Graded Exposure Therapy for Fear Avoidance Behaviour After Concussion

Mild Traumatic Brain Injury Clinical Trial

— GET-FAB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05365776
• Other study ID #: H21-02605
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: August 2024

Study information

• Verified date: May 2024
• Source: University of British Columbia
• Contact: Noah Silverberg, PhD
• Phone: 16047341313
• Email: noah.silverberg[@]ubc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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")

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Mild Traumatic Brain Injury

Intervention

Behavioral:
• 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.

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

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	The Generalized Anxiety Disorder-7	score of 0-15, where higher scores indicate severity of anxiety experienced.	3 months
Other	Personal Health Questionnaire-9	score of 0-27, where higher scores indicate severity of depression experienced.	3 months
Other	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
Primary	Rivermead Post Concussion Symptoms Questionnaire (RPQ): Change	Score of 0-64, with a higher score indicates worse symptoms.	3 months
Secondary	Fear Avoidance Behaviour after Traumatic Brain Injury Questionnaire (FAB-TBI): Change	score of 0-48, where higher score indicates higher avoidance.	3 months