Cognitive Behavioural Therapy for Postoperative Pain

(COPE Trial)

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether cognitive behavioral therapy (CBT), a type of talk therapy that helps change negative thought patterns, can reduce long-term pain after surgery for fractures. Participants will either receive CBT through a mobile app along with their usual care or just their standard care without CBT. The trial seeks individuals who have had an open or closed fracture in their arms or legs treated with surgery and are willing to try CBT. Participants must have access to a smartphone or tablet for the therapy sessions. The goal is to determine if CBT can lower the chances of experiencing moderate to severe pain a year after surgery. As an unphased trial, this study offers a unique opportunity to explore innovative pain management techniques that could enhance recovery and improve quality of life.

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 prior data suggests that Cognitive Behavioural Therapy is safe for reducing postoperative pain?

Research has shown that Cognitive Behavioral Therapy (CBT) safely treats pain after surgery, and most people tolerate it well. CBT involves talking with a therapist to change thoughts and feelings. It doesn't involve medication, so there are no drug-related side effects.

Studies have used CBT to help manage post-surgical pain, such as after a broken bone. Patients reported no major issues when using CBT for pain relief. It is considered a safe option for those seeking to manage pain without drugs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Cognitive Behavioral Therapy (CBT) for managing postoperative pain because it offers a unique approach compared to traditional options like pain medications or physical therapy. Unlike these standard treatments, CBT focuses on altering pain perception through mental strategies, which can help reduce reliance on medications, especially opioids. Delivered through a mobile app, the CBT program provides personalized support and feedback from a dedicated therapist, making it more accessible and convenient for patients. This innovative delivery method not only supports mental health but could also enhance recovery by empowering patients to manage their pain more effectively.

What evidence suggests that Cognitive Behavioural Therapy is effective for reducing postoperative pain?

Research has shown that cognitive behavioral therapy (CBT) can help reduce long-lasting pain after surgery. In this trial, participants in the intervention arm will receive CBT, which studies have demonstrated to be more effective at reducing pain and disability than usual care alone. Specifically, those who underwent CBT reported feeling less pain and could perform more everyday activities. Another study suggested that CBT might aid recovery from broken bones. By helping patients manage stress and anxiety, CBT could make recovery smoother and less painful. Overall, for those with ongoing pain after surgery, CBT appears promising in improving their condition. ^{1 5 6 7 8}

Who Is on the Research Team?

Sheila Sprague, PhD

Principal Investigator

McMaster University

Jason Busse, PhD

Principal Investigator

McMaster University

Are You a Good Fit for This Trial?

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.

You must have the ability to understand and communicate in the language required for cognitive behavioral therapy (CBT) as determined by the study staff.

I am willing to undergo cognitive behavioral therapy.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8730643/

Cognitive behavioral therapy to reduce persistent postsurgical ... A multi-site randomized-controlled trial investigating the effectiveness of CBT in reducing PPSP in patients with surgically treated extremity fractures.

2. pilotfeasibilitystudies.biomedcentral.com pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-024-01592-3

Cognitive Behavioural Therapy to Optimize Post-Operative ... Emerging evidence suggests that cognitive behavioural therapy (CBT) may improve outcomes after fracture repair. We conducted a pilot study to ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11877026/

Upskilling pain relief after surgery: a scoping review of ... Cognitive behavioral therapy cannot relieve postoperative pain and improve joint function after total knee arthroplasty in patients aged 70 ...

4. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0325122

The effect of cognitive behavioural therapy on pain and ... Results showed that CBT is more effective in reducing pain and disability compared to waiting list/usual care (WL/UC). CBT in conjunction with other active ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2772609625001236

Perioperative cognitive behavioural therapy compared with ... Nationwide implementation and outcomes of cognitive behavioral therapy for chronic pain over clinical video teleconferencing ... postoperative pain outcomes.

6. rapm.bmj.com rapm.bmj.com/content/50/2/93

Upskilling pain relief after surgery: a scoping review of ... Cognitive behavioral therapy cannot relieve postoperative pain and improve joint function after total knee arthroplasty in patients aged 70 years and older ...

7. withpower.com withpower.com/trial/phase-fractures-bone-2021-f19c0

Cognitive Behavioural Therapy for Postoperative Pain · Info ... What safety data exists for CBT in treating postoperative pain? ... Cognitive Behavioral Therapy (CBT) is considered a safe treatment for postoperative pain.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7718692/

A randomized controlled TRIal of cognitive BEhavioral ... This is the first trial that evaluates the effectiveness of cognitive behavioral therapy as a perioperative tool to improve pain and disability after spinal ...