Graded Exposure Therapy for Fear Avoidance Behaviour After Concussion (GET FAB): protocol for a multisite Canadian randomised controlled trial.

Introduction: Persistent symptoms after mild traumatic brain injury (mTBI) negatively affect daily functioning and quality of life. Fear avoidance behaviour, a coping style in which people avoid or escape from activities or situations that they expect will exacerbate their symptoms, maybe a particularly potent and modifiable risk factor for chronic disability after mTBI. This study will evaluate the efficacy of graded exposure therapy (GET) for reducing persistent symptoms following mTBI, with two primary aims: (1) To determine whether GET is more effective than usual care; (2) to identify for whom GET is the most effective treatment option, by evaluating whether baseline fear avoidance moderates differences between GET and an active comparator (prescribed aerobic exercise). Our findings will guide evidence-based care after mTBI and enable better matching of mTBI patients to treatments.
Methods and Analysis: We will conduct a multisite randomised controlled trial with three arms. Participants (n=220) will be recruited from concussion clinics and emergency departments in three Canadian provinces and randomly assigned (1:2:2 ratio) to receive enhanced usual care, GET or prescribed aerobic exercise. The outcome assessment will occur remotely 14-18 weeks following baseline assessment, after completing the 12-week treatment phase. The primary outcome will be symptom severity (Rivermead Post-concussion Symptoms Questionnaire).
Ethics and Dissemination: Informed consent will be obtained from all participants. All study procedures were approved by the local research ethics boards (University of British Columbia Clinical Research Ethics Board, University of Calgary Conjoint Health Research Ethics Board, University Health Network Research Ethics Board-Panel D). Operational approvals were obtained for Vancouver Coastal Health Research Institute and Provincial Health Services Authority. If GET proves effective, we will disseminate the GET treatment manual and present instructional workshops for clinicians.
Trial Registration Number: ClinicalTrials.gov #NCT05365776.
Competing Interests: Competing interests: AM declared a fellowship from the UBC Mental Health Institute and Department of Psychiatry. NS declared research grants from multiple granting agencies (Canada Foundation for Innovation, Canadian Institutes of Health Research, Mitacs, Ontario Brain Institute, US Department of Defense, WorkSafeBC, VGH+UBC Hospital Foundation) for research related to traumatic brain injury diagnosis, prognosis and treatment. He has received speaker fees for providing continuing medical education on these topics. KY declared grants from the Canadian Institutes of Health Research, National Institutes of Health, Brain Canada Foundation, Social Science and Humanities Research Council (Canada) and National Football League Scientific Advisory Board; royalties or licences from Guilford Press and Cambridge University Press; payments or honoraria from Northern California Neuropsychology Forum, Queensland Paediatric Rehabilitation Service (QPRS) and Queensland Children’s Hospital; support for attending Major League Soccer; participation on Independent Data Monitoring Committee (IDMC), Care for Post-Concussive Symptoms Effectiveness (CARE4PCS-2) Trial, National Institute for Child Health and Human Development; leadership or fiduciary roles as Editor (Neuropsychology), Consulting editor (Archives of Clinical Neuropsychology and Journal of Head Trauma Rehabilitation), Chair (Canadian Concussion Network), Scientific Advisory Committee (Brain Injury Canada), National Research Advisory Council, National Pediatric Rehabilitation Resource Center, Center for Pediatric Rehabilitation: Growing Research, Education, and Sharing Science (C-PROGRESS), Virginia Tech University. Other authors: None declared.
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