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| ID | Type | Description | Link |
|---|---|---|---|
| R33AT010117 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention as adjunct to Treatment as Usual | Experimental | 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. |
|
| Treatment as Usual | No 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindful Moms Yoga Mindfulness Intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | baseline to 3-months postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 3-months postpartum |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah E Lord, PhD | Geisel School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03766 | United States |
One participant enrolled but could not be contacted to complete baseline assessment.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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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).
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All participants were randomly assigned to the Intervention arm. | Posted | Number | participants who reported 'yes' to MOUD | baseline-3-months postpartum |
|
Baseline (pregnancy) to 3 months postpartum)(e.g., approximately 6 months).
Participants all randomized Into intervention condition.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sarah Lord, Ph.D. | Geisel School of Medicine | 6036467089 | sarah.e.lord@dartmouth.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 7, 2022 | Feb 17, 2025 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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Intervention as adjunct to usual care.
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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.
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| 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. | 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. | 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. | 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. | Baseline to 3-months postpartum |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Number of Participants who Self-Reported Medication Treatment for Opioid Use | Count of Participants | Participants |
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| Number of Participants Who Self-Reported Opioid and Other Substance use | Count of Participants | Participants |
|
| Depression Symptoms | The Edinburgh Prenatal Depression Scale was used to assess symptoms of depression. Total scores on this 10-item measure range from 0-30, with high scores indicating higher frequency of depression symptoms. Scores >= 14 indicative of high probability of moderate-severe depression. | Mean | Standard Deviation | units on a scale |
|
| Anxiety Symptoms | The Generalized Anxiety Disorder (GAD-7) screening measure was used to assess anxiety symptoms. The total score ranges from 0-21, with higher scores indicating greater frequency of anxiety symptoms. Scores >10 indicate high probability of moderate-severe anxiety. | Mean | Standard Deviation | units on a scale |
|
| Perceived Stress | Measured by Perceived Stress Scale-4. The Perceived Stress Scale-4 includes 4 questions on 5-point Likert (0-4). Total scores ranging from 0 to 16 with higher scores indicating greater stress. | Mean | Standard Deviation | units on a scale |
|
| Mindfulness | Measured by the Mindful Attention Awareness Scale, a 15-item measured on 6-point Likert scale. Higher scores associated with greater mindfulness. | Mean | Standard Deviation | units on a scale |
|
| Pain | no/low Pain: <5 yes/high Pain: >=5 visual analogue scale (0-10). Reported are number of participants that reported Yes/High pain symptoms. | Count of Participants | Participants |
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| Quality of Life | Measured by World Health Organization Quality of Life Brief instrument. Scores range from 0-100, with higher scores reflecting greater quality of life. | Mean | Standard Deviation | units on a scale |
|
| OG001 | 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. |
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| 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 | participants who completed 3 month assessment. | Posted | Count of Participants | Participants | baseline to 3-months postpartum |
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|
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| 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. | participants that completed 3 month assessment. | Posted | Count of Participants | Participants | Baseline to 3-months postpartum |
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| 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. | participants only randomized to intervention condition. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 3 months postpartum |
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|
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| 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. | Participants all randomized to intervention condition. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 3-months postpartum |
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|
|
| 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. | Participants all randomized to intervention condition. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 3-months postpartum |
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| 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. | Participants all randomized to intervention condition. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 3-months postpartum |
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| 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. | Participants all randomized to intervention condition. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 3-months postpartum |
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|
| 0 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | 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 | 0 | 0 | 0 | 0 | 0 |
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