Online Intervention to Promote Resilience to Traumatic Stress During Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Impact of Events Scale - Revised (IES-R)
研究概览
简要总结
The investigators will design, construct, and pilot a prototype of a trauma-informed online intervention, which will be called "SunnysideFlex," that functionally integrates a web-based intervention targeting skills to decrease symptoms of PTSD and better manage mood during and after pregnancy. SunnysideFlex will build upon the previously IRB-approved "Sunnyside" intervention which targeted skills to manage mood through an interactive website with didactic material and tools. Women in weeks 16-28 of their pregnancy who self-report symptoms of PTSD will be randomized to one of three study groups: (1) SunnysideFlex, (2) the original Sunnyside intervention (active control), or (3) treatment as usual (TAU). The SunnysideFlex intervention will consist of 6 weeks of trauma-informed online lessons during pregnancy and booster sessions at 2 weeks, 4 weeks, and 6 weeks postpartum. Outcomes will be measured at baseline, post-intervention, 6 weeks postpartum, and 12 weeks postpartum. SunnysideFlex has the potential to provide a novel paradigm for improving maternal and child health outcomes in high-risk, trauma-exposed women.
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
- 是
入选标准
- •18 years and older
- •Pregnant and between 16-28 weeks gestation
- •Are currently engaged in prenatal care with a healthcare provider (OB/GYN, nurse, midwife, etc.)
- •Endorse a history of one or more potentially traumatic events meeting Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) Criterion A for PTSD (i.e., "exposure to actual or threatened death, serious injury, or sexual violence," American Psychological Association [APA], p. 271) that is interpersonal in nature (e.g., sexual or physical assault, child abuse/maltreatment, witnessing family violence)
- •Endorse a score of 33 or greater on the PTSD Checklist for DSM-5 (PCL-5)
- •Have access to a broadband internet connection
- •Able to read and speak English
排除标准
- •Pregnant with multiples
- •Have visual, hearing, voice, or motor impairment that would prevent completion of study procedures
- •Have been diagnosed with a psychotic disorder, bipolar disorder, dissociative disorder, substance use disorder, or other diagnosis for which participation in this trial is either inappropriate or dangerous based on self-report
- •Report currently being in an abusive or unsafe relationship
- •Currently receiving treatment (medication or psychotherapy), or have an intention to resume antidepressant medication after delivery (i.e., women who discontinued their medication during pregnancy)
结局指标
主要结局
Impact of Events Scale - Revised (IES-R)
时间窗: 1 week
The IES-R assesses the past-week frequency of PTSD symptoms in reference to the participant's self-identified worst traumatic event
PTSD Checklist for DSM-5 (PCL-5)
时间窗: Past 30 days
The PCL-5 is a well validated screening tool for assessing PTSD symptoms and probable PTSD diagnosis. the PCL-5 checklist assesses frequency of past 30-day PTSD symptoms in reference to an individual's self-identified worst traumatic event. A total score of 33 or greater represents a positive PTSD screen and is the cut-off employed in the current study.
Patient Health Questionnaire-9 (PHQ-9)
时间窗: 2 weeks
Reflects overall functioning and impairment due to the depressive symptoms. PHQ-9 scoring interpretations are as follows: 1-4: minimal depressive symptoms; 5-9 mild depressive symptoms; 10-14: moderate depressive symptoms; 15-19: moderately severe depressive symptoms: 20-27: severe depressive symptoms.
次要结局
未报告次要终点
研究者
Jennifer Duffecy
Principal Investigator
University of Illinois at Chicago