Treatment for Patients With Chronic Post-Concussion Symptoms

Mild Traumatic Brain Injury Clinical Trial

Official title:

Cognitive Behavioral Treatment for Patients With Chronic Post-Concussion Symptoms

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03759808
• Other study ID #: 17-000346
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: February 1, 2023

Study information

• Verified date: October 2021
• Source: University of California, Los Angeles
• Contact: Aliyah R Snyder, PhD
• Phone: 3109169460
• Email: asnyder[@]mednet.ucla.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: February 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Concussion Post Syndrome
• Mild Traumatic Brain Injury
• Post-Concussion Syndrome

Intervention

Behavioral:
• Psychological 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.

Locations

Country	Name	City	State
United States	University of California, Los Angeles	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in depressive symptoms after treatment	Self-report measure of cognitive and somatic symptoms of depression, Beck Depression Inventory (BDI-II)	baseline and 6 weeks
Other	Change in anxiety symptoms after treatment	Self-report measure of cognitive and somatic symptoms of anxiety, Beck Anxiety Inventory (BAI)	baseline and 6 weeks
Other	Change in sleep quality after treatment	Self-report measure of sleep dysfunction, Pittsburgh Sleep Quality Index (PSQI)	baseline and 6 weeks
Other	Change in neurocognitive performance after treatment	Selected 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.	baseline and 6 weeks
Other	Change in perceived cognitive exertion after treatment	Change in self-reported physical, emotional, and perceived cognitive symptoms from pre- to post-neurocognitive assessment.	baseline and 6 weeks
Other	Change in illness perception after treatment	Change in self-reported perception of illness as measured by the Brief Illness Perception Questionnaire.	baseline and 6 weeks
Other	Change in behavioral avoidance and distress after treatment	Change in self-reported behavioral avoidance and distress due to anxiety as measured by the UCLA Behavioral Avoidance and Distress Scale	baseline and 6 weeks
Other	Change in disability perception due to injury after treatment	Change in self-reported disability in social, occupational, and family/home functioning as measured by the Sheehan Disability Scale	baseline and 6 weeks
Other	Change in orthostatic blood pressure after treatment	Change 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.	baseline and 6 weeks
Primary	Change in Self-Reported Symptoms After Treatment	Severity of self-reported symptoms on the Post-Concussion Symptom Inventory	baseline and 6 weeks
Primary	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	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
Secondary	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
Secondary	Change in respiration rate after treatment	Changes in respiration rate as measured through capnometer in response to stress paradigm	baseline and 6 weeks
Secondary	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
Secondary	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
Secondary	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