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

Last updated: February 16, 2024
Sponsor: Sean Rose
Overall Status: Active - Recruiting

Phase

N/A

Condition

Brain Injury

Treatment

Usual Care

C-STEP (Cognitive Behavioral Therapy)

Clinical Study ID

NCT04111991
STUDY00000529
  • Ages 10-18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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 cognitiveor other disability)
  • Anticipated inability to complete a brain MRI (due to claustrophobia, implantedhardware or other contraindications)
  • Pre-injury severe mental illness (defined as inpatient psychiatric hospitalization,suicide attempt, history of psychotic symptoms, or bipolar disorder)

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Usual Care
Phase:
Study Start date:
January 02, 2020
Estimated Completion Date:
December 31, 2024

Study 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.

Connect with a study center

  • Nationwide Children's Hospital

    Columbus, Ohio 43205
    United States

    Active - Recruiting

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