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Clinical Trials in Canada / NCT05365776
Active, not recruiting Not applicable

Graded Exposure Therapy for Fear Avoidance Behaviour After Concussion

NCT05365776 · tracked via the Priya Life Science Canada tracker
Phase
Not applicable
Started
2022-06-01
Last updated
2026-03-31

Condition(s) studied

Mild Traumatic Brain Injury

Investigational drug(s) / intervention(s)

Graded Exposure TherapyPrescribed aerobic exerciseEnhanced usual care

Graded Exposure Therapy: Graded exposure therapy is delivered by a psychologist over 12 individual (1:1) secure videoconference sessions. The core active ingredient is graded situational exposure to foster habituation and challenge beliefs that the avoided activities are dangerous. Homework exercises involve planned exposure exercises in the home and community to support generalization.

Prescribed aerobic exercise: Participants will be asked to complete 30 minutes of aerobic exercise on 5 days/week for a 12-week period. Participants select the mode (e.g., swimming, jogging, bicycling) and location of exercise (e.g., outdoors, a gym or community centre, at home). The initial exercise intensity target will be based on the Buffalo Concussion Bike Test. The target progression will be 3-5 beats per minute every two weeks.

Enhanced usual care: Usual care (education about concussion from the website: concussion.vch.ca/) will be enhanced through email message support.

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

Sex
ALL
Min age
18 Years
Max age
69 Years
Healthy volunteers
No
Inclusion Criteria: 1. aged 18-70 years; 2. sustained a concussion according to the ACRM mTBI Task Force definition between 1 and 24 months ago 3. fluent in English, because validated translations are not available for most questionnaires 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 Symptom Questionnaire. Exclusion Criteria: 1. medical contraindication to aerobic exercise (cardiac disease, chest pain with exertion, acute bone/joint/soft tissue injury aggravated by exercise) 2. change in cardiac medication within the last month, such as beta blockers, calcium channel 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 next year")

Primary outcome measure(s)

Trial sites (7)

FacilityCityRegionStatus
Calgary Brain Injury Program Calgary Alberta
Fraser Health Acquired Brain Injury and Concussion Services Langley British Columbia
G.F. Strong Adult Concussion Services Vancouver British Columbia
Sunnybrooke Traumatic Brain Injury Clinic Toronto Ontario
Head Injury Clinic at St. Michael's Toronto Ontario
Hull-Ellis Concussion and Research Clinic Toronto Ontario
Toronto Western Hospital Toronto Ontario

More University of British Columbia trials in Canada

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05365776 on ClinicalTrials.gov ↗ ← All trials in Canada