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

NCT ID: NCT04111991

Last Updated: 2025-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-02
• Study Completion Date: 2024-11-30

Brief Summary

This prospective randomized intervention study aims to determine if the Concussion Symptom Treatment Program (C-STEP), a cognitive behavioral therapy, improves outcomes for children with post-concussion syndrome.

Detailed Description

This prospective randomized intervention study aims to determine if C-STEP improves outcomes for children with post-concussion syndrome. Forty children with post-concussion syndrome referred to the Nationwide Children's Hospital (NCH) Complex Concussion Clinic will be randomized to receive either usual care in the NCH Complex Concussion Clinic (comparison) or usual care in the NCH Complex Concussion Clinic plus four weekly sessions of C-STEP (treatment).

C-STEP has been developed for patients with post-concussion syndrome. The CBT intervention involves 4 primary components: psychoeducation, activity management, sleep hygiene, and relaxation training (adapted from McNally et al., 2018). Psychoeducation involves providing patients and families with information about typical concussion symptoms and recovery, the role of non-injury/psychological factors in post-concussion syndrome, and information about the mind-body connection. Activity management involves setting specific goals to achieve a return to normal daily activities such as school attendance, schoolwork completion, household activities, and participating in social/leisure activities. The sleep hygiene component involves providing individualized recommendations to promote healthy sleep habits such as eliminating naps, keeping a consistent sleep schedule, turning off electronics at bedtime, or other needed modifications. Finally, relaxation training involves teaching specific evidence-based strategies for relaxation and coping with stress such as diaphragmatic breathing and progressive muscle relaxation.

Conditions

Post-Concussion Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Usual Care

Usual care in the NCH Complex Concussion Clinic

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: BEHAVIORAL

Usual care in the NCH in the Complex Concussion Clinic involves assessment and treatment with a neurologist for medical management of concussion, weekly sessions with an athletic trainer for exercise therapy, and physical therapy sessions depending on need

Usual Care + C-STEP

Usual care in the NCH Complex Concussion Clinic, plus 4 weekly sessions of C-STEP

Group Type: EXPERIMENTAL

Usual Care

Intervention Type: BEHAVIORAL

Usual care in the NCH in the Complex Concussion Clinic involves assessment and treatment with a neurologist for medical management of concussion, weekly sessions with an athletic trainer for exercise therapy, and physical therapy sessions depending on need

C-STEP (Cognitive Behavioral Therapy)

Intervention Type: BEHAVIORAL

The C-STEP intervention involves 4 primary components: psychoeducation, activity management, sleep hygiene, and relaxation training

Interventions

Usual Care

Usual care in the NCH in the Complex Concussion Clinic involves assessment and treatment with a neurologist for medical management of concussion, weekly sessions with an athletic trainer for exercise therapy, and physical therapy sessions depending on need

Intervention Type: BEHAVIORAL

C-STEP (Cognitive Behavioral Therapy)

The C-STEP intervention involves 4 primary components: psychoeducation, activity management, sleep hygiene, and relaxation training

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Children age 10-17 years or adults age 18 years (total age range 10-18) at the time of the enrollment visit
• Diagnosed concussion occurring between 1 month and 12 months prior to the enrollment visit
• Endorsing at least 2 symptoms on the SCAT-5 symptom checklist
• Intent to participate in the full CCC treatment program (including exercise visits once per week)

Exclusion Criteria

• Adults unable to consent, Prisoners, Females currently known to be pregnant, Non-English speaking patient
• Anticipated inability to complete surveys or other study procedures (due to cognitive or other disability)
• Anticipated inability to complete a brain MRI (due to claustrophobia, implanted hardware or other contraindications)
• Pre-injury severe mental illness (defined as inpatient psychiatric hospitalization, suicide attempt, history of psychotic symptoms, or bipolar disorder)

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nationwide Children's Hospital

OTHER

Sponsor Role: collaborator

Ohio State University

OTHER

Sponsor Role: collaborator

Sean Rose

OTHER

Sponsor Role: lead

Responsible Party

Sean Rose

Assistant Professor of Pediatrics

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Sean Rose, MD

Role: PRINCIPAL_INVESTIGATOR

Nationwide Children's Hospital

Locations

Nationwide Children's Hospital

Columbus, Ohio, United States

Countries

United States

Other Identifiers

STUDY00000529

Identifier Type: -

Identifier Source: org_study_id