Recruiting

Enhearten

Sponsor:

Washington University School of Medicine

Code:

NCT07211867

Conditions

Substance Use Disorder

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Enhearten with EMI

Waitlist Control Group

Study Details

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.

Conditions

Substance Use Disorder

Study ID

NCT07211867

Start date

Nov 24, 2025

Status verified date

Nov, 2025

Completion date

May, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

152 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Enhearten 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 post-partum women, and recently it has been adapted to include features designed to decrease self-stigma among app-users.

active comparator: Waitlist Control Group

Participants in this arm will have access to the intervention following the trial.

Interventions

Enhearten 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

Waitlist Control Group

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

Primary outcome measure

  • Self-stigma about substance use [ Time Frame: Baseline through 6-months post-intervention ]
  • Internalized stigma about substance use [ Time Frame: Baseline through 6-months post-intervention ]

Central Contacts and Locations

Central contacts

Alex T Ramsey, Ph.D.

314-362-5370aramsey@wustl.edu

Elecia Worley, MSW

314-362-9004e.m.worley@wustl.edu

Locations

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Alex T Ramsey, Ph.D.

314-362-5370aramsey@wustl.edu

Principal Investigator:

Alex T Ramsey, Ph.D.

More Information

Sponsor

Washington University School of Medicine

Last update posted

Nov 26, 2025

Last verified

Nov, 2025

Keywords

  • pregnant and postpartum women
  • self-stigma
  • digital interventions
  • substance use disorder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2025-11-26.