Cognitive Behavioural Therapy for Postoperative Pain
(COPE Trial)
Recruiting in Palo Alto (17 mi)
+10 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: McMaster University
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?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.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify whether you need to stop taking your current medications. It seems focused on psychological therapy, so you might not need to stop them, but it's best to check with the trial coordinators.
What data supports the idea that Cognitive Behavioural Therapy for Postoperative Pain is an effective treatment?
The available research shows that Cognitive Behavioural Therapy (CBT) can be effective in reducing postoperative pain and improving joint function. For example, one study found that CBT helped patients after joint surgery by reducing pain and improving how well their joints worked. Another study showed that CBT reduced negative thinking about pain before knee surgery, which led to better pain outcomes afterward. However, it's important to note that CBT may not be as effective for older patients, as one study found it did not improve pain or joint function for those aged 70 and older after knee surgery. Overall, CBT seems to help many people manage postoperative pain better than not using it at all.
12345What safety data exists for CBT in treating postoperative pain?
The research indicates that Cognitive Behavioral Therapy (CBT) is considered a safe treatment for postoperative pain. The study titled 'Patient-Centered Pain Care Using Artificial Intelligence and Mobile Health Tools' specifically mentions CBT for chronic pain as a safe alternative to opioid analgesics. While the other studies focus on the effectiveness of CBT in improving pain and joint function, they do not report any safety concerns, suggesting that CBT is generally safe for use in postoperative pain management.
14567Is Cognitive Behavioural Therapy a promising treatment for reducing pain after surgery?
Yes, Cognitive Behavioural Therapy (CBT) is a promising treatment for reducing pain after surgery. Research shows that CBT can help relieve postoperative pain, improve joint function, and reduce the risk of chronic pain after surgery. It works by changing unhelpful thoughts and behaviors, which can lead to better recovery and less pain.
14689Eligibility Criteria
Adults over 18 with a recent fracture fixed by surgery, who can understand CBT and have access to a smart device for the app. Excluded are those with fragile bones, no pain while fully weightbearing, active psychosis or substance issues, other psychological treatments during the study period, or in another conflicting trial.Inclusion Criteria
I had surgery to fix a broken bone with metal parts.
I am 18 years old or older.
You must have the ability to understand and communicate in the language required for cognitive behavioral therapy (CBT) as determined by the study staff.
+10 more
Exclusion Criteria
Anticipated problems, in the judgement of study personnel, with the patient participating in CBT intervention and/or returning for follow-up
You are currently in jail or prison.
Other reason to exclude the patient, as approved by the Methods Centre
+10 more
Participant Groups
The trial tests if Cognitive Behavioural Therapy (CBT) can reduce long-term moderate to severe pain after bone fractures compared to usual care. It aims to improve coping strategies and quality of life over a year following surgery.
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention - CBTExperimental Treatment1 Intervention
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.
Group II: ControlActive Control1 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.
Cognitive Behavioural Therapy is already approved in United States, Canada, European Union for the following indications:
🇺🇸 Approved in United States as Cognitive Behavioral Therapy for:
- Anxiety disorders
- Substance use disorders
- Depression
- Post-traumatic stress disorder (PTSD)
- Eating disorders
🇨🇦 Approved in Canada as Cognitive Behavioural Therapy for:
- Anxiety disorders
- Substance use disorders
- Depression
- Post-traumatic stress disorder (PTSD)
- Eating disorders
🇪🇺 Approved in European Union as Cognitive Behavioural Therapy for:
- Anxiety disorders
- Substance use disorders
- Depression
- Post-traumatic stress disorder (PTSD)
- Eating disorders
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
PRISMA HealthGreenwood, SC
Dartmouth-Hitchcock Medical CentreLebanon, NH
Indiana University Health Methodist HospitalIndianapolis, IN
University of Maryland - Capital Region Medical CenterLargo, MD
More Trial Locations
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Who Is Running the Clinical Trial?
McMaster UniversityLead Sponsor
Canadian Institutes of Health Research (CIHR)Collaborator
Orthopaedic Trauma AssociationCollaborator
References
Cognitive behavioral therapy achieves better benefits in relieving postoperative pain and improving joint function: A systematic review and meta-analysis of randomized controlled trials. [2023]Cognitive behavioral therapy (CBT) is a structured, short-term psychotherapy approach that may have positive effects in terms of relieving postoperative pain. The main objective of this study was to determine the effect of CBT on pain and joint function in patients after total joint arthroplasty.
