Ultrashort Cognitive Behavioral Intervention for Tokophobia- A Prospective Randomized Single Blinded Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Pregnancy-Related Anxiety Questionnaire
研究概览
简要总结
Women in their 3rd trimester, represent a unique segment of the tokophobic population. In these cases help is needed within a very short and limited period of time. To date, no specific treatment targets this population in order to ameliorate the anxiety and to provide these women and their newborns with better obstetric and psychiatric outcomes. The present study investigates an accessible individual two session intervention conducted by midwives skilled in CBT (cognitive behavioral therapy) . This intervention is designed to enable stronger emotional regulation and increase of their capacity to accept unexpected changes during labor and feelings of control. The investigators expect this psychological adjustment to lead to a better course of delivery, less interventions including caesarian sections, and subjective birth experience.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Hebrew speaking pregnant women week 32 + 0 to 37 + 0
- •fulfilling the criteria for a specific phobia diagnosed by SCID (Structured Clinical Interview for the Diagnostic) in accordance with DSM-V (Diagnostic and Statistical Manual) and the Fear of Vaginal Delivery Questionnaire (FDQ).
排除标准
- •Women who suffer from a psychotic disorder, PTSD or suicidal ideation
- •High risk pregnancies
- •Alcoholism or drug abuse and dependence.
研究组 & 干预措施
Study group
will receive 2 sessions of 90 minutes each of a cognitive behavioral protocol for the treatment of Tokophobia administered by a CBT trained midwife.
干预措施: CBT (Behavioral)
Control group
will receive 2 sessions of a delivery preparation course (practice as usual).
干预措施: Sham (Other)
结局指标
主要结局
Pregnancy-Related Anxiety Questionnaire
时间窗: In the end of second session of intervention- up to 4 weeks from screening
a widely used instrument to assess and identify pregnancy-specific anxiety in women
次要结局
未报告次要终点
