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

Not Applicable

Recruiting

• Conditions: Substance Use Disorder

• Registration Number: NCT07211867
• Lead Sponsor: Washington University School of Medicine

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.

Detailed Description

Pregnant and postpartum women (PPW) with substance use disorders (SUDs) face high levels of self-stigma, the internalization of negative feelings about oneself because of drug misuse. Self-stigma is highly correlated with numerous detrimental consequences including recovery outcomes and reduced engagement with SUD treatment. Furthermore, self-stigma prevents treatment initiation and engagement among PPW with SUDs, leading to additional adverse health outcomes for both mother and baby. Digital interventions have the potential to support healthier behaviors among PPW with SUDs and may also provide a promising method for reducing their self-stigma. Enhearten is a digital intervention that has been enhanced 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. In this study, the investigators will test this augmented version of Enhearten with a stigma-focused ecological momentary intervention (EMI) designed to: 1) screen for feelings of stigma and 2) counteract these vulnerabilities via just-in-time interventions. Specifically, the investigators will conduct an individual-level multi-center randomized control trial (RCT) to test the feasibility, acceptability, and efficacy of Enhearten on reducing self-stigma and on improving SUD treatment and recovery outcomes. Participants will be randomized to one of two groups: Enhearten with EMI or a waitlist control group (i.e., participants will have access to the intervention following the RCT). Recruitment will occur through treatment facilities and recovery homes throughout the United States, referrals from stakeholders including clinicians and peer support specialists, and approved research recruitment registries. This study will determine the efficacy and utility of Enhearten among PPW with SUDs, addressing a promising solution to supplement traditional in-person care, reduce self-stigma, and support continued motivation and adherence to treatment plans along the recovery journey.

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-26
• Study First Submitted QC: 2025-09-30
• Last Update Submitted: 2025-09-30
• Study Start: 2025-10-01
• Study First Posted: 2025-10-08
• Last Update Posted: 2025-10-08
• Primary Completion: 2027-03
• Study Completion: 2027-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 152

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Self-stigma about substance use	Baseline through 6-months post-intervention	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.
Internalized stigma about substance use	Baseline through 6-months post-intervention	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.

Secondary Outcome Measures

Name	Time	Method
Subjective norms towards using medication for addiction treatment	Baseline through 6 months post-intervention	Participants in each group will be assessed on a subjective norms measure towards use of medications for addiction treatment, stemming from the Theory of Planned Behavior.
Use of Medications for Addiction Treatment (MAT)	Baseline through 6-months post-intervention	Participants in each group will be assessed on self-reported use of medications for opioid use disorder or other medications for addiction treatment in the past 30 days.
Self-efficacy towards using medication for addiction treatment	Baseline through 6 months post-intervention	Participants in each group will be assessed on a self-efficacy measure towards use of medications for addiction treatment, stemming from the Theory of Planned Behavior.
Substance use	Baseline through 6 months post-intervention	Participants in each group will be assessed on self-reported use of substances for nonmedical purposes (i.e. opioids, methamphetamine, cocaine, MDMAs, etc) in the past 30 days. Substance use and related symptoms will be assessed using modified items from the National Survey on Drug Use and Health (NSDUH).
Substance use cravings	Baseline through 6 months post-intervention	Participants in each group will be assessed on self-reported cravings to use substances for nonmedical purposes (i.e. opioids, methamphetamine, cocaine, MDMAs, etc). Substance use cravings will be assessed using modified items from the Penn Alcohol Craving Scale (PACS).
Attitudes towards using medication for addiction treatment during pregnancy/postpartum	Baseline through 6 months post-intervention	Participants in each group will be assessed on an attitudes measure towards use of medications for addiction treatment during the pregnancy/postpartum period, stemming from the Theory of Planned Behavior. This measure uses a 6-point Likert scale ranging from "strongly disagree" to "strongly agree".
Mental health symptoms	Baseline through 6 months post-intervention	Participants in each group will be assessed on symptoms of mental health from the Medical Outcomes Survey, including symptoms related to depression, anxiety, and distress.
Acceptability of intervention	1-month post-intervention to 6-months post-intervention	Participants in the intervention group will be assessed on acceptability of the Enhearten app using a modified version of the Acceptability of Intervention Measure (AIM) questionnaire. The modified version of the AIM uses a 7-point Likert scale, ranging from "totally disagree" to "totally agree". Mean scores will be created with higher scores indicating higher levels of acceptability.
Infant feeding intentions	Baseline through 6 months post-intervention	Participants in each group who are pregnant will be assessed on intent to breastfeed using The Infant Feeding Intentions (IFI) scale. This measure uses a 5-point Likert-type scale ranging from "very much agree" to "very much disagree".
Usability and usefulness of intervention	1-month post-intervention to 6-months post-intervention	Participants in the intervention group will be assessed on usability and usefulness of the Enhearten app using a modified version of the Technology Acceptance Model (TAM). The TAM uses a 7-point Likert scale ranging from "totally disagree" to "totally agree" with higher scores indicating higher levels of usability and usefulness.

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 St Louis, Missouri, United States