mHealth to Help Pregnant and Postpartum Women in Recovery for Opioid Use Disorder
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Sobriety
研究概览
简要总结
The opioid epidemic has resulted in widespread detrimental consequences among vulnerable populations in Missouri, especially among pregnant and postpartum women (PPW) with opioid use disorder (OUD). Perinatal use of medication-assisted treatment (MAT) within a comprehensive treatment plan is the current standard of care, however PPW struggling with OUD may underestimate or misjudge its benefits. At the same time, emerging findings signal that mobile health (mHealth) technologies have the potential to support healthier behaviors among individuals with OUD. In this project, we will test the utility of a theoretically-based digital therapeutics tool (uMAT-R) to encourage MAT adherence and treatment retention while considering the unique needs of PPW. In Aim #1, we will conduct four focus groups with PPW with OUD (target users) on the intervention components of uMAT-R, gathering feedback on theory-driven components that are candidates for inclusion in the tool and eliciting suggestions for additional intervention components. In Aim #2, the tool will be beta-tested for technical/navigational issues among 20 participants. In Aim #3, we will conduct a pilot randomized controlled trial (RCT) among adult PPW with OUD (n=60). This RCT is designed to test the feasibility, acceptability, and preliminary efficacy of uMAT-R (n=40) versus a control group (n=20 who receive treatment-as-usual) regarding participants' treatment adherence, sobriety, and improved MAT attitudes, norms, and perceived control. Recruitment for all Aims will occur at a clinic in St. Louis, Missouri that provides perinatal medication-assisted treatment (MAT) and high-risk maternity care to PPW struggling with OUD. Clinically meaningful effect size and attrition estimates will aid in the planning of a larger RCT in which we will test uMAT-R on a larger scale and expand our recruitment to other clinics across Missouri and other states.
This novel technology could be an invaluable tool to assist physicians in the treatment of OUD among PPW.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant or up to 1 year postpartum
- •Receiving treatment at CARE
- •Adult (≥18 years of age)
- •U.S. resident
- •Currently on MAT
- •Fluent in English
- •women with opioid use disorder (OUD)
排除标准
- •Currently incarcerated
- •Patients with acute suicidality or psychotic disorders as assessed by CARE providers
研究组 & 干预措施
No Intervention : Control Group Access to uMAT-R but did not engage
No Intervention : Control Group Access to uMAT-R but did not engage
Experimental : Experimental Group A- Mobile App with Coaching Feature
Access to a coached program on uMAT-R App
干预措施: uMAT-R mobile app with coaching component (Device)
结局指标
主要结局
Sobriety
时间窗: Baseline, 1 month, 2 months, 6 months
DSM 5 criteria for OUD will be assessed using items from the NSDUH that are based on DSM IV criteria and match all but one of the DSM 5 criteria (craving). Craving will be assessed using the Penn Alcohol Craving Scale (PACS) modified for opioid use.
次要结局
未报告次要终点
