Behavioral Profile Matching: A Precision Medicine Approach to Concussion Rehabilitation
1 other identifier
interventional
64
1 country
1
Brief Summary
At least 1 in 5 people who sustain a concussion will have persistent symptoms and difficulties with daily activities. The researchers have identified two unhelpful coping styles following a concussion - avoidance and endurance. Individuals who engage in avoidance behavior may benefit from a different type of treatment than those who engage in endurance behavior. The researchers will evaluate whether assigning individuals to a specific psychologically-informed treatment tailored to their coping style is practical, acceptable, and beneficial for their recovery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 15, 2019
CompletedFirst Submitted
Initial submission to the registry
May 22, 2019
CompletedFirst Posted
Study publicly available on registry
June 3, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2021
CompletedNovember 16, 2021
November 1, 2021
1.8 years
May 22, 2019
November 15, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
World Health Organization Disability Assessment Schedule (WHODAS) 2.0 12-item
Initial assessment, past 30 days.
Secondary Outcomes (1)
Rivermead Postconcussion Symptom Questionnaire
initial assessment, past 24 hours.
Study Arms (2)
Graded exposure therapy
ACTIVE COMPARATORWeekly 60-min sessions with an occupational therapist and psychologist over 8 weeks.
Pacing + mindfulness
ACTIVE COMPARATORWeekly 60-min sessions with an occupational therapist and psychologist over 8 weeks.
Interventions
Gradually increased contact with avoided sensory stimuli (e.g., light, noise, movement) and activities (e.g., mental exertion, physical exercise, stressful activities) in order to increase tolerance.
Shifting from symptom-contingent to time-contingent activity stopping rules, minimizing activity level peaks (excessive endurance behavior) and valleys (prolonged periods of recuperative rest) to improve overall functioning.
Eligibility Criteria
You may qualify if:
- Aged 18-70 years old.
- Sustained a mild traumatic brain injury between 1 and 12 months ago.
- Fluent in English.
- Access to a computer, tablet, or smartphone with internet capability.
- + persistent moderate-severe symptoms on the Rivermead Postconcussion Symptom Questionnaire.
- High avoidance (Fear Avoidance Behavior after Traumatic Brain Injury; FAB-TBI) and/or endurance behavior (Behavioral Response to Illness Questionnaire - All-Nothing subscale).
You may not qualify if:
- Patients with a cardiac contraindication to aerobic exercise will be excluded
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
GF Strong Rehab Centre
Vancouver, British Columbia, V5Z 2G9, Canada
Related Publications (5)
Shi S, Picon EL, Rioux M, Panenka WJ, Silverberg ND. Catastrophizing is associated with excess cognitive symptom reporting after mild traumatic brain injury. Neuropsychology. 2024 Feb;38(2):126-133. doi: 10.1037/neu0000930. Epub 2023 Nov 2.
PMID: 37917438DERIVEDMikolic A, Panenka WJ, Iverson GL, Cotton E, Burke MJ, Silverberg ND. Litigation, Performance Validity Testing, and Treatment Outcomes in Adults With Mild Traumatic Brain Injury. J Head Trauma Rehabil. 2024 May-Jun 01;39(3):E153-E161. doi: 10.1097/HTR.0000000000000903. Epub 2023 Sep 29.
PMID: 37773600DERIVEDTerpstra AR, Louie DR, Iverson GL, Yeates KO, Picon E, Leddy JJ, Silverberg ND. Psychological Contributions to Symptom Provocation Testing After Concussion. J Head Trauma Rehabil. 2023 Mar-Apr 01;38(2):E146-E155. doi: 10.1097/HTR.0000000000000796. Epub 2022 Jun 9.
PMID: 35687896DERIVEDSilverberg 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: 34971596DERIVEDTerpstra AR, Cairncross M, Yeates KO, Vranceanu AM, Greenberg J, Hunt C, Silverberg ND. Psychological mediators of avoidance and endurance behavior after concussion. Rehabil Psychol. 2021 Nov;66(4):470-478. doi: 10.1037/rep0000390. Epub 2021 Aug 19.
PMID: 34410757DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Noah Silverberg, PhD
University of British Columbia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 22, 2019
First Posted
June 3, 2019
Study Start
May 15, 2019
Primary Completion
February 15, 2021
Study Completion
July 1, 2021
Last Updated
November 16, 2021
Record last verified: 2021-11