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 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 12:40 AM
NCT ID:
NCT02076867
Eligibility Criteria:
Inclusion Criteria:
* Patients aged 18-65 years
* Emergency department physician determines that physical symptoms and/ or impairment associated with the physical symptoms are not explained by physical pathology.
* Patients must meet diagnostic criteria for a Somatic Symptom or Related Disorder (SSRD) as assessed by the Structured Clinical Interview for DSM Disorders 5th Edition Research Version (SCID-5-RV).
* Symptom duration of at least 3 months or recurrently each month.
* Cut off of at least 4 symptoms for men and 6 for women using the SOMS.
* Participants consent to audio-visual taped sessions and the investigator accessing their electronic health records, if deemed necessary.
* Stable with pharmacotherapy over previous 4 weeks.
Exclusion Criteria:
* Symptoms which can be entirely explained by a medical condition.
* Already receiving ongoing psychological treatment.
* The research physician determines that the physical symptoms and/ or impairment has definite physical pathology.
* Any diagnosis of current psychosis, bipolar or manic depression, substance abuse/dependence or active suicidality as assessed by the SCID-5-RV.
* Complaints which are considered to be malingering or factitious.
* Patients who are unable to give informed consent to treatment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02076867
Study Brief:
Protocol Section:
NCT02076867