Abstract
Objective
To evaluate the feasibility of a clinical trial involving participants with concussion
randomized to treatments designed to address fear avoidance or endurance coping, which
are risk factors for disability. A secondary objective was to evaluate whether each
treatment could affect selective change on targeted coping outcomes.
Design
Randomized controlled trial.
Setting
Outpatient concussion clinics.
Participants
Adults (N=73, mean age=42.5y) who had persistent postconcussion symptoms and high
avoidance or endurance behavior were enrolled at a mean of 12.9 weeks post injury.
Ten participants did not complete treatment.
Interventions
Participants were randomized to an interdisciplinary rehabilitation program delivered
via videoconferencing and tailored to avoidance coping (graded exposure therapy [GET])
or endurance coping (operant condition-based pacing strategies plus mindfulness training
[Pacing+]).
Main Outcome Measures
Feasibility outcomes included screening efficiency, accrual, credibility, treatment
fidelity, adherence, and retention. Avoidance was measured with the Fear Avoidance
Behavior after Traumatic Brain Injury Questionnaire and endurance behavior with the
Behavioral Response to Illness Questionnaire.
Results
Screening efficiency, or the proportion of clinic patients who were assessed for eligibility,
was 44.5% (275 of 618). A total of 65.8% (73 of 111) of eligible patients were randomized
(37 to GET, 36 to Pacing+), meeting accrual targets; 91.7% (55 of 60) of participants
perceived treatment as credible. Therapists covered a mean of 96.8% of essential prescribed
elements, indicating excellent fidelity. The majority (71.2%; 47 of 66) of participants
consistently attended treatment sessions and completed between-session homework. Retention
was strong, with 65 of 73 (89%) randomized participants completing the outcome assessment.
GET was associated with greater posttreatment reductions in avoidance behavior compared
with Pacing+ (Cohen's drepeated measures, 0.81), whereas the treatment approach-specific effect of Pacing+ on endurance behavior
was less pronounced (Cohen's drepeated measures, 0.39).
Conclusions
These findings support a future efficacy-focused clinical trial. GET has the potential
to selectively reduce fear avoidance behavior after concussion, and, via this mechanism,
to prevent or reduce disability.
Keywords
List of abbreviations:
BRIQ (Behavioral Response to Illness Questionnaire), FAB-TBI (Fear Avoidance Behavior after Traumatic Brain Injury Questionnaire), GET (graded exposure therapy), Pacing+ (operant condition-based pacing strategies plus mindfulness training)To read this article in full you will need to make a payment
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Article info
Publication history
Published online: December 28, 2021
Accepted:
December 5,
2021
Received in revised form:
November 29,
2021
Received:
August 17,
2021
Footnotes
Presented in part at the 49th Annual Meeting of the International Neuropsychological Society (February 2021, virtual).
Supported by the Canadian Institutes of Health Research. NDS is supported by a Health Professional Investigator Award from the Michael Smith Foundation for Health Research. KOY is supported by the Ronald and Irene Ward Chair in Pediatric Brain Injury from the Alberta Children's Hospital Foundation. MTB, AB, CH, and MJB are members of the Concussion Ontario Network: Neuroinformatics to Enhance Clinical care and Translation-CONNECT (https://connectontario.ca/).
Clinical Trial Register No. (ClinicalTrials.gov): NCT03972579.
Disclosures: GLI serves as a scientific advisor for NanoDX, Sway Operations, LLC, and Highmark, Inc. He has a clinical and consulting practice in forensic neuropsychology, including expert testimony involving individuals who have sustained mild TBIs (eg, former athletes). He has received research funding from several test publishing companies, including ImPACT Applications, Inc, CNS Vital Signs, and Psychological Assessment Resources (PAR, Inc). He has received research funding as a principal investigator from the National Football League and subcontract grant funding as a collaborator from the Harvard Integrated Program to Protect and Improve the Health of National Football League Players Association Members. He acknowledges unrestricted philanthropic support from ImPACT Applications, Inc, the Mooney-Reed Charitable Foundation, the National Rugby League, and the Spaulding Research Institute. NDS has a private practice in forensic neuropsychology. The other authors have nothing to disclose.
Identification
Copyright
© 2021 by the American Congress of Rehabilitation Medicine.
