Cognitive-Behavioural Therapy as a Preventive Treatment for Post Traumatic Stress Disorder
Cognitive-Behavioural Therapy as a Preventive Treatment for Post Traumatic Stress Disorder: An Randomized Controlled Trial in the Acute Trauma Care
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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-
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Stockholm、瑞典、17177
- Karolinska Institutet
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Modified prolonged exposure therapy
Participants will receive three sessions of modified prolonged exposure therapy.
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Participants will receive three sessions of modified prolonged exposure therapy.
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安慰剂比较：Attention control
Participants will receive three sessions of supportive counselling and psychoeducation
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Participants will receive three sessions of supportive counselling and psychoeducation
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
CLINICIAN-ADMINISTERED PTSD SCALE for Diagnostic and Statistical Manual of Mental Disorders-5 (CAPS)
大体时间：Change 2-, 6- (primary endpoint) and 12 months after intervention
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Clinical interview that gives a continuous measure of PTSD severity and dichotomous diagnosis of PTSD
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Change 2-, 6- (primary endpoint) and 12 months after intervention
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-5 (PCL-5)
大体时间：Change 2-, 6- (primary endpoint) and 12 months after intervention
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Self-report questionnaire for the assessment of PTSD severity
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Change 2-, 6- (primary endpoint) and 12 months after intervention
|
|
Montgomery Åsberg Depression Rating Scale - Self-report (MADRS-S)
大体时间：Change from baseline to 2, 6 (primary endpoint) and 12 months after intervention
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Self-report questionnaire for the assessment of severity of depression
|
Change from baseline to 2, 6 (primary endpoint) and 12 months after intervention
|
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Euroqol (EQ-5D)
大体时间：Measured 6 months after intervention
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Measure of general health and quality of life
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Measured 6 months after intervention
|
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WHO Disability Assessment Schedule (WHODAS)
大体时间：Change 2-, 6- (primary endpoint) and 12 months after intervention
|
Measure of general health and function
|
Change 2-, 6- (primary endpoint) and 12 months after intervention
|
|
Adverse events
大体时间：Change 2-, 6- (primary endpoint) and 12 months after intervention
|
Measure of number adverse events
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Change 2-, 6- (primary endpoint) and 12 months after intervention
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Subjective unit of distress scale (SUD)
大体时间：Change at week 1, week 2 and week 3
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Ratings of distress
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Change at week 1, week 2 and week 3
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Intrusion diary
大体时间：Change at week 1, week 2 and week 3
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A self-report diary on number of intrusions
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Change at week 1, week 2 and week 3
|
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Insomnia Severity Index (ISI)
大体时间：Change 2-, 6- (primary endpoint) and 12 months after intervention
|
Self-report questionnaire regarding insomnia
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Change 2-, 6- (primary endpoint) and 12 months after intervention
|
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Multidimensional Scale of Perceived Social Support (MSPSS)
大体时间：Change 2-, 6- (primary endpoint) and 12 months after intervention
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A measure to assess for social support
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Change 2-, 6- (primary endpoint) and 12 months after intervention
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Trimbos Institute of costs in psychiatry (TIC-P)
大体时间：Measured at 6 (primary endpoint) months after the intervention
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Self-report measure on societal costs
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Measured at 6 (primary endpoint) months after the intervention
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- EPN 2015/1820-31
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