Treatment as Usual
Participants receive treatment as usual for OUD at the partner practice, which includes medication for OUD, individual and/or group counseling, and case management.
|
|---|---|---|
|
Self-reported Quality of Life
|
70.8 score on a scale
Standard Deviation 20.2
|
—
|
Adverse Events
Intervention as Adjunct to Treatment as Usual
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment as Usual
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place