SchizophreniaINVESTIGECCONCT06782672
Investigation of Objective Cognitive Effort in Neuropsychological Evaluation of Psychotic Disorders
An observational study of Schizophrenia and Psychotic Disorders, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Psychotic Disorders, Cognitive Impairment
- What is being tested?
- Cardiovascular measurements, Experimental memory task and Questionnaire and semi-structured psychological interview
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 27 Jan 2025to 1 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- Age ≥ 18 years and ≤60 years
- 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).
- Absence of any psychiatric disorder.
- non-inclusion criteria in both groups
- Neurological disorder or history of head trauma;
- Cardiovascular disease or treatment for hypertension;
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- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read more
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.
Read the 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).
- Conditions
- Schizophrenia, Psychotic Disorders, Cognitive Impairment, Motivation
- Being tested
- Cardiovascular measurements, Experimental memory task, Questionnaire and semi-structured psychological interview
- Keywords
- memory, effort, cardiovascular reactivity
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiovascular measurementsOther
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 taskOther
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 interviewOther
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
| Study group | Role | What they receive |
|---|---|---|
| psychotic disorders | 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. Receives: Other: Cardiovascular measurements; Other: Experimental memory task; Other: Questionnaire and semi-structured psychological interview | |
| non clinical, control | 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. Receives: Other: Cardiovascular measurements; Other: Experimental memory task; Other: Questionnaire and semi-structured psychological interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 minutes
Secondary outcomes (13)
Investigation of systolic blood pressure in both groups and difficulties
expressed in mmHg
Measured: 18 minutes
Investigation of diastolic blood pressure in both groups and difficulties
expressed in mmHg
Measured: 18 minutes
Investigation of heart rate pressure in both groups and difficulties
expressed in beats/minutes
Measured: 18 minutes
Comparison of correct performance
The percentage of correct responses between the two groups and in both levels of difficulty
Measured: 10 minutes
Comparison of errors
The rate of errors between the two groups and in both levels of difficulty
Measured: 10 minutes
Comparison of self-reported effort in both groups and both difficulties
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').
Measured: 1 minute
Comparison of self-reported difficulty in both groups and both difficulties
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').
Measured: 1 minute
Comparison of self-reported motivation in both groups and both difficulties
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').
Measured: 1 minute
Influence of depressed mood on effort
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.
Measured: 5 minutes
Influence of anxiety on effort
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.
Measured: 5 minutes
Influence of fatigue on effort
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.
Measured: 3 minutes
Influence of defeatist beliefs on effort
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.
Measured: 3 minutes
Influence of negatives symptomes on effort in schizophrenia group
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).
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start27 Jan 2025 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- fondation john bost
- Responsible party
- Sponsor
- Investigators
- Amandine Décombe, PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06782672
- Sponsor's protocol ID
- RECHLMPL23_0456
- Acronym
- INVESTIGECCO
- Status last verified
- Aug 2024
- First submitted
- 10 Dec 2024
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Objective Cognitive Effort in Neuropsychological Evaluation of Psychotic Disorders
- ClinicalTrials.gov ID
- NCT06782672
- Acronym / sponsor ID
- INVESTIGECCO / RECHLMPL23_0456
- Conditions
- Schizophrenia, Psychotic Disorders, Cognitive Impairment, Motivation
- Keywords
- memory, effort, cardiovascular reactivity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- fondation john bost
- Study start
- 27 Jan 2025 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 20 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| psychotic disorders | – | Other: Cardiovascular measurements, Other: Experimental memory task, Other: Questionnaire and semi-structured psychological interviewThe 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. |
| non clinical, control | – | Other: Cardiovascular measurements, Other: Experimental memory task, Other: Questionnaire and semi-structured psychological interviewThe 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (14 listed)
- Age ≥ 18 years and ≤60 years
- 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).
- Absence of any psychiatric disorder.
- non-inclusion criteria in both groups
- Neurological disorder or history of head trauma;
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiovascular measurementsMeasurement 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. | Other | non clinical, control, psychotic disorders |
| Experimental memory taskFirst, 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). | Other | non clinical, control, psychotic disorders |
| Questionnaire and semi-structured psychological interviewpsychopathological 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 | Other | non clinical, control, psychotic disorders |
Primary outcome
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.
13 secondary outcomes
Investigation of systolic blood pressure in both groups and difficulties
Time frame: 18 minutes
Investigation of diastolic blood pressure in both groups and difficulties
Time frame: 18 minutes
Investigation of heart rate pressure in both groups and difficulties
Time frame: 18 minutes
Comparison of correct performance
Time frame: 10 minutes
Comparison of errors
Time frame: 10 minutes
Comparison of self-reported effort in both groups and both difficulties
Time frame: 1 minute
Comparison of self-reported difficulty in both groups and both difficulties
Time frame: 1 minute
Comparison of self-reported motivation in both groups and both difficulties
Time frame: 1 minute
Influence of depressed mood on effort
Time frame: 5 minutes
Influence of anxiety on effort
Time frame: 5 minutes
Influence of fatigue on effort
Time frame: 3 minutes
Influence of defeatist beliefs on effort
Time frame: 3 minutes
Influence of negatives symptomes on effort in schizophrenia group
Time frame: 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amandine Décombe, PhD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia and Psychotic Disorders, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amandine Décombe, PhD (0467332425 ext. +33, a-decombe@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interaction effect of group x difficulty on cardiovascular reactivity (Pre-Ejection Period - PEP) (time frame: 18 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2025.