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Graded Exposure Therapy for Fear Avoidance Behaviour (GET FAB) After Concussion
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.
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.
Age
18 - 69 years
Sex
ALL
Healthy Volunteers
No
Calgary Brain Injury Program
Calgary, Alberta, Canada
Fraser Health Acquired Brain Injury and Concussion Services
Langley, British Columbia, Canada
G.F. Strong Adult Concussion Services
Vancouver, British Columbia, Canada
Sunnybrooke Traumatic Brain Injury Clinic
Toronto, Ontario, Canada
Head Injury Clinic at St. Michael's
Toronto, Ontario, Canada
Hull-Ellis Concussion and Research Clinic
Toronto, Ontario, Canada
Toronto Western Hospital
Toronto, Ontario, Canada
Start Date
June 1, 2022
Primary Completion Date
May 23, 2025
Completion Date
December 1, 2025
Last Updated
July 30, 2025
220
ESTIMATED participants
Graded Exposure Therapy
BEHAVIORAL
Prescribed aerobic exercise
BEHAVIORAL
Enhanced usual care
OTHER
Lead Sponsor
University of British Columbia
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07202494