CRISP (Concussion Recovery and Support Program)
BehavioralMental health intervention targeting suppressed emotion with a goal of facilitating recovery.
NCT Number: NCT07097792
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.
Interested in participating?
Request Info18 year–29 year
All sexes
Interventional
Not applicable
Seattle Children's Research Institute, Seattle, Washington, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Mental health intervention targeting suppressed emotion with a goal of facilitating recovery.
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.
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.
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.
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
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
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
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
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
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
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
Contact information is provided by the study sponsor or research team.
Seattle Children's Hospital
Other
Pilot Study of Concussion Recovery and Support Program (CRISP)
Acronym: CRISP
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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