Clinical trial NCT03759808: Treatment for Patients With Chronic Post-Concussion Symptoms
Official title: Cognitive Behavioral Treatment for Patients With Chronic Post-Concussion Symptoms
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mild Traumatic Brain Injury
Concussion Post Syndrome
Keywords: post-concussion syndrome
mild traumatic brain injury
autonomic dysfunction
concussion
capnometry-assisted respiratory training
cognitive behavioral therapy
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2018-11-30
Enrollment: 40
Sex: ALL
Minimum age (years): 13
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Self-Reported Symptoms After Treatment
timeFrame: baseline and 6 weeks
measure: Change Self-Reported Quality of Life After Treatment
timeFrame: baseline and 6 weeks
Secondary outcomes:
measure: Change in cerebral blood flow stress after treatment
timeFrame: baseline and 6 weeks
measure: Change in peak salivary cortisol after treatment
timeFrame: baseline and 6 weeks
measure: Change in respiration rate after treatment
timeFrame: baseline and 6 weeks
measure: Change in end-tidal carbon dioxide after treatment
timeFrame: baseline and 6 weeks
measure: Change in heart rate after treatment
timeFrame: baseline and 6 weeks
measure: Change in blood pressure after treatment
timeFrame: baseline and 6 weeks
Other outcomes:
measure: Change in depressive symptoms after treatment
timeFrame: baseline and 6 weeks
measure: Change in anxiety symptoms after treatment
timeFrame: baseline and 6 weeks
measure: Change in sleep quality after treatment
timeFrame: baseline and 6 weeks
measure: Change in neurocognitive performance after treatment
timeFrame: baseline and 6 weeks
measure: Change in perceived cognitive exertion after treatment
timeFrame: baseline and 6 weeks
measure: Change in illness perception after treatment
timeFrame: baseline and 6 weeks
measure: Change in behavioral avoidance and distress after treatment
timeFrame: baseline and 6 weeks
measure: Change in disability perception due to injury after treatment
timeFrame: baseline and 6 weeks
measure: Change in orthostatic blood pressure after treatment
timeFrame: baseline and 6 weeks
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Robert Asarnow, PhD
role: PRINCIPAL_INVESTIGATOR
References: