What is the mechanism of action of this treatment?

The most common treatments for Post-Concussion Syndrome (PCS) include cognitive behavioral therapy (CBT), pharmacotherapy, and physical rehabilitation. CBT works by helping patients reframe negative thought patterns and develop coping strategies, which can alleviate symptoms such as anxiety, depression, and cognitive impairments. Pharmacotherapy may involve medications like SSRIs or SNRIs to manage mood disorders, while physical rehabilitation focuses on improving balance and reducing dizziness. Understanding these mechanisms is crucial for PCS patients as it allows for targeted treatment plans that address specific symptoms, ultimately improving their quality of life and aiding in recovery.

What side effects are associated with this type of intervention?

Cognitive Behavioral Therapy (CBT) is a common treatment for Post-Concussion Syndrome (PCS) and is generally well-tolerated with minimal side effects. Some patients may experience temporary discomfort when confronting distressing thoughts or emotions during therapy sessions. Other common treatments for PCS include medications such as SSRIs and SNRIs, which can cause side effects like nausea, headache, dizziness, and sleep disturbances. It is important to discuss potential side effects with a healthcare provider to tailor the treatment plan to individual needs.

What prior FDA approvals exist?

There are no specific FDA-approved medications for the treatment of Post-Concussion Syndrome (PCS). However, Cognitive Behavioral Therapy (CBT) is a commonly used non-pharmacological treatment approach for managing PCS symptoms, particularly for addressing cognitive and emotional difficulties. The Concussion Symptom Treatment Program (C-STEP) is an example of a CBT-based intervention being studied for its efficacy in improving outcomes for children with PCS.

What other types of research exist?

Promising, novel alternatives to the Concussion Symptom Treatment Program (Cognitive Behavioral Therapy) for Post-Concussion Syndrome patients include Solution-Focused Brief Therapy (SFBT) and Virtual Reality Exposure Therapy (VRET). SFBT is a strengths-based approach that has been applied to brain injury rehabilitation, while VRET has shown efficacy in treating PTSD and anxiety, which may be beneficial for PCS patients.

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Cognitive Behavioral Therapy

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

No Placebo-Only Group

Summary

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.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change Pediatric Quality of Life Inventory, Version 4.0 (PedsQL)

Change in Sport Concussion Assessment Tool- Fifth Edition (SCAT-5) Concussion Symptoms

Secondary study objectives

Change in Auditory Attention and Working Memory

Change in Brain Connectivity

Change in Cognitive Flexibility

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Post-Concussion Syndrome (PCS) include cognitive behavioral therapy (CBT), pharmacotherapy, and physical rehabilitation. CBT works by helping patients reframe negative thought patterns and develop coping strategies, which can alleviate symptoms such as anxiety, depression, and cognitive impairments. Pharmacotherapy may involve medications like SSRIs or SNRIs to manage mood disorders, while physical rehabilitation focuses on improving balance and reducing dizziness. Understanding these mechanisms is crucial for PCS patients as it allows for targeted treatment plans that address specific symptoms, ultimately improving their quality of life and aiding in recovery.

Physical Activity and Intermittent Postconcussion Symptoms After a Period of Symptom-Limited Physical and Cognitive Rest.