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:
2025-12-24 @ 5:19 PM
Ignite Modification Date:
2025-12-24 @ 5:19 PM
NCT ID:
NCT05042050
Eligibility Criteria:
Inclusion Criteria:
* Is currently receiving care under an NHS Community Mental Health Team, and meets ICD-10 or ICD-11 criteria for a schizophrenia-spectrum diagnosis (schizophrenia, schizophreniform disorder, schizoaffective disorder, delusional disorder or psychotic disorder not otherwise specified) indicated by case notes, or under the care of an Early Intervention in Psychosis Service
* Aged 16 or above
* Medication stable for ≥ one month, as indicated by their Care Coordinator
* Has capacity to give written, informed consent
* Proficient in English to complete study questionnaires
* A score of one or more on the four psychosis-related trauma items (items 15 to 18) on the Trauma and Life Events Checklist (Carr et al., 2018b)
Exclusion Criteria:
* Has an acquired brain injury
* Has a history of substance misuse that is judged to be the acute cause of the psychotic experiences
* Currently experiencing an acute episode requiring inpatient care
* Currently undertaking psychological therapy
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT05042050
Study Brief:
Protocol Section:
NCT05042050