A Digital Intervention to Decrease Self-Stigma Among Pregnant and Postpartum Women With Substance Use Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Enhearten with EMI, Waitlist Control Group.
- Who it may be relevant to
- Registry conditions: Substance Use Disorder. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Behavioral 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 postpartum women, and recently it has been adapted to include features designed to decrease self-stigma among app-users - Behavioral Waitlist Control Group
Participants will receive access to Enhearten with EMI following the trial.
Primary outcome measures
- Self-stigma about substance use [Time frame: Baseline through 6-months post-intervention]
- Internalized stigma about substance use [Time frame: Baseline through 6-months post-intervention]
Secondary outcome measures (10)
- Use of Medications for Addiction Treatment (MAT) [Time frame: Baseline through 6-months post-intervention]
- Substance use [Time frame: Baseline through 6 months post-intervention]
- Substance use cravings [Time frame: Baseline through 6 months post-intervention]
- Attitudes towards using medication for addiction treatment during pregnancy/postpartum [Time frame: Baseline through 6 months post-intervention]
- Subjective norms towards using medication for addiction treatment [Time frame: Baseline through 6 months post-intervention]
- Self-efficacy towards using medication for addiction treatment [Time frame: Baseline through 6 months post-intervention]
- Mental health symptoms [Time frame: Baseline through 6 months post-intervention]
- Infant feeding intentions [Time frame: Baseline through 6 months post-intervention]
- Usability and usefulness of intervention [Time frame: 1-month post-intervention to 6-months post-intervention]
- Acceptability of intervention [Time frame: 1-month post-intervention to 6-months post-intervention]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Washington University School of Medicine — St Louis
Identifiers
NCT: NCT07211867 · 202302102 · R44DA055161