Skip to content

Treatment for Patients With Chronic Post-Concussion Symptoms

Cognitive Behavioral Treatment for Patients With Chronic Post-Concussion Symptoms

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03759808
Enrollment
40
Registered
2018-11-30
Start date
2018-06-01
Completion date
2023-02-01
Last updated
2021-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Concussion Post Syndrome, Mild Traumatic Brain Injury

Keywords

post-concussion syndrome, mild traumatic brain injury, autonomic dysfunction, concussion, capnometry-assisted respiratory training, cognitive behavioral therapy

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.

Interventions

BEHAVIORALPsychological Intervention

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.

Sponsors

University of California, Los Angeles
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
13 Years to 25 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Self-Reported Symptoms After Treatmentbaseline and 6 weeksSeverity of self-reported symptoms on the Post-Concussion Symptom Inventory
Change Self-Reported Quality of Life After Treatmentbaseline and 6 weeksSelf-reported scores on quality of life on Global Quality of Life Scale

Secondary

MeasureTime frameDescription
Change in blood pressure after treatmentbaseline and 6 weeksChanges in blood pressure (systolic/dyastolic in mmHg) in response to stress paradigm measured through Biopac system.
Change in cerebral blood flow stress after treatmentbaseline and 6 weeksChanges in cerebral blood flow dynamics in bilateral middle cerebral arteries as measured by transcranial doppler.
Change in peak salivary cortisol after treatmentbaseline and 6 weeksChanges 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 respiration rate after treatmentbaseline and 6 weeksChanges in respiration rate as measured through capnometer in response to stress paradigm
Change in end-tidal carbon dioxide after treatmentbaseline and 6 weeksChanges in end-tidal carbon dioxide measurement in response to stress paradigm measured through capnometer in mmHg
Change in heart rate after treatmentbaseline and 6 weeksChanges in heart rate (beats per minute) in response to stress paradigm measured through Biopac system.

Other

MeasureTime frameDescription
Change in behavioral avoidance and distress after treatmentbaseline and 6 weeksChange in self-reported behavioral avoidance and distress due to anxiety as measured by the UCLA Behavioral Avoidance and Distress Scale
Change in disability perception due to injury after treatmentbaseline and 6 weeksChange in self-reported disability in social, occupational, and family/home functioning as measured by the Sheehan Disability Scale
Change in orthostatic blood pressure after treatmentbaseline and 6 weeksChange in orthostatic blood pressure obtained via measurements in three different positions: supine, upright sitting, and standing, each held for 5 minutes. Measurement obtained via Biopac double finger cuff.
Change in depressive symptoms after treatmentbaseline and 6 weeksSelf-report measure of cognitive and somatic symptoms of depression, Beck Depression Inventory (BDI-II)
Change in anxiety symptoms after treatmentbaseline and 6 weeksSelf-report measure of cognitive and somatic symptoms of anxiety, Beck Anxiety Inventory (BAI)
Change in sleep quality after treatmentbaseline and 6 weeksSelf-report measure of sleep dysfunction, Pittsburgh Sleep Quality Index (PSQI)
Change in neurocognitive performance after treatmentbaseline and 6 weeksSelected subtest performance on attention, learning and memory, processing speed, and verbal fluency as measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) standardized assessment.
Change in perceived cognitive exertion after treatmentbaseline and 6 weeksChange in self-reported physical, emotional, and perceived cognitive symptoms from pre- to post-neurocognitive assessment.
Change in illness perception after treatmentbaseline and 6 weeksChange in self-reported perception of illness as measured by the Brief Illness Perception Questionnaire.

Countries

United States

Contacts

Primary ContactAliyah R Snyder, PhD
asnyder@mednet.ucla.edu3109169460

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026