Graded Exposure Therapy for Concussion

(GET-FAB Trial)

Not currently recruiting at 6 trial locations

Overseen By Tasha Klotz, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

Must not be taking: Beta blockers, Calcium channel blockers

Disqualifiers: Cardiac disease, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of graded exposure therapy in aiding concussion recovery. Graded exposure therapy is a behavioral treatment designed to reduce the fear of re-injury and help individuals resume normal activities. The trial also compares this therapy to prescribed aerobic exercise and enhanced usual care. Individuals who experienced a concussion in the last 1 to 24 months and have at least three moderate to severe symptoms, such as headaches or dizziness, may be suitable candidates. Participants must be comfortable using a computer or smartphone with internet access. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance recovery options for future patients.

Do I need to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you have changed your cardiac medication in the last month, you cannot participate.

Do I need to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, if you have changed your cardiac medication in the last month, you may not be eligible to participate.

What prior data suggests that graded exposure therapy is safe for concussion patients?

Research has shown that graded exposure therapy can reduce fear and avoidance in people with concussions. These behaviors often hinder recovery. Early results suggest that this therapy is not only acceptable to patients but may also aid in their recovery. Studies have not reported any serious side effects from graded exposure therapy, indicating that participants tolerate it well. Therefore, it appears to be a safe option for those considering joining a trial with this treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for concussion, which often focus on rest and medication, Graded Exposure Therapy introduces a new approach by gently reintroducing patients to activities that trigger symptoms, helping them gradually build tolerance. This method is unique because it actively engages the patient in their recovery, potentially speeding up the healing process and improving quality of life. Researchers are excited about this therapy because it could offer a more proactive and personalized recovery strategy, addressing the limitations of passive rest and enabling patients to resume their normal activities more swiftly and safely.

What evidence suggests that this trial's treatments could be effective for concussion?

Research has shown that graded exposure therapy (GET), which participants in this trial may receive, can aid recovery from concussions. In a small study, GET reduced fear avoidance behavior, where individuals avoid activities they believe might worsen their condition. This avoidance can hinder recovery, so reducing it is beneficial. Participants who used GET in the past showed improvement in their symptoms and managed daily activities more effectively. The therapy gradually introduces individuals to feared activities, helping them regain confidence and function. Early findings suggest that GET could be a valuable tool for enhancing recovery after a concussion. ^{1 3 4 6 7}

Who Is on the Research Team?

Noah Silverberg, PhD

Principal Investigator

University of British Columbia

Are You a Good Fit for This Trial?

This trial is for individuals who had a concussion between 1 and 12 months ago, can access the internet via computer or mobile device, have at least three moderate to severe symptoms on a specific questionnaire, and are fluent in English. It's not for those on beta-blockers, with exercise contraindications like heart disease or recent injuries, or involved in injury lawsuits.

Inclusion Criteria

I am fluent in English.

Access to a computer, tablet, or smartphone with internet capability

Sustained a concussion according to the ACRM mTBI Task Force definition between 1 and 24 months ago

Exclusion Criteria

Currently pregnant or will become pregnant within the next 3 months

Medical contraindication to aerobic exercise (cardiac disease, chest pain with exertion, acute bone/joint/soft tissue injury aggravated by exercise)

Involved in personal injury litigation for index concussion

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive graded exposure therapy, enhanced usual care, or prescribed aerobic exercise

3 months

Follow-up

Participants are monitored for changes in fear avoidance behaviour, post-concussion symptoms, and other health measures

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Graded Exposure Therapy

Trial Overview The study tests graded exposure therapy aimed at reducing fear avoidance behavior after a concussion against prescribed aerobic exercise and enhanced usual care. The goal is to see if this approach helps patients better cope with their symptoms and improve recovery.

How Is the Trial Designed?

Group I: Arm 1: Graded Exposure Therapy Experimental Treatment 1 Intervention

Group II: Arm 3: Enhanced usual care Active Control 1 Intervention

Group III: Arm 2: Prescribed Aerobic Exercise Active Control 1 Intervention

Graded Exposure Therapy is already approved in Canada for the following indications:

Approved in Canada as Graded Exposure Therapy for:

• Persistent symptoms after mild traumatic brain injury (mTBI)
• Fear avoidance behavior after concussion

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Published Research Related to This Trial

In a 3-month randomized controlled trial involving 461 Veterans with mild traumatic brain injury, the Concussion Coach app significantly reduced postconcussive symptom severity compared to Treatment-as-Usual, with an odds ratio of 1.29.

The app also improved self-efficacy in managing symptoms, which was linked to further reductions in both symptom severity and psychological distress, indicating that enhancing self-management skills is crucial for effective treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Concussion coach for postconcussive symptoms: A randomized, controlled trial of a smartphone application with Afghanistan and Iraq war Veterans. Belanger, HG., Toyinbo, P., Barrett, B., et al.[2023]

A study involving 17 college-aged individuals with recent concussions and anxiety revealed that concussions significantly disrupt daily activities, relationships, and academic/work performance, highlighting the need for comprehensive assessments beyond standard clinical evaluations.

Participants also reported changes in their self-perception and emotional state, but some found positive aspects post-injury, indicating that addressing both the negative impacts and potential benefits could enhance recovery strategies for this vulnerable group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of a Recent Concussion on College-Aged Individuals with Co-Occurring Anxiety: A Qualitative Investigation. Greenberg, J., Kanaya, MR., Bannon, SM., et al.[2023]

In a study of 637 children and adolescents with concussions, those with pre-existing anxiety disorders reported significantly more concussion symptoms and higher vision symptom severity scores compared to those without anxiety, indicating a link between anxiety and increased symptom severity.

