Treatment for Patients With Chronic Post-Concussion Symptoms

Cognitive Behavioral Treatment for Patients With Chronic Post-Concussion Symptoms

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.

Study Overview

• Status: Recruiting
• Conditions: Mild Traumatic Brain Injury; Concussion Post Syndrome
• Intervention / Treatment: Behavioral: Psychological Intervention

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aliyah R Snyder, PhD; Phone Number: 3109169460; Email: asnyder@mednet.ucla.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • Recruiting
      • University of California, Los Angeles
      • Contact: Aliyah R Snyder, PhD; Phone Number: 310-916-9460; Email: hips@mednet.ucla.ed
      • Contact: Alexandra Tanner, MS; Email: tannera@ucla.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Persistent Post-Concussion Symptoms; Concussed participants with persistent post-concussion symptoms (PPCS) who receive the psychological 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.

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Change in anxiety symptoms after treatment	Self-report measure of cognitive and somatic symptoms of anxiety, Beck Anxiety Inventory (BAI)	baseline and 6 weeks
Change in sleep quality after treatment	Self-report measure of sleep dysfunction, Pittsburgh Sleep Quality Index (PSQI)	baseline and 6 weeks
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Investigators: Principal Investigator: Robert Asarnow, PhD, University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Anticipated): February 1, 2023
• Study Completion (Anticipated): February 1, 2023

Study Registration Dates

• First Submitted: September 20, 2018
• First Submitted That Met QC Criteria: November 28, 2018
• First Posted (Actual): November 30, 2018

Study Record Updates

• Last Update Posted (Actual): October 29, 2021
• Last Update Submitted That Met QC Criteria: October 28, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: cognitive behavioral therapy; concussion; post-concussion syndrome; mild traumatic brain injury; autonomic dysfunction; capnometry-assisted respiratory training
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Brain Injuries, Traumatic; Post-Concussion Syndrome; Brain Concussion
• Other Study ID Numbers: 17-000346

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: All individual participant data that underlie results in a publication will be shared if requested by other researchers. These data will include Study Protocol, Statistical Analysis Plan, and Clinical Study Report. Data will be made available for sharing 6 months after publication and be available for a time frame of 2 years following initial publication. Access to IPD will be considered for researchers with a graduate degree or above for post-hoc analyses or replication efforts. Applications to access individual participant data will be reviewed by principal investigator and appointed co-investigators.
• IPD Sharing Time Frame: 6 months following initial publication, lasting for 2 years after initial publication.
• IPD Sharing Access Criteria: Access to individual participant data will be considered for researchers with a graduate degree or above for post-hoc analyses or replication efforts. Applications to access individual participant data will be reviewed by principal investigator and appointed co-investigators.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No