Mild Traumatic Brain InjuryGET-FABNCT05365776
Graded Exposure Therapy for Fear Avoidance Behaviour After Concussion
A study testing Graded Exposure Therapy and Prescribed aerobic exercise in people with Mild Traumatic Brain Injury, run by University of British Columbia at 7 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Mild Traumatic Brain Injury
- What is being tested?
- Graded Exposure Therapy and Prescribed aerobic exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 7 sitesCanada
- Study dates
- 1 Jun 2022to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- medical contraindication to aerobic exercise (cardiac disease, chest pain with exertion, acute bone/joint/soft tissue injury aggravated by exercise)
- change in cardiac medication within the last month, such as beta blockers, calcium channel blockers, or ivabradine
- involved in personal injury litigation for index mTBI
- currently pregnant or plan to become pregnant within the next three months
- severe/unstable medical or psychiatric condition that could worsen over the next year")
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Canada7 sites
Calgary Brain Injury Program
Calgary, Alberta, T2N 2T9
Fraser Health Acquired Brain Injury and Concussion Services
Langley, British Columbia, V1M 4A6
Sunnybrooke Traumatic Brain Injury Clinic
Toronto, Ontario, M4N 3M5
Head Injury Clinic at St. Michael's
Toronto, Ontario, M5B 1W8
Hull-Ellis Concussion and Research Clinic
Toronto, Ontario, M5G 2A2
Toronto Western Hospital
Toronto, Ontario, M5T 2S8
G.F. Strong Adult Concussion Services
Vancouver, British Columbia, V5Z 2G9
About this study
Official title: Graded Exposure Therapy for Fear Avoidance Behaviour (GET FAB) After Concussion
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.
Read the 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
- Being tested
- Graded Exposure Therapy, Prescribed aerobic exercise, Enhanced usual care
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Graded Exposure TherapyBehavioural
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 exerciseBehavioural
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 careOther
Usual care (education about concussion from the website: concussion.vch.ca/) will be enhanced through email message support.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Graded Exposure Therapy | Experimental | Not described Receives: Behavioral: Graded Exposure Therapy |
| Arm 2: Prescribed Aerobic Exercise | Active comparator | Not described Receives: Behavioral: Prescribed aerobic exercise |
| Arm 3: Enhanced usual care | Active comparator | Not described Receives: Other: Enhanced usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rivermead Post Concussion Symptoms Questionnaire (RPQ): Change
Score of 0-64, with a higher score indicates worse symptoms.
Measured: 3 months
Secondary outcomes (1)
Fear Avoidance Behaviour after Traumatic Brain Injury Questionnaire (FAB-TBI): Change
score of 0-48, where higher score indicates higher avoidance.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start1 Jun 2022
- Primary completion23 May 2025
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mild Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Noah Silverberg, University of British Columbia
- Investigators
- Noah Silverberg, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05365776
- Sponsor's protocol ID
- H21-02605
- Acronym
- GET-FAB
- Status last verified
- Mar 2026
- First submitted
- 10 Mar 2022
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified participant data (including data dictionaries).
Publications
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.
PubMed 34971596Mikolic 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.
PubMed 38950993
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Graded Exposure Therapy for Fear Avoidance Behaviour (GET FAB) After Concussion
- ClinicalTrials.gov ID
- NCT05365776
- Acronym / sponsor ID
- GET-FAB / H21-02605
- Conditions
- Mild Traumatic Brain Injury
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 23 May 2025 (actual)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 9 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Graded Exposure Therapy | Experimental | Behavioral: Graded Exposure Therapy |
| Arm 2: Prescribed Aerobic Exercise | Active comparator | Behavioral: Prescribed aerobic exercise |
| Arm 3: Enhanced usual care | Active comparator | Other: Enhanced usual care |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- medical contraindication to aerobic exercise (cardiac disease, chest pain with exertion, acute bone/joint/soft tissue injury aggravated by exercise)
- change in cardiac medication within the last month, such as beta blockers, calcium channel blockers, or ivabradine
- involved in personal injury litigation for index mTBI
- currently pregnant or plan to become pregnant within the next three months
- severe/unstable medical or psychiatric condition that could worsen over the next year")
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Graded Exposure TherapyGraded 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. | Behavioural | Arm 1: Graded Exposure Therapy |
| Prescribed aerobic exerciseParticipants 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. | Behavioural | Arm 2: Prescribed Aerobic Exercise |
| Enhanced usual careUsual care (education about concussion from the website: concussion.vch.ca/) will be enhanced through email message support. | Other | Arm 3: Enhanced usual care |
Primary outcome
Rivermead Post Concussion Symptoms Questionnaire (RPQ): Change
Time frame: 3 months
Score of 0-64, with a higher score indicates worse symptoms.
1 secondary outcome
Fear Avoidance Behaviour after Traumatic Brain Injury Questionnaire (FAB-TBI): Change
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Background: PubMed 34971596Silverberg 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.
- Derived from this study: PubMed 38950993Mikolic 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.
- Individual participant dataSharing planned: Yes. Deidentified participant data (including data dictionaries).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noah Silverberg, PhD principal investigator
University of British Columbia
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Graded Exposure Therapy and Prescribed aerobic exercise in people with Mild Traumatic Brain Injury, run by University of British Columbia at 7 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rivermead Post Concussion Symptoms Questionnaire (RPQ): Change (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05365776, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026; AzTrials last refreshed its copy on 30 Oct 2026.