Cognitive Behavioral Treatment for Patients With Chronic Post-Concussion Symptoms
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in Self-Reported Symptoms After Treatment
研究概览
简要总结
The current project will examine the effect of a brief psychological intervention on post-concussion symptoms, neurocognitive function, cerebral blood flow (CBF), and psychophysiological and salivary cortisol markers of autonomic nervous system (ANS) in a sample of 20 participants between 13-25 years of age who experience long-term post-concussive (PC) symptoms 2-9 months post-injury as well as 20 age- and sex-matched controls (non-injured) participants to provide normative data on all the above measures except for concussive symptoms.
详细描述
Participants with concussion will participate in six, home-based interventions designed to treat cognitive-behavioral factors that are maintaining their symptoms. The investigators hypothesize that the prolonged PC symptoms are in part due to disruption of autonomic nervous system function post-injury as well as exacerbation by the psychological response to the injury. This hypothesis is based on evidence showing that PC symptoms, including headache, fatigue, dizziness, and heightened anxiety overlap with upregulated sympathetic activity and elevated levels of salivary cortisol. There is evidence linking cognitive-behavioral factors (e.g., catastrophizing) to prolonged symptoms of autonomic overactivation after injury (e.g., anxiety, pain, etc.). The participants are taught shallow breathing techniques to normalize parasympathetic activity and provide cognitive-behavioral treatment to reduce psychological reactions to the injury that exacerbate the autonomic disruption and prolong recovery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •History of/or comorbid neurological conditions that might affect performance (including history of stroke, seizure disorder, moderate to severe traumatic brain injury, anoxia)
- •Severe cardiovascular conditions.
- •History of psychosis and current substance abuse or dependence.
- •Current severe symptoms of depression and/or anxiety.
- •Additional Exclusion Criteria for Controls:
- •* No history of concussion in the past year.
结局指标
主要结局
Change in Self-Reported Symptoms After Treatment
时间窗: baseline and 6 weeks
Severity of self-reported symptoms on the Post-Concussion Symptom Inventory
Change Self-Reported Quality of Life After Treatment
时间窗: baseline and 6 weeks
Self-reported scores on quality of life on Global Quality of Life Scale
次要结局
- Change in peak salivary cortisol after treatment(baseline and 6 weeks)
- Change in end-tidal carbon dioxide after treatment(baseline and 6 weeks)
- Change in cerebral blood flow stress after treatment(baseline and 6 weeks)
- Change in heart rate after treatment(baseline and 6 weeks)
- Change in respiration rate after treatment(baseline and 6 weeks)
- Change in blood pressure after treatment(baseline and 6 weeks)
研究者
Robert F. Asarnow, Ph.D
Study Principal Investigator
University of California, Los Angeles