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

Sponsor

Heinrich-Heine University, Duesseldorf (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05813080

Collaborator

(none)

436

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Psychotic Disorders Prevention	Device: "pronia.ai" medical device for high risk psychosis prognosis Other: Treatment-as-usual (TAU)	N/A

Detailed 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.

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

436 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

The aim of risk-adapted treatment (RAB) arm is to reduce the number of patients with an increased clinical risk for psychosis (ICD-10: schizophrenic disorders F2x.x, affective disorders F3x.3) to actually develop a manifest psychosis.The aim of risk-adapted treatment (RAB) arm is to reduce the number of patients with an increased clinical risk for psychosis (ICD-10: schizophrenic disorders F2x.x, affective disorders F3x.3) to actually develop a manifest psychosis.

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Dec 12, 2024

Anticipated Study Completion Date :

Mar 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CARE interventional treatment AI-computerassisted prognosis of high risk psychosis profile and adapted study-specific therapy taking place in early-recognition centers.	Device: "pronia.ai" medical device for high risk psychosis prognosis In addition to the computer-assisted prognosis of risk for reaching a psychosis, all patients assigned to the active treatment arm will receive additional in-depth clinical diagnostics including neuropsychological testing. Adapted psychological treatment will be offered consisting of 16 to 24 sessions over a period of six months.
Active Comparator: Standard of Care Control arm Treatment as usual (TAU) patient will receive their usual treatment from their local physicians and therapeutic personnel.	Other: Treatment-as-usual (TAU) Referral back to the previous care system. Further treatment is left to the referring primary care providers.

Arm

Intervention/Treatment

Experimental: CARE interventional treatment

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

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

In addition to the computer-assisted prognosis of risk for reaching a psychosis, all patients assigned to the active treatment arm will receive additional in-depth clinical diagnostics including neuropsychological testing. Adapted psychological treatment will be offered consisting of 16 to 24 sessions over a period of six months.

Active Comparator: Standard of Care Control arm

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

Other: Treatment-as-usual (TAU)

Referral back to the previous care system. Further treatment is left to the referring primary care providers.

Outcome Measures

Primary Outcome Measures

Structured Interview for Psychosis-Risk Syndromes (SIPS) [12-month after inclusion]
Presence of psychotic syndrome (POPS) criteria as modified according to the "PRONIA" study, resulting in a score of 0= "no psychosis" or 1= "psychosis"

Secondary Outcome Measures

Internalized Stigma of Mental Illness Scale (ISMI) [12-month after inclusion]
Consisting of 5-subscales, comprising of 29 items in total using response formats varying from 4-point Likert scales (1='not at all', 4='very often') to 5-point Likert scales (1='never', 5='very often'), assessing self-stigma in terms of alienation, adoption of stereotypes, experiences of discrimination, social withdrawal and stigma resistance.
Stigma-Stress-Scale [12-month after inclusion]
two dimensions are assessed, 8 items are rated on a 5-point Likert-scale from "strongly disagree" to "totally agree", capturing self-assessed-stigma stress.
Self-Identification of Mental Illness Scale (SELF-I) [12-month after inclusion]
5-point Likert-scale ranging from 1 = "not true at all" to 5 = " is completely true", capturing the degree of self-identification with mental illnesses.
Coming-Out with Mental Illness Scale (COMIS) [12-month after inclusion]
consisting of two subscales with 7 and 14 items, each with 7-step Likert-scale ranging from 1 = "do not agree at all" to 7 = " totally agree", capturing a potential change of strategies for dealing with mental illness.
Secrecy and disclosure-related distress - scale [12-month after inclusion]
7-point single-item-scale ranging from 1 = " not at all" to 7 = "very much", measuring the degree of subjective stress.
Psychosis own health-concern single score [12-month after inclusion]
5-point Likert-scale ranging from 1 = "not at all" to 5 = "strong", capturing the degree of self-concern in terms of getting a psychosis one day.
Numeracy Scale [12-month after inclusion]
A single score from 0 to 100% indicating the patient self-estimated amount of belief in risk for developing psychosis within the next 12 months.
Coping (Ten-Flex) [12-month after inclusion]
Patient self-estimation of likelihood for developing psychosis given on a visual analogue scale (VAS) indicating "I will not develop psychosis in the next 12 months" on the left side of the scale up to "I will definitely develop psychosis in the next 12 months" on the right side of the scale.
Risk Perception Scale [12-month after inclusion]
A score from 1 =no risk" to 7 = "absolutely certain" indicating the risk for developing psychosis.
Risk Recall Scale [12-month after inclusion]
A score from 1 = "much lower" to 5 "much higher" indicating the risk for developing psychosis compared to a healthy peer.
Health-related quality of life (EQ-5D) [12-month after inclusion]
patient questionnaire consisting of two sub-scores. a) score from 0-10 whereas a higher score indicates greater impairment; b) score from 0-100 whereas a higher score indicates better current health status to measure the quality of Life.
Brief Multidimensional Life Satisfaction Scale (BMLSS) [12-month after inclusion]
Score from 0-126, a higher score indicates a higher amount of satisfaction.
Client Sociodemographic and Service Receipt Inventory (CSSRI-EU) [12-month after inclusion]
Changes in service use are measured with a semi-structured interview to assess social and demographic data, accommodation data, detailed information regarding treatment, professional visits and social and health service utilization for estimating healthcare costs. Additionally, the CSSRI systematically records the use of psychiatric, medical, psycho-social and rehabilitative health services (direct costs) and productivity losses (indirect costs) and therefore completely covers the costs of the disease from an economic perspective.
Patient Satisfaction Questionnaire (ZUF-8) [12-month after inclusion]
8 Items with a total score of 8-32, ranging from 4 = "very satisfied" to 1="fairly satisfied" whereas a higher score indicates higher patient satisfaction.
Social and occupational assessment scale SOFAS [12-month after inclusion]
Scores from 0-100, a higher score indicates better social functioning.
Global Functioning Social Scale (GF:S) [12-month after inclusion]
Scores from 1-10, a higher score indicates better global functioning
Global Functioning Role Scale (GF:R) [12-month after inclusion]
Scores from 1-10, a higher score indicates better functioning
Secrecy-Symptoms Scale [12-month after inclusion]
Five questions (either yes or no) asking who the patient has told about the risk for developing psychosis

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 40 Years

Sexes Eligible for Study:

All

Accepts 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

Exclusion Criteria:

manifest psychosis (ICD-10 F2x.x, F3x.3) according to the definition of the Structured Interview for Psychosis-Risk Syndromes .
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 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 for >30 days (cumulative number of days). At or above the minimum dose for a psychotic first episode according to the the German Association for Psychiatry, Psychotherapy and Psychosomatics (DGPPN) S3 guidelines
an antipsychotic medication in the 3 months prior to baseline. (regardless of the length of time taken) at or above the minimum dose for a psychotic first episode according to the 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