Cognitive Behavioral Therapy for Post-Concussion Syndrome

Overseen by Sean Rose, MD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Sean Rose

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests if a cognitive behavioral therapy program called C-STEP can help children with ongoing concussion symptoms. The program includes education, activity management, sleep tips, and relaxation training.

Research Team

Sean Rose, MD

Principal Investigator

Nationwide Children's Hospital

Eligibility Criteria

This trial is for children and young adults aged 10-18 who have had a concussion between 1 to 12 months ago, are experiencing at least two post-concussion symptoms, and can commit to a treatment program. It's not for those with severe pre-injury mental illness, pregnant females, non-English speakers, or anyone unable to consent or complete the study procedures.

Inclusion Criteria

I have at least 2 symptoms listed on the SCAT-5.

I plan to follow the complete CCC treatment program, including weekly exercise.

I was diagnosed with a concussion between 1 and 12 months ago.

Exclusion Criteria

I have a history of severe mental illness, including hospitalization or bipolar disorder.

Anticipated inability to complete a brain MRI (due to claustrophobia, implanted hardware or other contraindications)

Anticipated inability to complete surveys or other study procedures (due to cognitive or other disability)

Treatment Details

Interventions

• C-STEP (Cognitive Behavioral Therapy)

Trial Overview The study is testing C-STEP (Cognitive Behavioral Therapy) against usual care in improving outcomes for individuals with post-concussion syndrome. Participants will be randomly assigned to one of these treatments to compare effectiveness.

Participant Groups

Group I: Usual Care + C-STEP Experimental Treatment 2 Interventions

Usual care in the NCH Complex Concussion Clinic, plus 4 weekly sessions of C-STEP

Group II: Usual Care Active Control 1 Intervention

Usual care in the NCH Complex Concussion Clinic

Who Is Running the Clinical Trial?

Sean Rose

Lead Sponsor

Trials

1

Recruited

40+

Nationwide Children's Hospital

Collaborator

Trials

354

Recruited

5,228,000+

Catherine Krawczeski

Nationwide Children's Hospital

Chief Medical Officer

MD

Timothy C. Robinson

Nationwide Children's Hospital

Chief Executive Officer since 2019

BSc in Psychology and Business Administration from Indiana University

Ohio State University

Collaborator

Trials

891

Recruited

2,659,000+

Dr. John J. Warner

Ohio State University

Chief Executive Officer since 2023

MD, MBA

Dr. Peter Mohler

Ohio State University

Chief Medical Officer since 2023

PhD in Molecular Biology