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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 0 to day 35

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Sean RoseLead Sponsor

Nationwide Children's HospitalOTHER

341 Previous Clinical Trials

5,220,466 Total Patients Enrolled

Ohio State UniversityOTHER

830 Previous Clinical Trials

505,704 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are my criteria compatible with this clinical trial's requirements?

"To qualify for this clinical trial, participants must suffer from post-concussion syndrome and be in the age range of 12 to 18 years old. The investigators are aiming to enroll 40 patients into the study."

Answered by AI

Is enrollment currently open to participants in this research endeavor?

"Affirmative. Clinicaltrials.gov contains information that confirms this medical trial is presently seeking enrolment and was first advertised on January 2nd 2020. The research team needs to recruit 40 patients from one location."

Answered by AI

Could you tell me how many participants are enrolled in this clinical study?

"Affirmative. Clinicaltrials.gov data verifies that this experiment, which was initially published on January 2nd 2020, is actively searching for participants. Forty individuals need to be recruited from one medical centre."

Answered by AI

Is this clinical trial open to individuals under 75 years of age?

"According to the data stipulated in this medical study's entrance requirements, 12 is the lowest age that any patient can be and 18 is the upper limit."

Answered by AI

What should the results of this investigation be expected to demonstrate?

"The primary assessment of this trial, lasting 35 days, will be the Pediatric Quality of Life Inventory Version 4.0 (PedsQL). Secondary objectives include evaluating Processing Speed with Coding and Symbol Search subtests from WISC-V or WAIS-IV; Brain Connectivity using an advanced neuroimaging protocol; and Auditory Attention & Working Memory using Digits Forward & Backward subtests from WISC-V/WAIS-IV respectively."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Sean Rose 2020. "Concussion Symptom Treatment and Education Program (C-STEP) in Post-Concussion Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04111991.

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