Actively Recruiting
A Digital Intervention to Decrease Self-Stigma Among Pregnant and Postpartum Women With Substance Use Disorder
Led by Washington University School of Medicine · Updated on 2025-11-26
152
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
W
Washington University School of Medicine
Lead Sponsor
N
National Institute on Drug Abuse (NIDA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate a digital intervention called Enhearten designed to reduce self-stigma and improve substance use disorder (SUD) treatment and recovery outcomes among pregnant and postpartum women (PPW) with SUDs. The study will test how feasible, acceptable, and effective Enhearten is in supporting adherence to medications for addiction treatment (MAT) while addressing the unique challenges and stigma faced by PPW. This trial is a randomized controlled study conducted at multiple centers to examine these effects over time. Participants will be randomly assigned to one of two groups: one group will use the Enhearten digital intervention with a stigma-focused ecological momentary intervention (EMI) that screens for feelings of stigma and provides just-in-time support, while the other group will be on a waitlist and receive access to Enhearten after the trial. Enhearten is tailored to encourage treatment retention and reduce self-stigma specifically for pregnant and postpartum women, adapting its features to their needs. During the study, participants will be monitored from baseline through six months after the intervention for changes in self-stigma and internalized stigma related to substance use. Researchers will also track medication use for addiction treatment, substance use and cravings, attitudes and self-efficacy towards treatment, mental health symptoms, and infant feeding intentions. The study will collect data on the usability and acceptability of the intervention from one to six months post-intervention. Overall participation will involve regular assessments to measure these outcomes and understand the intervention's impact on recovery and treatment adherence.
CONDITIONS
Brief Title
A Digital Intervention to Decrease Self-Stigma Among Pregnant and Postpartum Women With Substance Use Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant women and new mothers up to 12 months postpartum
- Adults 18 years of age or older
- Fluent in English
- Daily access to a smartphone or tablet to use the Enhearten app
- Self-reported history of substance use excluding alcohol, nicotine/tobacco, and prescribed drugs, or documented history confirmed by healthcare provider
You will not qualify if you...
- Significant cognitive impairment that affects ability to consent or complete study tasks as reported by participant or documented by healthcare provider
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote)
Duration - 6 months
Participants use the Enhearten digital intervention designed to reduce self-stigma and support adherence to medications for addiction treatment during pregnancy and postpartum, or are assigned to a waitlist control group.
Regular digital engagement with the app; assessments at baseline and periodically through 6 months
Duration - Up to 6 months post-treatment
Participants continue to be assessed for self-stigma, substance use, treatment retention, and mental health outcomes up to 6 months post-intervention.
Periodic assessments via digital surveys or calls
Trial Site Locations
Total: 1 location
1
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
Research Team
A
Alex T Ramsey, Ph.D.
E
Elecia Worley, MSW
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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