Preoperative cognitive-behavioural intervention improves in-hospital mobilisation and analgesic use for lumbar spinal fusion patients. [2022]Catastrophic thinking and fear-avoidance belief are negatively influencing severe acute pain following surgery causing delayed ambulation and discharge. We aimed to examine if a preoperative intervention of cognitive-behavioural therapy (CBT) could influence the early postsurgical outcome following lumbar spinal fusion surgery (LSF).
Occupational Therapy Practice With Cognitive Behavioral Therapy for Early Postoperative Pain: A Case Report. [2023]Structuring psychological interventions using cognitive behavioral therapy in the early postoperative period is crucial to mitigate the risk of chronic pain. In this study, specific practices were presented through the case of a woman in her 60s who experienced psychological factors, such as catastrophic thinking and anxiety, due to pain after high tibial osteotomy. The aim was to evaluate the structure of cognitive behavioral therapy and its application in the early postoperative period. Cognitive behavioral therapy was initiated postoperatively, incorporating three phases: cognitive restructuring, coping skills and active pacing, and occupational therapy. As a result of occupational therapy using cognitive behavioral therapy, the patient's pain and anxiety are reduced while achieving the goals. This case study suggests that cognitive behavioral therapy may promote goal attainment in cases where postoperative pain exacerbates psychological factors, such as catastrophic thinking and anxiety, ultimately leading to functional impairments. Implementation of cognitive behavioral therapy in Japan is lacking, necessitating urgent development. This case report serves as a foundational step in structuring cognitive behavioral therapy during the early postoperative period in Japan.
Preoperative cognitive-behavioral therapy for reducing pain catastrophizing and improving pain outcomes after total knee replacement: a randomized clinical trial. [2021]Cognitive-behavioral therapy (CBT) can reduce preoperative pain catastrophizing and may improve postsurgical pain outcomes. We hypothesized that CBT would reduce pain catastrophizing more than no-CBT controls and result in improved pain outcomes.
Cognitive behavioral therapy cannot relieve postoperative pain and improve joint function after total knee arthroplasty in patients aged 70 years and older. [2021]A randomized controlled trial was conducted to investigate whether cognitive behavioral therapy (CBT) can improve postoperative pain, knee function, and negative emotion in patients aged 70 years and older who underwent total knee arthroplasty (TKA).
Cognitive Behavioural Therapy to Optimize Post-Operative Fracture Recovery (COPE): protocol for a randomized controlled trial. [2023]Chronic, non-cancer pain affects approximately 20-30% of the population in North America, Europe, and Australia, with surgery and trauma frequently cited as inciting events. Prospective studies of fracture patients have demonstrated an association between somatic pre-occupation, poor coping, and low recovery expectations following surgery with persistent pain, functional limitations, and lower rates of return to work. 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.
Patient-Centered Pain Care Using Artificial Intelligence and Mobile Health Tools: A Randomized Comparative Effectiveness Trial. [2023]Cognitive behavioral therapy for chronic pain (CBT-CP) is a safe and effective alternative to opioid analgesics. Because CBT-CP requires multiple sessions and therapists are scarce, many patients have limited access or fail to complete treatment.
The Perioperative Pain Self-Management (PePS) randomized controlled trial protocol: Preventing chronic post-surgical pain and prolonged opioid use. [2023]Total joint arthroplasties are common orthopedic surgeries that carry risk for developing chronic post-surgical pain. In addition to pre- and post-operative pain severity, psychological distress (e.g., anxiety, pain catastrophizing) is a risk factor for chronic postsurgical pain. Cognitive behavioral therapy (CBT) for chronic pain is an empirically supported approach to managing chronic pain, functional impairment, and related distress. While CBT has been used extensively in patients with established chronic pain, using it as a preventive intervention targeting the transition from acute to chronic postsurgical pain is a novel application.
Psychological treatments for the management of postsurgical pain: a systematic review of randomized controlled trials. [2022]Inadequately managed pain is a risk factor for chronic postsurgical pain (CPSP), a growing public health challenge. Multidisciplinary pain-management programs with psychological approaches, including cognitive behavioral therapy (CBT), acceptance and commitment therapy (ACT), and mindfulness-based psychotherapy, have shown efficacy as treatments for chronic pain, and show promise as timely interventions in the pre/perioperative periods for the management of PSP. We reviewed the literature to identify randomized controlled trials evaluating the efficacy of these psychotherapy approaches on pain-related surgical outcomes.