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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
Mental health intervention targeting suppressed emotion with a goal of facilitating recovery.
Seattle Children's Research Institute
Seattle, Washington, United States
RECRUITINGUniversity of Washington
Seattle, Washington, United States
RECRUITINGTreatment 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.
Time frame: 10 weeks
HIT6 (Headache Impact Test, 6 item)
Self-report measure of headache severity, minimum 6 maximum 78, higher scores indicates greater symptoms.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline/ 5 weeks/ 10 weeks (trajectory over time)
PROMIS depression
Allina Flaat, MPH
CONTACT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
8 item scale to measure self-report of depressive symptoms, minimum 8, maximum 40 (5 likert x 8 items), higher indicates more symptoms
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline/ 4 weeks/ 8 weeks (trajectory over time)