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

Psychotic Disorders Clinical Trial

— CARE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05813080
• Other study ID #: HeinrichHeine
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: March 2025

Study information

• Verified date: August 2023
• Source: Heinrich-Heine University, Duesseldorf
• Contact: Sarah Maciej, Dr.
• Phone: +49 211 81 16263
• Email: sarah.maciej[@]med.uni-duesseldorf.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 (ICD-10: schizophrenic disorders F2x.x, affective disorders F3x.3) 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 436
• Est. completion date: March 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorders
• Prevention
• Psychotic Disorders

Intervention

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.

Other:
• Treatment-as-usual (TAU)
Referral back to the previous care system. Further treatment is left to the referring primary care providers.

Locations

Country	Name	City	State
Germany	Klinik für Psychiatrie, Psychotherapie und Psychosomatik, Universitätsklinikum Aachen, RWTH Universität Aachen	Aachen	NRW
Germany	Rheinhessen Fachklinik Alzey	Alzey	Rheinland-Pfalz
Germany	Charité - Universitätsmedizin Berlin	Berlin
Germany	Vivantes Klinikum Am Urban	Berlin
Germany	LWL-Universitätsklinikum Bochum der Ruhr--Universität Bochum, Klinik für Psychiatrie, Psychotherapie und Präventivmedizin	Bochum	NRW
Germany	KJPP LVR-Klinik Bon'n	Bonn	NRW
Germany	Universitätsklinikum Bonn Klinik für Psychiatrie und Psychotherapie	Bonn	NRW
Germany	UKD Dresden, Klinik und Poliklinik für Psychiatrie und Psychotherapie	Dresden	Sachsen
Germany	Klinik und Poliklinik für Psychiatrie und Psychotherapie Heinrich-Heine-Universität Düsseldorf	Düsseldorf	NRW
Germany	Klinik und Poliklinik für Psychiatrie und Psychotherapie, Universitätsklinikum Hamburg-Eppendorf {UKE)	Hamburg
Germany	Zentrum für Integrative Psychiatrie Kiel	Kiel	Schleswig-Holstein
Germany	Uniklinik Köln, Klinik und Poliklin-ik für Psychiatrie, Psychosomatik und Psychotherapie des Kindes- und Jugendalters	Köln	NRW
Germany	ZfP Reichenau - Akademisches Lehrkrankenhaus Universität Konstanz	Konstanz	Baden-Württemberg
Germany	Zentrum für Integrative Psychiatrie (ZIP) und Fachklinik für Junges Leben (JuLe) Kinder- und Jugendpsychiatrie	Lübeck	Schleswig-Holstein
Germany	Otto-von-Guericke- Universität Magdeburg	Magdeburg	Sachsen-Anhalt
Germany	Zentralinstitut für Seelische Gesundheit	Mannheim	Baden-Württemberg
Germany	Klinikum der Ludwig-Maximilians-Universität München	München	Bayern
Germany	Institut für Translationale Psychiatrie	Münster	NRW
Germany	Klinik für Psychiatrie und Psychotherapie Universität Tübingen	Tübingen	Baden-Württemberg
Germany	Zentrum für psychische Gesundheit, U11iversitätsklinikum Würzburg	Würzburg	Bayern

Sponsors (1)

Lead Sponsor	Collaborator
Heinrich-Heine University, Duesseldorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Structured Interview for Psychosis-Risk Syndromes (SIPS)	Presence of psychotic syndrome (POPS) criteria as modified according to the "PRONIA" study, resulting in a score of 0= "no psychosis" or 1= "psychosis"	12-month after inclusion
Secondary	Internalized Stigma of Mental Illness Scale (ISMI)	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.	12-month after inclusion
Secondary	Stigma-Stress-Scale	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.	12-month after inclusion
Secondary	Self-Identification of Mental Illness Scale (SELF-I)	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.	12-month after inclusion
Secondary	Coming-Out with Mental Illness Scale (COMIS)	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.	12-month after inclusion
Secondary	Secrecy and disclosure-related distress - scale	7-point single-item-scale ranging from 1 = " not at all" to 7 = "very much", measuring the degree of subjective stress.	12-month after inclusion
Secondary	Psychosis own health-concern single score	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.	12-month after inclusion
Secondary	Numeracy Scale	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.	12-month after inclusion
Secondary	Coping (Ten-Flex)	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.	12-month after inclusion
Secondary	Risk Perception Scale	A score from 1 =no risk" to 7 = "absolutely certain" indicating the risk for developing psychosis.	12-month after inclusion
Secondary	Risk Recall Scale	A score from 1 = "much lower" to 5 "much higher" indicating the risk for developing psychosis compared to a healthy peer.	12-month after inclusion
Secondary	Health-related quality of life (EQ-5D)	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.	12-month after inclusion
Secondary	Brief Multidimensional Life Satisfaction Scale (BMLSS)	Score from 0-126, a higher score indicates a higher amount of satisfaction.	12-month after inclusion
Secondary	Client Sociodemographic and Service Receipt Inventory (CSSRI-EU)	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.	12-month after inclusion
Secondary	Patient Satisfaction Questionnaire (ZUF-8)	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.	12-month after inclusion
Secondary	Social and occupational assessment scale SOFAS	Scores from 0-100, a higher score indicates better social functioning.	12-month after inclusion
Secondary	Global Functioning Social Scale (GF:S)	Scores from 1-10, a higher score indicates better global functioning	12-month after inclusion
Secondary	Global Functioning Role Scale (GF:R)	Scores from 1-10, a higher score indicates better functioning	12-month after inclusion
Secondary	Secrecy-Symptoms Scale	Five questions (either yes or no) asking who the patient has told about the risk for developing psychosis	12-month after inclusion