RecruitingNot ApplicableNCT07211867

A Digital Intervention to Decrease Self-Stigma Among Pregnant and Postpartum Women With Substance Use Disorder


Sponsor

Washington University School of Medicine

Enrollment

152 participants

Start Date

Nov 24, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Digital interventions have the potential to support healthier behaviors among pregnant and postpartum women (PPW) with substance use disorders (SUDs) and may also provide a promising method for reducing their self-stigma. Enhearten is a digital intervention designed to foster adherence to medications for addiction treatment (MAT) while considering the unique needs of PPW, but its effects on self-stigma, treatment retention, and SUD outcomes have not been rigorously tested. The investigators will conduct an individual-level multicenter randomized controlled trial to test the feasibility, acceptability, and efficacy of Enhearten on reducing self-stigma and on improving SUD treatment and recovery outcomes with a stigma-focused ecological momentary intervention (EMI) designed to: 1) screen for feelings of stigma and 2) counteract these vulnerabilities among PPW with SUD via just-in-time interventions.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria5

  • Pregnant women and new mothers (up to 12 months postpartum)
  • Adult (≥18 years of age)
  • Fluent in English
  • Currently owns or has ready (daily) access to a smartphone or tablet to use Enhearten.
  • Self-reports a history of substance use, excluding alcohol use, nicotine/tobacco use, and drugs taken as prescribed by a physician OR a history of substance use, excluding alcohol use, nicotine/tobacco use, and drugs taken as prescribed by a physician, is identified in chart review as documented by a healthcare provider

Exclusion Criteria1

  • \- Significant cognitive impairment that interferes with their ability to consent and complete study tasks as self-reported or documented in medical charts by a healthcare provider

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Interventions

BEHAVIORALEnhearten with EMI

Enhearten is a digital intervention that is designed to foster adherence to medications for addiction treatment (MAT) and treatment retention while considering the unique needs of pregnant and postpartum women, and recently it has been adapted to include features designed to decrease self-stigma among app-users

BEHAVIORALWaitlist Control Group

Participants will receive access to Enhearten with EMI following the trial.


Locations(1)

Washington University School of Medicine

St Louis, Missouri, United States

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NCT07211867


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