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

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT07211867
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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
  • Waitlist Control Group — BEHAVIORAL
    Participants will receive access to Enhearten with EMI following the trial.

Study Details

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.

Key Dates

Start date
Nov 24, 2025
Status verified
Nov 2025
Primary completion
Mar 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
152 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110
Alex T Ramsey, Ph.D.
[email protected]
314-362-5370
Alex T Ramsey, Ph.D. (PRINCIPAL_INVESTIGATOR)

Find similar trials in St Louis, MO

By condition
Substance use disorder
By specialty
Behavioral healthAddiction medicine
By research site
Washington University School of Medicine· St Louis, MO

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