The Role of Computerized Training in Post-Traumatic Stress Disorder
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Dysfunctional trauma-related appraisals as measured using an open-ended ambiguous scenarios task
研究概览
简要总结
The purpose of this study is to determine whether a computerized training, "Cognitive Bias Modification" targetting appraisals (CBM-App), can reduce dysfunctional appraisals of trauma in patients with Post-Traumatic Stress Disorder (PTSD), compared to a control condition. Other outcomes measured include symptoms of PTSD and trauma-relevant dysfunctional cognitions. Participants are recruited from inpatients with PTSD admitted to the Clinic for Psychosomatic Medicine and Psychotherapy, LWL University Clinic of Ruhr University of Bochum.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary diagnosis of Post-Traumatic Stress Disorder according to ICD-10 (F43.1), and DSM-5 (as assessed via Clinician Adminstered PTSD Scale for DSM-5)
- •motivated and willing to take part in the study (including questionnaire measures, computer training, filling out questionnaires after discharge)
- •aged 18-60 years, male or female
- •fluent in German
排除标准
- •Substance abuse/ substance dependence currently or in the past six months
- •active suicidal thoughts or intentions
- •psychotic disorder (past or present)
- •learning disability/ intellectual impairment
- •red-green colour blindness
研究组 & 干预措施
Intervention
Computerized Cognitive Bias Modification of Appraisals (CBM-App), developed from that used by Woud et al. (2012,2013). The intervention comprises 8 sessions completed over a period of 2 weeks. The training takes place while participants are also receiving specialized inpatient treatment for PTSD at the Clinic for Psychosomatic Medicine and Psychotherapy, LWL University Clinic of Ruhr University of Bochum.
干预措施: Cognitive Bias Modification of Appraisals (CBM-App) (Behavioral)
Control
Computerized Peripheral Vision Task (PVT), developed from that used by Calkins et al. (2015). The intervention comprises 8 sessions completed over a period of 2 weeks. The training takes place while participants are also receiving specialized inpatient treatment for PTSD at the Clinic for Psychosomatic Medicine and Psychotherapy, LWL University Clinic of Ruhr University of Bochum.
干预措施: Peripheral Vision Task (control condition) (Behavioral)
结局指标
主要结局
Dysfunctional trauma-related appraisals as measured using an open-ended ambiguous scenarios task
时间窗: Post-intervention (~ 2 weeks post-baseline)
次要结局
- Intrusions Questionnaire(Baseline, Mid-intervention (~1 week post-baseline), Post-intervention (~2 weeks post-baseline), End of inpatient admission (~6 weeks post-baseline), 6 weeks post-discharge, 3 months post-discharge)
- Trauma Implicit Associations Test (IAT)(Baseline, Post-intervention (~2 weeks post-baseline))
- Dysfunctional trauma-related appraisals as measured using an open-ended ambiguous scenarios task(Baseline, Mid-intervention (~1 week post-baseline), End of inpatient admission (~6 weeks post-baseline), 6 weeks post-discharge, 3 months post-discharge)
- Post-Traumatic Cognitions Inventory (PTCI)(Baseline, Mid-intervention (~1 week post-baseline), Post-intervention (~2 weeks post-baseline), End of inpatient admission (~6 weeks post-baseline), 6 weeks post-discharge, 3 months post-discharge)
- PTSD Checklist for DSM-5 (PCL-5)(Baseline, Mid-intervention (~1 week post-baseline), Post-intervention (~2 weeks post-baseline), End of inpatient admission (~6 weeks post-baseline), 6 weeks post-discharge, 3 months post-discharge)
研究者
Marcella Woud
Postdoctoral Research Fellow
Ruhr University of Bochum