Cognitive Behavioural Therapy to Optimize Post-Operative Recovery Trial
CompletedNot applicableNCT04274530
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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
- Pain, Postoperative
- Pain, Acute
- Pain, Chronic
- Fractures, Closed
- Fractures, Open
- Interventions
- 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)
| Facility | City | Province |
|---|---|---|
| University of Calgary - Foothills Hospital | Calgary | Alberta |
| Memorial University Newfoundland | St. John's | Newfoundland and Labrador |
| Hamilton Health Sciences - General Site | Hamilton | Ontario |
| Ottawa Civic Hospital | Ottawa | Ontario |
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04274530