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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

GET FAB Trial Summary

This trial will assess whether graded exposure therapy is effective in reducing fear avoidance behavior in people with concussion.

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.Check my eligibility

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.See study design

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.

GET FAB Trial 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.

GET FAB Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rivermead Post Concussion Symptoms Questionnaire (RPQ): Change

Secondary outcome measures

World Health Organization Disability Assessment Schedule (WHODAS) 2.0 12-item: interviewer version: Change.

Other outcome measures

Fear Avoidance Behaviour after Traumatic Brain Injury Questionnaire (FAB-TBI): Change

GET FAB 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

Find a Location

Who is running the clinical trial?

University of British ColumbiaLead Sponsor

1,418 Previous Clinical Trials

2,466,898 Total Patients Enrolled

Canadian Institutes of Health Research (CIHR)OTHER_GOV

1,345 Previous Clinical Trials

26,453,547 Total Patients Enrolled

Noah Silverberg, PhDPrincipal InvestigatorUniversity of British Columbia

5 Previous Clinical Trials

284 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are participating in this research protocol?

"This medical trial needs 220 eligible patients to join. They can register at the Sunnybrooke Traumatic brain injury Clinic in Langley, BC or with Fraser Health Acquired Brain Injury and Concussion Services in Calgary, AB."

Answered by AI

Is it possible to enlist in this clinical research?

"For this trial, 220 individuals aged 18-69 who have sustained a traumatic brain injury in the past 12 months must be enrolled. Selected patients should also possess fluency in English, access to internet enabled technology and present with 3 or more moderate-severe symptoms on the Rivermead Postconcussion Symptom Questionnaire."

Answered by AI

What is the current count of participating healthcare facilities in this experiment?

"Currently, 6 different medical centres are enrolling participants in this trial. This includes sites based in Langley, Calgary and Vancouver; among other locales. Selecting the facility nearest you is suggested to reduce any commuting challenges for patients who decide to take part."

Answered by AI

Are applications being accepted for participation in this clinical experiment?

"The details found on clinicaltrials.gov suggest that the trial is still recruiting participants, with initial postings made in early June 2022 and recent updates provided at the beginning of August."

Answered by AI