NCT06782672

Investigation of Objective Cognitive Effort in Neuropsychological Evaluation of Psychotic Disorders

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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).

Conditions

• Schizophrenia
• Psychotic Disorders
• Cognitive Impairment
• Motivation

Interventions

Type	Name	Description
OTHER	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 the brachial artery of the non-dominant arm. cardiovascular values will be measured continuously: * Each participant rested while watching a documentary for 8 minutes. * During two 5-minute memory tasks of different difficulty levels (easy and difficult), separated by a 5-minute break. The averages of the last 5 minutes during the resting period will constitute the resting values, and the averages of the 5 minutes of each difficulty level will constitute the values during cognitive effort.
OTHER	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?"; * How difficult did you find the task? * How motivated were you to perform the task? Responses will be in Likert scale format, ranging from 1 ("no effort at all", "very easy", "not at all motivated", respectively) to 7 ("a lot of effort", "very difficult", "very motivated", respectively).
OTHER	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

Timeline

• Start date: 2025-01-27
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2025-01-20
• Last updated: 2025-01-20

Locations

1 site across 1 country: France