Concussion Symptom Treatment and Education Program (C-STEP) in Post-Concussion Syndrome

Not Applicable

Recruiting

• Conditions: Post-Concussion Syndrome
• Interventions: Behavioral: Usual Care; Behavioral: C-STEP (Cognitive Behavioral Therapy)

• Registration Number: NCT04111991
• Lead Sponsor: Sean Rose

Brief Summary

This prospective randomized intervention study aims to determine if the Concussion Symptom Treatment Program (C-STEP), a cognitive behavioral therapy, improves outcomes for children with post-concussion syndrome.

Detailed Description

This prospective randomized intervention study aims to determine if C-STEP improves outcomes for children with post-concussion syndrome. Forty children with post-concussion syndrome referred to the Nationwide Children's Hospital (NCH) Complex Concussion Clinic will be randomized to receive either usual care in the NCH Complex Concussion Clinic (comparison) or usual care in the NCH Complex Concussion Clinic plus four weekly sessions of C-STEP (treatment).

C-STEP has been developed for patients with post-concussion syndrome. The CBT intervention involves 4 primary components: psychoeducation, activity management, sleep hygiene, and relaxation training (adapted from McNally et al., 2018). Psychoeducation involves providing patients and families with information about typical concussion symptoms and recovery, the role of non-injury/psychological factors in post-concussion syndrome, and information about the mind-body connection. Activity management involves setting specific goals to achieve a return to normal daily activities such as school attendance, schoolwork completion, household activities, and participating in social/leisure activities. The sleep hygiene component involves providing individualized recommendations to promote healthy sleep habits such as eliminating naps, keeping a consistent sleep schedule, turning off electronics at bedtime, or other needed modifications. Finally, relaxation training involves teaching specific evidence-based strategies for relaxation and coping with stress such as diaphragmatic breathing and progressive muscle relaxation.

Study Timeline

• Study First Submitted: 2019-09-30
• Study First Submitted QC: 2019-09-30
• Study First Posted: 2019-10-02
• Study Start: 2020-01-02
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-16
• Last Update Posted: 2024-02-20
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Children age 10-17 years or adults age 18 years (total age range 10-18) at the time of the enrollment visit
• Diagnosed concussion occurring between 1 month and 12 months prior to the enrollment visit
• Endorsing at least 2 symptoms on the SCAT-5 symptom checklist
• Intent to participate in the full CCC treatment program (including exercise visits once per week)

Exclusion Criteria

• Adults unable to consent, Prisoners, Females currently known to be pregnant, Non-English speaking patient
• Anticipated inability to complete surveys or other study procedures (due to cognitive or other disability)
• Anticipated inability to complete a brain MRI (due to claustrophobia, implanted hardware or other contraindications)
• Pre-injury severe mental illness (defined as inpatient psychiatric hospitalization, suicide attempt, history of psychotic symptoms, or bipolar disorder)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care + C-STEP	C-STEP (Cognitive Behavioral Therapy)	Usual care in the NCH Complex Concussion Clinic, plus 4 weekly sessions of C-STEP
Usual Care	Usual Care	Usual care in the NCH Complex Concussion Clinic
Usual Care + C-STEP	Usual Care	Usual care in the NCH Complex Concussion Clinic, plus 4 weekly sessions of C-STEP

Primary Outcome Measures

Name	Time	Method
Change Pediatric Quality of Life Inventory, Version 4.0 (PedsQL)	Day 0 to Day 35	This is a 23-item self and parent-reported quality of life metric. Each item is rated on a scale of 0-4. Scores range from 0-100 for each subscale (Physical Functioning; Emotional Functioning; Social Functioning; School Functioning) and for the total score. Higher scores are indicative of better quality of life.
Change in Sport Concussion Assessment Tool- Fifth Edition (SCAT-5) Concussion Symptoms	Day 0 to Day 35	This is a 22-item self and parent-reported list of common concussion symptoms filled out on a 0-6 Likert scale. Scores range from 0 to 122. Higher scores are indicative of worse concussion symptoms.

Secondary Outcome Measures

Name	Time	Method
Change in Brain Connectivity	Day 0 to Day 35	An advanced neuroimaging protocol will measure brain tissue volume, microstructure, and function.
Change in Auditory Attention and Working Memory	Day 0 to Day 35	The digit span forwards and backwards subtest from Wechsler Individual Scales of Intelligence, fifth edition (WISC-V) (age 12-16) or Wechsler Adult Intelligence Scales, fourth edition (WAIS-IV) (age 17-18) will test auditory attention and working memory. Age-normed scaled scores (range 1-19, higher is better performance) will be calculated for process scores of Digits Forward and Digits backward.
Change in Phonemic Verbal Fluency	Day 0 to Day 35	The Phonemic Verbal Fluency (letter fluency) subtest from the Delis Kaplan Executive Function Scales (DKEFS) will test executive functioning and phonemic verbal fluency. Age-normed scaled scores (range 1-19, higher is better performance) will be calculated for the phonemic fluency subtest.
Change in Performance Validity	Day 0 to Day 35	The Medical Symptom Validity Test- (MSVT) will test effort/performance validity. Percentage scores for immediate recognition, delayed recognition, consistency, paired associates, and free recalls will be calculated. Performance will be classified as Pass vs. Fail.
Change in Processing Speed	Day 0 to Day 35	The processing speed index, which consists of the Coding and Symbol Search subtests from the from WISC-V (age 12-16) or WAIS-IV (age 17-18) will test processing speed. Age-normed scaled scores (range 1-19, higher is better performance) will be calculated for Coding and Symbol Search subtests. Scaled scores for these will be summed and used to calculate the Processing Speed Index standard score (range 45-155, higher is better performance).
Change in Cognitive Flexibility	Day 0 to Day 35	The Letter Number Sequencing subtest from from DKEFS will test cognitive flexiblity. Age-normed scaled scores (range 1-19, higher is better performance) will be calculated for the number sequencing and letter-number sequencing trials.
Change in Verbal Memory	Day 0 to Day 35	The Lists (immediate, delayed, and recognition) subtest from the Child and Adolescent Memory Profile (ChAMP) tests verbal memory. Age-normed scaled scores (range 1-19, higher is better performance) will be calculated for Lists, Lists Delayed, and Lists recognition subtests.

Trial Locations

Locations (1)

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States