Opioid-use Disorder
Conditions
Keywords
Pregnancy, Mindfulness, Yoga, Substance Use Disorder
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.
Interventions
BEHAVIORALMindful 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.
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
Trustees of Dartmouth College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
The study will be blind to the Principal Investigators, the statistician, and to those on the team responsible for participant data collection. The study team will work to try to blind clinicians delivering treatment as usual to participant assignment but there is a chance that patients will reveal their condition to clinicians despite our best efforts. To achieve blindness, treatment assignment will done by the Project Manager, who will not be directly involved in evaluation data collection. Data collection will be conducted by the study Research Assistant who will be blinded to participant treatment assignment.
Intervention model description
Intervention as adjunct to usual care.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
One participant enrolled but could not be contacted to complete baseline assessment.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 3 |
| 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. | 0 |
| Total | 3 |
Baseline characteristics
| Characteristic | Intervention as Adjunct to Treatment as Usual | Treatment as Usual | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 0 Participants | 3 Participants |
| Anxiety Symptoms | 9.7 units on a scale STANDARD_DEVIATION 4.7 | — | 9.7 units on a scale STANDARD_DEVIATION 4.7 |
| Depression Symptoms | 13.0 units on a scale STANDARD_DEVIATION 1 | — | 13 units on a scale STANDARD_DEVIATION 1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 0 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Mindfulness | 3.6 units on a scale STANDARD_DEVIATION 0.53 | — | 3.6 units on a scale STANDARD_DEVIATION 0.53 |
| Number of Participants who Self-Reported Medication Treatment for Opioid Use | 3 Participants | 0 Participants | 3 Participants |
| Number of Participants Who Self-Reported Opioid and Other Substance use | 3 Participants | — | 3 Participants |
| Pain | 0 Participants | — | 0 Participants |
| Perceived Stress | 7.7 units on a scale STANDARD_DEVIATION 0.58 | — | 7.7 units on a scale STANDARD_DEVIATION 0.58 |
| Quality of Life | 57.5 units on a scale STANDARD_DEVIATION 5 | — | 57.5 units on a scale STANDARD_DEVIATION 5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 0 Participants | 3 Participants |
| Region of Enrollment United States | 3 participants | — | 3 participants |
| Sex: Female, Male Female | 3 Participants | 0 Participants | 3 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 0 |
| other Total, other adverse events | 0 / 3 | 0 / 0 |
| serious Total, serious adverse events | 0 / 3 | 0 / 0 |
Outcome results
Primary
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
Population: participants who completed 3 month assessment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention as Adjunct to Treatment as Usual | Number of Participants Who Self Reported Opioid Use | 3 Participants |
Primary
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
Population: All participants were randomly assigned to the Intervention arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention as Adjunct to Treatment as Usual | Number of Participants Who Self-reported Retention in Medication Treatment for Opioid Use Disorder | 2 participants who reported 'yes' to MOUD |
Secondary
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
Population: Participants all randomized to intervention condition.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention as Adjunct to Treatment as Usual | Anxiety Symptoms | 4.33 score on a scale | Standard Deviation 4.16 |
Secondary
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
Population: participants only randomized to intervention condition.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention as Adjunct to Treatment as Usual | Depression Symptoms | 9.0 score on a scale | Standard Deviation 4.6 |
Secondary
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
Population: Participants all randomized to intervention condition.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention as Adjunct to Treatment as Usual | Mindfulness | 4.09 score on a scale | Standard Deviation 1.37 |
Secondary
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
Population: participants that completed 3 month assessment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention as Adjunct to Treatment as Usual | Participant Report of Other Substance Use | 0 Participants |
Secondary
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
Population: Participants all randomized to intervention condition.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention as Adjunct to Treatment as Usual | Perceived Stress | 5.67 score on a scale | Standard Deviation 4.16 |
Other Pre-specified
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
Population: Participants all randomized to intervention condition.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention as Adjunct to Treatment as Usual | Self-reported Quality of Life | 70.8 score on a scale | Standard Deviation 20.2 |