Clinical trial NCT04274530: Cognitive Behavioural Therapy to Optimize Post-Operative Recovery Trial
Official title: Cognitive Behavioral Therapy to Optimize Post-Operative Recovery (COPE): A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pain, Postoperative
Pain, Acute
Pain, Chronic
Fractures, Closed
Fractures, Open
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Orthopaedic Trauma Association
name: Canadian Institutes of Health Research (CIHR)
First posted: 2020-02-18
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: The prevalence of moderate to severe Persistent Post-Surgical Pain at 12 months' post-fracture
timeFrame: 12 months post-fracture
Secondary outcomes:
measure: Short Form 36 (SF-36)
timeFrame: 12 months post-fracture
measure: Return to Function Questionnaire
timeFrame: 12 months post-fracture
measure: Brief Pain Inventory-Short Form (BPI-SF)
timeFrame: 12 months post-fracture
measure: Opioid Use
timeFrame: 12 months post-fracture
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Health Methodist Hospital
state: Indiana
city: Baltimore
country: United States
facility: University of Maryland - R Adams Cowley Shock Trauma Center
state: Maryland
city: Largo
country: United States
facility: University of Maryland - Capital Region Medical Center
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Centre
state: Massachusetts
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Centre
state: New Hampshire
city: Greenwood
country: United States
facility: PRISMA Health
state: South Carolina
city: Calgary
country: Canada
facility: University of Calgary - Foothills Hospital
state: Alberta
city: St. John's
country: Canada
facility: Memorial University Newfoundland
state: Newfoundland and Labrador
city: Hamilton
country: Canada
facility: Hamilton Health Sciences - General Site
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Civic Hospital
state: Ontario
Study officials:
affiliation: McMaster University
name: Sheila Sprague, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Jason Busse, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.