Transforming Health and Reducing PerInatal Anxiety Through Virtual Engagement (the HOPE THRIVE STUDY)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Anxiety Symptoms
研究概览
简要总结
The goal of this clinical trial is to evaluate whether digital cognitive behavioral therapy (dCBT) can be used to address clinical anxiety in marginalized and low-income pregnant people in California. The main question it aims to answer is:
What is the efficacy of digital cognitive behavioral therapy (dCBTI) for reducing clinical anxiety among marginalized and low-income pregnant people?
Participants will receive digital cognitive behavioral therapy immediately, or 10 weeks after enrollment (i.e., waitlist control). Participants will complete surveys and interviews until 6-8 weeks postpartum.
详细描述
Although therapist-delivered cognitive behavioral therapy (CBT) has been shown to be effective for treating clinical anxiety in non-marginalized pregnant populations, barriers to access exist among pregnant people (e.g., long waitlists, childcare issues, limited appointment windows). Recent innovations have focused on addressing barriers to CBT by adapting it for automated, digital delivery. Digital CBT (dCBT) has been shown to be effective for treating clinical anxiety in mostly White, higher socioeconomic status, pregnant, and non-pregnant populations. Person-centered adaptations of dCBT are likely needed to maximize access in marginalized and low-income pregnant people. This study addresses the critical need to evaluate whether dCBT can be used to address clinical anxiety in marginalized and low-income pregnant people in California.
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
- Double (Investigator, Outcomes Assessor)
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
- •California MediCal participant
- •Pregnant, 8-27 weeks gestation by ultrasound
- •18-years of age or older
- •English speaking
- •9th grade level of education or more
- •Daily access to web-enabled computer, smart phone, or tablet
- •Current elevated anxiety symptoms (score on the seven item Generalized Anxiety Disorder (GAD-7)questionnaire of 10 or more
排除标准
- •Received CBT for anxiety in the last 12-months
- •New or changed dose of prescription medication for anxiety, depressive symptoms, or poor sleep in < 4weeks
- •Self-reported diagnosis of schizophrenia, psychosis, bipolar disorder, seizure disorder, substance use disorder, severe cognitive impairment (characterized by experiences like forgetting events, having decreased periods of alertness, decreased social awareness)
- •Recent trauma to the head or brain damage
- •Serious physical health concerns necessitating surgery or hospitalization in the last 6-months
结局指标
主要结局
Anxiety Symptoms
时间窗: Baseline to 3, 6, and 10-weeks after the program start, and Baseline to 6-8 weeks postpartum
as measured by the Generalized Anxiety Disorder-7 (GAD-7) after 3-weeks, 6-weeks, and 10- weeks after enrollment, and at 6 to 8 weeks postpartum. The GAD-7 utilizes a sum score and the total score can range from 0-21, with higher scores indicating greater anxiety severity.
次要结局
- Stress Symptoms(Baseline to 3, 6, and 10-weeks after the program start, and Baseline to 6-8 weeks postpartum)
- Depressive Symptoms(Baseline to 3, 6, and 10-weeks after the program start, and Baseline to 6-8 weeks postpartum)
- Insomnia Symptoms(Baseline to 3, 6, and 10-weeks after the program start, and Baseline to 6-8 weeks postpartum)
- Pregnancy- Related Anxiety(Baseline to 3, 6, and 10-weeks after the program start, and Baseline to 6-8 weeks postpartum)