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临床试验/NCT00716638
NCT00716638已完成不适用

Trauma-focused CBT vs. EMDR in the Treatment of Posttraumatic Stress Disorder

VU University of Amsterdam2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2008年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
PTSD symptom severity: (a) interviewer rating (PSS-I); (b) self-report (PDS)

研究概览

简要总结

This study will evaluate the effectiveness of trauma-focused cognitive behaviour therapy (TF-CBT) versus eye movement desensitization and reprocessing (EMDR) in the treatment of trauma survivors with post-traumatic stress disorder (PTSD). Patients will be randomly assigned to TF-CBT or EMDR. Follow-up assessments will be conducted at 3 and 12 months post-treatment. In addition to comparing the efficacy of the two protocols, an additional focus will lie on identifying predictors for treatment outcome.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • A full diagnosis of PTSD according to the DSM-IV or subthreshold PTSD (criteria for intrusive re-experiencing are fulfilled and either three avoidance/numbing symptoms or two hyperarousal symptoms are present)
  • PTSD is related to one or more single-event traumas and participants have a clear memory of this event/these events (sufficient for constructing scenes to be used in exposure)
  • Age between 18 and 70
  • Sufficient fluency in Dutch to complete treatment and research protocol
  • If participants are using anti-depressants, they need 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

  • Dementia or other severe cognitive impairment
  • Psychosis
  • Depression with suicidal ideation
  • Bipolar disorder
  • Borderline Personality Disorder
  • Anti-social personality disorder
  • Substance dependence
  • Current use of tranquilizers
  • Exposure to prolonged and/or chronic trauma ("type-II-trauma")

研究组 & 干预措施

Treatment group 1

Experimental

Trauma-focused Cognitive Behavior Therapy (TF-CBT)

干预措施: Trauma-focused Cognitive Behavior Therapy (Behavioral)

Treatment group 2

Experimental

Eye Movement Desensitization and Reprocessing (EMDR)

干预措施: Eye Movement Desensitization and Reprocessing (EMDR) (Behavioral)

结局指标

主要结局

PTSD symptom severity: (a) interviewer rating (PSS-I); (b) self-report (PDS)

时间窗: Assessed at post-treatment, 3 months and 12 months follow-up

次要结局

  • Depressive symptom severity (Beck Depression Inventory, BDI)(assessed at post-treatment, 3 months and 12 months follow-up)
  • Severity of anxiety symptoms (Beck Anxiety Inventory, BAI)(assessed at posttreatment, 3 months and 12 months follow-up)
  • Trauma-related appraisal (Posttraumatic Cognitions Inventory, PTCI)(post-treatment)

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

VU University of Amsterdam

研究点 (2)

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