Cognitive-Behavioural Therapy as a Preventive Treatment for Post Traumatic Stress Disorder: An Randomized Controlled Trial in the Acute Trauma Care
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 352
- 试验地点
- 2
- 主要终点
- CLINICIAN-ADMINISTERED PTSD SCALE for Diagnostic and Statistical Manual of Mental Disorders-5 (CAPS)
研究概览
简要总结
This study will examine the use of modified prolonged exposure therapy in trauma patients recently exposed to trauma in an emergency room to prevent the onset of post-traumatic stress disorder.
详细描述
This study investigates if prolonged exposure is an effective treatment in reducing PTSD symptoms people who have recently experienced trauma. The study will also investigate predictive markers of PTSD, moderators of successful treatment and health economic aspects of the intervention.
Participants will first undergo an evaluation session that will include an interview (Immediate Stress Reaction Checklist) and questionnaires. Participants will subsequently be randomly assigned to receive either modified prolonged exposure therapy or attention control, starting the assigned intervention immediately. Participants in each arm will receive three weekly treatment sessions. Treatment will involve psychoeducation about common reactions to trauma, imaginal exposure (revisiting memories of a recent trauma out loud with a therapist and audio-recording these for review at home), exposure in vivo and breathing retraining. All participants will undergo assessments 2, 6 (primary endpoint) and 12 months after the intervention by blinded assessors. Patients unable to come to the clinic for follow-up assessments will be interviewed via telephone or skype. Source data will be quality monitored by an independent party (Karolinska trial alliance) according to the Helsinki Declaration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presenting to the emergency department at the Karolinska University hospital Solna in the past 72 hours before the intervention
- •Meets diagnostic criterion A for post-traumatic stress disorder in the fifth version of Diagnostic and Statistical Manual of Mental Disorders, DSM-5
排除标准
- •Do not want to participate in the study
- •Ongoing intoxication (e.g. severe alcohol intoxication)
- •Other serious psychiatric comorbidity that demands attention (e.g. manic episode, acute suicidal ideation)
- •Not oriented
- •Not having a memory ot the tramatic event
结局指标
主要结局
CLINICIAN-ADMINISTERED PTSD SCALE for Diagnostic and Statistical Manual of Mental Disorders-5 (CAPS)
时间窗: Change 2-, 6- (primary endpoint) and 12 months after intervention
Clinical interview that gives a continuous measure of PTSD severity and dichotomous diagnosis of PTSD
次要结局
- PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-5 (PCL-5)(Change 2-, 6- (primary endpoint) and 12 months after intervention)
- Montgomery Åsberg Depression Rating Scale - Self-report (MADRS-S)(Change from baseline to 2, 6 (primary endpoint) and 12 months after intervention)
- Intrusion diary(Change at week 1, week 2 and week 3)
- Trimbos Institute of costs in psychiatry (TIC-P)(Measured at 6 (primary endpoint) months after the intervention)
- Euroqol (EQ-5D)(Measured 6 months after intervention)
- WHO Disability Assessment Schedule (WHODAS)(Change 2-, 6- (primary endpoint) and 12 months after intervention)
- Insomnia Severity Index (ISI)(Change 2-, 6- (primary endpoint) and 12 months after intervention)
- Adverse events(Change 2-, 6- (primary endpoint) and 12 months after intervention)
- Subjective unit of distress scale (SUD)(Change at week 1, week 2 and week 3)
- Multidimensional Scale of Perceived Social Support (MSPSS)(Change 2-, 6- (primary endpoint) and 12 months after intervention)
研究者
Erik Andersson
Principal Investigator
Karolinska Institutet