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 @ 3:19 AM
Ignite Modification Date:
2025-12-25 @ 3:19 AM
NCT ID:
NCT06007105
Eligibility Criteria:
Inclusion criteria:
Participants with lived experience of psychosis must:
* Be consenting/assenting adults (age 18+)
* Be able to speak one of the main study languages: English, Chichewa, Krio, Shona, Yoruba
* Live within the pilot study area
* Have a current or past diagnosis of schizophrenia or other primary psychotic disorder, bipolar or depressive disorder with psychotic symptoms, or a maternal mental health or behavioural disorder with psychotic symptoms, as per the World Health Organisation's International Classification of Diseases Version 11 (see full list of eligible diagnoses, below).
For participants recruited from within the health care system, diagnosis will be confirmed from health records. For those identified in the community, a research worker will administer the World Health Organisation's Composite International Diagnostic Interview (WHO CIDI) screening tool for psychosis.
The following diagnoses are eligible for inclusion:
* Schizophrenia (6A20)
* Schizoaffective disorder (6A21)
* Schizotypal disorder (6A22)
* Acute and transient psychotic disorder (6A23)
* Delusional disorder (6A24)
* Other specified (6A2Y) or unspecified (6A2Z) primary psychotic disorder
* Bipolar type I disorder with psychotic symptoms (6A60.1, 6A60.5, 6A60.7, 6A60.A)
* Bipolar type II disorder with psychotic symptoms (6A61.3, 6A61.5)
* Single episode depressive disorder with psychotic symptoms (6A70.2, 6A70.4)
* Recurrent depressive disorder with psychotic symptoms (6A71.2, 6A71.4)
* Mental or behavioural disorder associated with pregnancy, childbirth or the puerperium, with psychotic symptoms (6E21)
Exclusion Criteria:
* People who are currently homeless, for logistical reasons; the SUCCEED intervention relies on PSWs and CSWs being able to regularly contact participants, including for home visits.
* People with secondary psychotic syndromes (6E61), as these are considered to be the direct consequences of physical health conditions as opposed to mental health conditions.
* People diagnosed with a substance-induced psychotic disorder (6C40.6-6C47.6), as recovery from substance use conditions is a specialist area outside the scope of the SUCCEED intervention under development.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06007105
Study Brief:
Protocol Section:
NCT06007105