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

NCT07211867 | Recruiting

• 2 other identifiers: 202302102R44DA055161
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Self-stigma about substance use

  Participants in each group will be assessed on levels of perceived self-stigma using the Brief Substance Use Stigma Scale ). The Brief Substance Use Stigma Scale uses a 5-point Likert scale, ranging from "strongly disagree" to "strongly agree". Mean scores will be created with higher scores indicating higher levels of stigma.

  Baseline through 6-months post-intervention

• Internalized stigma about substance use

  Participants in each group will be assessed on levels of perceived self-stigma using the Internalized Stigma of Substance Abuse Scale (ISSA). The Internalized Stigma of Substance Abuse Scale (ISSA) uses a 4-point Likert scale ranging from "strongly disagree" to "strongly agree". Mean scores will be created with higher scores indicating higher levels of stigma.

  Baseline through 6-months post-intervention

Secondary Outcomes (10)

• Use of Medications for Addiction Treatment (MAT)

  Baseline through 6-months post-intervention

• Substance use

  Baseline through 6 months post-intervention

• Substance use cravings

  Baseline through 6 months post-intervention

• Attitudes towards using medication for addiction treatment during pregnancy/postpartum

  Baseline through 6 months post-intervention

• Subjective norms towards using medication for addiction treatment

  Baseline through 6 months post-intervention

Study Arms (2)

Enhearten with EMI

EXPERIMENTAL

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.

Behavioral: Enhearten with EMI

Waitlist Control Group

ACTIVE COMPARATOR

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

Behavioral: Waitlist Control Group

Interventions

Enhearten with EMI BEHAVIORAL

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

Enhearten with EMI

Waitlist Control Group BEHAVIORAL

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

Waitlist Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

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Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Alex T Ramsey, Ph.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alex T Ramsey, Ph.D.

CONTACT

314-362-5370; aramsey@wustl.edu

Elecia Worley, MSW

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2025
• First Posted: October 8, 2025
• Study Start: November 24, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: The data will be made available 12 months after trial completion after data cleaning and quality control completion.
• Access Criteria: The research team will make datasets available to any individual who makes a direct request to the MPIs and indicates the data will be used for the purposes of research (per CFR Title 45 Part 46: "Research is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge"). In sharing participant data, the team will follow Office of Sponsored Projects' data sharing agreements at Washington University in St. Louis.

Locations

US (1)