The Personalized Psychological Treatment for Psychosis

Официальное название

Towards a Personalized Medicine Approach to Psychological Treatment for Psychosis

Обзор

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.

Подробное описание

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).

Вмешательства

• Поведенческое 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
• Поведенческое 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

Первичные конечные точки

• Sociodemographic Questionnaire [Срок оценки: Baseline]
• PSYRATS [Срок оценки: baseline, post-treatment and 6-month follow-up]
• PANSS [Срок оценки: baseline, post-treatment and 6-month follow-up]
• RSES [Срок оценки: baseline, post-treatment and 6-month follow-up]
• BCIS [Срок оценки: baseline, post-treatment and 6-month follow-up]

Вторичные конечные точки (12)

• GAF [Срок оценки: baseline, post-treatment and 6-month follow-up]
• DIAMOND [Срок оценки: baseline]
• WHOQOL-BREF [Срок оценки: baseline, post-treatment and 6-month follow-up]
• TEC [Срок оценки: baseline]
• CBQp [Срок оценки: baseline, post-treatment and 6-month follow-up]
• ISMI [Срок оценки: baseline, post-treatment and 6-month follow-up]
• QSLE-SV [Срок оценки: baseline, post-treatment and 6-month follow-up]
• RFQ [Срок оценки: baseline, post-treatment and 6-month follow-up]
• ISI [Срок оценки: baseline, post-treatment and 6-month follow-up]
• SUMD [Срок оценки: baseline, post-treatment and 6-month follow-up]
• B-IRI [Срок оценки: baseline, post-treatment and 6-month follow-up]
• BHS [Срок оценки: baseline, post-treatment and 6-month follow-up]

Критерии участия

Критерии включения

• 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);

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Испания · 2 центра

• Fundació Sant Joan de Déu — Barcelona
• Universitat Politècnica de Catalunya — Barcelona

Чили · 1 центр

• Universidad de Valparaíso — Valparaíso

Франция · 1 центр

• University Hospitals of Strasbourg — Strasbourg

Германия · 1 центр

• University Medical Center Hamburg-Eppendorf — Hamburg

Польша · 1 центр

• The Institute of Psychology, The Polish Academy of Sciences — Warsaw

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