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Graded Exposure Therapy for Concussion (GET-FAB Trial)
N/A
Recruiting
Led By Noah Silverberg, PhD
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Fluent in English, because validated translations are not available for most questionnaires and recruiting multilingual therapists is not feasible
Aged 18-70 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a therapy called Graded Exposure Therapy for adults who have ongoing symptoms after a concussion. The therapy helps them gradually face activities they fear, which can improve their recovery. The study aims to see if this approach is more effective.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While the trial description does not specify side effects directly related to the interventions being studied (graded exposure therapy and prescribed aerobic exercise), typical concerns may include increased anxiety during therapy sessions or physical strain from exercises.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fluent in English.
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I am between 18 and 70 years old.
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I have 3 or more severe symptoms after a concussion.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Rivermead Post Concussion Symptoms Questionnaire (RPQ): Change
Secondary study objectives
Fear Avoidance Behaviour after Traumatic Brain Injury Questionnaire (FAB-TBI): Change
Other study objectives
Personal Health Questionnaire-9
The Generalized Anxiety Disorder-7
The Post-Concussion Functional Scale-Screen
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Arm 1: Graded Exposure TherapyExperimental Treatment1 Intervention
Group II: Arm 2: Prescribed Aerobic ExerciseActive Control1 Intervention
Group III: Arm 3: Enhanced usual careActive Control1 Intervention
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Graded Exposure Therapy (GET) works by gradually exposing concussion patients to activities they fear or avoid due to concerns about overexertion and overstimulation. This method helps patients re-engage with their pre-injury activities in a controlled and systematic way, reducing fear and avoidance behaviors.
For concussion patients, this is crucial as it can improve their overall recovery by promoting normal activity levels, reducing anxiety, and preventing the long-term consequences of inactivity and social withdrawal.
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Who is running the clinical trial?
University of British ColumbiaLead Sponsor
1,481 Previous Clinical Trials
2,494,696 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,392 Previous Clinical Trials
26,527,246 Total Patients Enrolled
Noah Silverberg, PhDPrincipal InvestigatorUniversity of British Columbia
5 Previous Clinical Trials
284 Total Patients Enrolled