Mindful Moms in Recovery: Yoga-based Mindfulness Relapse Prevention for Pregnant Women With Opioid Use Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Number of Participants Who Self-reported Retention in Medication Treatment for Opioid Use Disorder
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Cognitive or psychiatric impairments that prohibit being able to provide informed consent.
- •Any physical conditions that prohibit activity such as gentle yoga.
研究组 & 干预措施
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.
干预措施: Mindful Moms Yoga Mindfulness Intervention (Behavioral)
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.
结局指标
主要结局
Number of Participants Who Self-reported Retention in Medication Treatment for Opioid Use Disorder
时间窗: 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
时间窗: 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
次要结局
- Participant Report of Other Substance Use(Baseline to 3-months postpartum)
- Depression Symptoms(Baseline to 3 months postpartum)
- Anxiety Symptoms(Baseline to 3-months postpartum)
- Perceived Stress(Baseline to 3-months postpartum)
- Mindfulness(Baseline to 3-months postpartum)
研究者
Sarah E. Lord
Director, Dissemination and Implementation Science Core
Trustees of Dartmouth College