Cognitive Behavioural Therapy to Optimize Post-Operative Fracture Recovery (COPE): protocol for a randomized controlled trial
Authors:   The COPE Investigators, Busse Jason W. , Sprague Sheila , Del Fabbro Gina , McKay Paula , Thabane Lehana , McCabe Randi E. , Nowakowski Matilda , Shibu Christy , Fleming Natalie , Johal Herman , Slobogean Gerard , Natoli Roman M. , Gitajn I. Leah , Schneider Prism , Devereaux P. J. , Schemitsch Emil H. , Bhandari Mohit , Guyatt Gordon H. , Hapidou Eleni , Chiaramonte Delia , Kehlet Henrick , Khan James , Johnson Aaron , Heels-Ansdell Diane , Bzovsky Sofia , Petrisor Brad A. , Williams Dale , Ristevski Bill , Al-Asiri Jamal , Denkers Matthew , Rajaratnam Kris , Gallant Jodi L. , MacRae Sarah , Pusztai Kaitlyn , Renaud Sara , Johal Nicki , Papp Steven , Lalonde Karl-Andre , Meulenkamp Bradley , Liew Allan , Mistry Manisha , Gammon Braden , Gofton Wade , Wilkin Geoffrey , Dodd-Moher Melanie , Puskas David , Marion Travis , Lefrancois Tina , Payandeh Jubin , Cullinan Claude , Wilson Tracy , Droll Kurt , Riediger Michael , Siddiqui Rabail , Littlefield Shalyn , Chahal Simrun , Wagar Paige , Schneider Prism S. , Ogunleye Tosin , Cherppukaran Tanya , Lienhard Karin , Smith Nicholas , Anthony Sarah , Butt Krista , Selby LaShann , Kovvur Murali , Lawrence Joshua , Sampson Skyler , Turner Kristin , Jaeblon Todd , Demyanovich Haley K. , Talwar Sneh , Benzel Caroline , Chockbengboun Theresa , Mullin Devin , Bateman Logan , Christian Melanie , DePalo Peter , Appleton Paul J. , Wixted John J. , Rodriguez Edward K. , McTague Michael F. , Wagner Katiri , Brackpool Kristina , Hegermiller Kate , Nguyen Nhi , Fentz Courteney , Diaz Maricela , Niceley Jill , Jeray Kyle J. , Schaller Thomas M. , Sridhar Michael S. , Adams John D. , Gurich Richard W. , Tanner Stephanie L. , Adams Kyle , Donohue Michelle , Bray Emily , Brignull Calleigh , Sprouse Harper 
Published: October 2022

Abstract
Importance
Chronic, non-cancer pain affects approximately 20–30% of the population in North America, Europe, and Australia, with surgery and trauma frequently cited as inciting events. Prospective studies of fracture patients have demonstrated an association between somatic pre-occupation, poor coping, and low recovery expectations following surgery with persistent pain, functional limitations, and lower rates of return to work. Psychological interventions, such as cognitive behavioural therapy (CBT), that are designed to modify unhelpful beliefs and behaviours have the potential to reduce persistent post-surgical pain and its associated effects among trauma patients.

Objective
To determine whether online CBT, versus usual care, reduces the prevalence of moderate to severe persistent post-surgical pain among participants with an open or closed fracture of the appendicular skeleton.

Design, setting, and participants
The Cognitive Behavioural Therapy to Optimize Post-Operative Fracture Recovery (COPE) protocol will be followed to conduct a multi-centre randomized controlled trial. Participants undergoing surgical repair of a long bone fracture will be randomized to receive either (1) online CBT modules with asynchronous therapist feedback or (2) usual care. The primary outcome will be the prevalence of moderate to severe persistent post-surgical pain over 12 months post-fracture. Secondary outcomes include the Short Form-36 Physical and Mental Component Summary scores, return to function, pain severity and pain interference over 12 months post-fracture, and the proportion of patients prescribed opioid class medications (and average dose) at 6 and 12 months post-fracture. The COPE trial will enroll 1000 participants with open and closed fractures of the appendicular skeleton from approximately 10 hospitals in North America.

Discussion
If CBT is effective in improving outcomes among patients with traumatic fractures, our findings will promote a new model of care that incorporates psychological barriers to recovery.

Trial registration
ClinicalTrials.gov Identifier: NCT04274530. Registered on 14 February 2020.