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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Treatment as usual (TAU) | No Intervention | Treatment as usual. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CRISP (Concussion Recovery and Support Program) | Behavioral | Mental health intervention targeting suppressed emotion with a goal of facilitating recovery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| HIT6 (Headache Impact Test, 6 item) | Self-report measure of headache severity, minimum 6 maximum 78, higher scores indicates greater symptoms. | Baseline, 5 weeks, 10 weeks (trajectory over time) |
| PROMIS fatigue short form |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sara PD Chrisman, MD MPH | Contact | 206-884-1490 | crisp@seattlechildrens.org | |
| Allina Flaat, MPH | Contact |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seattle Children's Research Institute | Recruiting | Seattle | Washington | 98104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31123837 | Background | 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. |
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Would consider sharing in a collaborative fashion given pilot nature of study
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| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| D006261 | Headache |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Randomized Controlled Trial
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Data analyst will be blinded
7 item self-report scale measuring issues with fatigue. Minimum 7, maximum 35, higher scores indicates more symptoms.
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | Baseline/ 4 weeks/ 8 weeks (trajectory over time) |
| University of Washington | Recruiting | Seattle | Washington | 98105 | United States |
|
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010549 | Personal Satisfaction |
| D001519 | Behavior |