Enhearten for Substance Use Disorder
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a digital tool called Enhearten, designed to assist pregnant women and new mothers with substance use disorders. The goal is to determine if this tool can reduce self-stigma (negative feelings about oneself) and improve treatment adherence and recovery. Participants will use Enhearten for just-in-time support during vulnerable moments. The study seeks pregnant women and new mothers up to 12 months postpartum with a history of substance use, excluding alcohol and nicotine, who have daily access to a smartphone or tablet. As an unphased trial, it offers participants the chance to contribute to innovative research that could lead to new methods of supporting recovery.
Do I have to stop taking my current medications for the trial?
The trial does not specify whether you need to stop taking your current medications. It focuses on supporting adherence to medications for addiction treatment, so you may be able to continue your prescribed medications.
What prior data suggests that this digital intervention is safe for pregnant and postpartum women with substance use disorders?
A previous study tested Enhearten with EMI to evaluate its effectiveness and potential side effects for individuals with substance use disorders. The study assessed the ease of use of the digital tool. Although the exact side effects were not detailed, digital tools like Enhearten typically pose low risk since they do not involve medication. Enhearten aims to assist pregnant and new mothers by reducing feelings of shame and supporting adherence to addiction treatment plans. This approach emphasizes mental and emotional support, which is generally safer than traditional drug treatments.12345
Why are researchers excited about this trial?
Researchers are excited about Enhearten because it’s a digital intervention aimed at supporting people with substance use disorder, specifically addressing the unique needs of pregnant and post-partum women. Unlike standard treatments like medication-assisted therapy, Enhearten incorporates features to reduce self-stigma, a crucial barrier to treatment adherence. Additionally, its integration with ecological momentary interventions (EMI) helps users stick to their medication schedules and remain engaged in their treatment journey.
What evidence suggests that Enhearten with EMI is effective for substance use disorder?
Research has shown that Enhearten, a digital tool, may help reduce feelings of self-judgment in pregnant and new mothers dealing with substance use issues. In this trial, participants will either receive the Enhearten intervention or join a waitlist control group. Studies have found that digital tools like Enhearten can complement traditional care by offering support when needed. Early results suggest that Enhearten helps women adhere to their addiction treatment plans and remain in treatment longer. The app is specifically designed to meet the needs of these women, making it a promising option. By addressing self-judgment, Enhearten could lead to better treatment outcomes for this group.34678
Who Is on the Research Team?
Alex T Ramsey, Ph.D.
Principal Investigator
Washington University School of Medicine
Are You a Good Fit for This Trial?
This trial is for pregnant and postpartum women who are dealing with substance use disorders. To join, they must be currently receiving or willing to start medication-assisted treatment for their addiction.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the Enhearten digital intervention designed to reduce self-stigma and improve SUD treatment outcomes
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Enhearten with EMI
Trial Overview
The study is testing 'Enhearten', a digital program aimed at reducing self-stigma and improving adherence to addiction treatments among these women. Participants will either receive this intervention or be placed in a waitlist control group.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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.
Participants in this arm will have access to the intervention following the trial.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Washington University School of Medicine
Lead Sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Citations
A Digital Intervention to Decrease Self-Stigma Among ...
This study will determine the efficacy and utility of Enhearten among PPW with SUDs, addressing a promising solution to supplement traditional in-person care, ...
Co-designing a mobile application to reduce self-stigma for ...
This study used the DDBT framework to collect feedback, iterate rapidly, and evaluate efficacy of Enhearten, a digital intervention for self- ...
Co-designing a mobile application to reduce self-stigma for ...
Conclusions These results support the potential of digital interventions to reduce self-stigma and improve perinatal OUD recovery outcomes. The ...
A Digital Intervention to Decrease Self-Stigma Among ...
This study will determine the efficacy and utility of Enhearten among PPW with SUDs, addressing a promising solution to supplement traditional ...
The past, current, and future role of the National Drug Abuse ...
The application of digital technologies to better assess, understand, and treat substance use disorders (SUDs) is a particularly promising and vibrant area ...
Enhearten for Substance Use Disorder
This N/A medical study run by Washington University School of Medicine is evaluating whether Enhearten with EMI will have tolerable side effects & efficacy ...
Partners
See fewer readmissions from overdoses and complications from addiction, and collect outcome data on patients to improve their overall care in the future.
an analysis of data from the World Mental Health Surveys - PMC
Among all people with substance use disorders, only 7.1% had received at least minimally adequate treatment in the past year (10.3%, 4.3% and 1.0%, respectively ...
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