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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Graded Exposure Therapy | Experimental |
| |
| Arm 2: Prescribed Aerobic Exercise | Active Comparator |
| |
| Arm 3: Enhanced usual care | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Rivermead Post Concussion Symptoms Questionnaire (RPQ): Change | Score of 0-64, with a higher score indicates worse symptoms. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Fear Avoidance Behaviour after Traumatic Brain Injury Questionnaire (FAB-TBI): Change | score of 0-48, where higher score indicates higher avoidance. | 3 months |
| 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 |
| The Generalized Anxiety Disorder-7 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Noah Silverberg, PhD | University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Calgary Brain Injury Program | Calgary | Alberta | T2N 2T9 | Canada | ||
| Fraser Health Acquired Brain Injury and Concussion Services |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34971596 | Background | Silverberg ND, Cairncross M, Brasher PMA, Vranceanu AM, Snell DL, Yeates KO, Panenka WJ, Iverson GL, Debert CT, Bayley MT, Hunt C, Baker A, Burke MJ; Canadian Traumatic Brain Injury Research Consortium (CTRC). Feasibility of Concussion Rehabilitation Approaches Tailored to Psychological Coping Styles: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2022 Aug;103(8):1565-1573.e2. doi: 10.1016/j.apmr.2021.12.005. Epub 2021 Dec 28. | |
| 38950993 |
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Deidentified participant data (including data dictionaries).
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Immediately following publication. No end date.
Upon reasonable request. Requests can be made to the Principal Investigator.
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| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Participants will be blinded to the study hypotheses and treatment arms, but not to the type of intervention they are receiving. Outcome assessors will be blinded to participants' treatment assignments.
|
| 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. |
|
score of 0-15, where higher scores indicate severity of anxiety experienced.
| 3 months |
| Personal Health Questionnaire-9 | score of 0-27, where higher scores indicate severity of depression experienced. | 3 months |
| The Post-Concussion Functional Scale-Screen | 0 (unable) - 5 (more than 2 hours), higher score means longer length of time an activity can be tolerated without symptoms. | baseline and 3 months |
| Langley |
| British Columbia |
| V1M 4A6 |
| Canada |
| G.F. Strong Adult Concussion Services | Vancouver | British Columbia | V5Z 2G9 | Canada |
| Sunnybrooke Traumatic Brain Injury Clinic | Toronto | Ontario | M4N 3M5 | Canada |
| Head Injury Clinic at St. Michael's | Toronto | Ontario | M5B 1W8 | Canada |
| Hull-Ellis Concussion and Research Clinic | Toronto | Ontario | M5G 2A2 | Canada |
| Toronto Western Hospital | Toronto | Ontario | M5T 2S8 | Canada |
| Derived |
| Mikolic A, Klotz T, Brasher P, Yeates K, Vranceanu AM, Kendall KD, Snell DL, Debert CT, Bayley M, Panenka W, Cairncross M, Hunt C, Burke M, Tartaglia MC, Silverberg N; Canadian Traumatic Brain Injury Research Consortium (CTRC). Graded Exposure Therapy for Fear Avoidance Behaviour After Concussion (GET FAB): protocol for a multisite Canadian randomised controlled trial. BMJ Open. 2024 Jul 1;14(6):e086602. doi: 10.1136/bmjopen-2024-086602. |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |