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

Primary Purpose

Mild Traumatic Brain Injury

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Graded Exposure Therapy
Prescribed aerobic exercise
Enhanced usual care
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Traumatic Brain Injury

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Calgary Brain Injury ProgramRecruiting
  • Fraser Health Acquired Brain Injury and Concussion ServicesRecruiting
  • G.F. Strong Adult Concussion ServicesRecruiting
  • Sunnybrooke Traumatic Brain Injury Clinic
  • Head Injury Clinic at St. Michael's
  • Hull-Ellis Concussion and Research Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Arm 1: Graded Exposure Therapy

Arm 2: Prescribed Aerobic Exercise

Arm 3: Enhanced usual care

Arm Description

Outcomes

Primary Outcome Measures

Rivermead Post Concussion Symptoms Questionnaire (RPQ): Change
Score of 0-64, with a higher score indicates worse symptoms.

Secondary Outcome Measures

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

Full Information

First Posted
March 10, 2022
Last Updated
August 10, 2022
Sponsor
University of British Columbia
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT05365776
Brief Title
Graded Exposure Therapy for Fear Avoidance Behaviour After Concussion
Acronym
GET FAB
Official Title
Graded Exposure Therapy for Fear Avoidance Behaviour (GET FAB) After Concussion
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Traumatic Brain Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: Graded Exposure Therapy
Arm Type
Experimental
Arm Title
Arm 2: Prescribed Aerobic Exercise
Arm Type
Active Comparator
Arm Title
Arm 3: Enhanced usual care
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Graded Exposure Therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Prescribed aerobic exercise
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Enhanced usual care
Intervention Description
Usual care (education about concussion from the website: concussion.vch.ca/) will be enhanced through text message support.
Primary Outcome Measure Information:
Title
Rivermead Post Concussion Symptoms Questionnaire (RPQ): Change
Description
Score of 0-64, with a higher score indicates worse symptoms.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
World Health Organization Disability Assessment Schedule (WHODAS) 2.0 12-item: interviewer version: Change.
Description
score of 12 to 60, where higher scores indicate higher disability or loss of function
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Fear Avoidance Behaviour after Traumatic Brain Injury Questionnaire (FAB-TBI): Change
Description
score of 0-48, where higher score indicates higher avoidance.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Noah Silverberg, PhD
Phone
16047341313
Ext
2316
Email
noah.silverberg@ubc.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Tasha Klotz, BA
Phone
16047341313
Ext
2316
Email
tasha.klotz@ubc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noah Silverberg, PhD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Calgary Brain Injury Program
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chantel Debert
Email
chantel.debert@albertahealthservices.ca
Facility Name
Fraser Health Acquired Brain Injury and Concussion Services
City
Langley
State/Province
British Columbia
ZIP/Postal Code
V1M 4A6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William Panenka
Email
will.panenka@ubc.ca
Facility Name
G.F. Strong Adult Concussion Services
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 2G9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Noah Silverberg
Email
noah.silverberg@ubc.ca
Facility Name
Sunnybrooke Traumatic Brain Injury Clinic
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Burke
Email
matthew.burke@sunnybrook.ca
Facility Name
Head Injury Clinic at St. Michael's
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Baker
Email
bakera@smh.ca
Facility Name
Hull-Ellis Concussion and Research Clinic
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2A2
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Bayley
Email
mark.bayley@uhn.ca

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
34971596
Citation
Silverberg ND, Cairncross M, Brasher PMA, Vranceanu AM, Snell DL, Yeates KO, Panenka WJ, Iverson GL, Debert CT, Bayley MT, Hunt C, Baker A, Burke MJ; Canadian Traumatic Brain Injury Research Consortium (CTRC). Feasibility of Concussion Rehabilitation Approaches Tailored to Psychological Coping Styles: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2022 Aug;103(8):1565-1573.e2. doi: 10.1016/j.apmr.2021.12.005. Epub 2021 Dec 28.
Results Reference
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Graded Exposure Therapy for Fear Avoidance Behaviour After Concussion

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