A Digital Intervention to Decrease Self-Stigma Among Pregnant and Postpartum Women With Substance Use Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- Self-stigma about substance use
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •- 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
研究组 & 干预措施
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.
干预措施: Enhearten with EMI (Behavioral)
Waitlist Control Group
Participants in this arm will have access to the intervention following the trial.
干预措施: Waitlist Control Group (Behavioral)
结局指标
主要结局
Self-stigma about substance use
时间窗: 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.
Internalized stigma about substance use
时间窗: 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.
次要结局
- Use of Medications for Addiction Treatment (MAT)(Baseline through 6-months post-intervention)
- Substance use(Baseline through 6 months post-intervention)
- Substance use cravings(Baseline through 6 months post-intervention)
- Attitudes towards using medication for addiction treatment during pregnancy/postpartum(Baseline through 6 months post-intervention)
- Subjective norms towards using medication for addiction treatment(Baseline through 6 months post-intervention)
- Self-efficacy towards using medication for addiction treatment(Baseline through 6 months post-intervention)
- Mental health symptoms(Baseline through 6 months post-intervention)
- Infant feeding intentions(Baseline through 6 months post-intervention)
- Usability and usefulness of intervention(1-month post-intervention to 6-months post-intervention)
- Acceptability of intervention(1-month post-intervention to 6-months post-intervention)
- Subjective norms towards using medication for addiction treatment(Baseline through 6 months post-intervention)
- Self-efficacy towards using medication for addiction treatment(Baseline through 6 months post-intervention)
- Use of Medications for Addiction Treatment (MAT)(Baseline through 6-months post-intervention)
- Substance use(Baseline through 6 months post-intervention)
- Substance use cravings(Baseline through 6 months post-intervention)
- Attitudes towards using medication for addiction treatment during pregnancy/postpartum(Baseline through 6 months post-intervention)
- Mental health symptoms(Baseline through 6 months post-intervention)
- Infant feeding intentions(Baseline through 6 months post-intervention)
- Usability and usefulness of intervention(1-month post-intervention to 6-months post-intervention)
- Acceptability of intervention(1-month post-intervention to 6-months post-intervention)