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ClinicalTrials.gov ID

NCT06603922

Lead Sponsor

Polish Academy of SciencesOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

252Estimated

Last Update Posted

Sep 19, 2024Actual

Start Date

Oct 1, 2024Estimated

Primary Completion Date

May 31, 2026Estimated

Completion Date

May 31, 2026Estimated

Official Title

Towards a Personalized Medicine Approach to Psychological Treatment for Psychosis

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).

• Schizophrenia
• Psychosis
• Schizophrenia Spectrum and Other Psychotic Disorders

• Psychological treatment (P-MCT)
• Psychological treatment (MCT)

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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)

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Double

Lead Sponsor

Polish Academy of SciencesOTHER

Collaborators

Fundació Sant Joan de DéuOTHER

Universitätsklinikum Hamburg-EppendorfOTHER

University Hospitals of StrasbourgUNKNOWN

Universitat Politècnica de CatalunyaOTHER

Universidad de ValparaisoOTHER

susana.ochoa@sjd.es+34673933553