The Personalized Psychological Treatment for Psychosis

NCT ID: NCT06603922

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 252 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2026-05-31

Brief 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.

Detailed Description

This prospective study will consist of a pilot, double-blind clinical trial comparing Personalized MCT (P-MCT) to classical MCT. This pilot study will serve as a basis to validate the profiling strategy of patients and to test whether a personalized approach to psychological interventions (P-MCT) is more effective than non-personalized interventions (classical MCT).

The experimental intervention will be P-MCT. Baseline data of the patients randomized to the P-MCT and classical MCT group will be entered into the prototype platform, which will output the patient's profile and an estimate of response to MCT and the specific homeworks to be included in the intervention. MCT dedicates one session to attributional biases, two to Jumping to Conclusions Bias, one to belief change, two to empathy, one to meta-memory, and one to self-esteem and two additional for self-esteem and stigma. 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.

All interventions will be conducted by psychologists or mental-health professionals trained in MCT. All the treatments will be conducted on-site and online. Both conditions patients will receive 10 sessions of MCT. Control intervention: The control group is an active group that will receive classical MCT for psychosis following the current program. Duration of intervention per patient: 10 weeks (1 session per week of one hour of length). Patients will be assessed at baseline, post-treatment, and 6-month follow up.

The sample will include patients with Schizophrenia Spectrum Disorders (n=252) from five clinical center (Poland, Germany, France, Chile and Spain).

Conditions

Schizophrenia; Psychosis; Schizophrenia Spectrum and Other Psychotic Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Personalized MCT (P-MCT)

Personalized Metacognitive training

Group Type: EXPERIMENTAL

Psychological treatment (P-MCT)

Intervention Type: BEHAVIORAL

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.

Metacognitive training (MCT)

Metacognitive training

Group Type: ACTIVE_COMPARATOR

Psychological treatment (MCT)

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Inpatients and outpatients with a DSM-IV-R and DSM-5 diagnosis of non-affective psychosis or Clinical High Risk for psychosis.

2. Presence of positive symptoms during the last year (PANSS delusions, suspiciousness or grandiosity >=3).

3. Adults, 18 - 65 years of age

4. Stable condition with no expected changes in medication (information from clinical services).

5. Lack of severe cognitive deficits (global assessment or/and information from clinical services);

Exclusion Criteria

1. Having received MCT in the previous year.

2. Neurological disorder, a history of head trauma or premorbid IQ below 70 (based on medical reports and/or other sources);

3. A score above 5 in the "Hostility" and the "Suspiciousness" items of the PANSS Positive subscale (to preserve group dynamics).

4. aggressive behavior (reports from clinical services if available)

5. High risk of suicide (verified with DIAMOND)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundació Sant Joan de Déu

OTHER

Sponsor Role: collaborator

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role: collaborator

University Hospitals of Strasbourg

UNKNOWN

Sponsor Role: collaborator

Universitat Politècnica de Catalunya

OTHER

Sponsor Role: collaborator

Universidad de Valparaiso

OTHER

Sponsor Role: collaborator

Polish Academy of Sciences

OTHER

Sponsor Role: lead

Responsible Party

Łukasz Gawęda

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Łukasz Gawęda, Professor

Role: PRINCIPAL_INVESTIGATOR

The Institute of Psychology, Polish Academy of Sciences

Locations

Universidad de Valparaíso

Valparaíso, Región de Valparaíso, Chile

University Hospitals of Strasbourg

Strasbourg, Strasbourg Cedex, France

University Medical Center Hamburg-Eppendorf

Hamburg, City state of Hamburg, Germany

The Institute of Psychology, The Polish Academy of Sciences

Warsaw, Warsaw, Poland

Fundació Sant Joan de Déu

Barcelona, Barcelona, Spain

Universitat Politècnica de Catalunya

Barcelona, Catalonia, Spain

Countries

Chile; France; Germany; Poland; Spain

Central Contacts

Łukasz Gawęda, Professor

Role: CONTACT

l.gaweda@psych.pan.pl

+48225831386

Facility Contacts

Vanessa Acuña, Professor

Role: primary

vaneacunaperez@gmail.com

+56982994134

Vanessa Acuña, Professor

Role: backup

Berna Fabrice, Professor

Role: primary

Fabrice.berna@chru-strasbourg.fr

+33-388116462

Berna Fabrice, Professor

Role: backup

Steffen Moritz, PhD

Role: primary

Moritz@uke.de

+49(40)7410-56565

Steffen Moritz, PhD

Role: backup

Susana Ochoa, PhD

Role: primary

susana.ochoa@sjd.es

+34673933553

Susana Ochoa, PhD

Role: backup

Other Identifiers

PerMed/V/82/PERMEPSY/2023

Identifier Type: -

Identifier Source: org_study_id