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Cognitive Behavioral Therapy

C-STEP (Cognitive Behavioral Therapy) for Post-Concussion Syndrome

N/A
Recruiting
Led By Sean Rose, MD
Research Sponsored by Sean Rose
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0 to day 35
Awards & highlights

Study Summary

This trial will test whether a cognitive behavioral therapy can improve outcomes for children with post-concussion syndrome.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since C-STEP involves therapy rather than medication, side effects may include discomfort from discussing personal issues or fatigue from participation but typically do not involve physical side effects like drugs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0 to day 35
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0 to day 35 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change Pediatric Quality of Life Inventory, Version 4.0 (PedsQL)
Change in Sport Concussion Assessment Tool- Fifth Edition (SCAT-5) Concussion Symptoms
Secondary outcome measures
Change in Auditory Attention and Working Memory
Change in Brain Connectivity
Change in Cognitive Flexibility
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Usual Care + C-STEPExperimental Treatment2 Interventions
Usual care in the NCH Complex Concussion Clinic, plus 4 weekly sessions of C-STEP
Group II: Usual CareActive Control1 Intervention
Usual care in the NCH Complex Concussion Clinic
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Usual Care
1990
Completed Phase 4
~7700

Find a Location

Who is running the clinical trial?

Sean RoseLead Sponsor
Nationwide Children's HospitalOTHER
341 Previous Clinical Trials
5,220,459 Total Patients Enrolled
Ohio State UniversityOTHER
837 Previous Clinical Trials
507,906 Total Patients Enrolled
~5 spots leftby Dec 2024
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