Treatment for Patients With Chronic Post-Concussion Symptoms
- Conditions
- Mild Traumatic Brain InjuryConcussion Post Syndrome
- Interventions
- Behavioral: Psychological Intervention
- Registration Number
- NCT03759808
- Lead Sponsor
- University of California, Los Angeles
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
Not provided
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Persistent Post-Concussion Symptoms Psychological Intervention Concussed participants with persistent post-concussion symptoms (PPCS) who receive the psychological intervention.
- Primary Outcome Measures
Name Time Method Change in Self-Reported Symptoms After Treatment baseline and 6 weeks Severity of self-reported symptoms on the Post-Concussion Symptom Inventory
Change Self-Reported Quality of Life After Treatment baseline and 6 weeks Self-reported scores on quality of life on Global Quality of Life Scale
- Secondary Outcome Measures
Name Time Method Change in peak salivary cortisol after treatment baseline and 6 weeks Changes in peak salivary cortisol concentration will be measured in response to stress paradigm. Measurements will be taken just prior to stress paradigm and then 20 minutes after its conclusion.
Change in end-tidal carbon dioxide after treatment baseline and 6 weeks Changes in end-tidal carbon dioxide measurement in response to stress paradigm measured through capnometer in mmHg
Change in cerebral blood flow stress after treatment baseline and 6 weeks Changes in cerebral blood flow dynamics in bilateral middle cerebral arteries as measured by transcranial doppler.
Change in heart rate after treatment baseline and 6 weeks Changes in heart rate (beats per minute) in response to stress paradigm measured through Biopac system.
Change in respiration rate after treatment baseline and 6 weeks Changes in respiration rate as measured through capnometer in response to stress paradigm
Change in blood pressure after treatment baseline and 6 weeks Changes in blood pressure (systolic/dyastolic in mmHg) in response to stress paradigm measured through Biopac system.
Trial Locations
- Locations (1)
University of California, Los Angeles
🇺🇸Los Angeles, California, United States