Mindful Moms in Recovery

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-01

Study Completion Date

2023-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Opioid-use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Intervention as adjunct to usual care.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

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.

Study Groups

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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.

Group Type EXPERIMENTAL

Mindful Moms Yoga Mindfulness Intervention

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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MMORE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No