Early Psychotherapeutic Intervention After Childbirth Trauma: Comparison Between EMDR and Supportive Expressive Dynamic Psychotherapy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Post-traumatic stress symptoms
研究概览
简要总结
There is increasing evidence that about 30% of women evaluate their childbirth as traumatic and that women could develop post-traumatic stress disorder (PTSD) in response to events of birth. The mean prevalence of post-partum PTSD (PP-PTSD) was reported as 3-4% in community samples and 15.7-18.95% in high-risk samples.
The primary aim is to investigate the effectiveness of Eye Movement Desesitization and Reprocessing (EMDR) in treating post-traumatic and postpartum depressive symptoms in women who had a traumatic childbirth as compared to Supportive Expressive Dynamic Psychotherapy (SEDP) as therapy as usual.
Secondary outcomes are:
- to evaluate the differences between EMDR and SEDP in preventing the onset of PTSD and Post-partum Depression after 3 months;
- to evaluate the effectiveness of EMDR and SEDP on anxiety and mother-child bonding; The subjects of the study will be 60 women who had a traumatic childbirth in the previous 2 days. Women with a Impact of Event Scale-Revised (IES-R) score > or = to 24 will be treated with 2-4 sessions of EMDR or with SEDP.
Two follow-up assessments will be scheduled: at 6-weeks post-partum (after the end of the psychotherapeutic intervention) and at 12-weeks post-partum.
详细描述
About 30% of women evaluate their childbirth as traumatic and 3-4% women could develop post-traumatic stress disorder (PTSD) in response to traumatic childbirth. There is also a high co-morbidity between post-traumatic stress symptoms and post-partum depressive symptoms.
The aims of the present research project are:
- to investigate the effectiveness of Eye Movement Desesitization and Reprocessing (EMDR) therapy in treating post-traumatic and post-partum depressive symptoms in women who have just experienced a traumatic childbirth as compared to Supportive Expressive Dynamic Psychotherapy (SEDP);
- to evaluate the differences between EMDR and SEDP in preventing the onset of PTSD and Post-partum Depression diagnoses after three-months post-partum;
- to evaluate the effectiveness of EMDR and SEDP on associated anxiety symptoms and on mother-child bonding both after the treatment and at the follow-up evaluation;
- to compare the effects of EMDR and SEDP on physiological indexes (i.e. HRV and skin conductance) measured during the first and last treatment sessions;
- to evaluate if these physiological indexes could predict the treatments outcome (e.g. respondents vs. non respondents).
The design of this study is a multicenter, randomized controlled clinical trial.
Patients will be consecutively recruited from three clinical centers:
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •having experienced a traumatic childbirth (e.g. difficult delivery with obstetric and gynecological problems; woman's inability to tolerate the pain);
- •a score on the lES-R > or = 24;
- •good comprehension of spoken Italian;
- •legal capacity to consent to the treatment;
排除标准
- •having a baby hospitalized in Special Care Baby Unit or Neonatal Intensive Care Unit (NICU) or with a serious, unstable medical condition; (2) having experienced a stillbirth or a live birth;
- •severe suicidality, including ideation, plan, and intent;
- •current serious psychological and psychiatric disorders, including psychotic disorders,bipolar disorders, active substance abuse;
- •presence of overt dementia;
- •a serious, unstable medical condition.
结局指标
主要结局
Post-traumatic stress symptoms
时间窗: 6 weeks post-partum
Reduction of post-traumatic stress symptoms, as assessed by Impact of Event Scale -Revised (IES-R). Total score range 0-88. Cut-off for presence post-traumatic symptoms\>=33.
次要结局
- Post-traumatic stress disorder diagnosis(12 weeks post-partum)
- Post-partum depression symptoms(6 weeks post-partum)
- Post-partum depression diagnosis(12 weeks post-partum)
研究者
luca ostacoli
Associate professor of clinical psychology
University of Turin, Italy