Clinical trial NCT03673358: Cognitive Behavioural Therapy to Optimize Post-Operative Recovery Pilot
Official title: Cognitive Behavioural Therapy to Optimize Post-Operative Recovery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pain, Postoperative
Fractures, Open
Fractures, Closed
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Orthopaedic Trauma Association
First posted: 2018-09-17
Enrollment: 83
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) with participants having a choice of 6 weekly one-on-one telephone or video therapy sessions OR completion of online therapy modules 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

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 fracture of the appendicular skeleton, or closed fracture of the lower extremity or pelvis. 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 in patients with an open fracture of the appendicular skeleton or closed fracture of the lower extremity or pelvis. This trial is a multi-centre 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 fracture of the appendicular skeleton or closed fracture of the lower extremity or pelvis. 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 online access from a smartphone/internet-enabled device with a minimum operating system able to use the CBT provider application or videoconferencing software applications.
* Provision of informed consent.

Exclusion Criteria:

* Fragility fracture.
* Stress fracture.
* Fracture of the hand.
* Fracture of the foot.
* 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.
* 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: BPI-SF
timeFrame: 12 months post-fracture
measure: Opioid Use
timeFrame: 12 months post-fracture
Other outcomes:
Locations:
city: Saint John
country: Canada
facility: The Moncton Hospital
state: New Brunswick
city: Halifax
country: Canada
facility: QEII Health Sciences Centre
state: Nova Scotia
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Civic Hospital
state: Ontario
city: Thunder Bay
country: Canada
facility: Thunder Bay Regional Health Sciences Centre
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: