Status:
COMPLETED
Cognitive Behavioural Therapy to Optimize Post-Operative Recovery Trial
Lead Sponsor:
McMaster University
Collaborating Sponsors:
Orthopaedic Trauma Association
Canadian Institutes of Health Research (CIHR)
Conditions:
Pain, Postoperative
Pain, Acute
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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, pa...
Detailed Description
The relationship between psychological factors, behaviors, and cognitive processes and the sensation of pain is well documented. Stress, distress, anxiety, depression, catastrophizing, fear-avoidance ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 18 2025
Estimated Enrollment :
1024 Patients enrolled
Trial Details
Trial ID
NCT04274530
Start Date
January 25 2021
End Date
August 18 2025
Last Update
September 5 2025
Active Locations (10)
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1
Indiana University Health Methodist Hospital
Indianapolis, Indiana, United States, 46202
2
University of Maryland - R Adams Cowley Shock Trauma Center
Baltimore, Maryland, United States, 21201
3
University of Maryland - Capital Region Medical Center
Largo, Maryland, United States, 20774
4
Beth Israel Deaconess Medical Centre
Boston, Massachusetts, United States, 02215