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临床试验/NCT00917397
NCT00917397已完成4 期

The Outcome of Treatment of Traumatised Refugees With Trauma-Focused Cognitive Behavioural Therapy and / or Antidepressants - a Randomised Controlled Trial

Caecilie Buhmann1 个研究点 分布在 1 个国家目标入组 280 人开始时间: 2009年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
280
试验地点
1
主要终点
Score on Harvard Traume Questionnaire (PTSD)

研究概览

简要总结

The purpose of the study is to investigate the effect of treatment of traumatized refugees with a diagnosis of Post-Traumatic Stress Disorder (PTSD). The existing evidence point towards antidepressants of the type SSRI and trauma-focused cognitive Behavioural Therapy being the most effective treatments of PTSD, but very little evidence of treatment effects exist for the group of multitraumatized refugees. This study therefore seeks to investigate the treatment effect of 6 months drug therapy with antidepressants (Sertraline and/ or Mianserine) and/or trauma-focused cognitive behavioral therapy. A total of 200 individual will undergo treatment. They will be randomized to 4 different groups: antidepressants, psychotherapy, a combination og drug and psychotherapy and a waiting list. Outcome measures include symptoms, life quality and function. Patients with a diagnosis of drug abuse or psychosis will not be included. The hypothesis is that a combination of antidepressants and psychotherapy will be more effective than either of the two treatment regimes on their own.

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

  • Adult traumatised refugee with PTSD

排除标准

  • psychosis and drug abuse

研究组 & 干预措施

Combination

Experimental

Both drug and psychotherapy

干预措施: Sertraline (Drug)

psychotherapy

Experimental

Trauma-focused cognitive behavioral therapy

干预措施: trauma-focused cognitive behavioural therapy (Behavioral)

Drug

Experimental

drug treatment and psychoeducation

干预措施: Sertraline (Drug)

Combination

Experimental

Both drug and psychotherapy

干预措施: trauma-focused cognitive behavioural therapy (Behavioral)

结局指标

主要结局

Score on Harvard Traume Questionnaire (PTSD)

时间窗: before entry, after 6 months treatment and at follow up

次要结局

未报告次要终点

研究者

发起方
Caecilie Buhmann
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Caecilie Buhmann

Dr

Psykiatrisk Center Gentofte

研究点 (1)

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