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临床试验/NCT06701123
NCT06701123已完成1 期

mHealth to Help Pregnant and Postpartum Women in Recovery for Opioid Use Disorder

Washington University School of Medicine1 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2023年7月1日最近更新:
适应症
干预措施

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

No Intervention : Control Group Access to uMAT-R but did not engage

Experimental : Experimental Group A- Mobile App with Coaching Feature

Experimental

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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