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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months post-fracture
Awards & highlights

COPE Trial 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.Check my eligibility
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.See study design
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.

COPE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I had surgery to fix a broken bone with metal parts.
Select...
I had surgery to fix a broken bone with metal parts.

COPE Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pain, Postoperative
Secondary outcome measures
Brief Pain Inventory-Short Form (BPI-SF)
Opioid Use
Return to Function Questionnaire
+1 more

COPE 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
2016
Completed Phase 3
~3800

Find a Location

Who is running the clinical trial?

Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,344 Previous Clinical Trials
26,452,417 Total Patients Enrolled
McMaster UniversityLead Sponsor
881 Previous Clinical Trials
2,596,886 Total Patients Enrolled
1 Trials studying Postoperative Pain
300 Patients Enrolled for Postoperative Pain
Orthopaedic Trauma AssociationOTHER
32 Previous Clinical Trials
4,016 Total Patients Enrolled

Media Library

Cognitive Behavioural Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04274530 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are enrollees currently being accepted for this experiment?

"This clinical trial is actively recruiting, as evidenced by its listing on clinicaltrials.gov which was initially posted on January 25th 2021 and recently updated September 21st 2021."

Answered by AI

What is the aggregate amount of participants in this medical experiment?

"Affirmative. Clinicaltrials.gov lists this clinical trial, which was initially posted on January 25th 2021, as actively looking for 1000 participants at 1 site. The study has been updated most recently on September 21st 2021."

Answered by AI

Who else is applying?

What state do they live in?
New York
How old are they?
18 - 65
What site did they apply to?
Hamilton Health Sciences - General Site
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Cognitive Behavioural Therapy to Optimize Post-Operative Recovery Trial
2021. "Cognitive Behavioural Therapy to Optimize Post-Operative Recovery Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04274530.
All > Acute Pain
~71 spots leftby Aug 2024
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