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

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ClinicalTrials.gov Identifier: NCT05365776
Recruitment Status : Recruiting
First Posted : May 9, 2022
Last Update Posted : August 15, 2022
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Noah Silverberg, University of British Columbia

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Mild Traumatic Brain Injury Behavioral: Graded Exposure Therapy Behavioral: Prescribed aerobic exercise Other: Enhanced usual care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Participants will be blinded to the study hypotheses and treatment arms, but not to the type of intervention they are receiving. Outcome assessors will be blinded to participants' treatment assignments.
Primary Purpose: Treatment
Official Title: Graded Exposure Therapy for Fear Avoidance Behaviour (GET FAB) After Concussion
Actual Study Start Date : June 1, 2022
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : August 2023

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.

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

Secondary Outcome Measures :
  1. 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

Other Outcome Measures:
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Sustained a concussion according to the World Health Organization Neurotrauma Task Force definition between 1 and 12 months ago;
  2. Fluent in English;
  3. Access to a computer, tablet, or smartphone with internet capability;
  4. 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. Beta-blocker medication use;
  3. Involved in personal injury litigation for the concussion;
  4. Fail performance validity testing.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05365776

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Contact: Noah Silverberg, PhD 16047341313 ext 2316 noah.silverberg@ubc.ca
Contact: Tasha Klotz, BA 16047341313 ext 2316 tasha.klotz@ubc.ca

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Canada, Alberta
Calgary Brain Injury Program Recruiting
Calgary, Alberta, Canada, T2N 2T9
Contact: Chantel Debert       chantel.debert@albertahealthservices.ca   
Canada, British Columbia
Fraser Health Acquired Brain Injury and Concussion Services Recruiting
Langley, British Columbia, Canada, V1M 4A6
Contact: William Panenka       will.panenka@ubc.ca   
G.F. Strong Adult Concussion Services Recruiting
Vancouver, British Columbia, Canada, V5Z 2G9
Contact: Noah Silverberg       noah.silverberg@ubc.ca   
Canada, Ontario
Sunnybrooke Traumatic Brain Injury Clinic Not yet recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Matthew Burke       matthew.burke@sunnybrook.ca   
Head Injury Clinic at St. Michael's Not yet recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: Andrew Baker       bakera@smh.ca   
Hull-Ellis Concussion and Research Clinic Not yet recruiting
Toronto, Ontario, Canada, M5G 2A2
Contact: Mark Bayley       mark.bayley@uhn.ca   
Sponsors and Collaborators
University of British Columbia
Canadian Institutes of Health Research (CIHR)
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Principal Investigator: Noah Silverberg, PhD University of British Columbia
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Responsible Party: Noah Silverberg, Principal Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT05365776    
Other Study ID Numbers: H21-02605
First Posted: May 9, 2022    Key Record Dates
Last Update Posted: August 15, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Deidentified participant data (including data dictionaries).
Time Frame: Immediately following publication. No end date.
Access Criteria: Upon reasonable request. Requests can be made to the Principal Investigator.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Concussion
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Head Injuries, Closed
Wounds, Nonpenetrating