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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Persistent Post-Concussion Symptoms | Experimental | Concussed participants with persistent post-concussion symptoms (PPCS) who receive the psychological intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psychological Intervention | Behavioral | 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. |
| 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 |
| 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 |
| 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 |
Inclusion criteria for patients:
Exclusion Criteria:
Additional Exclusion Criteria for Controls:
* No history of concussion in the past year.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aliyah R Snyder, PhD | Contact | 3109169460 | asnyder@mednet.ucla.edu |
| Name | Affiliation | Role |
|---|---|---|
| Robert Asarnow, PhD | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Los Angeles | Recruiting | Los Angeles | California | 90095 | United States |
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.
6 months following initial publication, lasting for 2 years after initial publication.
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.
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| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| D038223 | Post-Concussion Syndrome |
| D054969 | Primary Dysautonomias |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000083626 | Psychosocial Intervention |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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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.
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|
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 |
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 |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |
| D001342 | Autonomic Nervous System Diseases |