Improving Mental Health Following Early PREgnancy Loss Using a Brief Cognitive Task
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Number of intrusive memories of early pregnancy loss
研究概览
简要总结
This is a randomised controlled trial designed to investigate the impact of a brief-cognitive task based intervention on intrusive memories, mental health symptoms and daily functioning, in women following an early pregnancy loss.
详细描述
Women who have experienced an early pregnancy loss (miscarriage or ectopic pregnancy) will be randomly allocated to either a brief cognitive intervention or a placebo activity. Participants will be followed up at week 1, 1 month and 3 months following the intervention. It is hypothesised that those allocated to receive the brief cognitive task-based intervention will develop fever intrusive memories, less severe mental health symptoms and better day to day functioning when compared to women allocated to the placebo activity.
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
- Single (Participant)
盲法说明
Participants will be blinded to whether the activity they are assigned to is the experimental intervention or the placebo activity.
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
- •Age 18 years and over
- •Diagnosis of early pregnancy loss (EPL) (missed miscarriage, incomplete miscarriage, complete miscarriage, ectopic pregnancy)
- •Fluent in English
- •Access to a smart device (e.g. phone or tablet)
- •Within 72 hours of EPL (including diagnosis of complete miscarriage or completion of treatment for ectopic pregnancy, missed miscarriage or incomplete miscarriage)
排除标准
- •Women who, in the opinion of the researcher, are unable to give fully informed consent to the study due to for example learning impairment or language barrier.
- •Women with a viable intrauterine pregnancy
- •Women with a pregnancy loss occurring after 20 weeks gestation
- •History of severe mental illness or substance misuse
结局指标
主要结局
Number of intrusive memories of early pregnancy loss
时间窗: Week 1
Number of intrusive memories during the first week following early pregnancy loss recorded by participants in a brief daily diary(morning, afternoon, evening and night) for 7 days.
次要结局
- Number of intrusive memories of early pregnancy loss(Week 5)
- Character of intrusive memories(Week 1 and week 5)
- Severity of PTSD symptoms(1 month and 3 months)
- Frequency and Severity of Functional Impairment(1 month and 3 months)
- Severity of re-experiencing symptoms cluster(1 month and 3 months)
- Number of women meeting the diagnostic threshold for PTSD diagnosis(1 month and 3 months)
- Severity of Anxiety symptoms(1 month and 3 months)
- Severity of Depressions Symptoms(1 month and 3 months)
- Number of women meeting the diagnostic threshold for moderate/severe anxiety(1 month and 3 months)
- Number of women meeting the diagnostic threshold for moderate/severe depression(1 month and 3 months)