Clinical trial NCT05365776: Graded Exposure Therapy for Fear Avoidance Behaviour After Concussion
Official title: Graded Exposure Therapy for Fear Avoidance Behaviour (GET FAB) After Concussion
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mild Traumatic Brain Injury
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2022-05-09
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: 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 outcomes:
measure: Rivermead Post Concussion Symptoms Questionnaire (RPQ): Change
timeFrame: 3 months
Secondary outcomes:
measure: Fear Avoidance Behaviour after Traumatic Brain Injury Questionnaire (FAB-TBI): Change
timeFrame: 3 months
Other outcomes:
measure: World Health Organization Disability Assessment Schedule (WHODAS) 2.0 12-item: interviewer version: Change.
timeFrame: 3 months
measure: The Generalized Anxiety Disorder-7
timeFrame: 3 months
measure: Personal Health Questionnaire-9
timeFrame: 3 months
measure: The Post-Concussion Functional Scale-Screen
timeFrame: baseline and 3 months
Locations:
city: Calgary
country: Canada
facility: Calgary Brain Injury Program
state: Alberta
city: Langley
country: Canada
facility: Fraser Health Acquired Brain Injury and Concussion Services
state: British Columbia
city: Vancouver
country: Canada
facility: G.F. Strong Adult Concussion Services
state: British Columbia
city: Toronto
country: Canada
facility: Sunnybrooke Traumatic Brain Injury Clinic
state: Ontario
city: Toronto
country: Canada
facility: Head Injury Clinic at St. Michael's
state: Ontario
city: Toronto
country: Canada
facility: Hull-Ellis Concussion and Research Clinic
state: Ontario
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
Study officials:
affiliation: University of British Columbia
name: Noah Silverberg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.