Cognitive Behavioural Therapy to Optimize Post-Operative Recovery Pilot

NCT03673358 | Terminated

• 1 other identifier: COPE-001
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 6

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

Conditions

Pain, Postoperative; Fractures, Open; Fractures, Closed

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

• 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. Participants will have the choice of completing six real-time telephone or video-delivered CBT sessions with a therapist OR complete online modules with asynchronous feedback with a dedicated therapist in addition to standard of care for their fracture injury.

Behavioral: Cognitive Behavioural Therapy

No intervention- - 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. Other Name: 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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (6)

The Moncton Hospital

Saint John, New Brunswick, E2L 4L2, Canada

Location

QEII Health Sciences Centre

Halifax, Nova Scotia, Canada

Location

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

London Health Sciences Centre

London, Ontario, Canada

Location

Ottawa Civic Hospital

Ottawa, Ontario, Canada

Location

Thunder Bay Regional Health Sciences Centre

Thunder Bay, Ontario, Canada

Location

MeSH Terms

Conditions

Pain, Postoperative; Fractures, Open; Fractures, Closed

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: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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

Study Record Dates

• First Submitted: September 13, 2018
• First Posted: September 17, 2018
• Study Start: January 9, 2019
• Primary Completion: August 8, 2019
• Study Completion: August 8, 2019
• Last Updated: January 29, 2020

Record last verified: 2020-01

Locations

CA (6)