Investigation of Objective Cognitive Effort in Neuropsychological Evaluation of Psychotic Disorders

Not yet recruiting

• Conditions: Schizophrenia; Motivation; Psychotic Disorders; Cognitive Impairment

• Registration Number: NCT06782672
• Lead Sponsor: University Hospital, Montpellier

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).

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-12-10
• Study First Submitted QC: 2025-01-17
• Last Update Submitted: 2025-01-17
• Study First Posted: 2025-01-20
• Last Update Posted: 2025-01-20
• Study Start: 2025-01-27
• Primary Completion: 2026-07-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Interaction effect of group x difficulty on cardiovascular reactivity (Pre-Ejection Period - PEP)	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 Outcome Measures

Name	Time	Method
Investigation of systolic blood pressure in both groups and difficulties	18 minutes	expressed in mmHg
Investigation of diastolic blood pressure in both groups and difficulties	18 minutes	expressed in mmHg
Investigation of heart rate pressure in both groups and difficulties	18 minutes	expressed in beats/minutes
Comparison of correct performance	10 minutes	The percentage of correct responses between the two groups and in both levels of difficulty
Comparison of errors	10 minutes	The rate of errors between the two groups and in both levels of difficulty
Comparison of self-reported effort in both groups and both difficulties	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').
Comparison of self-reported difficulty in both groups and both difficulties	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').
Comparison of self-reported motivation in both groups and both difficulties	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').
Influence of depressed mood on effort	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.
Influence of anxiety on effort	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.
Influence of fatigue on effort	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.
Influence of defeatist beliefs on effort	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.
Influence of negatives symptomes on effort in schizophrenia group	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).

Trial Locations

Locations (1)

Montpellier University Hospital; 🇫🇷 Montpellier, France