Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2025-12-25 @ 12:12 AM
NCT ID:
NCT03673358
Eligibility Criteria:
Inclusion Criteria:
* Adult men or women aged 18 years and older.
* Presenting to fracture clinic within 2-12 weeks following an acute open fracture of the appendicular skeleton or closed fracture of the lower extremity or pelvis. Patients with multiple fractures may be included.
* Fracture treated operatively with internal fixation.
* Willing to participate in CBT
* Language skills and cognitive ability required to participate in CBT (in the judgement of site research personnel).
* Consistent online access from a smartphone/internet-enabled device with a minimum operating system able to use the CBT provider application or videoconferencing software applications.
* Provision of informed consent.
Exclusion Criteria:
* Fragility fracture.
* Stress fracture.
* Fracture of the hand.
* Fracture of the foot.
* Concomitant injury which, in the opinion of the attending surgeon, is likely to impair function for as long as or longer than the patient's extremity fracture.
* Active psychosis.
* Active suicidality.
* Active substance use disorder that, in the judgement of the treating surgeon, would interfere in the patient's ability to partake in the CBT and/or the trial.
* Already participating in, or planning to, start other psychological treatments (including CBT) within the duration of the study (12 months).
* Anticipated problems, in the judgement of study personnel, with the patient participating in CBT intervention and/or returning for follow-up.
* Incarceration.
* Currently enrolled in a study that does not permit co-enrolment in other trials.
* Previously enrolled in the COPE trial.
* Other reason to exclude the patient, as approved by the Methods Centre.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03673358
Study Brief:
Protocol Section:
NCT03673358