Concussion recovery and support program for young adults
Pilot Study of Concussion Recovery and Support Program (CRISP)
This pilot randomized trial will test whether a six-session online therapy called CRISP helps 18–30-year-olds with concussion-related headaches feel and function better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 29 Years |
| Sex | All |
| Sponsor | Seattle Children's Hospital Academic / other |
| Locations | 2 sites (Seattle, Washington and 1 other locations) |
| Trial ID | NCT07097792 on ClinicalTrials.gov |
What this trial studies
CRISP is an adaptation of Emotional Awareness and Expression Therapy (EAET) designed to target emotional processes that may drive persistent post-concussion symptoms. In this pilot randomized controlled trial, about 40 participants ages 18–30 with concussion-related headache will be randomized and will complete six 60-minute CRISP sessions delivered via Zoom. Participants will complete symptom and function questionnaires at baseline, 5 weeks, and 10 weeks to measure feasibility, acceptability, and preliminary efficacy. The study is powered for pilot outcomes and feasibility rather than definitive efficacy.
Who should consider this trial
Good fit: Ideal candidates are English-speaking 18–30-year-olds who had a concussion between 2 weeks and 2 years ago and who are experiencing new or worsening headache since the injury.
Not a fit: People who are non-English speakers, have significant chronic medical complexity, housing instability, or active severe mental health issues (for example recent suicidality or psychiatric hospitalization) were excluded and may not benefit or be eligible.
Why it matters
Potential benefit: If successful, CRISP could reduce persistent concussion-related headaches and improve daily functioning for affected young adults.
How similar studies have performed: EAET has shown moderate benefits (effect sizes ~0.4–0.5) for headache and other chronic pain conditions in prior randomized trials, but applying it specifically to post-concussion symptoms is novel and untested in larger trials.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Seattle, Washington and 1 other locations
- Seattle Children's Research Institute — Seattle, Washington, United States (Recruiting)
- University of Washington — Seattle, Washington, United States (Recruiting)
Study contacts
- Study coordinator: Sara PD Chrisman, MD MPH
- Email: crisp@seattlechildrens.org
- Phone: 206-884-1490
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.