跳至主要内容
临床试验/NCT02989987
NCT02989987已完成不适用

Narrative Exposure Therapy for Survivors of Sexual and Gender Based Violence in Eastern DR Congo

University of Konstanz2 个研究点 分布在 1 个国家目标入组 201 人开始时间: 2016年9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
201
试验地点
2
主要终点
SVQ: Severity of shame (sumscore)

研究概览

简要总结

Throughout the last 10 years Narrative Exposure Therapy (NET) has evolved as one of the most effective, culturally sensitive trauma interventions. In the present study the effectiveness of NET delivered by trained health personnel in a sample of survivors of sexual and gender based violence (SGBV) who suffer from Posttraumatic Stress Disorder (PTSD) will be assessed. Structured baseline, 3 and 6 month follow up interviews will be administered to assess the main outcome measures PTSD and shame. The trial will take place in Goma, DR Congo, where SGBV and its sequelae has been a major problem.

详细描述

Participants will be recruited through local NGOs and eligible clients randomized to the treatment (NET; app. N=100) or treatment-as-usual control (app. N=100) group, respectively. At baseline, 3-month and 6-month post-treatment, sociodemographic data, trauma exposure - esp. SGBV, PTSD, dissociation, shame, functionality and depression will be assessed in a structured interview. The interviews will be conducted by blind Congolese psychological interviewers after an intensive 3-weeks training and continuous supervision.

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
Single (Outcomes Assessor)

入排标准

年龄范围
16 Years 至 80 Years(Child, Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • SGBV survivors (event happened more than 4 weeks ago)
  • PTSD diagnosis (DSM-5)

排除标准

  • Acute psychosis
  • Signs of cerebro-organic disease
  • Acute drug or alcohol intoxication

研究组 & 干预措施

Narrative Exposure Therapy

Active Comparator

According to the NET manual (one lifeline session and 7 exposure sessions; see Schauer et al. 2011).

干预措施: Narrative Exposure Therapy (Behavioral)

Treatment-as-usual

Active Comparator

Social support (provided on demand)

干预措施: Social Support (Behavioral)

结局指标

主要结局

SVQ: Severity of shame (sumscore)

时间窗: Change from baseline to 3 and 6 months post treatment

Shame Variability Questionnaire (Brown, Rizvi \& Linehan, unpublished)

PSS-I: Posttraumatic Stress Disorder symptom severity (sumscore and diagnosis)

时间窗: Change from baseline to 3 and 6 months post treatment

PTSD Symptom Scale - Interview (PSS-I; Foa \& Tolin, 2000)

次要结局

  • PHQ: Depression symptom severity (sumscore)(Change in 3 and 6 months post treatment)
  • Functionality (sumscore)(3 and 6 months post treatment)
  • ShutD: Severity of Shutdown Dissociation Symptoms (sumscore)(Change from baseline to 3 and 6 months post treatment)

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

Anke Köbach

Postdoctoral Researcher

University of Konstanz

研究点 (2)

Loading locations...

相似试验