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 @ 2:07 AM
Ignite Modification Date:
2025-12-25 @ 2:07 AM
NCT ID:
NCT05603260
Eligibility Criteria:
Inclusion Criteria:
* Age 16-65
* Experiencing subclinical or clinical psychotic auditory vocal hallucinations as confirmed by a clinician and as indicated by an intensity score of 4 or more on subscale 1.3 (perceptual abnormalities) of the Comprehensive Assessment of At Risk Mental States (CAARMS) or as indicated by a score of 3 or more on item P3 (hallucinatory behavior) of the Positive and Negative Syndrome Scale (PANSS).
* A Diagnostic and Statistical Manual-5 (DSM-5; American Psychiatric Association, 2013) diagnosis in the psychosis spectrum (codes: DSM-5 codes: 297.1; 298.8; 295.40; 295.90; 295.70; 298.8; 298.9) or defined as Ultra High Risk/At Risk Mental State (ARMS or UHR) according to the CAARMS estimated by a clinician.
* Willing to complete daily monitoring throughout the duration of the study.
* Willing to be assigned to a specific imagery intervention.
* Able to attend 3 consecutive weekly session of imagery intervention and during this period 3 online check-ups.
* Able and willing to sign informed consent
Exclusion Criteria:
* Any current or previous neurological disorder or organic brain disease.
* Acute confusional state or delirium not caused by the psychotic disorder.
* Unwillingness to participate
* Intelligence quotient (IQ) \< 70 estimated by clinician.
* Current severe substance or alcohol misuse impacting treatment (clinicians assessment).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
65 Years
Study:
NCT05603260
Study Brief:
Protocol Section:
NCT05603260