Brain Concussion, Headache, Mild Traumatic Brain Injury
Conditions
Keywords
mental health, therapy, emotional awareness and expression therapy
Brief summary
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
BEHAVIORALCRISP (Concussion Recovery and Support Program)
Mental health intervention targeting suppressed emotion with a goal of facilitating recovery.
Sponsors
Seattle Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Data analyst will be blinded
Intervention model description
Randomized Controlled Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 29 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Evaluation Inventory, short form | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PROMIS fatigue short form | 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. |
| Fear of Concussive Symptoms Questionnaire (FOCSQ) | 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 |
| Post Concussion Symptom Scale (PCSS) | 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 |
| PROMIS (Patient Reported Outcome Measurement Information System) anxiety | 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 |
| HIT6 (Headache Impact Test, 6 item) | Baseline, 5 weeks, 10 weeks (trajectory over time) | Self-report measure of headache severity, minimum 6 maximum 78, higher scores indicates greater symptoms. |
| Emotional Approach Coping (EAC) | 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 |
| Psychological Insight | 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 |
| 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 |
| PROMIS depression | 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 |
Countries
United States
Contacts
Primary ContactSara PD Chrisman, MD MPH
Backup ContactAllina Flaat, MPH
Outcome results
None listed