Brain ConcussionCRISPNCT07097792
Concussion Recovery and Support Program
A study testing CRISP (Concussion Recovery and Support Program) in people with Brain Concussion and Mild Traumatic Brain Injury, run by Seattle Children's Hospital at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 29 years
- Conditions the study is for
- Brain Concussion, Mild Traumatic Brain Injury, Headache
- What is being tested?
- CRISP (Concussion Recovery and Support Program)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Oct 2025to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Allina Flaat, MPH contact
United States2 sites, 2 recruiting
- Recruiting
Seattle Children's Research Institute
Seattle, Washington, 98104
Sara P Chrisman, MD MPH, 206-884-1490, crisp@seattlechildrens.org
- Recruiting
University of Washington
Seattle, Washington, 98105
Bethany Pester, PhD, 206-884-1490, crisp@seattlechildrens.org
About this study
Official title: Pilot Study of Concussion Recovery and Support Program (CRISP)
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.
Read the detailed description
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.
- Conditions
- Brain Concussion, Mild Traumatic Brain Injury, Headache
- Being tested
- CRISP (Concussion Recovery and Support Program)
- Keywords
- mental health, therapy, emotional awareness and expression therapy
- Medical subject headings
- Brain Concussion, Headache, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRISP (Concussion Recovery and Support Program)Behavioural
Mental health intervention targeting suppressed emotion with a goal of facilitating recovery.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: CRISP (Concussion Recovery and Support Program) |
| Treatment as usual (TAU) | No intervention | Treatment as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 weeks
Secondary outcomes (9)
HIT6 (Headache Impact Test, 6 item)
Self-report measure of headache severity, minimum 6 maximum 78, higher scores indicates greater symptoms.
Measured: Baseline, 5 weeks, 10 weeks (trajectory over time)
PROMIS fatigue short form
7 item self-report scale measuring issues with fatigue. Minimum 7, maximum 35, higher scores indicates more symptoms.
Measured: Baseline/ 5 weeks/ 10 weeks (trajectory over time)
Fear of Concussive Symptoms Questionnaire (FOCSQ)
Self-report measure of fear-avoidance of activities due to concussive symptoms. Minimum 0, maximum 96 (24 items x 4 likert), higher is worse
Measured: Baseline/ 5 weeks/ 10 weeks (trajectory over time)
Post Concussion Symptom Scale (PCSS)
Self-report measure of concussive symptoms, minimum 0, maximum 132 (22 items x 6 likert), higher indicates more symptoms
Measured: Baseline/ 5 weeks/ 10 weeks (trajectory over time)
PROMIS (Patient Reported Outcome Measurement Information System) anxiety
8 item scale to measure self-report of anxiety, minimum 8, maximum 40 (5likert x 8), higher indicates more symptoms
Measured: Baseline/ 5 weeks/ 10 weeks (trajectory over time)
PROMIS depression
8 item scale to measure self-report of depressive symptoms, minimum 8, maximum 40 (5 likert x 8 items), higher indicates more symptoms
Measured: Baseline/ 5 weeks/ 10 weeks (trajectory over time)
Emotional Approach Coping (EAC)
Self-report survey to measure ability to acknowledge and express emotion, minimum 8, maximum 32 (4 likert x 8), higher indicates more symptoms
Measured: Baseline/ 5 weeks/ 10 weeks (trajectory over time)
Psychological Insight
6 item self-report scale to measure psychological insight, minimum 0, maximum 24 (4 likert x 6), higher indicates greater insight
Measured: 10 weeks (post-intervention only)
PROMIS sleep disturbance SF
Self-report measure of sleep disturbance, minimum 8, maximum 40 (5 likert x 8), higher indicates more symptoms
Measured: Baseline/ 4 weeks/ 8 weeks (trajectory over time)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start13 Oct 2025
- Primary completion21 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain ConcussionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara PD Chrisman, MD MPH, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07097792
- Sponsor's protocol ID
- 00005446
- Acronym
- CRISP
- Status last verified
- Nov 2025
- First submitted
- 24 Jul 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Would consider sharing in a collaborative fashion given pilot nature of study
Publications
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.
PubMed 31123837
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Concussion Recovery and Support Program (CRISP)
- ClinicalTrials.gov ID
- NCT07097792
- Acronym / sponsor ID
- CRISP / 00005446
- Conditions
- Brain Concussion, Mild Traumatic Brain Injury, Headache
- Keywords
- mental health, therapy, emotional awareness and expression therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Study start
- 13 Oct 2025 (actual)
- Primary completion
- 21 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 31 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| CRISP | Experimental | Behavioral: CRISP (Concussion Recovery and Support Program)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. |
| Treatment as usual (TAU) | No intervention | –Treatment as usual. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CRISP (Concussion Recovery and Support Program)Mental health intervention targeting suppressed emotion with a goal of facilitating recovery. | Behavioural | CRISP |
Primary outcome
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.
9 secondary outcomes
HIT6 (Headache Impact Test, 6 item)
Time frame: Baseline, 5 weeks, 10 weeks (trajectory over time)
PROMIS fatigue short form
Time frame: Baseline/ 5 weeks/ 10 weeks (trajectory over time)
Fear of Concussive Symptoms Questionnaire (FOCSQ)
Time frame: Baseline/ 5 weeks/ 10 weeks (trajectory over time)
Post Concussion Symptom Scale (PCSS)
Time frame: Baseline/ 5 weeks/ 10 weeks (trajectory over time)
PROMIS (Patient Reported Outcome Measurement Information System) anxiety
Time frame: Baseline/ 5 weeks/ 10 weeks (trajectory over time)
PROMIS depression
Time frame: Baseline/ 5 weeks/ 10 weeks (trajectory over time)
Emotional Approach Coping (EAC)
Time frame: Baseline/ 5 weeks/ 10 weeks (trajectory over time)
Psychological Insight
Time frame: 10 weeks (post-intervention only)
PROMIS sleep disturbance SF
Time frame: Baseline/ 4 weeks/ 8 weeks (trajectory over time)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Background: PubMed 31123837Lumley 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.
- Individual participant dataSharing planned: Undecided. Would consider sharing in a collaborative fashion given pilot nature of study
Related trials for Brain Concussion
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Electroencephalography Markers of Brain Stimulation in Post-Concussion Patients
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RecruitingPhase 1
Rehabilitation Through Virtual Immersion & Integrated Exposure for Mild Traumatic Brain Injury (ReVIVE for mTBI)
Traumatic Brain Injuries, TBI (Traumatic Brain Injury)
Not yet recruitingObservational study
Cognitive Effects of Hyperbaric Oxygen Therapy (HBOT) After a Traumatic Brain Injury
Traumatic Brain Injury, Post-Concussion Syndrome
Recruiting
Percutaneous Electrical Nerve Field Stimulation (PENFS) in Patients With Post Concussion Syndrome (PCS)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Allina Flaat, MPH contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CRISP (Concussion Recovery and Support Program) in people with Brain Concussion and Mild Traumatic Brain Injury, run by Seattle Children's Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara PD Chrisman, MD MPH (206-884-1490, crisp@seattlechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Evaluation Inventory, short form (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07097792, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.