The Personalized Psychological Treatment for Psychosis

Summary

The main aim of the clinical trial is to validate the Machin Learning (ML) predictive model for personalized Metacognitive Training (MCT) by comparing classic MCT to personalized MCT (P-MCT) among patients diagnosed with psychosis who had a history of delusions. More precisely, we will compare classic MCT to P-MCT in a randomized clinical trial.We expect personalised MCT treatment will see more improvement than classical MCT in outcome variables measuring treatment efficacy.

Conditions

• Schizophrenia
• Psychosis
• Schizophrenia Spectrum and Other Psychotic Disorders

Interventions

BEHAVIORAL

Psychological treatment (P-MCT)

Personalization will be performed according to the results obtained from the platform. Both the classic MCT and personalized MCT will be the same with regard to specific modules that are offered to patients. However, the personalized MCT will have personalized homeworks that target specific factors, in which patients have deficits. For instance, patients with deficits in self-esteem (based on the results from the platform) will be provided with homework addressing this aspect. We identified five domains that will be personalized: 1. self-esteem; 2. cognitive insight; 3. delusions; 4. positive symptoms; 5. completion.

BEHAVIORAL

Psychological treatment (MCT)

Metacognitive training is a cognitive approach to the treatment of positive symptoms in psychosis. Metacognitive training consists of ten modules referring to common cognitive issues and biases in solving problems in schizophrenia. The topics of MCT include the following: attribution blaming and taking credit (module 1), jumping to conclusions (modules 2 \& 7), changing beliefs (module 3), deficits in theory of mind and social cognition (modules 4 and 6), overconfidence in (memory) errors (module 5), mood (module 8), self-esteem (9) and stigma (10). Each session lasts 45-60 min and follows a protocol defined in the 'Metacognitive Training for Psychosis (MCT)' manual. The MCT for Schizophrenia programme will be applied to the group (6-12 persons) applied by therapists in each center. The training format (online or in-person) as well as the frequency (1 or 2 times per week) will vary depending on the center.

Sponsors & Collaborators

• Fundació Sant Joan de Déu

  collaborator OTHER

• Universitätsklinikum Hamburg-Eppendorf

  collaborator OTHER

• University Hospitals of Strasbourg

  collaborator UNKNOWN

• Universitat Politècnica de Catalunya

  collaborator OTHER

• Universidad de Valparaiso

  collaborator OTHER

• Polish Academy of Sciences

  lead OTHER

Principal Investigators

• Łukasz Gawęda, Professor · The Institute of Psychology, Polish Academy of Sciences

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-10-01

Primary Completion

2026-05-31

Completion

2026-05-31

Countries

• Chile
• France
• Germany
• Poland
• Spain

Study Locations