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NCT Number: NCT07097792

Concussion Recovery and Support Program

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.

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Key information

Age range

18 year–29 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seattle Children's Research Institute, Seattle, Washington, United States

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About this study

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 persistent concussion/ mTBI. CRISP is an adaptation of an evidence-based treatment for chronic pain called Emotional Awareness and Expression Therapy (EAET). EAET targets underlying emotional responses that appear to drive persistent symptoms, and has been found effective for treating headache and other types of pain in randomized controlled trials with moderately strong effect sizes (0.4-0.5).

Individuals who participate in this study will complete 6 sessions of CRISP with a trained therapist over zoom (each 60 minutes) and will also fill out surveys at multiple time points (baseline, 5 weeks, 10 weeks).

Aim 1: Evaluate feasibility and acceptability of CRISP with a pilot study of n=40 individuals with concussion ages 18-30 years who are struggling with headache. Hypothesis: CRISP will be a feasible and acceptable approach to treating AYA with concussion.

Aim 2: Collect pilot data regarding efficacy of CRISP for reducing concussion symptoms and improving function (particularly regarding headache). Hypothesis: Pilot data may show benefit from this approach for improving recovery, though we do not expect significance given the sample size.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CRISP (Concussion Recovery and Support Program)

Behavioral

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

Primary outcomes

  1. Treatment Evaluation Inventory, short form

    Time frame: 10 weeks

    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.

Secondary outcomes

  1. HIT6 (Headache Impact Test, 6 item)

    Time frame: Baseline, 5 weeks, 10 weeks (trajectory over time)

    Self-report measure of headache severity, minimum 6 maximum 78, higher scores indicates greater symptoms.

  2. PROMIS fatigue short form

    Time frame: Baseline/ 5 weeks/ 10 weeks (trajectory over time)

    7 item self-report scale measuring issues with fatigue. Minimum 7, maximum 35, higher scores indicates more symptoms.

  3. Fear of Concussive Symptoms Questionnaire (FOCSQ)

    Time frame: Baseline/ 5 weeks/ 10 weeks (trajectory over time)

    Self-report measure of fear-avoidance of activities due to concussive symptoms. Minimum 0, maximum 96 (24 items x 4 likert), higher is worse

  4. Post Concussion Symptom Scale (PCSS)

    Time frame: Baseline/ 5 weeks/ 10 weeks (trajectory over time)

    Self-report measure of concussive symptoms, minimum 0, maximum 132 (22 items x 6 likert), higher indicates more symptoms

  5. PROMIS (Patient Reported Outcome Measurement Information System) anxiety

    Time frame: Baseline/ 5 weeks/ 10 weeks (trajectory over time)

    8 item scale to measure self-report of anxiety, minimum 8, maximum 40 (5likert x 8), higher indicates more symptoms

  6. PROMIS depression

    Time frame: Baseline/ 5 weeks/ 10 weeks (trajectory over time)

    8 item scale to measure self-report of depressive symptoms, minimum 8, maximum 40 (5 likert x 8 items), higher indicates more symptoms

  7. Emotional Approach Coping (EAC)

    Time frame: Baseline/ 5 weeks/ 10 weeks (trajectory over time)

    Self-report survey to measure ability to acknowledge and express emotion, minimum 8, maximum 32 (4 likert x 8), higher indicates more symptoms

  8. Psychological Insight

    Time frame: 10 weeks (post-intervention only)

    6 item self-report scale to measure psychological insight, minimum 0, maximum 24 (4 likert x 6), higher indicates greater insight

  9. PROMIS sleep disturbance SF

    Time frame: Baseline/ 4 weeks/ 8 weeks (trajectory over time)

    Self-report measure of sleep disturbance, minimum 8, maximum 40 (5 likert x 8), higher indicates more symptoms

Study contacts

Contact information is provided by the study sponsor or research team.

Allina Flaat, MPH

CONTACT

Sara PD Chrisman, MD MPH

CONTACT

[email protected]

206-884-1490

Sponsors and collaborators

Lead sponsor

Seattle Children's Hospital

Other

Registry information

Official study title

Pilot Study of Concussion Recovery and Support Program (CRISP)

Acronym: CRISP

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 31, 2025
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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