Computer-assisted Risk Evaluation in the Early Detection of Psychotic Disorders (CARE)

Heinrich-Heine University, Duesseldorf

Status: Active, not recruiting

Conditions: Prevention; Psychotic Disorders

Treatments: Other: Treatment-as-usual (TAU); Device: "pronia.ai" medical device for high risk psychosis prognosis

Study type: Interventional

Funder types: Other

Identifiers

NCT05813080

HeinrichHeine

Details and patient eligibility

About

Multicenter randomized controlled trial (RCT) with artificial intelligence (AI)-staged early diagnostics and risk-adapted treatment (RAB) as interventional treatment arm and treatment-as-usual (TAU) as control treatment arm for patients with an increased clinical risk for psychosis.

Full description

The study is a Investigator Initiated Trial (IIT)/Other clinical trial of a class 2a medical device according to article 82 medical devices regulation of the European Union.

The aim of risk-adapted treatment (RAB) arm is to reduce the number of patients with an increased clinical risk for psychosis to actually develop a manifest psychosis.

Patients assigned to the active treatment arm will receive additional in-depth clinical diagnostics including neuropsychological testing.

The AI-supported algorithm "pronia.ai" uses information from both the individual patient data of the specialized routine diagnostics as well as from in-depth clinical diagnostics.

There are two predictions, an individual quantitative assessment of the individual risk of transition to psychosis and the individual prognosis with regard to the level of psychosocial functioning 12 months after inclusion in the study.

The therapists and patients receive a non-binding risk profile from the AI-based recommendation to adjust the treatment intensity from 16 to 24 sessions over a period of six months.

The cognitive behavioral therapy-based manual "Integrated Preventive Psychological Preventive Psychological Intervention (IPPI)" manual is used. In the treatment-as-usual arm (TAU),the patients receive referral back to the previous care system; further treatment (and additional diagnostics, if necessary) is left to the referring primary care providers.

Enrollment: 260 patients

Sex: All

Ages: 16 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The increased risk of psychosis includes either a symptomatic "ultra high-risk" stage of the Structured Interview for Psychosis-Risk Syndromes or the "Cognitive Disturbances" risk criterion of the Schizophrenia Proneness Instrument - Children and Youth and Adult versions
• ages 16 to 40
• Presence of a written informed consent from the patient and, if applicable, the legal guardian.

Exclusion criteria

• manifest psychosis according to the definition of the Structured Interview for Psychosis-Risk Syndromes (according to the PRONIA-study) (At least one P-syndrome with a rating of 6 on a daily frequency and for a period of more than one week)
• Lack of capacity to give consent (the patient lacks the capacity to consent if the individual case with regard to the specific treatment measure is excluded. Only when the physician has concrete indications that the patient's capacity to consent may be lacking, he may and must must examine it. Mental disorders (e.g. delirium, dementia, psychosis, mania, depression) or cognitive impairments can have an influence on the capacity to consent. Indications for doubts of a ability to give informed consent exist if the physician has the impression that the patient is not able to understand the provided patient information and is not able to reproduce essential information about the study in his or her own words and is not aware of the possible consequences of the proposed measures
• Severe suicidality during the recruitment phase (CDSS items 8 ≥2)
• A current or past neurological disease of the brain.
• a current or past known somatic disease that potentially affects the structure or function of the brain
• Antipsychotic medication in the indication treatment of psychotic symptoms for >30 days (cumulative number of days) at or above the starting dose for psychosis according to the current German Association for Psychiatry, Psychotherapy and Psychosomatics (DGPPN) S3 guidelines.
• an antipsychotic medication in the indication treatment of psychotic symptoms in the 3 months prior to the initial examination (regardless of the duration of use) at or above the starting dose for psychosis according to the current DGPPN S3 guidelines
• An inadequate level of hearing for neurocognitive testing
• a current or past head trauma with unconsciousness (>5 min).
• a current or past alcohol dependence (ICD-10 F10.x)
• A current polytoxicomania (multiple substance dependence) or polytoxicomania in the past 6 months (ICD-10 F19.x)
• Presence of medical reasons that contraindicate performance of an MRI
• Insufficient language skills to understand the indication and the purpose of the intended examinations and interventions
• stationary accommodation against the patient's will

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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260 participants in 2 patient groups

CARE interventional treatment

Experimental group

Description:

AI-computerassisted prognosis of high risk psychosis profile and adapted study-specific therapy taking place in early-recognition centers.

Treatment:

Device: "pronia.ai" medical device for high risk psychosis prognosis

Standard of Care Control arm

Active Comparator group

Description:

Treatment as usual (TAU) patient will receive their usual treatment from their local physicians and therapeutic personnel.

Treatment:

Other: Treatment-as-usual (TAU)