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NCT Number: NCT05365776

Graded Exposure Therapy for Fear Avoidance Behaviour 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.

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Key information

Conditions

Mild Traumatic Brain Injury Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Head Injuries, Closed Nervous System Diseases Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Calgary Brain Injury Program, Calgary, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • aged 18-70 years;
  • sustained a concussion according to the ACRM mTBI Task Force definition between 1 and 24 months ago
  • fluent in English, because validated translations are not available for most questionnaires and recruiting multilingual therapists is not feasible;
  • access to a computer, tablet, or smartphone with internet capability;
  • 3 or more moderate-severe symptoms on the Rivermead Postconcussion Symptom Questionnaire.

Exclusion criteria

  • medical contraindication to aerobic exercise (cardiac disease, chest pain with exertion, acute bone/joint/soft tissue injury aggravated by exercise)
  • change in cardiac medication within the last month, such as beta blockers, calcium channel blockers, or ivabradine
  • involved in personal injury litigation for index mTBI
  • currently pregnant or plan to become pregnant within the next three months
  • severe/unstable medical or psychiatric condition that could worsen over the next year")

Treatment and study plan

Graded Exposure Therapy

Behavioral

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

Behavioral

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

Other

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

Primary outcomes

  1. Rivermead Post Concussion Symptoms Questionnaire (RPQ): Change

    Time frame: 3 months

    Score of 0-64, with a higher score indicates worse symptoms.

Secondary outcomes

  1. Fear Avoidance Behaviour after Traumatic Brain Injury Questionnaire (FAB-TBI): Change

    Time frame: 3 months

    score of 0-48, where higher score indicates higher avoidance.

Other outcomes

  1. World Health Organization Disability Assessment Schedule (WHODAS) 2.0 12-item: interviewer version: Change.

    Time frame: 3 months

    score of 12 to 60, where higher scores indicate higher disability or loss of function

  2. The Generalized Anxiety Disorder-7

    Time frame: 3 months

    score of 0-15, where higher scores indicate severity of anxiety experienced.

  3. Personal Health Questionnaire-9

    Time frame: 3 months

    score of 0-27, where higher scores indicate severity of depression experienced.

  4. The Post-Concussion Functional Scale-Screen

    Time frame: baseline and 3 months

    0 (unable) - 5 (more than 2 hours), higher score means longer length of time an activity can be tolerated without symptoms.

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

Graded Exposure Therapy for Fear Avoidance Behaviour (GET FAB) After Concussion

Acronym: GET-FAB

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
May 9, 2022
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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