NCT07211867 A Digital Intervention to Decrease Self-Stigma Among Pregnant and Postpartum Women With Substance Use Disorder
| NCT ID | NCT07211867 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Washington University School of Medicine |
| Condition | Substance Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 152 participants |
| Start Date | 2025-11-24 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 152 participants in total. It began in 2025-11-24 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Alex T Ramsey, Ph.D.
PRINCIPAL INVESTIGATOR
Washington University School of Medicine
Frequently Asked Questions
Who can join the NCT07211867 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Substance Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07211867 currently recruiting?
Yes, NCT07211867 is actively recruiting participants. Contact the research team at aramsey@wustl.edu for enrollment information.
Where is the NCT07211867 trial being conducted?
This trial is being conducted at St Louis, United States.
Who is sponsoring the NCT07211867 clinical trial?
NCT07211867 is sponsored by Washington University School of Medicine. The principal investigator is Alex T Ramsey, Ph.D. at Washington University School of Medicine. The trial plans to enroll 152 participants.