Cognitive Behavioural Therapy for Postoperative Pain

(COPE Trial)

Recruiting at 10 trial locations

Overseen By Natalie Fleming, MSW

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: McMaster University

Disqualifiers: Fragility fracture, Stress fracture, Active psychosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6-8 weeks

1000 Participants Needed

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on cognitive behavioural therapy for pain management.

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. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Cognitive Behavioral Therapy for postoperative pain?

Research shows that Cognitive Behavioral Therapy (CBT) can help reduce postoperative pain and improve joint function, especially after surgeries like total joint arthroplasty and lumbar spinal fusion. It also helps in reducing pain-related anxiety and catastrophic thinking, which can lead to better pain management and faster recovery. ^{1 2 3 4 5}

What 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. ^{1 4 5 6 7}

Is Cognitive Behavioral Therapy (CBT) safe for humans?

Cognitive Behavioral Therapy (CBT) is generally considered safe for humans and is often used as an alternative to medications for managing chronic pain. ^{1 4 5 6 7}

Is 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. ^{1 4 6 8 9}

How is Cognitive Behavioural Therapy (CBT) different from other treatments for postoperative pain?

Cognitive Behavioural Therapy (CBT) is unique because it focuses on changing unhelpful beliefs and behaviors to manage pain, rather than using medication. It is a psychological approach that can prevent the transition from acute to chronic pain after surgery, which is a novel application compared to traditional pain management methods. ^{1 4 6 8 9}

Research Team

Sheila Sprague, PhD

Principal Investigator

McMaster University

Jason Busse, PhD

Principal Investigator

McMaster University

Eligibility 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.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive cognitive behavioural therapy (CBT) via online modules and in-app therapist support for 6-8 weeks

6-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of pain, quality of life, and opioid use

12 months

Treatment Details

Interventions

• Cognitive Behavioural Therapy

Trial Overview 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.

Participant Groups

Group I: Intervention - CBT Experimental Treatment 1 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: Control Active Control 1 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

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Orthopaedic Trauma Association

Collaborator

Trials

34

Recruited

5,100+

Findings from Research

Cognitive behavioral therapy (CBT) significantly reduces pain intensity in patients after total joint arthroplasty during the early postoperative period (up to 3 months), as shown by various pain scales (NRS, VAS, PCS).

While CBT's impact on pain diminishes over time (not significant after 12 months), it does lead to improvements in quality of life (measured by EQ-5D) in the longer term, indicating its potential benefits for patients recovering from surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy achieves better benefits in relieving postoperative pain and improving joint function: A systematic review and meta-analysis of randomized controlled trials. Zhang, F., Wang, LY., Chen, ZL., et al.[2023]

A preoperative cognitive-behavioral therapy (CBT) intervention did not significantly reduce self-reported back pain after lumbar spinal fusion surgery, but it did help more patients achieve independent mobility in the first three postoperative days.

Patients who received CBT tended to use less analgesics, suggesting that the therapy may enhance coping strategies for pain, even though the overall length of hospital stay remained unchanged.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative cognitive-behavioural intervention improves in-hospital mobilisation and analgesic use for lumbar spinal fusion patients. Rolving, N., Nielsen, CV., Christensen, FB., et al.[2022]

Cognitive behavioral therapy (CBT) applied in the early postoperative period can effectively reduce pain and anxiety in patients, as demonstrated in a case study of a woman in her 60s after high tibial osteotomy.

The structured approach of CBT, which includes cognitive restructuring, coping skills, and occupational therapy, not only alleviated the patient's psychological distress but also helped her achieve functional goals, highlighting the need for more widespread implementation of CBT in postoperative care in Japan.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Occupational Therapy Practice With Cognitive Behavioral Therapy for Early Postoperative Pain: A Case Report. Hara, R., Hiraga, Y., Hirakawa, Y.[2023]

Cognitive-behavioral therapy (CBT) significantly reduced pain catastrophizing scores in patients undergoing knee surgery, with the 4-week telehealth CBT showing an 85% completion rate and a median reduction of -9 points in pain catastrophizing scores compared to no-CBT controls.

