Cognitive Behavioural Therapy to Optimize Post-Operative Recovery Trial

Pain, Postoperative Clinical Trial

— COPE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04274530
• Other study ID #: COPE-Definitive
• Status: Recruiting
• Phase: N/A
• Start date: January 25, 2021
• Est. completion date: August 2024

Study information

• Verified date: March 2024
• Source: McMaster University
• Contact: Paula McKay
• Phone: 289-237-0791
• Email: mckayp[@]mcmaster.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 (and average dose) 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Pain
• Chronic Pain
• Fractures, Bone
• Fractures, Closed
• Fractures, Open
• Pain, Acute
• Pain, Chronic
• Pain, Postoperative

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Canada	University of Calgary - Foothills Hospital	Calgary	Alberta
Canada	Hamilton Health Sciences - General Site	Hamilton	Ontario
Canada	Ottawa Civic Hospital	Ottawa	Ontario
Canada	Memorial University Newfoundland	St. John's	Newfoundland and Labrador
United States	University of Maryland - R Adams Cowley Shock Trauma Center	Baltimore	Maryland
United States	Beth Israel Deaconess Medical Centre	Boston	Massachusetts
United States	PRISMA Health	Greenville	South Carolina
United States	PRISMA Health	Greenwood	South Carolina
United States	Indiana University Health Methodist Hospital	Indianapolis	Indiana
United States	University of Maryland - Capital Region Medical Center	Largo	Maryland
United States	Dartmouth-Hitchcock Medical Centre	Lebanon	New Hampshire

Sponsors (3)

Lead Sponsor	Collaborator
McMaster University	Canadian Institutes of Health Research (CIHR), Orthopaedic Trauma Association

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Short Form 36 (SF-36)	General health related quality of life will be assessed by the SF-36. The SF-36 is an established, reliable and validated health status measure. It is a self-administered, 36-item questionnaire that measures health-related quality of life in 8 domains related to physical, social, mental, and emotional functioning, bodily pain, and general health. Both physical and mental summary scores can be obtained. Each domain is scored separately from 0 (lowest level) to 100 (highest level).	12 months post-fracture
Secondary	Return to Function Questionnaire	Return to function will be measured by when participants' return to work, household activities, and leisure activities, as well as when they achieve 80% of their pre-injury function. The return to function outcome will be assessed using the Return to Function questionnaire.	12 months post-fracture
Secondary	Brief Pain Inventory-Short Form (BPI-SF)	The Brief Pain Inventory (BPI) assess pain severity and its impact on function. Participants will rate their pain on a scale from 0-10 (0 being No Pain, and 10 being Pain as bad as you can imagine). Participants will also rate how pain has interfered with their every day life on a scale from 0-10 (0 being Does not interfere, and 10 being Completely Interferes).	12 months post-fracture
Secondary	Opioid Use	Patient-reported use of opioid class medications. To determine if CBT versus usual care reduces the proportion of participants taking opioid class medications at 6 months and 12 months.	12 months post-fracture