Investigation of Objective Cognitive Effort in Neuropsychological Evaluation of Psychotic Disorders (INVESTIGECCO)

University Hospital Center (CHU)

Status: Not yet enrolling

Conditions: Motivation; Psychotic Disorders; Cognitive Impairment; Schizophrenia

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

Study type: Observational

Funder types: Other

Identifiers

NCT06782672

RECHLMPL23_0456

Details and patient eligibility

About

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.

Full 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).

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

100 participants in 2 patient groups

psychotic disorders

Description:

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.

Treatment:

Other: Questionnaire and semi-structured psychological interview

Other: Experimental memory task

Other: Cardiovascular measurements

non clinical, control

Description:

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.

Treatment:

Other: Questionnaire and semi-structured psychological interview

Other: Experimental memory task

Other: Cardiovascular measurements