Graded Exposure Therapy for Fear Avoidance Behaviour After Concussion (GET FAB)

December 13, 2023 updated by: Noah Silverberg, University of British Columbia

Graded Exposure Therapy for Fear Avoidance Behaviour (GET FAB) After Concussion

Concussions are very common. Although many people recover well from concussion, some will have persistent symptoms and difficulties with daily activities. How people cope with their symptoms following concussion powerfully influences their recovery. Fear avoidance behaviour is a particularly unhelpful approach to coping, in which people perceive their pre-injury activities as unnecessarily dangerous and take great care to avoid overexertion and overstimulation. The investigators developed and pilot tested a behavioural therapy, called graded exposure therapy, to reduce fear avoidance behaviour. Our preliminary work suggested that graded exposure therapy was acceptable to patients with concussion and possibly beneficial for their recovery. The GET FAB after concussion study will assess the effectiveness of graded exposure therapy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

GET FAB is a multisite randomized controlled trial designed to evaluate a behavioural treatment (graded exposure therapy) for adults with persistent symptoms after concussion. Participants in this study will be recruited from a network of concussion clinics in Canada. This study follows from the investigators' prior work establishing that (1) fear avoidance behaviour is a risk factor for poor concussion outcome, (2) graded exposure therapy reduces fear avoidance behaviour, and (3) graded exposure therapy is perceived as credible and is well-tolerated by patients with persistent post-concussion symptoms.

Participants will be assigned at random (in a 1:2:2 ratio) to receive enhanced usual care, graded exposure therapy group, or another therapy that might have similar benefits (prescribed aerobic exercise). The investigators hypothesize that patients who participate in graded exposure therapy will have reduced fear avoidance behaviour and improved daily functioning compared to other treatment conditions and this difference will be greatest for patients who enter the study with high fear avoidance behaviour.

Study Type

Interventional

Enrollment (Estimated)

220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Alberta
    • British Columbia
      • Langley, British Columbia, Canada, V1M 4A6
        • Recruiting
        • Fraser Health Acquired Brain Injury and Concussion Services
        • Contact:
      • Vancouver, British Columbia, Canada, V5Z 2G9
    • Ontario
      • Toronto, Ontario, Canada, M5T 2S8
      • Toronto, Ontario, Canada, M4N 3M5
      • Toronto, Ontario, Canada, M5B 1W8
        • Recruiting
        • Head Injury Clinic at St. Michael's
        • Contact:
      • Toronto, Ontario, Canada, M5G 2A2
        • Recruiting
        • Hull-Ellis Concussion and Research Clinic
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. aged 18-70 years;
  2. sustained a concussion according to the ACRM mTBI Task Force definition between 1 and 24 months ago
  3. fluent in English, because validated translations are not available for most questionnaires and recruiting multilingual therapists is not feasible;
  4. access to a computer, tablet, or smartphone with internet capability;
  5. 3 or more moderate-severe symptoms on the Rivermead Postconcussion Symptom Questionnaire.

Exclusion Criteria:

  1. medical contraindication to aerobic exercise (cardiac disease, chest pain with exertion, acute bone/joint/soft tissue injury aggravated by exercise);
  2. not been stable on a medication, such as beta blockers, calcium channel blockers, or ivabradine, for at least a month;
  3. involved in personal injury litigation for index concussion
  4. currently pregnant or will become pregnant within the next 3 months
  5. severe/unstable medical or psychiatric condition or medical condition that could get worse in the next year
  6. confounding factors present at time of injury.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1: Graded Exposure Therapy
Behavioral: Graded Exposure Therapy
Graded exposure therapy is delivered by a psychologist over 12 individual (1:1) secure videoconference sessions. The core active ingredient is graded situational exposure to foster habituation and challenge beliefs that the avoided activities are dangerous. Homework exercises involve planned exposure exercises in the home and community to support generalization.
Active Comparator: Arm 2: Prescribed Aerobic Exercise
Behavioral: Prescribed aerobic exercise
Participants will be asked to complete 30 minutes of aerobic exercise on 5 days/week for a 12-week period. Participants select the mode (e.g., swimming, jogging, bicycling) and location of exercise (e.g., outdoors, a gym or community centre, at home). The initial exercise intensity target will be based on the Buffalo Concussion Bike Test. The target progression will be 3-5 beats per minute every two weeks.
Active Comparator: Arm 3: Enhanced usual care
Other: Enhanced usual care
Usual care (education about concussion from the website: concussion.vch.ca/) will be enhanced through text message support.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rivermead Post Concussion Symptoms Questionnaire (RPQ): Change
Time Frame: 3 months
Score of 0-64, with a higher score indicates worse symptoms.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
World Health Organization Disability Assessment Schedule (WHODAS) 2.0 12-item: interviewer version: Change.
Time Frame: 3 months
score of 12 to 60, where higher scores indicate higher disability or loss of function
3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fear Avoidance Behaviour after Traumatic Brain Injury Questionnaire (FAB-TBI): Change
Time Frame: 3 months
score of 0-48, where higher score indicates higher avoidance.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Collaborators

Canadian Institutes of Health Research (CIHR)

Investigators

  • Principal Investigator: Noah Silverberg, PhD, University of British Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

March 10, 2022

First Submitted That Met QC Criteria

May 3, 2022

First Posted (Actual)

May 9, 2022

Study Record Updates

Last Update Posted (Actual)

December 14, 2023

Last Update Submitted That Met QC Criteria

December 13, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H21-02605

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified participant data (including data dictionaries).

IPD Sharing Time Frame

Immediately following publication. No end date.

IPD Sharing Access Criteria

Upon reasonable request. Requests can be made to the Principal Investigator.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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