Graded Exposure Therapy for Fear Avoidance Behaviour After Concussion

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Mild Traumatic Brain Injury

Intervention / Treatment
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* Behavioral: Graded Exposure Therapy
* Behavioral: Prescribed aerobic exercise
* Other: Enhanced usual care


Participation Criteria
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Eligibility Criteria
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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); not been stable on a medication, such as beta blockers, calcium channel blockers, or ivabradine, for at least a month; involved in personal injury litigation for index concussion currently pregnant or will become pregnant within the next 3 months severe/unstable medical or psychiatric condition or medical condition that could get worse in the next year confounding factors present at time of injury.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1: Graded Exposure Therapy<br> | Behavioral: Graded Exposure Therapy<br>* 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.<br>|
| Active Comparator: Arm 2: Prescribed Aerobic Exercise<br> | Behavioral: Prescribed aerobic exercise<br>* 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.<br>|
| Active Comparator: Arm 3: Enhanced usual care<br> | Other: Enhanced usual care<br>* Usual care (education about concussion from the website: concussion.vch.ca/) will be enhanced through text message support.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rivermead Post Concussion Symptoms Questionnaire (RPQ): Change | Score of 0-64, with a higher score indicates worse symptoms. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| World Health Organization Disability Assessment Schedule (WHODAS) 2.0 12-item: interviewer version: Change. | score of 12 to 60, where higher scores indicate higher disability or loss of function | 3 months |