Graded Exposure Therapy for Fear Avoidance Behaviour After Concussion

NCT ID: NCT05365776

Last Updated: 2025-07-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2025-12-31

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.

Conditions

Mild Traumatic Brain Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Arm 1: Graded Exposure Therapy

Group Type: EXPERIMENTAL

Graded Exposure Therapy

Intervention Type: 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.

Arm 2: Prescribed Aerobic Exercise

Group Type: ACTIVE_COMPARATOR

Prescribed aerobic exercise

Intervention Type: 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.

Arm 3: Enhanced usual care

Group Type: ACTIVE_COMPARATOR

Enhanced usual care

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Enhanced usual care

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

Intervention Type: OTHER

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")

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Noah Silverberg

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Noah Silverberg, PhD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

Calgary Brain Injury Program

Calgary, Alberta, Canada

Fraser Health Acquired Brain Injury and Concussion Services

Langley, British Columbia, Canada

G.F. Strong Adult Concussion Services

Vancouver, British Columbia, Canada

Sunnybrooke Traumatic Brain Injury Clinic

Toronto, Ontario, Canada

Head Injury Clinic at St. Michael's

Toronto, Ontario, Canada

Hull-Ellis Concussion and Research Clinic

Toronto, Ontario, Canada

Toronto Western Hospital

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: BACKGROUND

PMID: 34971596 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 38950993 (View on PubMed)

Other Identifiers

H21-02605

Identifier Type: -

Identifier Source: org_study_id