Investigation of Objective Cognitive Effort in Neuropsychological Evaluation of Psychotic Disorders

Обзор

Psychotic disorders are characterised by a heterogeneity of symptoms, including cognitive disorders, which predict functional outcome. To date, the evaluation of cognitive functions essentially measures performance. Cognitive effort and the influence of psychological factors are rarely considered. Based on the principle of energy conservation, the Motivational Intensity Theory (MIT) allows to test cognitive effort independently of performance, by measuring cardiovascular reactivity, as well as controlling for psychological factors (e.g., mood, fatigue, anxiety). The main aim of this study is to investigate in a memory task the interaction between cognitive effort, performance and psychological factors in individuals with psychotic disorders compared to a non-clinical group, based on the predictions of the MIT. This study will provide insights into the nature of cognitive impairment in psychotic disorders: primary or secondary to motivational (effort) or psychological (mood, fatigue, anxiety) difficulties.

Подробное описание

The study will be proposed to patients with psychotic disorders (n=50) and non clinical participants (n = 50) aged 18 to 60.

This is a non-interventional, randomized, prospective experimental study with mixed design: 2 groups (psychotic disorders vs. non-clinical) with 2 repeated measures of difficulty (easy vs. difficult).

The study comprises a single visit with memory tests recording cardiovascular, and performance data, as well as participants' perceptions of the task (effort invested, difficulty, motivation to perform the task), followed by a psychological assessment using questionnaires and a semi-structured interview.

The study of these different measures (cardiovascular, performance, perception) will enable us to refine the understanding of cognitive deficits in psychotic disorders, taking psychopathological variables into account. will provide better direction for the care of this population: cognitive remediation for primary cognitive disorders vs. cognitive and behavioral therapies for cognitive disorders secondary to psychopathological variables (mood, fatigue, defeatist beliefs, motivational deficits).

Вмешательства

• Другое Cardiovascular measurements
  Measurement of pre-ejection period is the period between the onset of electrical excitation of the left ventricle and the opening of the aortic valve and heart rate will be continuous. These data will be collected using a cardiograph measuring the ECG signal and impedance cardiography (ICG). The system's four electrodes are positioned on the middle axillary line at the end of the sternum and at the base of the neck. Blood pressure measurements (PAS and PAD) will be taken from a cuff placed on
• Другое Experimental memory task
  First, a quiet period with the viewing of a documentary film (8min). Then, participants will perform two 5-minute memory tasks of different difficulty levels (memorizing 3 letters corresponds to the easy level vs. 7 letters to the difficult level), separated by a 5-minute break. The order of difficulty will be counterbalanced. At the end of each difficulty level, self-report measures assessed by the following questions will be collected: * "How much effort did you exert during the task?"; * H
• Другое Questionnaire and semi-structured psychological interview
  psychopathological measures collected using questionnaires: * Beck Depression Inventory (BDI-II): mood * State-Trait Anxiety Inventory (Form Y) (STAY-Y): anxiety * Multidimensional Fatigue Inventory, 20-item version (MFI-20=): fatigue * General Self-Efficacy Scale (GSES): defeatist beliefs * Clinical Assessment Interview for Negative Symptoms (CAINS) : psychotic symptoms for the psychotic disorders group

Первичные конечные точки

• Interaction effect of group x difficulty on cardiovascular reactivity (Pre-Ejection Period - PEP) [Срок оценки: 18 minutes]

Вторичные конечные точки (12)

• Investigation of systolic blood pressure in both groups and difficulties [Срок оценки: 18 minutes]
• Investigation of diastolic blood pressure in both groups and difficulties [Срок оценки: 18 minutes]
• Investigation of heart rate pressure in both groups and difficulties [Срок оценки: 18 minutes]
• Comparison of correct performance [Срок оценки: 10 minutes]
• Comparison of errors [Срок оценки: 10 minutes]
• Comparison of self-reported effort in both groups and both difficulties [Срок оценки: 1 minute]
• Comparison of self-reported difficulty in both groups and both difficulties [Срок оценки: 1 minute]
• Comparison of self-reported motivation in both groups and both difficulties [Срок оценки: 1 minute]
• Influence of depressed mood on effort [Срок оценки: 5 minutes]
• Influence of anxiety on effort [Срок оценки: 5 minutes]
• Influence of fatigue on effort [Срок оценки: 3 minutes]
• Influence of defeatist beliefs on effort [Срок оценки: 3 minutes]

Критерии участия

Inclusion Criteria in both groups

\- Age ≥ 18 years and ≤60 years

Inclusion criteria for the psychotic disorders group:

\- Patients with a diagnosis within the schizophrenia spectrum and other psychotic disorders according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5; APA, 2015).

Inclusion criterion for the non-clinical group:

\- Absence of any psychiatric disorder.

non-inclusion criteria in both groups

• Neurological disorder or history of head trauma;
• Cardiovascular disease or treatment for hypertension;
• Substance abuse or dependence disorder;
• Individuals who cannot understand or speak French;
• Non-affiliation with a social security system;
• Individuals participating in another study that includes an ongoing exclusion period;
• Individuals who have not provided written informed consent to participate in the study;
• Pregnant or breastfeeding women;
• Absence of written consent from the legal guardian for patients under guardianship;
• Absence of notification to the curator for patients under curatorship.

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Франция · 1 центр

• Montpellier University Hospital — Montpellier

Идентификаторы

NCT: NCT06782672 · RECHLMPL23_0456

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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