Despite the reduction in pain catastrophizing, the study found no significant difference in actual pain outcomes at 3 months post-surgery between the CBT and no-CBT groups, indicating that while CBT can help with mental preparation, it may not directly translate to lower postoperative pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative cognitive-behavioral therapy for reducing pain catastrophizing and improving pain outcomes after total knee replacement: a randomized clinical trial. Buvanendran, A., Sremac, AC., Merriman, PA., et al.[2021]

Cognitive Behavioral Therapy (CBT) significantly reduced anxiety levels in patients aged 70 and older after total knee arthroplasty, showing a decrease of 4.3 points at 7 days and 8.2 points at 14 days post-surgery compared to preoperative scores.

However, CBT did not demonstrate any significant impact on postoperative pain, knee function, or depression levels at earlier time points, indicating that while it may help with anxiety, it does not improve physical recovery outcomes after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy cannot relieve postoperative pain and improve joint function after total knee arthroplasty in patients aged 70 years and older. Chen, W., Sun, JN., Hu, ZH., et al.[2021]

The COPE trial will investigate whether online cognitive behavioral therapy (CBT) can reduce the prevalence of moderate to severe persistent post-surgical pain in 1000 participants with fractures over a 12-month period, compared to usual care.

If successful, the study could lead to a new model of care that addresses psychological factors affecting recovery from traumatic fractures, potentially improving pain management and functional outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Behavioural Therapy to Optimize Post-Operative Fracture Recovery (COPE): protocol for a randomized controlled trial. [2023]

A study involving 278 patients with chronic back pain found that an AI-driven cognitive behavioral therapy for chronic pain (AI-CBT-CP) was noninferior to standard telephone CBT-CP, showing similar effectiveness in reducing disability and pain over 6 months.

AI-CBT-CP not only achieved better clinical outcomes for patients but also required less than half the therapist time compared to traditional CBT-CP, suggesting it could improve access to treatment for more patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Centered Pain Care Using Artificial Intelligence and Mobile Health Tools: A Randomized Comparative Effectiveness Trial. Piette, JD., Newman, S., Krein, SL., et al.[2023]

The Perioperative Pain Self-Management (PePS) program, based on cognitive behavioral therapy, is being tested to see if it can effectively reduce significant surgical site pain at 6 months post-surgery compared to standard care in a randomized control trial involving surgical patients.

This innovative intervention aims to prevent chronic post-surgical pain and reduce reliance on opioids, highlighting its potential as a scalable solution for managing pain in orthopedic surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Perioperative Pain Self-Management (PePS) randomized controlled trial protocol: Preventing chronic post-surgical pain and prolonged opioid use. Hadlandsmyth, K., Burgess, DJ., Leparski, RF., et al.[2023]

A systematic review of five trials involving various surgical procedures found that cognitive behavioral therapy (CBT) significantly reduces pain intensity and disability in patients experiencing postsurgical pain.

The review highlights the need for further research to optimize the delivery and efficacy of CBT and explore newer psychological approaches for managing postsurgical pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological treatments for the management of postsurgical pain: a systematic review of randomized controlled trials. Nicholls, JL., Azam, MA., Burns, LC., et al.[2022]

References

1. Japan pubmed.ncbi.nlm.nih.gov

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]

2. England pubmed.ncbi.nlm.nih.gov

Preoperative cognitive-behavioural intervention improves in-hospital mobilisation and analgesic use for lumbar spinal fusion patients. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Occupational Therapy Practice With Cognitive Behavioral Therapy for Early Postoperative Pain: A Case Report. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Preoperative cognitive-behavioral therapy for reducing pain catastrophizing and improving pain outcomes after total knee replacement: a randomized clinical trial. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy cannot relieve postoperative pain and improve joint function after total knee arthroplasty in patients aged 70 years and older. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Cognitive Behavioural Therapy to Optimize Post-Operative Fracture Recovery (COPE): protocol for a randomized controlled trial. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Patient-Centered Pain Care Using Artificial Intelligence and Mobile Health Tools: A Randomized Comparative Effectiveness Trial. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

The Perioperative Pain Self-Management (PePS) randomized controlled trial protocol: Preventing chronic post-surgical pain and prolonged opioid use. [2023]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Psychological treatments for the management of postsurgical pain: a systematic review of randomized controlled trials. [2022]