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临床试验/NCT01443182
NCT01443182已完成不适用

Treatment of PTSD in Adult Survivors of Early Chronic Interpersonal Trauma

VU University of Amsterdam1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2011年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
68
试验地点
1
主要终点
Clinician Administered PTSD Scale (CAPS)

研究概览

简要总结

Eye movement desensitization and reprocessing (EMDR) and trauma-focused cognitive-behavioural therapy (TF-CBT) have both been found to be effective in treating post-traumatic stress disorder (PTSD) following single-event traumas and to be more effective than pure anxiety management or stabilization treatments. However, much less is known about the efficacy of the different treatment approaches in survivors of repeated or chronic interpersonal trauma. Recent evidence suggests that a combination of stabilization treatment + TF-CBT is efficacious in this population. Although EMDR is also often used in survivors of chronic interpersonal trauma, evidence on its efficacy are still poor. The aim of the current study is to compare the efficacy of (1) stabilization + TF-CBT and (2) stabilization + EMDR using a randomized controlled trial in a routine clinical setting.

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
None

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

入选标准

  • meeting DSM-IV criteria for PTSD
  • having experienced repeated or chronic interpersonal trauma (e.g., sexual or physical abuse)
  • at least 18 years of age
  • having sufficient fluency in Dutch to complete treatment and research protocol
  • participants using prescribed anti-depressant medication are required to be on a stable dose for at least 2 weeks before the beginning of treatment and remain on this dose throughout the treatment.

排除标准

  • psychiatric problems that may interfere with the study participation or that require more intensive care than can be offered in the present study, including dementia, psychotic symptoms, depression with suicidal ideation, full-blown borderline personality disorder, substance dependence
  • current use of tranquilizers

结局指标

主要结局

Clinician Administered PTSD Scale (CAPS)

时间窗: Pre- (baseline) and post-assessment (after treatment termination) and 3 month follow up (3 month after post assessment and 12 month follow up))

Posttraumatic Diagnostic Scale (PDS)

时间窗: Pre- (baseline) and post-assessment (after treatment termination) and 3 month follow up (3 month after post assessment and 12 month follow up). Before each treatment session

次要结局

  • Dissociative Experiences Scale (DES)(Pre- (baseline), after the first 8 treatment sessions and post-assessment (after treatment termination) and 3 month follow up (3 month after post assessment and 12 month follow up)))
  • Difficulties in Emotion Regulation Scale (DERS)(Pre- (baseline), after the first 8 treatment sessions and post-assessment (after treatment termination) and 3 month follow up (3 month after post assessment and 12 month follow up)))
  • Beck Anxiety Inventory (BAI)(Pre- (baseline), after the first 8 treatment sessions and post-assessment (after treatment termination) and 3 month follow up (3 month after post assessment and 12 month follow up)))
  • Beck Depression Inventory (BDI)(Pre- (baseline), after the first 8 treatment sessions and post-assessment (after treatment termination) and 3 month follow up (3 month after post assessment and 12 month follow up)))
  • Inventory of Interpersonal Problems (IIP)(Pre- (baseline), after the first 8 treatment sessions and post-assessment (after treatment termination) and 3 month follow up (3 month after post assessment and 12 month follow up)))

研究者

发起方
VU University of Amsterdam
申办方类型
Other
责任方
Principal Investigator
主要研究者

Paul M.G.Emmelkamp

Professor

University of Amsterdam

研究点 (1)

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