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Towards a Personalized Medicine Approach to Psychological Treatment for Psychosis

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study aims to compare the efficacy of classical Metacognitive Training (MCT) and personalized Metacognitive Training (P-MCT) for individuals with psychosis. MCT is a psychoeducational program derived from cognitive-behavioral therapy (CBT) that targets cognitive biases associated with psychotic symptoms. The goal is to assess which intervention is more effective to improve the overall functioning of individuals with psychosis. The study will use machine learning to personalize the treatment approach and evaluate its impact on clinical symptoms, cognitive functions, and quality of life.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
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• Adults, 18 - 65 years of age.

• Patient affiliated to health insurance

• Inpatients and outpatients with DSM-5 diagnosis of schizophrenia spectrum disorder.

• Presence of positive symptoms at inclusion (PANSS delusions, suspiciousness or grandiosity ≥3).

• Stable condition with no expected changes in medication or symptoms during the last 3 months (information from clinical services, note that stable condition includes lack of suicidality).

• Patient providing informed consent.

Locations
Other Locations
France
Service de psychiatrie
RECRUITING
Strasbourg
Contact Information
Primary
Fabrice BERNA, MD
fabrice.berna@chru-strasbourg.fr
33 (0)3 88 11 64 62
Time Frame
Start Date: 2026-04-03
Estimated Completion Date: 2027-04-01
Participants
Target number of participants: 51
Treatments
Active_comparator: Classical MCT (MCT)
In this arm, participants will follow the standard Metacognitive Training (MCT) protocol. They will receive 10 one-hour sessions of classical MCT delivered in a group setting, following the current standard program. In addition to the sessions, participants will be given standardized homework tasks to reinforce the skills learned between sessions. This group serves as the active control in the study.
Experimental: Personalized MCT (P-MCT)
Participants in this arm will receive Personalized Metacognitive Training (P-MCT), an experimental intervention that uses a machine learning (ML) predictive platform to personalize the homework assignments. While the core MCT program remains unchanged, P-MCT customizes the homework based on individual patient profiles, specifically targeting areas where the patient is predicted to benefit the least. The goal is to enhance the effects of the standard MCT by providing personalized support through tailored exercises.
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Strasbourg, France

This content was sourced from clinicaltrials.gov