Cognitive Behavioural Therapy to Optimize Post-Operative Recovery Trial

Completed · Not applicable

Conditions studied: Pain, Postoperative, Pain, Acute, Pain, Chronic, Fractures, Closed, Fractures, Open

In brief

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.

Key facts

Study ID

NCT04274530

Run by

McMaster University

People needed

1024

Starts

2021-01-25

Expected to finish

2025-08-18

Last updated by the study team

2025-09-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Indiana University Health Methodist Hospital — Indianapolis, Indiana, United States
• University of Maryland - R Adams Cowley Shock Trauma Center — Baltimore, Maryland, United States
• University of Maryland - Capital Region Medical Center — Largo, Maryland, United States
• Beth Israel Deaconess Medical Centre — Boston, Massachusetts, United States
• Dartmouth-Hitchcock Medical Centre — Lebanon, New Hampshire, United States
• PRISMA Health — Greenwood, South Carolina, United States
• University of Calgary - Foothills Hospital — Calgary, Alberta, Canada
• Memorial University Newfoundland — St. John's, Newfoundland and Labrador, Canada
• Hamilton Health Sciences - General Site — Hamilton, Ontario, Canada
• Ottawa Civic Hospital — Ottawa, Ontario, Canada

Full record on ClinicalTrials.gov

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