Graded Exposure Therapy for Concussion
(GET-FAB Trial)
Recruiting in Palo Alto (17 mi)
+6 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: University of British Columbia
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?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.
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.
What data supports the idea that Graded Exposure Therapy for Concussion is an effective treatment?
The available research shows that fear avoidance behavior after a concussion is linked to negative outcomes like more symptoms and emotional distress. While the studies focus on measuring fear avoidance, they highlight the importance of addressing these behaviors to improve recovery. Although specific data on Graded Exposure Therapy for Concussion isn't provided, the research suggests that treatments targeting fear avoidance, like Graded Exposure Therapy, could potentially help by reducing these negative behaviors and improving recovery. However, the studies also indicate that current tools to measure fear avoidance need improvement, so more research is needed to confirm the effectiveness of Graded Exposure Therapy for Concussion.
12345What safety data exists for Graded Exposure Therapy for Concussion?
The provided research does not directly address the safety data for Graded Exposure Therapy for Concussion or its variants like GET, GET FAB. The studies focus on fear avoidance behavior, anxiety, and other factors related to concussion recovery, but do not evaluate the safety of Graded Exposure Therapy specifically.
13678Is Graded Exposure Therapy a promising treatment for concussion?
Yes, Graded Exposure Therapy is a promising treatment for concussion because it helps reduce fear and avoidance behaviors, which are linked to negative outcomes like emotional distress and disability. By addressing these behaviors, the therapy can improve recovery and quality of life for those with a concussion.
13568Eligibility Criteria
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.
I am between 18 and 70 years old.
Access to a computer, tablet, or smartphone with internet capability
+2 more
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
+3 more
Participant Groups
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.
3Treatment groups
Experimental Treatment
Active Control
Group I: Arm 1: Graded Exposure TherapyExperimental Treatment1 Intervention
Group II: Arm 3: Enhanced usual careActive Control1 Intervention
Group III: Arm 2: Prescribed Aerobic ExerciseActive Control1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Calgary Brain Injury ProgramCalgary, Canada
Hull-Ellis Concussion and Research ClinicToronto, Canada
Sunnybrooke Traumatic Brain Injury ClinicToronto, Canada
Head Injury Clinic at St. Michael'sToronto, Canada
More Trial Locations
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Who Is Running the Clinical Trial?
University of British ColumbiaLead Sponsor
Canadian Institutes of Health Research (CIHR)Collaborator
References
Normative Data for the Fear Avoidance Behavior After Traumatic Brain Injury Questionnaire in a Clinical Sample of Adults With Mild TBI. [2023]Fear avoidance behavior after a concussion or mild traumatic brain injury (mTBI) is associated with a number of adverse outcomes, such as higher symptom burden, emotional distress, and disability. The Fear Avoidance Behavior after Traumatic Brain Injury Questionnaire (FAB-TBI) is a recently developed and validated self-report measure of fear avoidance after mTBI. The objective of this study was to derive clinical normative data for the FAB-TBI. To determine whether demographic stratification was necessary and to further support clinical interpretation, we also explored associations between fear avoidance behavior and demographic and injury variables.
Feasibility of Concussion Rehabilitation Approaches Tailored to Psychological Coping Styles: A Randomized Controlled Trial. [2022]To evaluate the feasibility of a clinical trial involving participants with concussion randomized to treatments designed to address fear avoidance or endurance coping, which are risk factors for disability. A secondary objective was to evaluate whether each treatment could affect selective change on targeted coping outcomes.
