[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100576236":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":37,"locations":43,"responsibleParty":56,"collaborators":58,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":69,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":10,"studyType":76,"phases":10,"briefSummary":77,"conditions":78,"keywords":83,"overallStatus":87,"whyStopped":10,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"University Hospital, Montpellier","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"psychotic disorders",null,"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.\n\nThe people with psychotic disorders recruited for this study are currently being cared for at the adult psychiatry department of Montpellier University Hospital.\n\nParticipants 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.",[13,14,15],"Other: Cardiovascular measurements","Other: Experimental memory task","Other: Questionnaire and semi-structured psychological interview",{"label":17,"type":10,"description":18,"interventionNames":19},"non clinical, control","The non-clinical population should be similar to the psychotic disorders population in terms of age, level of education and gender.\n\nParticipants 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.",[13,14,15],[21,25,29],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":10},"Cardiovascular measurements","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.\n\nThese 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.\n\nBlood pressure measurements (PAS and PAD) will be taken from a cuff placed on the brachial artery of the non-dominant arm.\n\ncardiovascular values will be measured continuously:\n\n* Each participant rested while watching a documentary for 8 minutes.\n* During two 5-minute memory tasks of different difficulty levels (easy and difficult), separated by a 5-minute break.\n\nThe 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.",[17,9],{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":10},"Experimental memory task","First, a quiet period with the viewing of a documentary film (8min).\n\nThen, 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.\n\nAt the end of each difficulty level, self-report measures assessed by the following questions will be collected:\n\n* \"How much effort did you exert during the task?\";\n* How difficult did you find the task?\n* 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).",[17,9],{"type":6,"name":30,"description":31,"armGroupLabels":32,"otherNames":10},"Questionnaire and semi-structured psychological interview","psychopathological measures collected using questionnaires:\n\n* Beck Depression Inventory (BDI-II): mood\n* State-Trait Anxiety Inventory (Form Y) (STAY-Y): anxiety\n* Multidimensional Fatigue Inventory, 20-item version (MFI-20=): fatigue\n* General Self-Efficacy Scale (GSES): defeatist beliefs\n* Clinical Assessment Interview for Negative Symptoms (CAINS) : psychotic symptoms for the psychotic disorders group",[17,9],[34],{"name":35,"affiliation":5,"role":36},"Amandine Décombe, PhD","PRINCIPAL_INVESTIGATOR",[38],{"name":35,"role":39,"phone":40,"phoneExt":41,"email":42},"CONTACT","0467332425","+33","a-decombe@chu-montpellier.fr",[44],{"facility":45,"status":10,"city":46,"state":10,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":10},"Montpellier University Hospital","Montpellier","34295","France","FR",{"type":51,"coordinates":52},"Point",[53,54],3.87635,43.61093,{"lat":54,"lon":53},{"type":57,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[59],{"name":60,"class":61},"fondation john bost","UNKNOWN","100576236","investigation-of-objective-cognitive-effort-in-neuropsychological-evaluation-of-psychotic-disorders-100576236",false,"NCT06782672","Investigation of Objective Cognitive Effort in Neuropsychological Evaluation of Psychotic Disorders","INVESTIGECCO","Inclusion Criteria in both groups\n\n\\- Age ≥ 18 years and ≤60 years\n\nInclusion criteria for the psychotic disorders group:\n\n\\- 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).\n\nInclusion criterion for the non-clinical group:\n\n\\- Absence of any psychiatric disorder.\n\nnon-inclusion criteria in both groups\n\n* Neurological disorder or history of head trauma;\n* Cardiovascular disease or treatment for hypertension;\n* Substance abuse or dependence disorder;\n* Individuals who cannot understand or speak French;\n* Non-affiliation with a social security system;\n* Individuals participating in another study that includes an ongoing exclusion period;\n* Individuals who have not provided written informed consent to participate in the study;\n* Pregnant or breastfeeding women;\n* Absence of written consent from the legal guardian for patients under guardianship;\n* Absence of notification to the curator for patients under curatorship.",true,"ALL","18 Years","60 Years",{"count":74,"type":75},100,"ESTIMATED","OBSERVATIONAL","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.\n\nBased 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).\n\nThe 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.\n\nThis 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.",[79,80,81,82],"Schizophrenia","Psychotic Disorders","Cognitive Impairment","Motivation",[84,85,86],"memory","effort","cardiovascular reactivity","NOT_YET_RECRUITING","2025-01-17",{"date":90,"type":91},"2025-01-20","ACTUAL",{"date":93,"type":75},"2025-01-27",{"date":95,"type":75},"2026-07-01",{"name":5,"class":6},1]