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Cognitive Behavioural Therapy for Postoperative Pain (COPE Trial)

N/A

Recruiting

Led By Jason Busse, PhD

Research Sponsored by McMaster University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Fracture treated operatively with internal fixation

Fracture treated operatively with internal fixation.

Must not have

Fragility fracture

Stress fracture

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months post-fracture

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare CBT to usual care to see if it can help reduce moderate to severe persistent post-surgical pain in patients with appendicular fractures.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

CBT is generally safe but may include temporary increases in distress as patients confront and work through difficult emotions and thoughts related to their injury and recovery.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I had surgery to fix a broken bone with metal parts.

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I had surgery to fix a broken bone with metal parts.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a fracture from a minor injury.

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I have a stress fracture.

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I can put my full weight on my feet without feeling pain in the area of my fracture.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months post-fracture

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months post-fracture

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months post-fracture for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pain, Postoperative

Secondary study objectives

Brief Pain Inventory-Short Form (BPI-SF)

Opioid Use

Return to Function Questionnaire

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cognitive Behavioural Therapy

2002

Completed Phase 3

~4030

0 / 5Eligibility criteria met