Concussion Recovery and Support Program (CRISP)

Pilot Study of Concussion Recovery and Support Program (CRISP)

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.

Study Overview

• Status: Recruiting
• Conditions: Headache; Brain Concussion; Mild Traumatic Brain Injury
• Intervention / Treatment: Behavioral: CRISP (Concussion Recovery and Support Program)

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sara PD Chrisman, MD MPH; Phone Number: 206-884-1490; Email: crisp@seattlechildrens.org
• Study Contact Backup: Name: Allina Flaat, MPH

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98105
      • Recruiting
      • University of Washington
      • Contact: Bethany Pester, PhD; Phone Number: 206-884-1490; Email: crisp@seattlechildrens.org
    • Seattle, Washington, United States, 98104
      • Recruiting
      • Seattle Children's Research Institute
      • Contact: Sara P Chrisman, MD MPH; Phone Number: 206-884-1490; Email: crisp@seattlechildrens.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Treatment as usual (TAU); Treatment as usual.
Experimental: CRISP; 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.	Behavioral: CRISP (Concussion Recovery and Support Program); Mental health intervention targeting suppressed emotion with a goal of facilitating recovery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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	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)

Collaborators and Investigators

• Sponsor: Seattle Children's Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2025
• Primary Completion (Estimated): July 21, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: July 24, 2025
• First Submitted That Met QC Criteria: July 24, 2025
• First Posted (Actual): July 31, 2025

Study Record Updates

• Last Update Posted (Actual): November 18, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: mental health; therapy; emotional awareness and expression therapy
• Additional Relevant MeSH Terms: Brain Injuries, Traumatic; Pain; Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Personal Satisfaction; Headache; Brain Concussion; Psychological Well-Being
• Other Study ID Numbers: 00005446

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Would consider sharing in a collaborative fashion given pilot nature of study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No