Concussion Recovery and Support Program
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-29
SponsorSeattle Children's Hospital
About this trial
Pilot randomized controlled trial (RCT) comparing a novel intervention Concussion Recovery and Support Program (CRISP) for adolescents and young adults (AYA) 18-29 yo with concussion/ mild TBI.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosed with a concussion and at least 2 weeks from injury but less than two years.
New or worsening headache since concussion
Had at least one day with headache last week of moderate severity or two days with headache of any severity
Disqualifiers
Non-English speaking
Chronic medical illness/ medical complexity
Housing instability
Acute mental health issues such as active suicidality, psychiatric hospitalization within the past 6 months, ER visit for suicidality in the past 6 months or experiencing psychosis or delusions
Trial design
Design model
Parallel
Treatments tested in this trial
CRISP (Concussion Recovery and Support Program)
BehavioralMental health intervention targeting suppressed emotion with a goal of facilitating recovery.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: CRISPExperimental treatment 1 intervention
Group B: Treatment as usual (TAU)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
Treatment Evaluation Inventory, short form
Self-report form regarding acceptability of treatment approach. Minimum 0, maximum 24 (6 items x 4 likert), higher scores indicate higher rating of treatment acceptability.
Time frame
10 weeksSecondary outcomes
1
HIT6 (Headache Impact Test, 6 item)
Self-report measure of headache severity, minimum 6 maximum 78, higher scores indicates greater symptoms.
Time frame
Baseline, 5 weeks, 10 weeks (trajectory over time)2
PROMIS fatigue short form
7 item self-report scale measuring issues with fatigue. Minimum 7, maximum 35, higher scores indicates more symptoms.
Time frame
Baseline/ 5 weeks/ 10 weeks (trajectory over time)3
Fear of Concussive Symptoms Questionnaire (FOCSQ)
Self-report measure of fear-avoidance of activities due to concussive symptoms. Minimum 0, maximum 96 (24 items x 4 likert), higher is worse
Time frame
Baseline/ 5 weeks/ 10 weeks (trajectory over time)4
Post Concussion Symptom Scale (PCSS)
Self-report measure of concussive symptoms, minimum 0, maximum 132 (22 items x 6 likert), higher indicates more symptoms
Time frame
Baseline/ 5 weeks/ 10 weeks (trajectory over time)Sponsors and contacts
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Source ClinicalTrials.gov