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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a specific cognitive behavioral therapy called C-STEP can help children with post-concussion syndrome improve their symptoms. The study compares two groups: one receiving usual concussion care and another receiving usual care plus four C-STEP sessions. It is ideal for children aged 10-17 who have had a concussion in the past month to a year and still experience symptoms like headaches or dizziness. Participants must commit to attending weekly exercise sessions as part of their treatment. As an unphased trial, this study provides a unique opportunity for participants to contribute to innovative research that could enhance post-concussion care for children.

Will I have to stop taking my current medications?

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

What prior data suggests that C-STEP is safe for children with post-concussion syndrome?

Research has shown that cognitive behavioral therapy (CBT) safely aids children with post-concussion syndrome. Studies have found that CBT integrates well into children's healthcare and is generally manageable for them. Reports have not indicated any serious side effects from using CBT for concussion symptoms, which should reassure parents and participants. Overall, CBT has a strong track record of addressing emotional issues after a concussion without causing harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about C-STEP for post-concussion syndrome because it adds a cognitive-behavioral therapy approach to the usual care, which traditionally focuses on physical rest and gradual return to activities. Unlike standard treatments that primarily address physical symptoms, C-STEP aims to tackle the cognitive and emotional challenges often experienced after a concussion. By offering structured therapy sessions, C-STEP could potentially improve recovery outcomes by directly addressing the psychological aspects of post-concussion syndrome. This innovative approach could lead to more comprehensive and effective care for individuals suffering from long-term concussion effects.

What evidence suggests that C-STEP might be an effective treatment for post-concussion syndrome?

Research has shown that cognitive behavioral therapy (CBT) can help individuals with post-concussion syndrome, which involves ongoing symptoms after a concussion. In one study with 200 teenagers, those who received treatment similar to C-STEP experienced fewer symptoms after three months. Another case involved a professional rugby player who had 20 concussions and felt much better after CBT sessions. CBT helps manage emotional issues and other symptoms related to post-concussion syndrome. In this trial, participants will receive either usual care or usual care plus C-STEP. Overall, these studies suggest that CBT, like C-STEP, can lessen the impact of post-concussion symptoms. ^{1 2 4 5 6}

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

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]

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]

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]

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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1077722923001001

Cognitive-Behavioral Therapy for Persistent Post- ... While many youths recover from concussions within several weeks, a subset of patients experience persistent postconcussive symptoms (PPCS), lasting 4 weeks ...

2. withpower.com withpower.com/trial/phase-post-concussion-syndrome-2020-10c28

Cognitive Behavioral Therapy for Post-Concussion ... A 27-year-old professional rugby player with a history of 20 concussions showed significant improvement in post-concussion syndrome after 30 sessions of ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2776909

Effect of Collaborative Care on Persistent Postconcussive ... Findings In this randomized clinical trial of 200 adolescents, those who received collaborative care reported fewer postconcussive symptoms at 3 ...

4. cognitivefxusa.com cognitivefxusa.com/blog/cognitive-behavioral-therapy-for-post-concussion-syndrome

Cognitive Behavioral Therapy for Post-Concussion ... Cognitive behavioral therapy can help to resolve certain post-concussion syndrome symptoms, especially emotional struggles.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32712533/

Effects of cognitive behavioral therapy for adults with post ... Primary outcomes included the severity of symptoms of post-concussion syndrome, depression, anxiety, and social integration. Secondary outcomes were fatigue, ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK534786/

Postconcussive Syndrome - StatPearls - NCBI Bookshelf - NIH Physical and cognitive rest is recommended for at least the first 24 to 48 hours post-injury as outlined by Zurich guidelines. In terms of ...