Cognitive Behavioral Therapy for Post-Concussion Syndrome

Overseen By Sean Rose, MD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Sean Rose

Disqualifiers: Pregnancy, Non-English, Severe mental illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 5 weeks

37 Participants Needed

What You Need to Know Before You Apply

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is cognitive behavioral therapy safe for humans?

Cognitive behavioral therapy (CBT) is generally considered safe for humans, as it is a well-established treatment used for various conditions, including mental health issues and post-concussion symptoms. While specific safety data for CBT in post-concussion syndrome is not detailed in the provided research, CBT is widely used and typically does not have significant safety concerns. ^{1 2 3 4 5}

How does the treatment C-STEP differ from other treatments for post-concussion syndrome?

C-STEP is unique because it focuses on cognitive-behavioral therapy (CBT), which is a psychological approach that helps patients change negative thought patterns and behaviors. This is different from other treatments like medication or physical rehabilitation, as it specifically targets the cognitive and emotional aspects of post-concussion syndrome. ^{4 6 7 8 9}

What data supports the effectiveness of the treatment C-STEP for Post-Concussion Syndrome?

Research shows that cognitive-behavioral therapy (CBT), which is part of the C-STEP program, can help reduce symptoms and improve quality of life for people with Post-Concussion Syndrome by addressing both cognitive (thinking-related) and emotional challenges. ^{6 9 10 11 12}

Who Is on the Research Team?

Sean Rose, MD

Principal Investigator

Nationwide Children's Hospital

Are You a Good Fit for This Trial?

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)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive usual care plus four weekly sessions of C-STEP, which includes psychoeducation, activity management, sleep hygiene, and relaxation training

5 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• C-STEP

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.

How Is the Trial Designed?

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+

Ohio State University

Collaborator

Trials

891

Recruited

2,659,000+

Published Research Related to This Trial

A 27-year-old professional rugby player with a history of 20 concussions showed significant improvement in post-concussion syndrome after 30 sessions of cervical rehabilitation, with lasting benefits observed over 6 years.

Post-treatment, the player's cervical spinal alignment improved significantly, and he experienced only two additional concussions in the following six years, suggesting that correcting cervical alignment may help reduce the risk of future concussions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-concussion syndrome and concussion incidence improved in a pro rugby player following cervical spine rehab: case study and 6-year follow-up. Strauss, S., Lightstone, DF., Fedorchuk, C., et al.[2023]

Postconcussion syndrome (PCS) is a complex condition with symptoms that can persist for months or years, and it can be divided into early-phase and late-phase posttraumatic disorders, influenced by various psychosocial factors.

Effective treatment for PCS requires a careful diagnosis of symptoms and comorbid conditions, with a recommended approach that includes managing treatable symptoms and incorporating guided aerobic exercise to aid recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postconcussion syndrome. Dwyer, B., Katz, DI.[2019]

A randomized controlled trial involving 73 adults with persistent postconcussion symptoms showed that graded exposure therapy (GET) significantly reduced fear avoidance behavior compared to operant condition-based pacing strategies plus mindfulness training (Pacing+).

The study demonstrated strong feasibility for future trials, with high treatment adherence (89% completion rate) and excellent treatment fidelity (96.8% of essential elements covered), indicating that GET could be an effective intervention to help prevent disability after concussion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Concussion Rehabilitation Approaches Tailored to Psychological Coping Styles: A Randomized Controlled Trial. Silverberg, ND., Cairncross, M., Brasher, PMA., et al.[2022]

Education about head injury effects and reassurance about symptom recovery were the most frequently reported effective interventions for post-concussion syndrome, highlighting the importance of patient support during recovery.

Other useful treatments included graded resumption of activity, antidepressant medication, and cognitive restructuring, indicating a multifaceted approach to managing post-concussion symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A survey of treatments for post-concussion syndrome. Mittenberg, W., Burton, DB.[2019]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Cognitive and psychological interventions for the reduction of post-concussion symptoms in patients with mild traumatic brain injury: a systematic review. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Effects of CranioSacral therapy upon symptoms of post-acute concussion and Post-Concussion Syndrome: A pilot study. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Concussion Symptom Treatment and Education Program: A Feasibility Study. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral prevention of postconcussion syndrome in at-risk patients: a pilot randomized controlled trial. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Interventions to Address the Needs of Adults With Postconcussion Syndrome: A Systematic Review. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Post-concussion syndrome and concussion incidence improved in a pro rugby player following cervical spine rehab: case study and 6-year follow-up. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Description of an early cognitive behavioral intervention (UPFRONT-intervention) following mild traumatic brain injury to prevent persistent complaints and facilitate return to work. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Use of the Progressive Return to Activity Guidelines May Expedite Symptom Resolution After Concussion for Active Duty Military. [2020]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Postconcussion syndrome. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Feasibility of Concussion Rehabilitation Approaches Tailored to Psychological Coping Styles: A Randomized Controlled Trial. [2022]

11. England pubmed.ncbi.nlm.nih.gov

A survey of treatments for post-concussion syndrome. [2019]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Rehabilitation from postconcussion syndrome: nonpharmacological treatment. [2014]