Investigation of Objective Cognitive Effort in Neuropsychological Evaluation of Psychotic Disorders

NCT06782672 | Not Yet Recruiting

• 1 other identifier: RECHLMPL23_0456
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Psychotic Disorders; Cognitive Impairment; Motivation

Keywords

memory; effort; cardiovascular reactivity

Outcome Measures

Primary Outcomes (1)

• Interaction effect of group x difficulty on cardiovascular reactivity (Pre-Ejection Period - PEP)

  The difference score between the pre-ejection period (PEP) during the task (easy and difficult) and the PEP at rest (i.e., baseline), expressed in ms.

  18 minutes

Secondary Outcomes (13)

• Investigation of systolic blood pressure in both groups and difficulties

  18 minutes

• Investigation of diastolic blood pressure in both groups and difficulties

  18 minutes

• Investigation of heart rate pressure in both groups and difficulties

  18 minutes

• Comparison of correct performance

  10 minutes

• Comparison of errors

  10 minutes

Study Arms (2)

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.

Other: Cardiovascular measurements; Other: Experimental memory task; Other: Questionnaire and semi-structured psychological interview

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.

Other: Cardiovascular measurements; Other: Experimental memory task; Other: Questionnaire and semi-structured psychological interview

Interventions

Cardiovascular measurements 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.

non clinical, control; psychotic disorders

Experimental memory task 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).

non clinical, control; psychotic disorders

Questionnaire and semi-structured psychological interview 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; psychotic disorders

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Non-clinical group: Absence of any psychiatric disorder, community sample 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), selected from the adult psychiatry department, inpatient or outpatient hospitalisation

You may qualify if:

• \- 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).
• \- 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 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.

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• fondation john bost: collaborator

Study Sites (1)

Montpellier University Hospital

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Cognitive Dysfunction

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Cognition Disorders; Neurocognitive Disorders

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Amandine Décombe, PhD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amandine Décombe, PhD

CONTACT

0467332425; a-decombe@chu-montpellier.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: January 20, 2025
• Study Start: January 27, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 20, 2025

Record last verified: 2024-08

Locations

FR (1)