Graded Exposure Therapy for Fear Avoidance Behaviour After Concussion

NCT05365776 | Active Not Recruiting

• 1 other identifier: H21-02605
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 7

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.

Conditions

Mild Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• Rivermead Post Concussion Symptoms Questionnaire (RPQ): Change

  Score of 0-64, with a higher score indicates worse symptoms.

  3 months

Secondary Outcomes (1)

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

  3 months

Other Outcomes (4)

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

  3 months

• The Generalized Anxiety Disorder-7

  3 months

• Personal Health Questionnaire-9

  3 months

Study Arms (3)

Arm 1: Graded Exposure Therapy

EXPERIMENTAL

Behavioral: Graded Exposure Therapy

Arm 2: Prescribed Aerobic Exercise

ACTIVE COMPARATOR

Behavioral: Prescribed aerobic exercise

Arm 3: Enhanced usual care

ACTIVE COMPARATOR

Other: Enhanced usual care

Interventions

Prescribed aerobic exercise BEHAVIORAL

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.

Arm 2: Prescribed Aerobic Exercise

Enhanced usual care OTHER

Usual care (education about concussion from the website: concussion.vch.ca/) will be enhanced through email message support.

Arm 3: Enhanced usual care

Graded Exposure Therapy BEHAVIORAL

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.

Arm 1: Graded Exposure Therapy

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• medical contraindication to aerobic exercise (cardiac disease, chest pain with exertion, acute bone/joint/soft tissue injury aggravated by exercise)
• change in cardiac medication within the last month, such as beta blockers, calcium channel blockers, or ivabradine
• involved in personal injury litigation for index mTBI
• currently pregnant or plan to become pregnant within the next three months
• severe/unstable medical or psychiatric condition that could worsen over the next year")

Sponsors & Collaborators

• University of British Columbia: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (7)

Calgary Brain Injury Program

Calgary, Alberta, T2N 2T9, Canada

Location

Fraser Health Acquired Brain Injury and Concussion Services

Langley, British Columbia, V1M 4A6, Canada

Location

G.F. Strong Adult Concussion Services

Vancouver, British Columbia, V5Z 2G9, Canada

Location

Sunnybrooke Traumatic Brain Injury Clinic

Toronto, Ontario, M4N 3M5, Canada

Location

Head Injury Clinic at St. Michael's

Toronto, Ontario, M5B 1W8, Canada

Location

Hull-Ellis Concussion and Research Clinic

Toronto, Ontario, M5G 2A2, Canada

Location

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

Related Publications (2)

• 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.

  PMID: 34971596 BACKGROUND

• Mikolic A, Klotz T, Brasher P, Yeates K, Vranceanu AM, Kendall KD, Snell DL, Debert CT, Bayley M, Panenka W, Cairncross M, Hunt C, Burke M, Tartaglia MC, Silverberg N; Canadian Traumatic Brain Injury Research Consortium (CTRC). Graded Exposure Therapy for Fear Avoidance Behaviour After Concussion (GET FAB): protocol for a multisite Canadian randomised controlled trial. BMJ Open. 2024 Jul 1;14(6):e086602. doi: 10.1136/bmjopen-2024-086602.

  PMID: 38950993 DERIVED

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Noah Silverberg, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 10, 2022
• First Posted: May 9, 2022
• Study Start: June 1, 2022
• Primary Completion: May 23, 2025
• Study Completion (Estimated): December 30, 2026
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Upon reasonable request. Requests can be made to the Principal Investigator.

Locations

CA (7)