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NCT Number: NCT07211867

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

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.

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Key information

Conditions

Substance Use Disorder Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location status: Recruiting

Location contact

Alex T Ramsey, Ph.D.

CONTACT

[email protected]

314-362-5370

Alex T Ramsey, Ph.D.

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

waitlist control group

Behavioral

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

Primary outcomes

  1. Self-stigma about substance use

    Time frame: 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.

  2. Internalized stigma about substance use

    Time frame: 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 outcomes

  1. Use of Medications for Addiction Treatment (MAT)

    Time frame: 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.

  2. Substance use

    Time frame: 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).

  3. Substance use cravings

    Time frame: 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). The scale uses a 0-6 Likert scale for each of its five items, with a total possible score ranging from 0 to 30, where higher total scores reflect more intense or frequent cravings.

  4. Attitudes towards using medication for addiction treatment during pregnancy/postpartum

    Time frame: 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".

  5. Subjective norms towards using medication for addiction treatment

    Time frame: 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.

  6. Self-efficacy towards using medication for addiction treatment

    Time frame: 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.

  7. Mental health symptoms

    Time frame: 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.

  8. Infant feeding intentions

    Time frame: 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".

  9. Usability and usefulness of intervention

    Time frame: 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.

  10. Acceptability of intervention

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alex T Ramsey, Ph.D.

CONTACT

[email protected]

314-362-5370

Elecia Worley, MSW

CONTACT

[email protected]

314-362-9004

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 8, 2025
Registry last updated
Nov 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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