Investigation of Objective Cognitive Effort in Neuropsychological Evaluation of Psychotic Disorders

NCT ID: NCT06782672

Last Updated: 2025-01-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-27
• Study Completion Date: 2026-07-01

Brief 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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

psychotic disorders

The target population is people with a psychotic disorder (diagnosed as schizophrenia or schizoaffective disorder) according to DSM 5 criteria, aged between 18 and 60.

The people with psychotic disorders recruited for this study are currently being cared for at the adult psychiatry department of Montpellier University Hospital.

Participants will have a single visit with memory tests and data recording (cardiovascular, performance, perceptions), followed by a psychological assessment using questionnaires and a semi-structured interview.

Cardiovascular measurements

Intervention Type: OTHER

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.

Experimental memory task

Intervention Type: OTHER

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).

Questionnaire and semi-structured psychological interview

Intervention Type: OTHER

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

non clinical, control

The non-clinical population should be similar to the psychotic disorders population in terms of age, level of education and gender.

Participants will have a single visit with memory tests and data recording (cardiovascular, performance, perceptions), followed by a psychological assessment using questionnaires and a semi-structured interview.

Cardiovascular measurements

Intervention Type: OTHER

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.

Experimental memory task

Intervention Type: OTHER

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).

Questionnaire and semi-structured psychological interview

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: 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).

Intervention Type: 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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years and ≤60 years

• 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.

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

fondation john bost

UNKNOWN

Sponsor Role: collaborator

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amandine Décombe, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

Montpellier University Hospital

Montpellier, , France

Countries

France

Central Contacts

Amandine Décombe, PhD

Role: CONTACT

a-decombe@chu-montpellier.fr

0467332425 ext. +33

Other Identifiers

RECHLMPL23_0456

Identifier Type: -

Identifier Source: org_study_id