Treatment for Patients With Chronic Post-Concussion Symptoms

NCT03759808 | Unknown

• 1 other identifier: 17-000346
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Change in cerebral blood flow stress after treatment

  baseline and 6 weeks

• Change in peak salivary cortisol after treatment

  baseline and 6 weeks

• Change in respiration rate after treatment

  baseline and 6 weeks

• Change in end-tidal carbon dioxide after treatment

  baseline and 6 weeks

• Change in heart rate after treatment

  baseline and 6 weeks

Other Outcomes (9)

• Change in depressive symptoms after treatment

  baseline and 6 weeks

• Change in anxiety symptoms after treatment

  baseline and 6 weeks

• Change in sleep quality after treatment

  baseline and 6 weeks

Study Arms (1)

Persistent Post-Concussion Symptoms

EXPERIMENTAL

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

Behavioral: Psychological Intervention

Interventions

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.

Persistent Post-Concussion Symptoms

Eligibility Criteria

• Age: 13 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

RECRUITING

MeSH Terms

Conditions

Brain Concussion; Post-Concussion Syndrome; Primary Dysautonomias

Interventions

Psychosocial Intervention

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating; Autonomic Nervous System Diseases

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Robert Asarnow, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aliyah R Snyder, PhD

CONTACT

3109169460; asnyder@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: September 20, 2018
• First Posted: November 30, 2018
• Study Start: June 1, 2018
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: October 29, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 6 months following initial publication, lasting for 2 years after initial publication.
• 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.

Locations

US (1)