Cognitive Behavioural Therapy to Optimize Post-Operative Recovery Trial

NCT04274530 | Completed

• 1 other identifier: COPE-Definitive
• Study Type: interventional
• Target: 1,024
• Locations: 2 countries
• Sites: 10

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

  The primary outcome is PPSP according to the World Health Organization's (WHO) proposed definition. The WHO's definition requires 4 criteria for the diagnosis of PPSP: 1) Pain that began after surgery or a tissue trauma is experienced; 2) The pain is in an area of preceding surgery or tissue trauma, 3) The pain persisted for at least three months after the initiating event, and 4) The pain is not better explained by an infection, a malignancy, a pre-existing pain condition or any other alternative cause.

  12 months post-fracture

Secondary Outcomes (4)

• Short Form 36 (SF-36)

  12 months post-fracture

• Return to Function Questionnaire

  12 months post-fracture

• Brief Pain Inventory-Short Form (BPI-SF)

  12 months post-fracture

• Opioid Use

  12 months post-fracture

Study Arms (2)

Intervention - CBT

EXPERIMENTAL

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.

Behavioral: Cognitive Behavioural Therapy

Control

NO INTERVENTION

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.

Interventions

Cognitive Behavioural Therapy 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.

Also known as: CBT

Intervention - CBT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• McMaster University: lead
• Orthopaedic Trauma Association: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (10)

Indiana University Health Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

University of Maryland - R Adams Cowley Shock Trauma Center

Baltimore, Maryland, 21201, United States

Location

University of Maryland - Capital Region Medical Center

Largo, Maryland, 20774, United States

Location

Beth Israel Deaconess Medical Centre

Boston, Massachusetts, 02215, United States

Location

Dartmouth-Hitchcock Medical Centre

Lebanon, New Hampshire, 03766, United States

Location

PRISMA Health

Greenwood, South Carolina, 29615, United States

Location

University of Calgary - Foothills Hospital

Calgary, Alberta, Canada

Location

Memorial University Newfoundland

St. John's, Newfoundland and Labrador, Canada

Location

Hamilton Health Sciences - General Site

Hamilton, Ontario, L8L 2X2, Canada

Location

Ottawa Civic Hospital

Ottawa, Ontario, Canada

Location

Related Publications (2)

• 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.

  PMID: 39799376 DERIVED

• 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.

  PMID: 36273187 DERIVED

MeSH Terms

Conditions

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

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Fractures, Bone; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Sheila Sprague, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

• Jason Busse, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants with operatively managed extremity fractures 2-12 weeks post-fracture fixation will be randomized to receive either cognitive behavioural therapy (CBT) delivered through a mobile application or standard of care (control). Outcomes will be assessed at 3 months, 6 months, 9 months, and 12 months' post-fracture.

Study Record Dates

• First Submitted: February 14, 2020
• First Posted: February 18, 2020
• Study Start: January 25, 2021
• Primary Completion: August 18, 2025
• Study Completion: August 18, 2025
• Last Updated: September 5, 2025

Record last verified: 2025-08

Locations

US (6); CA (4)