The Personalized Psychological Treatment for Psychosis

NCT06603922 | Not Yet Recruiting

• 1 other identifier: PerMed/V/82/PERMEPSY/2023
• Study Type: interventional
• Target: 252
• Locations: 5 countries
• Sites: 6

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.

Conditions

Schizophrenia; Psychosis; Schizophrenia Spectrum and Other Psychotic Disorders

Keywords

personalized medicine; psychological treatment; metacognitive training; machine learning; software platform

Outcome Measures

Primary Outcomes (5)

• Sociodemographic Questionnaire

  A sociodemographic sheet will be captured the following information: age, gender/sex, marital status, years of education, living situation, number of siblings, whether they live in rural or urban areas, employment status, symptom onset, previous hospitalisations, history of suicide attempts, family mental health history, current substance use, current pharmacological treatment (name and dosage), diagnosis (options: schizophrenia,unspecified psychotic disorder, schzoaffective disorder, delusional disorder, brief psychotic disorder, schizophreniform disorder), comorbidity, other medical illnesses, and in female patients, age at menarche, age at menopause, hormone treatment (if applicable), menstrual cycle description, date of last menstrual period, amenorrhoea.

  Baseline

• PSYRATS

  Psychotic Symptom Rating Scale. The PSYRATS comprises hallucinations (11 items) and delusions (6 items) subscales, each one designed to assess the psychological aspects of the symptoms on a five-point scale, from 0 to 4.

  baseline, post-treatment and 6-month follow-up

• PANSS

  The Positive and Negative Syndromes Scale.PANSS is a semi-structured interview assessing 30 symptoms on a 7-point scale, from 1 (absent) to 7 (extreme). Symptoms are rated over seven days prior to the assessment.

  baseline, post-treatment and 6-month follow-up

• RSES

  Rosenberg's Self-Esteem Scale.A 10-item scale that measures global self-worth by measuring both positive and negative feelings about the self. The scale is believed to be unidimensional. All items are answered using a 4-point Likert scale ranging from strongly agree to strongly disagree.

  baseline, post-treatment and 6-month follow-up

• BCIS

  Beck Cognitive Insight Scale.The BCIS aims to assess patients' self-reflectiveness about cognitive processes and problems and (over-) confidence in decision-making. The self-report questionnaire consists of 15 items which measure "self-reflectiveness" (9 items; e.g., "At times, I have misunderstood other people's attitudes towards me.") and "self-certainty" (6 items; e.g., "My interpretations of my experiences are definitely right."). A composite index of the BCIS termed "cognitive insight" is calculated by subtracting the self-certainty subscore from the self-reflectiveness subscore.

  baseline, post-treatment and 6-month follow-up

Secondary Outcomes (20)

• GAF

  baseline, post-treatment and 6-month follow-up

• DIAMOND

  baseline

• WHOQOL-BREF

  baseline, post-treatment and 6-month follow-up

• TEC

  baseline

• CBQp

  baseline, post-treatment and 6-month follow-up

Study Arms (2)

Personalized MCT (P-MCT)

EXPERIMENTAL

Personalized Metacognitive training

Behavioral: Psychological treatment (P-MCT)

Metacognitive training (MCT)

ACTIVE COMPARATOR

Metacognitive training

Behavioral: Psychological treatment (MCT)

Interventions

Psychological treatment (P-MCT) 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.

Personalized MCT (P-MCT)

Psychological treatment (MCT) 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.

Metacognitive training (MCT)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Inpatients and outpatients with a DSM-IV-R and DSM-5 diagnosis of non-affective psychosis or Clinical High Risk for psychosis.
• Presence of positive symptoms during the last year (PANSS delusions, suspiciousness or grandiosity \>=3).
• Adults, 18 - 65 years of age
• Stable condition with no expected changes in medication (information from clinical services).
• Lack of severe cognitive deficits (global assessment or/and information from clinical services);

You may not qualify if:

• Having received MCT in the previous year.
• Neurological disorder, a history of head trauma or premorbid IQ below 70 (based on medical reports and/or other sources);
• A score above 5 in the "Hostility" and the "Suspiciousness" items of the PANSS Positive subscale (to preserve group dynamics).
• aggressive behavior (reports from clinical services if available)
• High risk of suicide (verified with DIAMOND)

Sponsors & Collaborators

• Polish Academy of Sciences: lead
• Fundació Sant Joan de Déu: collaborator
• Universitätsklinikum Hamburg-Eppendorf: collaborator
• University Hospitals of Strasbourg: collaborator
• Universitat Politècnica de Catalunya: collaborator
• Universidad de Valparaiso: collaborator

Study Sites (6)

Universidad de Valparaíso

Valparaíso, Región de Valparaíso, 2340000, Chile

Location

University Hospitals of Strasbourg

Strasbourg, Strasbourg Cedex, 67091, France

Location

University Medical Center Hamburg-Eppendorf

Hamburg, Hamburg, 20246, Germany

Location

The Institute of Psychology, The Polish Academy of Sciences

Warsaw, Warsaw, 00-378, Poland

Location

Fundació Sant Joan de Déu

Barcelona, Barcelona, 08950, Spain

Location

Universitat Politècnica de Catalunya

Barcelona, Catalonia, 08034, Spain

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Schizophrenia Spectrum and Other Psychotic Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Łukasz Gawęda, Professor

  The Institute of Psychology, Polish Academy of Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Łukasz Gawęda, Professor

CONTACT

+48225831386; l.gaweda@psych.pan.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Assessment should be provided blind to patients' allocation (MCT vs. P-MCT). Researchers should pay attention that assessors do not learn the conditions allocation. Assessors should not discuss the content of the MCT/P-MCT sessions. At the same time, assessors should not discuss patient allocation with clinical staff. Assessors should be experienced in clinical interviews with patients suffering from psychosis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: The sample will be randomized into P-MCT or classical MCT in a RCT where the user's participants (patients diagnosed with non-affective psychoses) and evaluators will be blind to the treatment condition.

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); ES (2); FR (1); CL (1); PL (1)