Cognitive Behavioural Therapy to Optimize Post-Operative Recovery Trial

NCT ID: NCT04274530

Last Updated: 2025-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1024 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-25
• Study Completion Date: 2025-08-18

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, 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.

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 behaviors, and poor coping strategies appear to have a significant positive relationship with both acute and chronic pain. Evidence suggests that these psychological factors can cause alterations along the spinal and supraspinal pain pathways which influence the perception of pain. Previous studies suggest that patients' beliefs and expectations may be associated with clinical outcomes, including self-reported pain. Previous studies in trauma patients have demonstrated patients' beliefs and expectations regarding their recovery following surgery are associated with functional limitations, lower rates of return to work, and reduced quality of life one year after injury. Furthermore, up to two thirds of patients with operative managed extremity fractures demonstrate unhelpful illness beliefs that increase risks of negative outcomes, including persistent pain. 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.

Our primary objective is to determine if CBT, versus usual care, reduces the prevalence of moderate to severe PPSP over 12 months post-fracture in participants with an open or closed fracture of the appendicular skeleton. Our secondary objectives are to determine if CBT, versus usual care: 1) increases physical functioning, 2) improves mental functioning, 3) accelerates return to function, 4) reduces pain severity, and 5) reduces pain interference over 12 months post-fracture, and 6) reduces the proportion of participants prescribed opioid class medications at 6 and 12 months post-fracture. This trial is a multi-centre randomized controlled trial (RCT) of 1,000 participants with an open fracture of the appendicular skeleton or closed fracture of the lower extremity or pelvis treated with internal fixation.

Conditions

Pain, Postoperative; Pain, Acute; Pain, Chronic; Fractures, Closed; Fractures, Open

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Intervention - CBT

Participants in this arm will receive cognitive behavioural therapy (CBT). Participants will complete a series of online modules via a mobile application in addition to standard of care for their fracture injury. Participants will be assigned a dedicated CBT therapist, and receive feedback and support from their therapist via in-app messaging. The CBT program will last approximately 6-8 weeks.

Group Type: EXPERIMENTAL

Cognitive Behavioural Therapy

Intervention Type: BEHAVIORAL

Participants who are randomized to the CBT intervention will be encouraged to begin CBT immediately following randomization. The CBT intervention will focus on addressing maladaptive beliefs related to pain and recovery as well as teaching skills to enhance coping and management of pain symptoms. The specific focus of CBT sessions will be informed by each individual patient's responses to baseline questionnaires. All other aspects of post-operative care will be at the discretion of participant's surgeon.

Control

Participants in the control arm of the study will receive standard of care treatment for their fracture(s) but will not receive any Cognitive Behavioral Therapy.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cognitive Behavioural Therapy

Participants who are randomized to the CBT intervention will be encouraged to begin CBT immediately following randomization. The CBT intervention will focus on addressing maladaptive beliefs related to pain and recovery as well as teaching skills to enhance coping and management of pain symptoms. The specific focus of CBT sessions will be informed by each individual patient's responses to baseline questionnaires. All other aspects of post-operative care will be at the discretion of participant's surgeon.

Intervention Type: BEHAVIORAL

Other Intervention Names

CBT

Eligibility Criteria

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 trials.
• Previously enrolled in the COPE trial.
• Other reason to exclude the patient, as approved by the Methods Centre.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Orthopaedic Trauma Association

OTHER

Sponsor Role: collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sheila Sprague, PhD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Jason Busse, PhD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

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

Countries

United States; Canada

References

Gouveia K, Sprague S, Gallant JL, MacRae S, Del Fabbro G, Bzovsky S, McKay P, Johal H, Busse JW; COPE Investigators. Cognitive Behavioural Therapy to Optimize Post-Operative Recovery (COPE): a randomized controlled feasibility trial in extremity fracture patients. Pilot Feasibility Stud. 2025 Jan 11;11(1):3. doi: 10.1186/s40814-024-01592-3.

Reference Type: DERIVED

PMID: 39799376 (View on PubMed)

COPE Investigators. Cognitive Behavioural Therapy to Optimize Post-Operative Fracture Recovery (COPE): protocol for a randomized controlled trial. Trials. 2022 Oct 22;23(1):894. doi: 10.1186/s13063-022-06835-3.

Reference Type: DERIVED

PMID: 36273187 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan: Version 1.0

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Document Type: Statistical Analysis Plan: Version 2.0

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Document Type: Statistical Analysis Plan: Version 3.0

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Document Type: Statistical Analysis Plan: Version 4.0

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Document Type: Statistical Analysis Plan: Version 5.0

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Document Type: Statistical Analysis Plan: Version 5.0_Signed

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Other Identifiers

COPE-Definitive

Identifier Type: -

Identifier Source: org_study_id