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Record W4400201763 · doi:10.1136/bmjopen-2024-086602

Graded Exposure Therapy for Fear Avoidance Behaviour After Concussion (GET FAB): protocol for a multisite Canadian randomised controlled trial

2024· article· en· W4400201763 on OpenAlexafffundabout
Ana Mikolić, T. Klotz, Penelope M. A. Brasher, Keith Owen Yeates, Ana‐Maria Vranceanu, Karen D. Kendall, Deborah L. Snell, Chantel T. Debert, Mark Bayley, William J. Panenka, Molly Cairncross, Cindy Hunt, Matthew J. Burke, Maria Carmela Tartaglia, Noah D. Silverberg

Bibliographic record

VenueBMJ Open · 2024
Typearticle
Languageen
FieldMedicine
TopicTraumatic Brain Injury Research
Canadian institutionsSunnybrook Health Science CentreSt. Michael's HospitalSimon Fraser UniversityBC Mental Health & Substance Use ServicesPublic Health OntarioUniversity of British Columbia HospitalAlberta Children's HospitalToronto Rehabilitation InstituteUniversity of TorontoOccupational Cancer Research CentreHealth Sciences CentreUniversity Health NetworkAcadia UniversityHotchkiss Brain InstituteVancouver Coastal HealthVancouver Coastal Health Research InstituteUniversity of British ColumbiaUniversity of Calgary
FundersCanadian Institutes of Health ResearchVancouver Coastal Health Research InstituteProvincial Health Services Authority
KeywordsMedicineResearch ethicsRandomized controlled trialRivermead post-concussion symptoms questionnaireConcussionInstitutional review boardPhysical therapyInformed consentInjury preventionPoison controlFamily medicinePsychiatryAlternative medicineRehabilitationEmergency medicine

Abstract

fetched live from OpenAlex

INTRODUCTION: Persistent symptoms after mild traumatic brain injury (mTBI) negatively affect daily functioning and quality of life. Fear avoidance behaviour, a coping style in which people avoid or escape from activities or situations that they expect will exacerbate their symptoms, maybe a particularly potent and modifiable risk factor for chronic disability after mTBI. This study will evaluate the efficacy of graded exposure therapy (GET) for reducing persistent symptoms following mTBI, with two primary aims: (1) To determine whether GET is more effective than usual care; (2) to identify for whom GET is the most effective treatment option, by evaluating whether baseline fear avoidance moderates differences between GET and an active comparator (prescribed aerobic exercise). Our findings will guide evidence-based care after mTBI and enable better matching of mTBI patients to treatments. METHODS AND ANALYSIS: We will conduct a multisite randomised controlled trial with three arms. Participants (n=220) will be recruited from concussion clinics and emergency departments in three Canadian provinces and randomly assigned (1:2:2 ratio) to receive enhanced usual care, GET or prescribed aerobic exercise. The outcome assessment will occur remotely 14-18 weeks following baseline assessment, after completing the 12-week treatment phase. The primary outcome will be symptom severity (Rivermead Post-concussion Symptoms Questionnaire). ETHICS AND DISSEMINATION: Informed consent will be obtained from all participants. All study procedures were approved by the local research ethics boards (University of British Columbia Clinical Research Ethics Board, University of Calgary Conjoint Health Research Ethics Board, University Health Network Research Ethics Board-Panel D). Operational approvals were obtained for Vancouver Coastal Health Research Institute and Provincial Health Services Authority. If GET proves effective, we will disseminate the GET treatment manual and present instructional workshops for clinicians. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov #NCT05365776.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame machine prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.

metaresearch head score (Codex)0.032
metaresearch head score (Gemma)0.025
Version: metacan-v3-hybrid-931329e0061cValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Randomized trial · Consensus signal: Randomized trial
GenreCandidate signal: Protocol · Consensus signal: Protocol
Teacher disagreement score0.066
Threshold uncertainty score0.220

Distilled classifier scores by category (both heads)

CategoryCodexGemma
Metaresearch0.0320.025
Meta-epidemiology (narrow)0.0060.003
Meta-epidemiology (broad)0.0100.006
Bibliometrics0.0020.005
Science and technology studies0.0040.003
Scholarly communication0.0050.002
Open science0.0040.002
Research integrity0.0060.006
Insufficient payload (model declined to judge)0.0660.007

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.144
GPT teacher head0.481
Teacher spread0.337 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.

The models applied no category: nothing in the taxonomy fit this work.
Study designRandomized trial
Domainnot available
GenreProtocol

How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".

Quick stats

Citations4
Published2024
Admission routes3
Has abstractyes

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