What side effects are associated with this type of intervention?

Common treatments for concussion include cognitive-behavioral therapy (CBT) and graded exposure therapy, which aim to address psychological symptoms and reduce fear avoidance behavior. Known side effects of CBT can include temporary increases in anxiety or distress as patients confront their fears and anxieties. Graded exposure therapy, specifically designed to reduce fear avoidance, may also cause initial discomfort or anxiety as patients gradually face activities they have been avoiding. However, these side effects are generally mild and tend to decrease as therapy progresses.

What prior FDA approvals exist?

Currently, there are no specific FDA-approved pharmacological treatments for concussion. The primary focus for managing concussion symptoms includes rest and gradual return to activities. Graded Exposure Therapy, which aims to reduce fear avoidance behavior, is a behavioral intervention rather than a drug treatment. This therapy has shown promise in helping patients cope with persistent symptoms by gradually reintroducing them to activities they perceive as dangerous. While pharmacological treatments for concussion are still under investigation, behavioral therapies like Graded Exposure Therapy are being explored for their potential benefits in recovery.

What other types of research exist?

Promising alternatives to Graded Exposure Therapy for concussion patients include Cognitive Behavioral Therapy (CBT), which focuses on changing maladaptive thought patterns and behaviors, and Mindfulness-Based Stress Reduction (MBSR), which helps patients manage symptoms through mindfulness practices. Additionally, Transcranial Magnetic Stimulation (TMS) has shown potential in improving cognitive function and reducing symptoms in various neurological conditions and may be considered as an emerging treatment option.

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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 below

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

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 more

Awards & 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

0 / 3Eligibility criteria met

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.