Clinical trial NCT06782672: Investigation of Objective Cognitive Effort in Neuropsychological Evaluation of Psychotic Disorders
Official title: Investigation of Objective Cognitive Effort in Neuropsychological Evaluation of Psychotic Disorders
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Schizophrenia
Psychotic Disorders
Cognitive Impairment
Motivation
Keywords: memory
effort
cardiovascular reactivity
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: fondation john bost
First posted: 2025-01-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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).

Eligibility 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.

Primary outcomes:
measure: Interaction effect of group x difficulty on cardiovascular reactivity (Pre-Ejection Period - PEP)
timeFrame: 18 minutes
Secondary outcomes:
measure: Investigation of systolic blood pressure in both groups and difficulties
timeFrame: 18 minutes
measure: Investigation of diastolic blood pressure in both groups and difficulties
timeFrame: 18 minutes
measure: Investigation of heart rate pressure in both groups and difficulties
timeFrame: 18 minutes
measure: Comparison of correct performance
timeFrame: 10 minutes
measure: Comparison of errors
timeFrame: 10 minutes
measure: Comparison of self-reported effort in both groups and both difficulties
timeFrame: 1 minute
measure: Comparison of self-reported difficulty in both groups and both difficulties
timeFrame: 1 minute
measure: Comparison of self-reported motivation in both groups and both difficulties
timeFrame: 1 minute
measure: Influence of depressed mood on effort
timeFrame: 5 minutes
measure: Influence of anxiety on effort
timeFrame: 5 minutes
measure: Influence of fatigue on effort
timeFrame: 3 minutes
measure: Influence of defeatist beliefs on effort
timeFrame: 3 minutes
measure: Influence of negatives symptomes on effort in schizophrenia group
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Montpellier University Hospital
Study officials:
affiliation: University Hospital, Montpellier
name: Amandine Décombe, PhD
role: PRINCIPAL_INVESTIGATOR
References: