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 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 12:05 AM
NCT ID:
NCT03196258
Eligibility Criteria:
The inclusion criteria are:
1. Adult men or women aged 18 years and older.
2. Acute open or closed fracture(s) of the appendicular skeleton. Patients with multiple fractures may be included.
3. Fracture treated operatively with internal fixation.
4. Screened for eligibility within 6 weeks of their fracture.
5. Cognitive ability and language skills required to participate in the CBT intervention (in the judgement of site research personnel).
6. Able to start the CBT within 8 weeks of their fracture surgery.
7. Provision of informed consent.
8. Screen positive for unhelpful illness beliefs (SPOC scores ≥74), as assessed at 6 weeks' post-surgical fixation.
The exclusion criteria are:
1. Fragility fracture.
2. Stress fracture.
3. 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.
4. Active psychosis.
5. Active suicidality.
6. 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 study.
7. Already participating in, or planning to start other psychological treatments (including CBT) within the duration of the study (12 months).
8. Anticipated problems with the patient attending CBT sessions and/or returning for follow-up.
9. Incarceration.
10. Other reason to exclude the patient, as specified.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03196258
Study Brief:
Protocol Section:
NCT03196258