Actively Recruiting

Phase Not Applicable
Age: 18Years - 29Years
All Genders
ID07097792

Pilot Study of Concussion Recovery and Support Program (CRISP) for Young Adults with Concussion and Headache

Led by Seattle Children's Hospital · Updated on 2025-11-18

40

Participants Needed

2

Research Sites

1 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the Concussion Recovery and Support Program (CRISP), a new approach adapted from Emotional Awareness and Expression Therapy (EAET), for young adults aged 18 to 29 with persistent concussion or mild traumatic brain injury (mTBI) who experience headaches. This pilot randomized controlled trial aims to explore the feasibility, acceptability, and preliminary effectiveness of CRISP in improving symptoms and function related to concussion. The study compares two groups: one receiving the CRISP intervention and the other receiving treatment as usual. CRISP involves six 60-minute sessions delivered remotely via Zoom over a 10-week period. The therapy focuses on addressing emotional responses that may contribute to ongoing symptoms after concussion. Participants will complete surveys at the start, 5 weeks, and 10 weeks to track changes in headache impact, fatigue, anxiety, depression, sleep disturbance, and concussion symptoms. Researchers will also assess treatment acceptability and psychological insight at 10 weeks. The study is led by Seattle Children's Hospital and lasts approximately 10 weeks for each participant.

CONDITIONS

Brief Title

Concussion Recovery and Support Program

Who Can Participate

Age: 18Years - 29Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with a concussion between 2 weeks and 2 years ago
  • New or worsening headache since concussion
  • At least one day with moderate headache or two days with any headache in the last week
  • Age between 18 and 29 years
Not Eligible

You will not qualify if you...

  • Non-English speaking
  • Chronic medical illness or medical complexity
  • Housing instability
  • Acute mental health issues such as active suicidality, psychiatric hospitalization, ER visit for suicidality within the past 6 months, psychosis, or delusions
  • Age outside 18 to 29 years range (implied exclusion based on inclusion age limits but explicitly stated here for clarity if needed for screening purposes) (optional if not in source explicitly, but since age is inclusion, no need to list here explicitly so omitted in output as per source only)
  • None stated beyond above criteria in source, so excluded here only those listed above (excluded by source only, age exclusion not explicitly stated so omitted here for accuracy).

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or virtual) for eligibility assessment

Outpatient Treatment

Duration - 10 weeks

Participants complete 6 sessions of the CRISP behavioral intervention targeting emotional responses related to concussion symptoms, delivered over Zoom.

6 sessions over 10 weeks (virtual)

Outpatient Treatment

Duration - 10 weeks

Participants assigned to treatment as usual without intervention are observed for comparison.

No scheduled intervention visits

Trial Site Locations

Total: 2 locations

1

Seattle Children's Research Institute

Seattle, Washington, United States, 98104

Actively Recruiting

2

University of Washington

Seattle, Washington, United States, 98105

Actively Recruiting

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Research Team

S

Sara PD Chrisman, MD MPH

A

Allina Flaat, MPH

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Emotional Awareness and Expression Therapy for Chronic Pain: Rationale, Principles and Techniques, Evidence, and Critical Review.

Mark A Lumley, Howard Schubiner

https://pubmed.ncbi.nlm.nih.gov/31123837