NCT01033708Unknown不适用
A Randomized Control Trial of Narrative Exposure Therapy Versus Treatment as Usual in the Therapy of Borderline Personality Disorder
Zentrum für Integrative Psychiatrie2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2009年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Clinician-Administered PTSD Scale (CAPS)
研究概览
简要总结
Definition of the efficacy of NET compared with "treatment as usual" in the treatment of patients with complex traumatic disease (borderline personality disorder (BPD) and posttraumatic stress disorder (PTSD)) as assessed by structured clinical interviews. Furthermore, to evaluate the sleep, cortisol level and epigenetic differences in the process of the specific therapy compared to treatment as usual.
详细描述
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:
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Clinician-Administered PTSD Scale (CAPS)
时间窗: 0 - 1 - 6 - 12 - 24 month
次要结局
- Borderline symptom checklist 23 (BSL)(0 - 1 - 6 - 12 - 24)
研究者
研究点 (2)
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