Treatment for Patients With Chronic Post-Concussion Symptoms
Primary Purpose
Mild Traumatic Brain Injury, Concussion Post Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Psychological Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Mild Traumatic Brain Injury focused on measuring post-concussion syndrome, mild traumatic brain injury, autonomic dysfunction, concussion, capnometry-assisted respiratory training, cognitive behavioral therapy
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.
Sites / Locations
- University of California, Los AngelesRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Persistent Post-Concussion Symptoms
Arm Description
Concussed participants with persistent post-concussion symptoms (PPCS) who receive the psychological intervention.
Outcomes
Primary Outcome Measures
Change in Self-Reported Symptoms After Treatment
Severity of self-reported symptoms on the Post-Concussion Symptom Inventory
Change Self-Reported Quality of Life After Treatment
Self-reported scores on quality of life on Global Quality of Life Scale
Secondary Outcome Measures
Change in cerebral blood flow stress after treatment
Changes in cerebral blood flow dynamics in bilateral middle cerebral arteries as measured by transcranial doppler.
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.
Change in respiration rate after treatment
Changes in respiration rate as measured through capnometer in response to stress paradigm
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
Change in heart rate after treatment
Changes in heart rate (beats per minute) in response to stress paradigm measured through Biopac system.
Change in blood pressure after treatment
Changes in blood pressure (systolic/dyastolic in mmHg) in response to stress paradigm measured through Biopac system.
Full Information
NCT ID
NCT03759808
First Posted
September 20, 2018
Last Updated
October 28, 2021
Sponsor
University of California, Los Angeles
1. Study Identification
Unique Protocol Identification Number
NCT03759808
Brief Title
Treatment for Patients With Chronic Post-Concussion Symptoms
Official Title
Cognitive Behavioral Treatment for Patients With Chronic Post-Concussion Symptoms
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
February 1, 2023 (Anticipated)
Study Completion Date
February 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Persistent Post-Concussion Symptoms
Arm Type
Experimental
Arm Description
Concussed participants with persistent post-concussion symptoms (PPCS) who receive the psychological intervention.
Intervention Type
Behavioral
Intervention Name(s)
Psychological Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Self-Reported Symptoms After Treatment
Description
Severity of self-reported symptoms on the Post-Concussion Symptom Inventory
Time Frame
baseline and 6 weeks
Title
Change Self-Reported Quality of Life After Treatment
Description
Self-reported scores on quality of life on Global Quality of Life Scale
Time Frame
baseline and 6 weeks
Secondary Outcome Measure Information:
Title
Change in cerebral blood flow stress after treatment
Description
Changes in cerebral blood flow dynamics in bilateral middle cerebral arteries as measured by transcranial doppler.
Time Frame
baseline and 6 weeks
Title
Change in peak salivary cortisol after treatment
Description
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.
Time Frame
baseline and 6 weeks
Title
Change in respiration rate after treatment
Description
Changes in respiration rate as measured through capnometer in response to stress paradigm
Time Frame
baseline and 6 weeks
Title
Change in end-tidal carbon dioxide after treatment
Description
Changes in end-tidal carbon dioxide measurement in response to stress paradigm measured through capnometer in mmHg
Time Frame
baseline and 6 weeks
Title
Change in heart rate after treatment
Description
Changes in heart rate (beats per minute) in response to stress paradigm measured through Biopac system.
Time Frame
baseline and 6 weeks
Title
Change in blood pressure after treatment
Description
Changes in blood pressure (systolic/dyastolic in mmHg) in response to stress paradigm measured through Biopac system.
Time Frame
baseline and 6 weeks
Other Pre-specified Outcome Measures:
Title
Change in depressive symptoms after treatment
Description
Self-report measure of cognitive and somatic symptoms of depression, Beck Depression Inventory (BDI-II)
Time Frame
baseline and 6 weeks
Title
Change in anxiety symptoms after treatment
Description
Self-report measure of cognitive and somatic symptoms of anxiety, Beck Anxiety Inventory (BAI)
Time Frame
baseline and 6 weeks
Title
Change in sleep quality after treatment
Description
Self-report measure of sleep dysfunction, Pittsburgh Sleep Quality Index (PSQI)
Time Frame
baseline and 6 weeks
Title
Change in neurocognitive performance after treatment
Description
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.
Time Frame
baseline and 6 weeks
Title
Change in perceived cognitive exertion after treatment
Description
Change in self-reported physical, emotional, and perceived cognitive symptoms from pre- to post-neurocognitive assessment.
Time Frame
baseline and 6 weeks
Title
Change in illness perception after treatment
Description
Change in self-reported perception of illness as measured by the Brief Illness Perception Questionnaire.
Time Frame
baseline and 6 weeks
Title
Change in behavioral avoidance and distress after treatment
Description
Change in self-reported behavioral avoidance and distress due to anxiety as measured by the UCLA Behavioral Avoidance and Distress Scale
Time Frame
baseline and 6 weeks
Title
Change in disability perception due to injury after treatment
Description
Change in self-reported disability in social, occupational, and family/home functioning as measured by the Sheehan Disability Scale
Time Frame
baseline and 6 weeks
Title
Change in orthostatic blood pressure after treatment
Description
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.
Time Frame
baseline and 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aliyah R Snyder, PhD
Phone
3109169460
Email
asnyder@mednet.ucla.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Asarnow, PhD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aliyah R Snyder, PhD
Phone
310-916-9460
Email
hips@mednet.ucla.ed
First Name & Middle Initial & Last Name & Degree
Alexandra Tanner, MS
Email
tannera@ucla.edu
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Treatment for Patients With Chronic Post-Concussion Symptoms
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