Comparison of Treatments for Complex Posttraumatic Stress Disorder -a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Modum Bad
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Clinician-Administered PTSD Scale (CAPS-5) for the Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
研究概览
简要总结
This study compares three established, manual based psychotherapies for Complex Post-traumatic Stress disorder (CPTSD) in patients with childhood trauma (e.g. sexual abuse, violence). The primary aim of the study is to compare phase-oriented treatment (Stabilization + Exposure) with two non-phased treatments, Exposure and Stabilization.
详细描述
Available treatment procedures for PTSD are largely developed within the context of adult trauma (e.g. accidents, natural disasters, rape or combat). The need for additional treatment options targeting dysfunctional affect regulation and interpersonal problems in patients suffering after childhood trauma is debated in research and clinical settings.
96 patients will be recruited from referrals to an in-patient clinic in Norway called Modum Bad. After assessment, patients will be randomly assigned to one of three treatment arms. One-third will receive 10 weeks of Prolonged Exposure, one-third 10 weeks of Skills Training in Affect and Interpersonal Regulation (STAIR), and the last third a phase-based treatment lasting 16 weeks (STAIR + Narrative Therapy).
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)
盲法说明
Outcome is assessed with CAPS-V by research assistants blind to the patients allocation to treatment arms
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •childhood trauma (e.g. sexual abuse, violence prior to age 18),
- •a diagnosis of Posttraumatic Stress Disorder PTSD according to DSM-5
- •a diagnosis of Complex PTSD according to the suggested additional criteria for complex PTSD in International Classification of Diseases (ICD-11)
排除标准
- •severe psychotic disorder
- •dissociative identity disorder (DID)
- •active phase substance dependence
- •acute suicidality
- •major current life crisis
- •severely disturbed group functioning
- •mental disability
结局指标
主要结局
Clinician-Administered PTSD Scale (CAPS-5) for the Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
时间窗: approximately 15 months
30 items structured interview corresponding to the definition of PTSD in DSM-5. 20 items correspond to the symptoms for PTSD and are scored on a 0-4 severity scale to establish symptom severity (range 0-40)
次要结局
- The PTSD Checklist for DSM-5 (PCL-5)(approximately 15 months)
- Inventory of Interpersonal Problems (IIP-64)(approximately 15 months)
- Beck Depression Inventory-Second Edition (BDI-II)(approximately 15 months)