Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06782672

Investigation of Objective Cognitive Effort in Neuropsychological Evaluation of Psychotic Disorders

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Schizophrenia Cognition Disorders Cognitive Dysfunction Cognitive Impairment Mental Disorders Motivation Neurocognitive Disorders Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Montpellier University Hospital

Montpellier, 34295, France

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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).

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

Primary outcomes

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

    Time frame: 18 minutes

    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.

Secondary outcomes

  1. Investigation of systolic blood pressure in both groups and difficulties

    Time frame: 18 minutes

    expressed in mmHg

  2. Investigation of diastolic blood pressure in both groups and difficulties

    Time frame: 18 minutes

    expressed in mmHg

  3. Investigation of heart rate pressure in both groups and difficulties

    Time frame: 18 minutes

    expressed in beats/minutes

  4. Comparison of correct performance

    Time frame: 10 minutes

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

  5. Comparison of errors

    Time frame: 10 minutes

    The rate of errors between the two groups and in both levels of difficulty

  6. Comparison of self-reported effort in both groups and both difficulties

    Time frame: 1 minute

    Self-reported effort will assess through the following question:

    • "How much effort did you exert during the task?" Response will be on a Likert scale ranging from 1 ('Not at all effort') to 7 ('A lot of effort').

  7. Comparison of self-reported difficulty in both groups and both difficulties

    Time frame: 1 minute

    Self-reported difficulty will assess through the following question:

    "How difficult did you find the task?" Response will be on a Likert scale ranging from 1 ('Very easy') to 7 ('Very difficult').

  8. Comparison of self-reported motivation in both groups and both difficulties

    Time frame: 1 minute

    Self-reported motivation will assess through the following question:

    "How motivated were you to complete the task?" Response will be on a Likert scale ranging from 1 ('Not at all motivated') to 7 ('Very motivated').

  9. Influence of depressed mood on effort

    Time frame: 5 minutes

    Beck Depression Inventory (BDI-II, Beck et al., 1996, internal consistency α = .92). This self-administered questionnaire consists of 21 items, each scored from 0 to 3. The total score ranges from 0 to 63.

    The higher the score, the more severe the depression.

  10. Influence of anxiety on effort

    Time frame: 5 minutes

    State-Trait Anxiety Inventory (Form Y) (STAY-Y, Spielberger et al., 1983, Bruchon-Schweitzer & Paulhan, 1993 for French validation, internal consistency α = .91). The STAY-Y assesses two scales momentary anxiety and trait anxiety, each comprising 20 items. Scores range from 1 ("Not at all for the momentary anxiety scale, "Almost never" for the trait anxiety scale) to 4 ("A lot", "Almost always", respectively). The higher the score, the more severe the anxiety.

  11. Influence of fatigue on effort

    Time frame: 3 minutes

    Multidimensional Fatigue Inventory, 20-item version (IMF-20, Smets et al., 1995, Gentille et al., 2003 for French validation, internal consistency α > .70). This scale comprises 20 items ranging from 1 ("Strongly disagree") to 5 ("Strongly agree").The total score is between 4 and 20, the higher the score, the greater the fatigue felt.The MFI has 5 subscales: general fatigue, mental fatigue, reduced motivation, physical fatigue, reduced activities.

  12. Influence of defeatist beliefs on effort

    Time frame: 3 minutes

    General Self-Efficacy Scale (GSES, Schwarzer & Jerusalem, 1995, Dumont et al., 2000, for French validation, internal consistency α > .76).This scale measures feelings of self-efficacy . This scale measures feelings of self-efficacy (the opposite of defeatist beliefs). It comprises 10 items, scored on a Likert scale ranging from 1 ("Not at all true") to 4 ("Totally true"). The higher the score, the higher the sense of self-efficacy, and the lower the person's self-defeating beliefs.

  13. Influence of negatives symptomes on effort in schizophrenia group

    Time frame: 30 minutes

    Clinical Assessment Interview for Negative Symptoms (CAINS, Kring et al., 2013; Laraki et al., 2022 for French validation, internal consistency α = 0.87). This is a semi-structured interview assessing the negative symptoms of schizophrenia.

    This interview is composed of 13 items ranging from 0 (absence/no deficit) to 5 (severe deficit). The interview includes two subscales: motivation and pleasure (MAP, 9 items) and expressivity (EXP, 4 items).

Study contacts

Contact information is provided by the study sponsor or research team.

Amandine Décombe, PhD

CONTACT

[email protected]

0467332425 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

  • fondation john bost

Registry information

Acronym: INVESTIGECCO

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 20, 2025
Registry last updated
Jan 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.