Mild Traumatic Brain InjuryNCT03759808
Treatment for Patients With Chronic Post-Concussion Symptoms
A study testing Psychological Intervention in people with Mild Traumatic Brain Injury and Concussion Post Syndrome, run by University of California, Los Angeles at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 13 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Traumatic Brain Injury, Concussion Post Syndrome
- What is being tested?
- Psychological Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2018to 1 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of California, Los Angeles
Los Angeles, California, 90095
Aliyah R Snyder, PhD, 310-916-9460, hips@mednet.ucla.ed
Alexandra Tanner, MS, tannera@ucla.edu
About this study
Official title: 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.
Read the 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.
- Being tested
- Psychological Intervention
- Keywords
- post-concussion syndrome, mild traumatic brain injury, autonomic dysfunction, concussion, capnometry-assisted respiratory training, cognitive behavioral therapy
- Medical subject headings
- Brain Concussion, Post-Concussion Syndrome, Primary Dysautonomias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Persistent Post-Concussion Symptoms | Experimental | Concussed participants with persistent post-concussion symptoms (PPCS) who receive the psychological intervention. Receives: Behavioral: Psychological Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Self-Reported Symptoms After Treatment
Severity of self-reported symptoms on the Post-Concussion Symptom Inventory
Measured: 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
Measured: baseline and 6 weeks
Secondary outcomes (6)
Change in cerebral blood flow stress after treatment
Changes in cerebral blood flow dynamics in bilateral middle cerebral arteries as measured by transcranial doppler.
Measured: 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.
Measured: baseline and 6 weeks
Change in respiration rate after treatment
Changes in respiration rate as measured through capnometer in response to stress paradigm
Measured: 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
Measured: 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.
Measured: 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.
Measured: baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2018
- Study start1 Jun 2018
- Primary completion1 Feb 2023 (estimated)
- Study completion1 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert F. Asarnow, Ph.D, University of California, Los Angeles
- Investigators
- Robert Asarnow, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03759808
- Sponsor's protocol ID
- 17-000346
- Status last verified
- Oct 2021
- First submitted
- 20 Sep 2018
- Last updated
- 29 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioral Treatment for Patients With Chronic Post-Concussion Symptoms
- ClinicalTrials.gov ID
- NCT03759808
- Acronym / sponsor ID
- 17-000346
- Keywords
- post-concussion syndrome, mild traumatic brain injury, autonomic dysfunction, concussion, capnometry-assisted respiratory training, cognitive behavioral therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Feb 2023 (estimated)
- Study completion
- 1 Feb 2023 (estimated)
- First posted
- 30 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Persistent Post-Concussion Symptoms | Experimental | Behavioral: Psychological InterventionConcussed participants with persistent post-concussion symptoms (PPCS) who receive the psychological intervention. |
Who may qualify
- Ages
- 13 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
- No history of concussion in the past year.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychological InterventionPsychological 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. | Behavioural | Persistent Post-Concussion Symptoms |
Primary outcome
Change in Self-Reported Symptoms After Treatment
Time frame: baseline and 6 weeks
Severity of self-reported symptoms on the Post-Concussion Symptom Inventory
Change Self-Reported Quality of Life After Treatment
Time frame: baseline and 6 weeks
Self-reported scores on quality of life on Global Quality of Life Scale
6 secondary outcomes
Change in cerebral blood flow stress after treatment
Time frame: baseline and 6 weeks
Change in peak salivary cortisol after treatment
Time frame: baseline and 6 weeks
Change in respiration rate after treatment
Time frame: baseline and 6 weeks
Change in end-tidal carbon dioxide after treatment
Time frame: baseline and 6 weeks
Change in heart rate after treatment
Time frame: baseline and 6 weeks
Change in blood pressure after treatment
Time frame: baseline and 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2021.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Asarnow, PhD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychological Intervention in people with Mild Traumatic Brain Injury and Concussion Post Syndrome, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aliyah R Snyder, PhD (3109169460, asnyder@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Self-Reported Symptoms After Treatment (time frame: baseline and 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2021.