NCT07097792

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress71%
Oct 2025Jul 2026

First Submitted

Initial submission to the registry

July 24, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 31, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

October 13, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2026

Expected
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Last Updated

November 18, 2025

Status Verified

November 1, 2025

Enrollment Period

9 months

First QC Date

July 24, 2025

Last Update Submit

November 14, 2025

Conditions

Brain ConcussionMild Traumatic Brain InjuryHeadache

Keywords

mental healththerapyemotional awareness and expression therapy

Outcome Measures

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.

    10 weeks

Secondary Outcomes (9)

  • HIT6 (Headache Impact Test, 6 item)

    Baseline, 5 weeks, 10 weeks (trajectory over time)

  • PROMIS fatigue short form

    Baseline/ 5 weeks/ 10 weeks (trajectory over time)

  • Fear of Concussive Symptoms Questionnaire (FOCSQ)

    Baseline/ 5 weeks/ 10 weeks (trajectory over time)

  • Post Concussion Symptom Scale (PCSS)

    Baseline/ 5 weeks/ 10 weeks (trajectory over time)

  • PROMIS (Patient Reported Outcome Measurement Information System) anxiety

    Baseline/ 5 weeks/ 10 weeks (trajectory over time)

  • +4 more secondary outcomes

Study Arms (2)

CRISP

EXPERIMENTAL

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.

Behavioral: CRISP (Concussion Recovery and Support Program)

Treatment as usual (TAU)

NO INTERVENTION

Treatment as usual.

Interventions

CRISP (Concussion Recovery and Support Program)BEHAVIORAL

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

CRISP

Eligibility Criteria

Age18 Years - 29 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Seattle Children's Research Institute

Seattle, Washington, 98104, United States

RECRUITING

University of Washington

Seattle, Washington, 98105, United States

RECRUITING

Related Publications (1)

  • Lumley MA, Schubiner H. Emotional Awareness and Expression Therapy for Chronic Pain: Rationale, Principles and Techniques, Evidence, and Critical Review. Curr Rheumatol Rep. 2019 May 23;21(7):30. doi: 10.1007/s11926-019-0829-6.

    PMID: 31123837BACKGROUND

MeSH Terms

Conditions

Brain ConcussionHeadachePsychological Well-Being

Condition Hierarchy (Ancestors)

Brain Injuries, TraumaticBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemHead Injuries, ClosedWounds and InjuriesWounds, NonpenetratingPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPersonal SatisfactionBehavior

Central Study Contacts

Sara PD Chrisman, MD MPH

CONTACT

206-884-1490crisp@seattlechildrens.org

Allina Flaat, MPH

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Data analyst will be blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 24, 2025

First Posted

July 31, 2025

Study Start

October 13, 2025

Primary Completion (Estimated)

July 21, 2026

Study Completion (Estimated)

July 31, 2026

Last Updated

November 18, 2025

Record last verified: 2025-11

Locations

US(2)