The Outcome of Treatment of Traumatised Refugees With Trauma-Focused Cognitive Behavioural Therapy and / or Antidepressants - a Randomised Controlled Trial
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
- 否
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
Both drug and psychotherapy
干预措施: Sertraline (Drug)
psychotherapy
Trauma-focused cognitive behavioral therapy
干预措施: trauma-focused cognitive behavioural therapy (Behavioral)
Drug
drug treatment and psychoeducation
干预措施: Sertraline (Drug)
Combination
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
Caecilie Buhmann
Dr
Psykiatrisk Center Gentofte
