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NCT07097792NARecruiting

Concussion Recovery and Support Program

Seattle Children's Hospital

Start Date

10/13/2025

Completion Date

7/31/2026

Summary

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.

Detailed Description

The authors are conducting a pilot study to examine the feasibility, acceptability and pilot efficacy of a novel intervention called CRISP for young adults with persistent concussion/ mTBI. CRISP is an adaptation of an evidence-based treatment for chronic pain called Emotional Awareness and Expression Therapy (EAET). EAET targets underlying emotional responses that appear to drive persistent symptoms, and has been found effective for treating headache and other types of pain in randomized controlled trials with moderately strong effect sizes (0.4-0.5). Individuals who participate in this study will complete 6 sessions of CRISP with a trained therapist over zoom (each 60 minutes) and will also fill out surveys at multiple time points (baseline, 5 weeks, 10 weeks). Aim 1: Evaluate feasibility and acceptability of CRISP with a pilot study of n=40 individuals with concussion ages 18-30 years who are struggling with headache. Hypothesis: CRISP will be a feasible and acceptable approach to treating AYA with concussion. Aim 2: Collect pilot data regarding efficacy of CRISP for reducing concussion symptoms and improving function (particularly regarding headache). Hypothesis: Pilot data may show benefit from this approach for improving recovery, though we do not expect significance given the sample size.

Eligibility Criteria

Age Range: 18 years to 29 years

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Interventions

BEHAVIORAL

CRISP (Concussion Recovery and Support Program)

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Conditions

Brain ConcussionMild Traumatic Brain InjuryHeadache

Locations

Seattle Children's Research Institute

Seattle, Washington 98104

United States

University of Washington

Seattle, Washington 98105

United States