A fMRI Study of the Treatment of Danish Veterans With Post-Traumatic Stress Disorder With Prolonged Exposure Therapy: Study Protocol for a Case-control Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 主要终点
- Psychometric changes
研究概览
简要总结
In this article, the investigators report the design and protocol of a functional magnetic resonance imaging study (fMRI) of the treatment of Danish veterans with PTSD with Prolonged Exposure Therapy (PE). In total 30 Danish veterans will be recruited, who meet the ICD-10 diagnostic criteria for PTSD, and treated with PE. A group of controls will be recruited consisting of age-appropriate same sex veterans who have participated in international missions similar to the patient group
详细描述
Primary outcome measures are the changes in d2-test assessment of attention and concentration, Beck Depression Inventory, Post-traumatic Symptom Scale-Interview version and PTSD Checklist- Military Version.
Secondary outcome measures concern changes of Brain Derived Neurotrophic Factor (BNDF) and changes in the brain structure with focus on the hippocampal function using fMRI.
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
- None
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Cases: Danish veterans with ICD-10 diagnostic criteria for PTSD
- •Controls: Danish veterans without ICD-10 diagnostic criteria for PTSD
排除标准
- •Participants who have an active abuse of psychoactive substances with daily consumption.
- •Participants who consume more than 21 units of alcohol per week, and who, during the last month, have had repetitive episodes with craving, episodes of loss of control due to alcohol consumption, and a weakened ability to manage consumption, stop or reduce consumption
- •Participants who have a current ICD-10 diagnosis within:
- •F20 to F29 Schizophrenia
- •Schizotypical mental disorder
- •Delusional disorder
- •Acute and transient psychotic disorders and Schizoaffective psychosis
- •F30 Manic single episode
- •F31 Bipolar affective disorder
- •F60.2 Dyssocial personality structure
- •F60.3 Emotionally unstable personality structure
- •F90 Hyperkinetic disorder (ADHD) F98.8 Other behavioural and emotional disorders in childhood and adolescence (ADD)
- •Participants who have a daily intake of sedative, anxiolytic
- •Participants who score below 23 on the Mini Mental State Examination, and (5)
- •Participants who within the last 3 months have had a serious suicide attempt.
- •Exclusion criteria related to the fMRI scanning include:
- •Ferromagnetic prostheses (including straps prostheses, clips on blood vessels, pacemakers, and metal splinters)
- •claustrophobia and movements during the scan.
结局指标
主要结局
Psychometric changes
时间窗: Baseline - 3-6-12-36 months
Primary outcome measures are the changes in d2-test assessment of attention and concentration, Beck Depression Inventory, Post-traumatic Symptom Scale-Interview version and PTSD Checklist- Military Version.
次要结局
- Biomedical changes(Baseline - end of treatment - 36 months)
研究者
Jørgen Aagaard
MD, professor, senior consultant, DrMedSc
Aalborg University Hospital