Graded Exposure Therapy for Fear Avoidance Behaviour After Concussion

Last updated: February 7, 2025
Sponsor: University of British Columbia
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Brain Injury

Neurologic Disorders

Treatment

Prescribed aerobic exercise

Enhanced usual care

Graded Exposure Therapy

Clinical Study ID

NCT05365776
H21-02605
  • Ages 18-69
  • All Genders

Study Summary

Concussions are very common. Although many people recover well from concussion, some will have persistent symptoms and difficulties with daily activities. How people cope with their symptoms following concussion powerfully influences their recovery. Fear avoidance behaviour is a particularly unhelpful approach to coping, in which people perceive their pre-injury activities as unnecessarily dangerous and take great care to avoid overexertion and overstimulation. The investigators developed and pilot tested a behavioural therapy, called graded exposure therapy, to reduce fear avoidance behaviour. Our preliminary work suggested that graded exposure therapy was acceptable to patients with concussion and possibly beneficial for their recovery. The GET FAB after concussion study will assess the effectiveness of graded exposure therapy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. aged 18-70 years;

  2. sustained a concussion according to the ACRM mTBI Task Force definition between 1and 24 months ago

  3. fluent in English, because validated translations are not available for mostquestionnaires and recruiting multilingual therapists is not feasible;

  4. access to a computer, tablet, or smartphone with internet capability;

  5. 3 or more moderate-severe symptoms on the Rivermead Postconcussion SymptomQuestionnaire.

Exclusion

Exclusion Criteria:

  1. medical contraindication to aerobic exercise (cardiac disease, chest pain withexertion, acute bone/joint/soft tissue injury aggravated by exercise)

  2. change in cardiac medication within the last month, such as beta blockers, calciumchannel blockers, or ivabradine

  3. involved in personal injury litigation for index mTBI

  4. currently pregnant or plan to become pregnant within the next three months

  5. severe/unstable medical or psychiatric condition that could worsen over the nextyear")

Study Design

Total Participants: 220
Treatment Group(s): 3
Primary Treatment: Prescribed aerobic exercise
Phase:
Study Start date:
June 01, 2022
Estimated Completion Date:
December 31, 2025

Study Description

GET FAB is a multisite randomized controlled trial designed to evaluate a behavioural treatment (graded exposure therapy) for adults with persistent symptoms after concussion. Participants in this study will be recruited from a network of concussion clinics in Canada. This study follows from the investigators' prior work establishing that (1) fear avoidance behaviour is a risk factor for poor concussion outcome, (2) graded exposure therapy reduces fear avoidance behaviour, and (3) graded exposure therapy is perceived as credible and is well-tolerated by patients with persistent post-concussion symptoms.

Participants will be assigned at random (in a 1:2:2 ratio) to receive enhanced usual care, graded exposure therapy group, or another therapy that might have similar benefits (prescribed aerobic exercise). The investigators hypothesize that patients who participate in graded exposure therapy will have reduced fear avoidance behaviour and improved daily functioning compared to other treatment conditions and this difference will be greatest for patients who enter the study with high fear avoidance behaviour.

Connect with a study center

  • Calgary Brain Injury Program

    Calgary, Alberta T2N 2T9
    Canada

    Site Not Available

  • Fraser Health Acquired Brain Injury and Concussion Services

    Langley, British Columbia V1M 4A6
    Canada

    Site Not Available

  • G.F. Strong Adult Concussion Services

    Vancouver, British Columbia V5Z 2G9
    Canada

    Site Not Available

  • Head Injury Clinic at St. Michael's

    Toronto, Ontario M5B 1W8
    Canada

    Site Not Available

  • Hull-Ellis Concussion and Research Clinic

    Toronto, Ontario M5G 2A2
    Canada

    Site Not Available

  • Sunnybrooke Traumatic Brain Injury Clinic

    Toronto, Ontario M4N 3M5
    Canada

    Site Not Available

  • Toronto Western Hospital

    Toronto, Ontario M5T 2S8
    Canada

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.