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Investigation of Objective Cognitive Effort in Neuropsychological Evaluation of Psychotic Disorders

ConditionsSchizophreniaPsychotic DisordersCognitive ImpairmentMotivation
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-60
SponsorUniversity Hospital, Montpellier

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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;

Disqualifiers

None

Trial 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

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Cardiovascular measurements

    Other intervention

    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

    Other intervention

    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

    Other intervention

    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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: psychotic disorders3 interventions
Group B: non clinical, control3 interventions

Trial outcomes

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.

Time frame
18 minutes

Secondary outcomes

1

Investigation of systolic blood pressure in both groups and difficulties

expressed in mmHg

Time frame
18 minutes
2

Investigation of diastolic blood pressure in both groups and difficulties

expressed in mmHg

Time frame
18 minutes
3

Investigation of heart rate pressure in both groups and difficulties

expressed in beats/minutes

Time frame
18 minutes
4

Comparison of correct performance

The percentage of correct responses between the two groups and in both levels of difficulty

Time frame
10 minutes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Montpellier

Lead sponsor

fondation john bost

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: