Improving Mental Health and Physiological Stress Responses in Mothers Following Traumatic Childbirth and in Their Infants: a Randomised Controlled Trial (START)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 147
- 试验地点
- 2
- 主要终点
- presence and severity of PTSD symptoms: self-report (mother)
研究概览
简要总结
This randomized controlled study aims to investigate the effects of a brief computerized intervention (the computer game "Tetris") on intrusive memories and other posttraumatic stress symptoms following an emergency cesarean section (ECS). Women who have undergone an emergency cesarian section will be randomly allocated to either the brief computerized intervention plus usual care or an attention placebo control group plus usual care within the first 6 hours following the ECS. Women and their infants will be followed up at ≤ 1 week postpartum, 6 weeks postpartum, and 6 months postpartum. It is predicted that women given the brief computerized intervention will develop fewer intrusive memories and less posttraumatic stress symptoms than those who are not. This will inform the development of a simple computerized early intervention to prevent distressing psychological symptoms after a traumatic event, such as an ECS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •had an ECS at ≥ 34 weeks gestation
- •gave birth to a live baby
- •answered with a score of ≥ 2 separately for at least two out of four screening questions regarding perceived threat
- •gave written consent
- •if the woman agrees to participate
- •was present at the childbirth
- •gave written consent
排除标准
- •don't speak French sufficiently well to participate in assessments
- •have an established intellectual disability or psychotic illness
- •severe illness of mother or infant (e.g. cancer, cardiovascular disease, severe neurodevelopmental difficulties, malformations)
- •infant requires intensive care
- •alcohol abuse and/or illegal drug use during pregnancy
- •don't speak French sufficiently well to participate in assessments
结局指标
主要结局
presence and severity of PTSD symptoms: self-report (mother)
时间窗: 6 weeks postpartum
PTSD Checklist (PCL-5): subscale and total scores
presence and severity of PTSD symptoms: clinician-rated (mother)
时间窗: 6 weeks postpartum
Clinician-administered PTSD scale (CAPS): subscale and total scores
次要结局
- presence and severity of ASD symptoms (mother)(< 6 hours after ECS, ≤ 1 week postpartum)
- presence and severity of PTSD symptoms: self-report (mother)(6 months postpartum)
- salivary cortisol: daily profile (mother and infant)(≤ 1 week and 6 months postpartum)
- presence and severity of depression symptoms (mother)(< 6 hours after ECS, ≤ 1 week, 6 weeks, 6 months postpartum)
- presence and severity of anxiety symptoms (mother)(< 6 hours after ECS, ≤ 1 week, 6 weeks, 6 months postpartum)
- infant behavior (mother)(6 months postpartum)
- presence and severity of PTSD symptoms: clinician-rated (mother)(6 months postpartum)
- sleep time and duration (mother)(≤ 1 week postpartum)
- frequency of intrusive traumatic memories (mother)(≤ 1 week postpartum)
- sleep quantity and quality (mother)(≤ 1 week, 6 weeks, 6 months postpartum)
- salivary cortisol: stress reactivity (mother and infant)(≤ 1 week and 6 months postpartum)
- heart rate variability: stress reactivity (mother and infant)(≤ 1 week and 6 months postpartum)
- mother-infant-bonding (mother)(≤ 1 week, 6 weeks, 6 months postpartum)
- sleep and physical activity (mother)(≤ 1 week and 6 months postpartum)
- heart rate variability: resting state (mother and infant)(≤ 1 week and 6 months postpartum)
- maternal emotional availability(6 months postpartum)
- infant development(6 months postpartum)
研究者
Antje Horsch
Assistant Professor
Centre Hospitalier Universitaire Vaudois