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临床试验/NCT02852616
NCT02852616已完成不适用

Progression and Remittance of Traumatic Stress-related Symptoms During and After Narrative Exposure Therapy

University of Konstanz2 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2015年12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
85
试验地点
2
主要终点
Change in the progression of PTSD symptoms (PCL-5)

研究概览

简要总结

Narrative Exposure Therapy (NET) has been proven to be effective in the treatment of Posttraumatic Stress Disorder (PTSD) and trauma-related depression in more than a dozen controlled clinical trials. Symptom reduction was greatest during long-term follow-ups after the completion of the therapy.

In the current study, we will investigate the progression of PTSD symptoms and emotional stress before, during and after therapy. After a semi-structured interview all participants will be asked to report in monthly telephone interviews their core symptoms. Structured interviews after 6 and 12 months are used to validate the outcome. A convenience sample of individuals with a PTSD will be offered participation in the study.

详细描述

Participants will be recruited through the Center of Excellence for Psychotraumatology, University of Konstanz, with focus on refugees. All of them (approx. 100) will receive a structured interview and a detailed diagnosis. The interview includes questions about sociodemography, traumatic events, PTSD and depression symptomatology. Individuals with a PTSD diagnosis (up to 30) will be offered a Narrative Exposure Therapy (NET).

Irrespective of treatment and diagnosis, respondents are asked to participate in monthly telephone interviews assessing trauma-related and emotional distress and changes in life. Interviews assessing PTSD, depression symptoms and emotional distress will be conducted 6 and 12 months after the initial interview.

In addition, participants receiving NET will rate their PTSD symptoms and functionality prior to each therapy session.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
12 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • For treatment group: PTSD diagnosis (DSM-IV or V)
  • For non-treatment group: none

排除标准

  • Acute psychosis
  • Cerebro-organic disease
  • Acute drug or alcohol intoxication
  • Already receiving another psychotherapy
  • Anti-epileptic drugs at baseline

研究组 & 干预措施

Narrative Exposure Therapy

Active Comparator

Participants with a PTSD diagnosis

干预措施: Narrative Exposure Therapy (Behavioral)

no / standard treatment

No Intervention

Participants with a PTSD diagnosis / other mental health problems / no mental health problems

结局指标

主要结局

Change in the progression of PTSD symptoms (PCL-5)

时间窗: baseline, 3 and 6 months follow-up

PTSD symptoms are measured with the PTSD Checklist - 5 (PCL-5; Weathers, Litz, et al., 2013)

次要结局

  • Change in the progression of emotional distress symptoms (RHS-15)(up to 1 year)

研究者

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

Prof. Dr. Thomas Elbert

Professor for Clinical Psychology and Behavioural Neuroscience

University of Konstanz

研究点 (2)

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