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Идёт набор NCT07211867

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

Без фазы С лечением Substance Use Disorder

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Enhearten with EMI, Waitlist Control Group.
Кому может быть актуально
Состояния в реестре: Substance Use Disorder. Базовые параметры: от 18 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

  • Self-stigma about substance use [Срок оценки: Baseline through 6-months post-intervention]
  • Internalized stigma about substance use [Срок оценки: Baseline through 6-months post-intervention]
Вторичные конечные точки (10)
  • Use of Medications for Addiction Treatment (MAT) [Срок оценки: Baseline through 6-months post-intervention]
  • Substance use [Срок оценки: Baseline through 6 months post-intervention]
  • Substance use cravings [Срок оценки: Baseline through 6 months post-intervention]
  • Attitudes towards using medication for addiction treatment during pregnancy/postpartum [Срок оценки: Baseline through 6 months post-intervention]
  • Subjective norms towards using medication for addiction treatment [Срок оценки: Baseline through 6 months post-intervention]
  • Self-efficacy towards using medication for addiction treatment [Срок оценки: Baseline through 6 months post-intervention]
  • Mental health symptoms [Срок оценки: Baseline through 6 months post-intervention]
  • Infant feeding intentions [Срок оценки: Baseline through 6 months post-intervention]
  • Usability and usefulness of intervention [Срок оценки: 1-month post-intervention to 6-months post-intervention]
  • Acceptability of intervention [Срок оценки: 1-month post-intervention to 6-months post-intervention]

Критерии участия

Критерии включения

  • 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

Критерии исключения

\- 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Washington University School of Medicine — St Louis

Идентификаторы

NCT: NCT07211867 · 202302102 · R44DA055161

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