Concussion Recovery and Support Program
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CRISP (Concussion Recovery and Support Program).
- Who it may be relevant to
- Registry conditions: Brain Concussion, Mild Traumatic Brain Injury, Headache. Basic parameters: 18 years — 29 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Pilot Study of Concussion Recovery and Support Program (CRISP)
Overview
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.
Interventions
- Behavioral CRISP (Concussion Recovery and Support Program)
Mental health intervention targeting suppressed emotion with a goal of facilitating recovery.
Primary outcome measures
- Treatment Evaluation Inventory, short form [Time frame: 10 weeks]
Secondary outcome measures (9)
- 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)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Seattle Children's Research Institute — Seattle
- University of Washington — Seattle
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. PMID 31123837
Identifiers
NCT: NCT07097792 · 00005446