MedTrace Logo

Cognitive Behavioural Therapy to Optimize Post-Operative Recovery Trial

NCT04274530 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1024

Last updated 2025-09-05

No results posted yet for this study

Summary

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.

Conditions

  • Pain, Postoperative
  • Pain, Acute
  • Pain, Chronic
  • Fractures, Closed
  • Fractures, Open

Interventions

BEHAVIORAL

Cognitive Behavioural Therapy

Participants who are randomized to the CBT intervention will be encouraged to begin CBT immediately following randomization. The CBT intervention will focus on addressing maladaptive beliefs related to pain and recovery as well as teaching skills to enhance coping and management of pain symptoms. The specific focus of CBT sessions will be informed by each individual patient's responses to baseline questionnaires. All other aspects of post-operative care will be at the discretion of participant's surgeon.

Sponsors & Collaborators

  • Orthopaedic Trauma Association

    collaborator OTHER

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • McMaster University

    lead OTHER

Principal Investigators

  • Sheila Sprague, PhD · McMaster University

  • Jason Busse, PhD · McMaster University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-25
Primary Completion
2025-08-18
Completion
2025-08-18

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04274530 on ClinicalTrials.gov