Fear avoidance behavior in youth with poor recovery from concussion: measurement properties and correlates of a new scale. [2021]The objective of the current study was to develop a measure of fear avoidance behavior after concussion for youth and parent respondents and examine its basic psychometric properties and correlates. Children (N = 51) who were seen in a hospital concussion clinic after sustaining a concussion (M = 7.6 months, SD = 7.01) and their primary caregiver (N = 51)completed self- and informant-report measures of fear avoidance (Pediatric Fear Avoidance Behavior after Traumatic Brain Injury Questionnaire; PFAB-TBI), post-concussion symptoms (Health Behavior Inventory), emotional distress (Strengths and Difficulties Questionnaire), and quality of life (Pediatric Quality of Life Inventory Version 4.0). The self- and informant-report PFAB-TBI scores were moderately correlated (r = 0.51, p < 0.001). Neither measure demonstrated floor or ceiling effects. Both had strong internal consistency (Cronbach's α = 0.87 and 0.89, respectively). The PFAB-TBI self-report was positively correlated with somatic symptoms (r = 0.37), emotional distress (r = 0.39), and negatively associated with quality of life (r = -0.57). The PFAB-TBI informant-report was positively associated with informant reported somatic symptoms (r = 0.52) and emotional distress (r = .50) Overall, the PFAB-TBI has desirable basic measurement properties and expected correlations with clinical outcomes. This measure can potentially help clinicians and researchers better understand the impacts of fear avoidance behavior after pediatric concussion.
Quantifying Fear Avoidance Behaviors in People With Concussion: A COSMIN-Informed Systematic Review. [2023]OBJECTIVE: The validity of existing fear avoidance behavior patient-reported outcome measures (PROMs) for concussion is unknown. This study aims to (1) identify PROMs that assess fear avoidance behavior in individuals with concussion and (2) assess the measurement properties of these PROMs. DESIGN: A systematic review of outcome measurement instruments using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist. LITERATURE SEARCH: We performed a systematic search of 7 databases. STUDY SELECTION CRITERIA: Studies were included if they assessed fear avoidance behavior (eg, kinesiophobia or cogniphobia) in participants with concussion, occurring in all settings (eg, sport, falls, assaults). DATA SYNTHESIS: Methodological quality of the PROMs was assessed using the COSMIN checklist, and the certainty of the evidence was assessed using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach. RESULTS: We identified 40 studies assessing fear avoidance. Four studies (n = 875 participants, representing 3 PROMs) were eligible for COSMIN assessment. Content validity for all PROMs was insufficient due to extreme risk of bias. The Fear Avoidance Short Form Scale demonstrated the greatest validity: moderate-certainty evidence for sufficient structural validity and internal consistency, and low-certainty evidence for measurement invariance. CONCLUSION: Current PROMs for measuring fear avoidance behaviors in people with concussion have insufficient content validity and should be used with caution in research and clinical practice. J Orthop Sports Phys Ther 2023;53(9):540-565. Epub: 10 August 2023. doi:10.2519/jospt.2023.11685.
The Impact of a Recent Concussion on College-Aged Individuals with Co-Occurring Anxiety: A Qualitative Investigation. [2023]College-aged individuals with anxiety are vulnerable to developing persistent concussion symptoms, yet evidence-based treatments for this population are limited. Understanding these individuals' perspectives is critical for developing effective interventions. We conducted qualitative interviews with 17 college-aged individuals (18-24 years old) with a recent (≤10 weeks) concussion and at least mild anxiety (≥5 on the GAD-7 questionnaire) to understand the life impact of their concussion. We identified 5 themes: (1) disruption to daily activities (e.g., reduced participation in hobbies and physical activity); (2) disruption to relationships (e.g., reduced social engagement, feeling dismissed by others, stigma, and interpersonal friction); (3) disruptions in school/work (e.g., challenges participating due to light sensitivity, cognitive or sleep disturbance, and related emotional distress); (4) changes in view of the self (e.g., feeling "unlike oneself", duller, or more irritable), and (5) finding "silver linings" after the injury (e.g., increased motivation). Concussions impact the lives of college-aged individuals with co-occurring anxiety in a broad range of domains, many of which remain largely neglected in standard concussion clinical assessment and treatment. Assessing and addressing these issues has the potential to limit the negative impact of concussion, promote recovery, and potentially help prevent persistent concussion symptoms in this at-risk population.
