Treatment for Patients With Chronic Post-Concussion Symptoms

Study Overview
=================
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.

Official Title
-----------------
Cognitive Behavioral Treatment for Patients With Chronic Post-Concussion Symptoms

Conditions
-----------------
Mild Traumatic Brain Injury, Concussion Post Syndrome

Intervention / Treatment
-----------------
* Behavioral: Psychological Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria for patients: Between the ages of 13-25 Diagnosed with a concussion or mild traumatic brain injury by a physician Currently experiencing post-concussive symptoms for at least two months after their injury but no longer than 9 months. Fluent English speaker Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 25 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: An open trial will be conducted in patients with persistent post-concussion symptoms compared to non-injured controls in order to determine whether the intervention (controlled breathing and cognitive behavioral therapy for anxiety) improves parasympathetic, HPA axis activity and cerebral blood flow, and whether improvement in parasympathetic and HPA axis activity predicts reduction in PPCS symptoms. We will compare baseline evaluations to the evaluation conducted after brief CBT and controlled breathing training to demonstrate the feasibility of normalizing parasympathetic, and HPA axis activity via this intervention. If we obtain the predicted results in the current study we will design a much larger study to identify the mechanisms of change. Healthy, non-injured control participants will provide normative data on all measures except for concussion-relevant outcomes.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Persistent Post-Concussion Symptoms<br>Concussed participants with persistent post-concussion symptoms (PPCS) who receive the psychological intervention. | Behavioral: Psychological Intervention<br>* Psychological treatment protocol designed to treat anxiety and avoidance in an adolescent/young adult population. The focus of treatment will be to address cognitive and behavioral factors associated with prolonged symptoms. Cognitive factors that may be addressed include, but are not limited to, catastrophizing, black or white thinking, and false expectations. Behavior factors that may be addressed include, but are not limited to, avoidance, relaxation, and behavioral activation. The psychological intervention is also designed to help reduce psychophysiological arousal associated with anxiety and stress. Participants will also be taught controlled shallow breathing exercises designed to normalize the ratio of sympathetic/parasympathetic activity.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Self-Reported Symptoms After Treatment | Severity of self-reported symptoms on the Post-Concussion Symptom Inventory | baseline and 6 weeks | 
| Change Self-Reported Quality of Life After Treatment | Self-reported scores on quality of life on Global Quality of Life Scale | baseline and 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cerebral blood flow stress after treatment | Changes in cerebral blood flow dynamics in bilateral middle cerebral arteries as measured by transcranial doppler. | baseline and 6 weeks | 
| Change in peak salivary cortisol after treatment | 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. | baseline and 6 weeks | 
| Change in respiration rate after treatment | Changes in respiration rate as measured through capnometer in response to stress paradigm | baseline and 6 weeks | 
| Change in end-tidal carbon dioxide after treatment | Changes in end-tidal carbon dioxide measurement in response to stress paradigm measured through capnometer in mmHg | baseline and 6 weeks | 
| Change in heart rate after treatment | Changes in heart rate (beats per minute) in response to stress paradigm measured through Biopac system. | baseline and 6 weeks | 
| Change in blood pressure after treatment | Changes in blood pressure (systolic/dyastolic in mmHg) in response to stress paradigm measured through Biopac system. | baseline and 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
post-concussion syndrome, mild traumatic brain injury, autonomic dysfunction, concussion, capnometry-assisted respiratory training, cognitive behavioral therapy