Digital support to reduce self-stigma for pregnant and postpartum women with substance use disorder
Official title: A Digital Intervention to Decrease Self-Stigma Among Pregnant and Postpartum Women With Substance Use Disorder
Run by Washington University School of Medicine · NCT07211867 · Data updated 2026-11-12
This project will test whether a smartphone program called Enhearten can reduce self‑stigma and help pregnant and postpartum women with substance use disorder stay in treatment and improve recovery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 152 (estimated) |
| Sponsor | Washington University School of Medicine Academic / other |
| Locations | 1 site (St Louis, Missouri) |
| Status | Recruiting |
| Started | November 24, 2025 |
| Main results expected | January 2028 |
| Study ends | March 2028 |
| Registry record updated | November 4, 2026 |
| Trial ID | NCT07211867 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adult (≥18) pregnant women or new mothers up to 12 months postpartum who are fluent in English, have a history of non‑alcohol/non‑nicotine substance use, and have daily access to a smartphone or tablet are ideal candidates.
✕Probably not a fit
People without daily access to a smartphone or tablet, those not fluent in English, those whose substance use is limited to alcohol or nicotine only, or individuals with significant cognitive impairment are unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter individual-level randomized controlled trial will compare an augmented version of the Enhearten app (which includes a stigma-focused ecological momentary intervention, or EMI) to a waitlist control. Enhearten is designed to screen for momentary feelings of stigma and deliver just-in-time messages to counteract those vulnerabilities while promoting adherence to medications for addiction treatment. Pregnant women and new mothers up to 12 months postpartum with a history of substance use will be enrolled, randomized, and followed to measure self-stigma, treatment retention, and substance use outcomes. Feasibility and acceptability of the digital intervention will also be measured alongside efficacy outcomes.
Why it matters
Potential benefit: If successful, Enhearten could lower self-stigma, improve retention in addiction treatment, and lead to better recovery outcomes for pregnant and postpartum women.
How similar studies have gone: Some digital and EMI approaches have shown promise for supporting medication adherence and behavior change in other populations, but this specific stigma‑focused Enhearten intervention for pregnant and postpartum women with SUD is relatively novel and not yet proven.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: \- 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
Where it's running
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Washington University School of Medicine
St Louis, Missouri, United States Recruiting
Study contacts
- Principal investigator: Alex T Ramsey, Ph.D. — Washington University School of Medicine
- Study coordinator: Alex T Ramsey, Ph.D.
- Email: aramsey@wustl.edu
- Phone: 314-362-5370
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.