Concussion Recovery and Support Program

Not Applicable

Not yet recruiting

• Conditions: Brain Concussion; Mild Traumatic Brain Injury; Headache

• Registration Number: NCT07097792
• Lead Sponsor: Seattle Children's Hospital

Brief Summary

Pilot randomized controlled trial (RCT) comparing a novel intervention Concussion Recovery and Support Program (CRISP) for adolescents and young adults (AYA) 18-30 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, 4 weeks, 8 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 Timeline

• Study First Submitted: 2025-07-24
• Study First Submitted QC: 2025-07-24
• Study First Posted: 2025-07-31
• Status Verified: 2025-09
• Study Start: 2025-09-15
• Last Update Submitted: 2025-09-17
• Last Update Posted: 2025-09-22
• Primary Completion: 2026-07-21
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Diagnosed with a concussion and at least 2 weeks from injury but less than one year.
• 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
• 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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Treatment Evaluation Inventory, short form	8 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 Outcome Measures

Name	Time	Method
HIT6 (Headache Impact Test, 6 item)	Baseline, 4 weeks, 8 weeks (trajectory over time)	Self-report measure of headache severity, minimum 6 maximum 78, higher scores indicates greater symptoms.
Fatigue and Altered Cognition Scale (FACS)	Baseline/ 4 weeks/ 8 weeks (trajectory over time)	20 item self-report scale measuring issues with fatigue and cognition. Minimum 0, maximum 100, (score reported as an average) higher scores indicates more symptoms.
Fear of Concussive Symptoms Questionnaire (FOCSQ)	Baseline/ 4 weeks/ 8 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
Post Concussion Symptom Scale (PCSS)	Baseline/ 4 weeks/ 8 weeks (trajectory over time)	Self-report measure of concussive symptoms, minimum 0, maximum 132 (22 items x 6 likert), higher indicates more symptoms
PROMIS (Patient Reported Outcome Measurement Information System) anxiety	Baseline/ 4 weeks/ 8 weeks (trajectory over time)	8 item scale to measure self-report of anxiety, minimum 8, maximum 40 (5likert x 8), higher indicates more symptoms
PROMIS depression	Baseline/ 4 weeks/ 8 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
Emotional Approach Coping (EAC)	Baseline/ 4 weeks/ 8 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
Psychological Insight	Baseline/ 4 weeks/ 8 weeks (trajectory over time)	6 item self-report scale to measure psychological insight, minimum 0, maximum 24 (4 likert x 6), higher indicates more symptoms
PROMIS sleep disturbance SF	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
PC-PTSD (Primary care post traumatic stress disorder screener)	Baseline/ 4 weeks/ 8 weeks (trajectory over time)	5 item measure of PTSD symptoms, minimum 0, maximum 6, higher indicates worse

Trial Locations

Locations (2)

Seattle Children's Research Institute; 🇺🇸 Seattle, Washington, United States

University of Washington; 🇺🇸 Seattle, Washington, United States