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Not yet recruiting NCT06603922

The Personalized Psychological Treatment for Psychosis

No phase Interventional Schizophrenia Psychosis Schizophrenia Spectrum and Other Psychotic Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Psychological treatment (P-MCT), Psychological treatment (MCT).
Who it may be relevant to
Registry conditions: Schizophrenia, Psychosis, Schizophrenia Spectrum and Other Psychotic Disorders. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Chile, France, Germany, Poland, Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Towards a Personalized Medicine Approach to Psychological Treatment for Psychosis

Overview

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).

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
  • 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 (modu

Primary outcome measures

  • Sociodemographic Questionnaire [Time frame: Baseline]
  • PSYRATS [Time frame: baseline, post-treatment and 6-month follow-up]
  • PANSS [Time frame: baseline, post-treatment and 6-month follow-up]
  • RSES [Time frame: baseline, post-treatment and 6-month follow-up]
  • BCIS [Time frame: baseline, post-treatment and 6-month follow-up]
Secondary outcome measures (12)
  • GAF [Time frame: baseline, post-treatment and 6-month follow-up]
  • DIAMOND [Time frame: baseline]
  • WHOQOL-BREF [Time frame: baseline, post-treatment and 6-month follow-up]
  • TEC [Time frame: baseline]
  • CBQp [Time frame: baseline, post-treatment and 6-month follow-up]
  • ISMI [Time frame: baseline, post-treatment and 6-month follow-up]
  • QSLE-SV [Time frame: baseline, post-treatment and 6-month follow-up]
  • RFQ [Time frame: baseline, post-treatment and 6-month follow-up]
  • ISI [Time frame: baseline, post-treatment and 6-month follow-up]
  • SUMD [Time frame: baseline, post-treatment and 6-month follow-up]
  • B-IRI [Time frame: baseline, post-treatment and 6-month follow-up]
  • BHS [Time frame: baseline, post-treatment and 6-month follow-up]

Eligibility criteria

Inclusion criteria

  • 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);

Exclusion criteria

  • 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Spain · 2 centers
  • Fundació Sant Joan de Déu — Barcelona
  • Universitat Politècnica de Catalunya — Barcelona
Chile · 1 center
  • Universidad de Valparaíso — Valparaíso
France · 1 center
  • University Hospitals of Strasbourg — Strasbourg
Germany · 1 center
  • University Medical Center Hamburg-Eppendorf — Hamburg
Poland · 1 center
  • The Institute of Psychology, The Polish Academy of Sciences — Warsaw

Identifiers

NCT: NCT06603922 · PerMed/V/82/PERMEPSY/2023

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