Clinical Trial

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

Recruiting
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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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-09-30; most recent amendment 2025-11-25.
Trial Details
NCT Number NCT07211867
Lead Sponsor Washington University School of Medicine
Collaborators: National Institute on Drug Abuse (NIDA)
Conditions Substance Use Disorder
Enrollment 152 participants
Start Date 2025-11-24
Primary Completion 2027-03 (estimated)
Study Completion 2027-05 (estimated)
Updated on ClinicalTrials.gov 2025-11-26