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 @ 4:08 AM
Ignite Modification Date:
2025-12-25 @ 4:08 AM
NCT ID:
NCT02444520
Eligibility Criteria:
Patients that fit the eligibility criteria will be invited to take part in the study. Patients will be considered eligible for inclusion in this study if they fulfil all of the following criteria:
(i) have a PPS diagnosis (which are medically unexplained) (ii) are greater than or equal to 18 and less than or equal to 65 years old (iii) are registered with a GP practice in South London that has consented to taking part in PRINCE Primary (iv) have had 6 or more consultations in the last year (not necessarily for the same symptom or directly related to PPS (v) have given written informed consent, provided baseline data before randomisation and can speak and read English at a level adequate for participation in the.
Patients will be excluded from the study if the patient has:
(i) active psychosis (ii) drug or alcohol addiction as indicated in the patient's medical notes (iii) current benzodiazepine use exceeding the equivalent of 10mg diazepam per day (iv) had any psychotherapy treatment within the last year (not inclusive of general visits from community psychiatric teams) (v) dissociative seizures (vi) if they are at imminent risk of self-harm, after psychiatric/ psychological assessment (vii) taking part in the PRINCE Secondary study or the ACTIB Study (Everitt et al., 2015).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02444520
Study Brief:
Protocol Section:
NCT02444520