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Cognitive Behavioural Therapy to Optimize Post-Operative Recovery Trial

CompletedNot applicableNCT04274530
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

Brief summary (from the registry)

Psychological factors such as stress, distress, anxiety, depression, and poor coping strategies may be associated with ongoing pain following injuries such as fractures. To study this relationship, patients will undergo cognitive behavioural therapy (CBT) which is designed to modify such thoughts with the goal of reducing ongoing pain and improving quality of life. The goal of this study is to determine if CBT, versus usual care, reduces the prevalence of moderate to severe persistent post-surgical pain (PPSP) over 12-months post-fracture in patients with an open or closed fracture of the appendicular skeleton, treated with internal fixation.

Study details

Official title
Cognitive Behavioral Therapy to Optimize Post-Operative Recovery (COPE): A Randomized Controlled Trial
Conditions
Sponsor
McMaster University
Collaborators
Orthopaedic Trauma Association; Canadian Institutes of Health Research (CIHR)
Start date
2021-01-25
Primary completion
2025-08-18
Sex
All
Age range
from 18 Years
Results posted
No results posted in this snapshot
Countries
Canada, United States
Total sites listed
10

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Adult men or women aged 18 years and older. * Presenting to fracture clinic within 2-12 weeks following an acute open or closed fracture of the appendicular skeleton. Patients with multiple fractures may be included. * Fracture treated operatively with internal fixation. * Willing to participate in CBT. * Language skills and cognitive ability required to participate in CBT (in the judgement of site research personnel). * Consistent access to a smart phone and/or tablet that is capable of running the CBT provider's application. * Provision of informed consent. Exclusion Criteria: * Fragility fracture. * Stress fracture. * Concomitant injury which, in the opinion of the attending surgeon, is likely to impair function for as long as or longer than the patient's extremity fracture. * Among patients who are fully weightbearing, those not experiencing any pain in the fracture region. * Active psychosis. * Active suicidality. * Active substance use disorder that, in the judgement of the treating surgeon, would interfere in the patient's ability to partake in the CBT and/or the trial. * Already participating in, or planning to, start other psychological treatments (including CBT) within the duration of the study (12 months). * Anticipated problems, in the judgement of study personnel, with the patient participating in CBT intervention and/or returning for follow-up. * Incarceration. * Currently enrolled in a study that does not permit co-enrolment in other trials. * Previously enrolled in the COPE trial. * Other reason to exclude the patient, as approved by the Methods Centre.

Canadian sites (4)

FacilityCityProvince
University of Calgary - Foothills HospitalCalgaryAlberta
Memorial University NewfoundlandSt. John'sNewfoundland and Labrador
Hamilton Health Sciences - General SiteHamiltonOntario
Ottawa Civic HospitalOttawaOntario
Canadian sites for NCT04274530CalgarySt. John'sHamiltonOttawa
Canadian sites for NCT04274530. 4 mapped locations with coordinates in the registry. Schematic plot, not to scale.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04274530