Clinical trial NCT04111991: Concussion Symptom Treatment and Education Program (C-STEP) in Post-Concussion Syndrome
Official title: Effectiveness of a Psychological Intervention for Children With Post-concussion Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-Concussion Syndrome
Keywords: Behavior Therapy, Cognitive
Post-Concussion Syndrome
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
Collaborators: name: Nationwide Children's Hospital
name: Ohio State University
First posted: 2019-10-02
Enrollment: 37
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Change in Sport Concussion Assessment Tool- Fifth Edition (SCAT-5) Concussion Symptoms
timeFrame: Day 0 to Day 35
measure: Change Pediatric Quality of Life Inventory, Version 4.0 (PedsQL)
timeFrame: Day 0 to Day 35
Secondary outcomes:
measure: Change in Brain Connectivity
timeFrame: Day 0 to Day 35
measure: Change in Auditory Attention and Working Memory
timeFrame: Day 0 to Day 35
measure: Change in Processing Speed
timeFrame: Day 0 to Day 35
measure: Change in Phonemic Verbal Fluency
timeFrame: Day 0 to Day 35
measure: Change in Cognitive Flexibility
timeFrame: Day 0 to Day 35
measure: Change in Verbal Memory
timeFrame: Day 0 to Day 35
measure: Change in Performance Validity
timeFrame: Day 0 to Day 35
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Sean Rose, MD
role: PRINCIPAL_INVESTIGATOR
References: