Recruiting

CRISP

Sponsor:

Seattle Children's Hospital

Code:

NCT07097792

Conditions

Brain Concussion

Mild Traumatic Brain Injury

Headache

Eligibility Criteria

Sex: All

Age: 18 - 29

Healthy Volunteers: Not accepted

Interventions

CRISP (Concussion Recovery and Support Program)

Study Details

Brief 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.

Conditions

Brain Concussion

Mild Traumatic Brain Injury

Headache

Study ID

NCT07097792

Start date

Oct 13, 2025

Status verified date

Nov, 2025

Completion date

Jul 31, 2026

Anticipated

Primary completion date

Jul 21, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 29

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CRISP

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.

no intervention: Treatment as usual (TAU)

Treatment as usual.

Interventions

CRISP (Concussion Recovery and Support Program)

Mental health intervention targeting suppressed emotion with a goal of facilitating recovery.

Primary outcome measure

  • Treatment Evaluation Inventory, short form [ Time Frame: 10 weeks ]

Central Contacts and Locations

Central contacts

Sara PD Chrisman, MD MPH

206-884-1490crisp@seattlechildrens.org

Locations

Seattle Children's Research Institute

Recruiting

Seattle, Washington, United States, 98104

Contacts

Sara P Chrisman, MD MPH

206-884-1490crisp@seattlechildrens.org

University of Washington

Recruiting

Seattle, Washington, United States, 98105

Contacts

Bethany Pester, PhD

206-884-1490crisp@seattlechildrens.org

More Information

Sponsor

Seattle Children's Hospital

Last update posted

Nov 18, 2025

Last verified

Nov, 2025

Keywords

  • mental health
  • therapy
  • emotional awareness and expression therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Seattle Children's Hospital on 2025-11-18.