Graded Exposure Therapy for Fear Avoidance Behaviour After Concussion (GET FAB)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05365776|
Recruitment Status : Recruiting
First Posted : May 9, 2022
Last Update Posted : August 15, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Mild Traumatic Brain Injury||Behavioral: Graded Exposure Therapy Behavioral: Prescribed aerobic exercise Other: Enhanced usual care||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||220 participants|
|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.|
|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|
|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.
- Rivermead Post Concussion Symptoms Questionnaire (RPQ): Change [ Time Frame: 3 months ]Score of 0-64, with a higher score indicates worse symptoms.
- 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
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 69 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Sustained a concussion according to the World Health Organization Neurotrauma Task Force definition between 1 and 12 months ago;
- Fluent in English;
- Access to a computer, tablet, or smartphone with internet capability;
- 3 or more moderate-severe symptoms on the Rivermead Postconcussion Symptom Questionnaire.
- Medical contraindication to aerobic exercise (cardiac disease, chest pain with exertion, acute bone/joint/soft tissue injury aggravated by exercise);
- Beta-blocker medication use;
- Involved in personal injury litigation for the concussion;
- Fail performance validity testing.
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
|Contact: Noah Silverberg, PhD||16047341313 ext firstname.lastname@example.org|
|Contact: Tasha Klotz, BA||16047341313 ext email@example.com|
|Calgary Brain Injury Program||Recruiting|
|Calgary, Alberta, Canada, T2N 2T9|
|Contact: Chantel Debert firstname.lastname@example.org|
|Canada, British Columbia|
|Fraser Health Acquired Brain Injury and Concussion Services||Recruiting|
|Langley, British Columbia, Canada, V1M 4A6|
|Contact: William Panenka email@example.com|
|G.F. Strong Adult Concussion Services||Recruiting|
|Vancouver, British Columbia, Canada, V5Z 2G9|
|Contact: Noah Silverberg firstname.lastname@example.org|
|Sunnybrooke Traumatic Brain Injury Clinic||Not yet recruiting|
|Toronto, Ontario, Canada, M4N 3M5|
|Contact: Matthew Burke email@example.com|
|Head Injury Clinic at St. Michael's||Not yet recruiting|
|Toronto, Ontario, Canada, M5B 1W8|
|Contact: Andrew Baker firstname.lastname@example.org|
|Hull-Ellis Concussion and Research Clinic||Not yet recruiting|
|Toronto, Ontario, Canada, M5G 2A2|
|Contact: Mark Bayley email@example.com|
|Principal Investigator:||Noah Silverberg, PhD||University of British Columbia|
|Responsible Party:||Noah Silverberg, Principal Investigator, University of British Columbia|
|Other Study ID Numbers:||
|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.|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Brain Injuries, Traumatic
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Head Injuries, Closed