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

Sean Rose

Status: Enrolling

Conditions: Post-Concussion Syndrome

Treatments: Behavioral: C-STEP (Cognitive Behavioral Therapy); Behavioral: Usual Care

Study type: Interventional

Funder types: Other

Identifiers

NCT04111991

STUDY00000529

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 10 to 18 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Usual Care

Active Comparator group

Description:

Usual care in the NCH Complex Concussion Clinic

Treatment:

Behavioral: Usual Care

Usual Care + C-STEP

Experimental group

Description:

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

Treatment:

Behavioral: Usual Care

Behavioral: C-STEP (Cognitive Behavioral Therapy)