Evidence map›Paper›PMID 39799376›Full record

ArticlePilot and feasibility studies2025

Cognitive Behavioural Therapy to Optimize Post-Operative Recovery (COPE): a randomized controlled feasibility trial in extremity fracture patients.

Kyle Gouveia, Sheila Sprague, Jodi L Gallant, Sarah MacRae, Gina Del Fabbro, Sofia Bzovsky, Paula McKay, Herman Johal, Jason W Busse, COPE Investigators

Registry-linked trialAbstract read
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In one paragraph

Article in Pilot and feasibility studies, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04274530 (Cognitive Behavioral Therapy to Optimize Post-Operative Recovery), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04274530 nacompletednot on this map

Cognitive Behavioral Therapy to Optimize Post-Operative Recovery (COPE): A Randomized Controlled Trial

TypeinterventionalSponsorMcMaster UniversityRan2021 to 2025Enrolled1,024ConditionsPain, Postoperative, Pain, Acute, Pain, Chronic, Fractures, ClosedArmsCognitive Behavioural Therapy
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Kyle GouveiaDepartment of Surgery,, Division of Orthopaedic Surgery, McMaster University, 293 Wellington St. N, Suite 110, Hamilton, ON, L8L 8E7, Canada.
Sheila SpragueDepartment of Surgery,, Division of Orthopaedic Surgery, McMaster University, 293 Wellington St. N, Suite 110, Hamilton, ON, L8L 8E7, Canada. sprags@mcmaster.ca.ORCID http://orcid.org/0000-0003-1466-8063
Jodi L GallantDepartment of Surgery,, Division of Orthopaedic Surgery, McMaster University, 293 Wellington St. N, Suite 110, Hamilton, ON, L8L 8E7, Canada.
Sarah MacRaeDepartment of Surgery,, Division of Orthopaedic Surgery, McMaster University, 293 Wellington St. N, Suite 110, Hamilton, ON, L8L 8E7, Canada.
Gina Del FabbroDepartment of Surgery,, Division of Orthopaedic Surgery, McMaster University, 293 Wellington St. N, Suite 110, Hamilton, ON, L8L 8E7, Canada.
Sofia BzovskyDepartment of Surgery,, Division of Orthopaedic Surgery, McMaster University, 293 Wellington St. N, Suite 110, Hamilton, ON, L8L 8E7, Canada.
Paula McKayDepartment of Surgery,, Division of Orthopaedic Surgery, McMaster University, 293 Wellington St. N, Suite 110, Hamilton, ON, L8L 8E7, Canada.
Herman JohalDepartment of Surgery,, Division of Orthopaedic Surgery, McMaster University, 293 Wellington St. N, Suite 110, Hamilton, ON, L8L 8E7, Canada.
Jason W BusseDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada. bussejw@mcmaster.ca.
COPE Investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOutcomes following surgery to operatively manage extremity fractures are variable, and up to two-thirds of patients report chronic post-surgical pain. Preliminary evidence suggests that psychotherapy directed at improving coping skills and reducing somatic vigilance may improve outcomes among fracture patients. The objective of this pilot study was to test the feasibility and acceptability of a randomized controlled trial comparing an online cognitive behavioural therapy (CBT) program versus usual care in patients with an operatively managed open or closed extremity fracture.

methodsWe conducted a single-centre internal pilot study over a 10-month period in patients with at least one operatively managed open or closed fracture of the appendicular skeleton. Participants were randomized to an online CBT program or usual care and followed for 12 months. The goals of our pilot study were to determine an acceptable rate of recruitment, the degree to which participants randomized to CBT were compliant with treatment, the site investigator's ability to adhere to study protocol and data collection procedures, and our ability to achieve high follow-up rates. Feasibility criteria were evaluated using a graded "traffic light" approach, in which "green light" indicates moving forward with the definitive trial, "yellow light" indicates proceeding with modifications to the protocol and trial procedures, and "red light" indicates a definitive trial is not feasible without significant protocol and trial procedure modifications.

resultsWe enrolled 94 participants over 10 months, which resulted in a "yellow light" for recruitment. Participant compliance with completion of the online CBT program received a "yellow light", with 60% of participants who were randomized to CBT completing all seven modules. However, 40% of participants in the CBT-arm withdrew from the program, resulting in a "red light". Adherence with the study protocol activities at baseline was relatively high (88%) which resulted in a "yellow light". Follow-up was 85% (80 of 94) at 12 months, resulting in a "yellow light".

conclusionsThese results suggest feasibility of a definitive, multi-centre trial to compare CBT versus usual care in the management of persistent post-operative pain in fracture patients despite the pilot phase identifying some challenges with enrollment timelines, compliance with the CBT program, and participant follow-up. For the definitive trial, we will expand participant recruitment to additional centres and implement strategies to optimize participant engagement and compliance with the CBT program and follow-up.

trial registrationClincialTrials.gov (NCT04274530). Registered February 18, 2020, https://classic. CLINICALTRIALS: gov/ct2/show/NCT04274530 .

Indexed as

Chronic painCognitive behavioural therapyFeasibilityPilot study

Identifiers

PMID39799376
PMCPMC11724510

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.