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

The Washington University

Status and phase: Completed; Early Phase 1

Conditions: Opioid Use Disorders

Treatments: Device: uMAT-R mobile app with coaching component

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06701123

201805132

5R34DA050453 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 69 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1. Pregnant or up to 1 year postpartum

2. Receiving treatment at CARE

3. Adult (≥18 years of age)

4. U.S. resident

5. Currently on MAT

6. Fluent in English

7. women with opioid use disorder (OUD)

   Exclusion Criteria:

8. Currently incarcerated

9. Patients with acute suicidality or psychotic disorders as assessed by CARE providers

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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69 participants in 2 patient groups

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

No Intervention group

Description:

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

Experimental : Experimental Group A- Mobile App with Coaching Feature

Experimental group

Description:

Access to a coached program on uMAT-R App

Treatment:

Device: uMAT-R mobile app with coaching component