Recruiting

Chronic Post-Concussion

Sponsor:

UCLA

Code:

NCT03759808

Conditions

Mild Traumatic Brain Injury

Concussion Post Syndrome

Eligibility Criteria

Sex: All

Age: 13 - 25

Healthy Volunteers: Accepted

Interventions

Psychological Intervention

Study Details

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.

Conditions

Mild Traumatic Brain Injury

Concussion Post Syndrome

Study ID

NCT03759808

Start date

Jun 1, 2018

Status verified date

Oct, 2021

Completion date

Feb 1, 2023

Anticipated

Primary completion date

Feb 1, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 25

Healthy Volunteers: Accepted

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 Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Persistent Post-Concussion Symptoms

Concussed participants with persistent post-concussion symptoms (PPCS) who receive the psychological intervention.

Interventions

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.

Primary outcome measure

  • Change in Self-Reported Symptoms After Treatment [ Time Frame: baseline and 6 weeks ]
  • Change Self-Reported Quality of Life After Treatment [ Time Frame: baseline and 6 weeks ]

Central Contacts and Locations

Central contacts

Aliyah R Snyder, PhD

3109169460asnyder@mednet.ucla.edu

Locations

University of California, Los Angeles

Recruiting

Los Angeles, California, United States, 90095

Contacts

Aliyah R Snyder, PhD

310-916-9460hips@mednet.ucla.ed

Alexandra Tanner, MS

tannera@ucla.edu

More Information

Sponsor

University of California, Los Angeles

Last update posted

Oct 29, 2021

Last verified

Oct, 2021

Keywords

  • post-concussion syndrome
  • mild traumatic brain injury
  • autonomic dysfunction
  • concussion
  • capnometry-assisted respiratory training
  • cognitive behavioral therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2021-10-29.