A Randomized Control Trial of Narrative Exposure Therapy Versus Treatment as Usual in the Therapy of Borderline Personality Disorder (NET)
研究概览
详细说明
Experimental intervention:
Narrative Exposure Therapy (NET), an evidence-based trauma-focussed treatment, suitable for survivors of prolonged and repeated exposure to traumatic stress and childhood adversity.
Control intervention:
Treatment as usual.
Follow-up per patient:
3 follow-up assessments- 4 weeks, 6 months,12 months and 24 months after end of experimental/ control intervention
Duration of intervention per patient:
Both treatment types will be conducted for 10-14 sessions of 60-90 min in length.
Additionally 5 sleep laboratory investigations (1 pre- and 4 post- intervention (4 weeks, 6 months, 12 months, 24 months after treatment)) will be carried out. Additionally the cortisol level in the hair and epigenetic markers will be recorded. The estimated observation time is 2 years.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
-
-
-
Kiel、德国、24105
- 招聘中
- Zentrum Integrative Psychiatrie
-
接触:
- Pabst, psychologist
- 电话号码:+49 431 9900 2681
- 邮箱:a.pabst@zip-kiel.de
-
接触:
- Seeck, MD
- 电话号码:+49 431 9900 2681
- 邮箱:m.seeck-hirschner@zip-kiel.de
-
首席研究员:
- Aldenhoff, MD
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- DSM-IV -TR Diagnosis axis II: borderline personality disorder; axis I: posttraumatic stress disorder
- stable medication
- age 18-45 years, gender female
- legal competence
- sufficient cognitive function
- sufficient knowledge of the German or English language
Exclusion Criteria:
Known severe internal, neurological, musculoskeletal, endocrinological or sleep disorders with organic origin (clinical examination during the screening visit, judged by the investigator)
- gravidity (positive ß-HCG test)
- continuing and not interruptible exposure to sexual or physical abuse
- acute suicidal tendency
- positive drug-screening in urine toxicology test
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器:treatment as usual
Treatment as usual
|
Narrative Exposure Therapy (NET), an evidence-based trauma-focussed treatment, suitable for survivors of prolonged and repeated exposure to traumatic stress and childhood adversities
|
|
实验性的:narrative exposure therapy
Narrative Exposure Therapy (NET), an evidence-based trauma-focussed treatment, suitable for survivors of prolonged and repeated exposure to traumatic stress and childhood adversities
|
Narrative Exposure Therapy (NET), an evidence-based trauma-focussed treatment, suitable for survivors of prolonged and repeated exposure to traumatic stress and childhood adversities
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Clinician-Administered PTSD Scale (CAPS)
大体时间:0 - 1 - 6 - 12 - 24 month
|
0 - 1 - 6 - 12 - 24 month
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Borderline symptom checklist 23 (BSL)
大体时间:0 - 1 - 6 - 12 - 24
|
0 - 1 - 6 - 12 - 24
|
合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.