Children and adolescents with anxiety experienced prolonged recovery times, taking longer to recover from concussion symptoms, return to school, and resume physical activities, with adjusted hazard ratios indicating a threefold increase in recovery time compared to their peers without anxiety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Concussion symptomology and recovery in children and adolescents with pre-existing anxiety. Martin, AK., Petersen, AJ., Sesma, HW., et al.[2021]

The Pediatric Fear Avoidance Behavior after Traumatic Brain Injury Questionnaire (PFAB-TBI) was developed and showed strong internal consistency and moderate correlation between self-reports from children and informant reports from caregivers, indicating it is a reliable tool for assessing fear avoidance behavior after concussion.

The PFAB-TBI scores were significantly correlated with post-concussion symptoms and emotional distress, while negatively impacting quality of life, suggesting that fear avoidance behavior is an important factor to consider in the recovery process for youth after a concussion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fear avoidance behavior in youth with poor recovery from concussion: measurement properties and correlates of a new scale. Cairncross, M., Brooks, BL., Virani, S., et al.[2021]

In a study of 129 youth aged 10-18 who suffered concussions, pre-injury panic symptoms and total symptom severity were identified as strong predictors of post-injury anxiety, indicating the need for careful emotional assessment before and after a concussion.

The study found that non-sports-related concussions and vestibular dysfunction significantly increased the risk of developing clinical levels of anxiety post-injury, emphasizing the importance of comprehensive evaluations in concussion management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical predictors of post-injury anxiety in adolescent patients following concussion. Gillie, BL., Fazio-Sumrok, V., Eagle, SR., et al.[2022]

A randomized controlled trial involving 73 adults with persistent postconcussion symptoms showed that graded exposure therapy (GET) significantly reduced fear avoidance behavior compared to operant condition-based pacing strategies plus mindfulness training (Pacing+).

The study demonstrated strong feasibility for future trials, with high treatment adherence (89% completion rate) and excellent treatment fidelity (96.8% of essential elements covered), indicating that GET could be an effective intervention to help prevent disability after concussion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Concussion Rehabilitation Approaches Tailored to Psychological Coping Styles: A Randomized Controlled Trial. Silverberg, ND., Cairncross, M., Brasher, PMA., et al.[2022]

In a study of 563 adults with mild traumatic brain injury (mTBI), it was found that females exhibited higher levels of fear avoidance behavior compared to males, suggesting that clinical normative data for the Fear Avoidance Behavior after Traumatic Brain Injury Questionnaire (FAB-TBI) should be stratified by sex.

The study also revealed that factors such as loss of consciousness and higher postconcussion symptom burden were linked to increased fear avoidance behavior, while the time since injury did not significantly affect FAB-TBI scores.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Normative Data for the Fear Avoidance Behavior After Traumatic Brain Injury Questionnaire in a Clinical Sample of Adults With Mild TBI. Cairncross, M., Debert, CT., Hunt, C., et al.[2023]

A systematic review identified that existing patient-reported outcome measures (PROMs) for assessing fear avoidance behavior in concussion patients have insufficient content validity, indicating they may not accurately capture the intended behaviors.

Among the PROMs evaluated, the Fear Avoidance Short Form Scale showed the best measurement properties, with moderate-certainty evidence for structural validity and internal consistency, but caution is still advised in their use due to potential biases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantifying Fear Avoidance Behaviors in People With Concussion: A COSMIN-Informed Systematic Review. Sherwood, LJ., Korakakis, V., Mosler, AB., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38950993

Graded Exposure Therapy for Fear Avoidance Behaviour ... This study will evaluate the efficacy of graded exposure therapy (GET) for reducing persistent symptoms following mTBI, with two primary aims.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11218021/

Graded Exposure Therapy for Fear Avoidance Behaviour ... In a pilot randomised controlled trial (RCT), we demonstrated that graded exposure therapy (GET) selectively reduced fear avoidance behaviour ...

3. bmjopen.bmj.com bmjopen.bmj.com/content/14/6/e086602.abstract

protocol for a multisite Canadian randomised controlled trial The outcome assessment will occur remotely 14–18 weeks following baseline assessment, after completing the 12-week treatment phase. The primary outcome will be ...

4. researchgate.net researchgate.net/publication/381904664_Graded_Exposure_Therapy_for_Fear_Avoidance_Behaviour_After_Concussion_GET_FAB_protocol_for_a_multisite_Canadian_randomised_controlled_trial

Graded Exposure Therapy for Fear Avoidance Behaviour ... Before and after treatment, the single-item fear avoidance measure correlated moderately with anxiety (ρ = 0.34), depression (ρ = 0.43), post- ...

5. withpower.com withpower.com/trial/graded-exposure-therapy-for-concussion-a7f17

Graded Exposure Therapy for Concussion (GET-FAB Trial) Yes, Graded Exposure Therapy is a promising treatment for concussion because it helps reduce fear and avoidance behaviors, which are linked to negative outcomes ...

6. bmjopen.bmj.com bmjopen.bmj.com/content/bmjopen/14/6/e086602.full.pdf

Graded Exposure Therapy for Fear Avoidance Behaviour ... The RPQ is the only outcome measure designated as 'core' in the National Institute of Neuro- logical Disorders and Stroke Common Data Elements ...

7. semanticscholar.org semanticscholar.org/paper/e13f18f690d3f46b5e8ae12ba11c2d7877acbd29

Graded Exposure Therapy for Fear Avoidance Behaviour ... The findings will guide evidence-based care after mTBI and enable better matching of mTBI patients to treatments and disseminate the GET treatment manual ...