CRISP Program for Concussion

(CRISP Trial)

Recruiting at 1 trial location

Overseen By Sara PD Chrisman, MD MPH

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Seattle Children's Hospital

Disqualifiers: Non-English, Acute mental health, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

Duration: 8 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called the Concussion Recovery and Support Program (CRISP) for young people aged 18-29 who have experienced a concussion or mild traumatic brain injury. The goal is to determine if CRISP can alleviate symptoms like headaches by addressing emotional responses that might prolong these issues. Participants will receive either the CRISP treatment or regular care to compare results. The trial seeks individuals diagnosed with a concussion who have experienced new or worsening headaches since the injury. As an unphased trial, this study offers a unique opportunity to contribute to understanding and improving concussion recovery strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the CRISP program is safe for adolescents and young adults with concussion?

Research shows that the CRISP (Concussion Recovery and Support Program) is based on Emotional Awareness and Expression Therapy (EAET), a treatment originally used for chronic pain. EAET helps individuals manage emotional reactions that might prolong symptoms. Although specific safety data for CRISP is not yet available, past studies have shown EAET to be safe for chronic pain.

Since CRISP is still under testing, detailed safety information is not yet available. However, because CRISP is based on EAET, which has been safely used for chronic pain, it suggests that CRISP might also be safe. This trial is a pilot study, focusing primarily on assessing the safety and acceptability of the treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CRISP (Concussion Recovery and Support Program) because it offers a fresh approach to treating concussions by adapting a method originally used for chronic pain known as EAET (Emotional Awareness and Expression Therapy). Unlike traditional concussion treatments that often focus on physical rest and gradual return to activities, CRISP targets underlying emotional reactions that may contribute to prolonged symptoms. This method could lead to a more holistic recovery by addressing emotional factors over six sessions within ten weeks, potentially offering relief to those who haven't responded to standard care.

What evidence suggests that the CRISP program is effective for concussion recovery?

Research suggests that CRISP, a version of Emotional Awareness and Expression Therapy (EAET), might help with concussion symptoms. EAET was originally used to treat long-lasting pain by addressing emotions that could prolong symptoms. Although specific data on CRISP's effectiveness for concussions is not yet available, EAET has shown promise in easing symptoms for other conditions. In this trial, participants will receive either the CRISP program or treatment as usual (TAU). By better managing emotions, individuals might recover from concussions more effectively. The CRISP program is designed to be completed in six sessions over ten weeks, providing a comprehensive approach to support recovery. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for English-speaking young adults aged 18-30 who have had a concussion between 2 weeks and a year ago. They must have experienced headaches since the injury, with at least one moderate headache last week or two of any severity.

Inclusion Criteria

I have new or worsening headaches since my concussion.

I had a moderate headache for at least one day or any headache for two days last week.

I was diagnosed with a concussion between 2 weeks and 1 year ago.

Exclusion Criteria

I do not speak English.

I have not had recent severe mental health crises or hospital visits for them.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants complete 8 sessions of CRISP with a trained therapist over Zoom, each lasting 60 minutes

8 weeks

8 virtual visits

Follow-up

Participants are monitored for safety and effectiveness after treatment through surveys at multiple time points

4 weeks

Surveys at baseline, 4 weeks, and 8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CRISP (Concussion Recovery and Support Program)

Trial Overview The study tests the Concussion Recovery and Support Program (CRISP), designed to aid recovery in adolescents and young adults after a concussion. It's a pilot randomized controlled trial comparing CRISP to standard care.

How Is the Trial Designed?

Group I: CRISP Experimental Treatment 1 Intervention

CRISP is an adaptation of an approach called EAET that was originally designed to treat individuals with chronic pain. The goal of this approach is to target underlying emotional reactions that may be causing symptoms to persist. This intervention will be delivered in 6 sessions over 10 weeks.

Group II: Treatment as usual (TAU) Active Control 1 Intervention

Treatment as usual.

Who Is Running the Clinical Trial?

Seattle Children's Hospital

Lead Sponsor

Trials

319

Recruited

5,232,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07097792

Concussion Recovery and Support Program (CRISP) 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 ...

2. withpower.com withpower.com/trial/phase-mild-traumatic-brain-injury-mtbi-7-2025-6e5b2

CRISP Program for Concussion (CRISP Trial) This trial is for English-speaking young adults aged 18-30 who have had a concussion between 2 weeks and a year ago. They must have experienced headaches since ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8126315/

Predicting outcome following mild traumatic brain injury Predicting outcome following mild traumatic brain injury: protocol for the longitudinal, prospective, observational Concussion Recovery (CREST) cohort study

4. htsyndication.com htsyndication.com/us-fed-news/article/clinical-trial%3A-concussion-recovery-and-support-program/555746579

Clinical Trial: Concussion Recovery and Support Program Brief Summary: Pilot randomized controlled trial (RCT) comparing a novel intervention Concussion Recovery and Support Program (CRISP) for ...

5. tandfonline.com tandfonline.com/doi/full/10.1080/02699052.2023.2230878

Full article: Describing the patient journey through ... To identify treatment provider sequences and healthcare pathway characteristics and outcomes for people with mild traumatic brain injury (mTBI) in New Zealand.

6. ctv.veeva.com ctv.veeva.com/study/concussion-recovery-and-support-program

Concussion Recovery and Support Program (CRISP) CRISP is an adaptation of an evidence-based treatment for chronic pain called Emotional Awareness and Expression Therapy (EAET). EAET targets ...

7. reporter.nih.gov reporter.nih.gov/project-details/11130160

RePORT ⟩ RePORTER We're sorry but RePORTER doesn't work properly without JavaScript enabled. Please enable it to continue.

8. nytimes.com nytimes.com/athletic/1261858/2019/10/08/failure-to-disclose-the-mysterious-absence-of-critical-data-from-uncs-renowned-concussion-research/

Failure to Disclose: The mysterious absence of critical data ... A nine-month investigation by The Athletic raises troubling questions.