Mindful Moms in Recovery
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Opioid Use Disorder
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Intervention as adjunct to usual care.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.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
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...
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.
Tracking Information
- NCT #
- NCT04584502
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Trustees of Dartmouth College
- Investigators
- Principal Investigator: Sarah E Lord Geisel School of Medicine
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