Concussion Recovery and Support Program (CRISP)

Seattle Children's Healthcare System

Status: Enrolling

Conditions: Mild Traumatic Brain Injury; Brain Concussion; Headache

Treatments: Behavioral: CRISP (Concussion Recovery and Support Program)

Study type: Interventional

Funder types: Other

Identifiers

NCT07097792

00005446

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 29 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

CRISP

Experimental group

Description:

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:

Behavioral: CRISP (Concussion Recovery and Support Program)

Treatment as usual (TAU)

No Intervention group

Description:

Treatment as usual.