CompletedNot Applicable

Cognitive Behavioural Therapy to Optimize Post-Operative Recovery Trial

United States1,024 participantsStarted 2021-01-25

Plain-language 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, 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 tr…

What they're measuring

The prevalence of moderate to severe Persistent Post-Surgical Pain at 12 months' post-fracture

Timeframe: 12 months post-fracture

Trial details

NCT IDNCT04274530

SponsorMcMaster University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08-18