Concussion symptomology and recovery in children and adolescents with pre-existing anxiety. [2021]To examine pre-existing anxiety disorders as a risk factor for increased concussion symptomology and prolonged recovery in children and adolescents.
Clinical predictors of post-injury anxiety in adolescent patients following concussion. [2022]The purpose of the current study was to examine predictors (e.g., pre-injury anxiety and sub-types, concussion symptom severity, neurocognitive performance, and vestibular/ocular-motor impairment) of post-injury anxiety scores following concussion among youth aged 10-18 years. This observational cohort study enrolled patients (n = 129) within 30 days of a diagnosed concussion. Patients completed Screening for Child Anxiety Related Disorders-Child Reports (SCARED-C), Generalized Anxiety Disorder-7 (GAD-7), Post-concussion Symptom Scale, neurocognitive testing, and Vestibular-Ocular Motor Screening. Logistic regression analyses were conducted to evaluate the role of risk factors and clinical outcomes as predictors of mild (GAD-7 > 5) and moderate levels (GAD-7 > 10) of post-injury anxiety. Twenty-two percent (n = 28) of patients reported clinical levels of pre-injury anxiety, and 13% (n = 17) reported clinical levels of post-injury anxiety. The logistic regression model predicting mild or greater anxiety was significant (R2 = 31.7%; p < 0.001) and supported pre-injury panic symptoms (OR = 1.38) and total symptom severity (OR = 1.04) as the most robust predictors. The logistic regression model predicting clinical anxiety was significant (R2 = 47.2%; p < 0.001) and supported non-SRC injury type (OR = 9.48), vestibular dysfunction (OR = 1.74) and pre-injury panic symptoms (OR = 1.57) as the most robust predictors. Results suggest that clinicians should employ measures of pre-injury and post-injury emotional functioning when evaluating and treating concussion among adolescents. Moreover, these results highlight the importance of assessing different types of pre-injury and post-injury anxiety in the context of concussion management.
Concussion coach for postconcussive symptoms: A randomized, controlled trial of a smartphone application with Afghanistan and Iraq war Veterans. [2023]Objective: Investigate the effectiveness of Concussion Coach, an interactive smartphone application, as a treatment for residual neurobehavioral symptoms and distress in Veterans with a history of mild traumatic brain injury (mild TBI). Methods: Veterans with mild TBI were randomized to Concussion Coach (n = 238) or Treatment-as-Usual (TAU) (n = 241) in a 3-month randomized controlled trial. Primary outcome measures included postconcussive symptom (PCS) severity as measured by the Neurobehavioral Symptom Inventory (NSI), and psychological distress as measured by the Brief Symptom Inventory-18 (BSI-18). Measures of self-efficacy, social support, and comfort with technology were administered as potential moderators and mediators. An intention-to-treat (ITT) analysis was performed (N = 461: Concussion Coach = 231 and TAU = 230) using Bayesian Network (BN)modeling. Results: The probability of decreased PCS severity was significantly greater for those assigned to Concussion Coach, .35 [.32,.37], than for TAU, .29 (.27, .32), with an odds ratio (OR) of 1.29. Also, Concussion Coach showed a significantly greater probability of increased self-efficacy (.36 [.32, .39]) than did TAU (.28 [.25, .30], OR = 1.42). In turn, self-efficacy (increased vs. decreased) showed a significantly greater probability of decreased PCS severity (.51 [.47, .54] vs. .27 [.24, .30], OR = 2.71) and decreased psychological distress (.53 [.49, .56] vs. .32 [.29, .35], OR = 2.35), suggesting that self-efficacy may have mediated Concussion Coach effects. Conclusions: Concussion Coach is effective at reducing PCS severity and psychological distress. Increased self-efficacy/perception of self-management of symptoms may be key to successful treatment of residual symptoms in those with history of concussion.