[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658508":3},{"organization":4,"outcomesModule":7,"designInfo":40,"detailedDescription":48,"studyPopulation":39,"armGroups":49,"interventions":60,"overallOfficials":39,"centralContacts":66,"locations":39,"responsibleParty":76,"collaborators":80,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":39,"eligibilityCriteria":91,"healthyVolunteers":87,"sex":92,"minAge":93,"maxAge":94,"enrollmentInfo":95,"targetDuration":39,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":106,"overallStatus":113,"whyStopped":39,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":119,"leadSponsor":121,"locationsCount":39},{"fullName":5,"class":6},"University of Geneva, Switzerland","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":39},[9],{"measure":10,"description":11,"timeFrame":12},"Apathy score on the Brief Negative Symptom Scale (BNSS)","Apathy is measured with the BNSS apathy composite score. The score is the sum of seven items: three for anhedonia (intensity of pleasure during activities, frequency of pleasurable activities, intensity of expected pleasure from future activities), two for asociality (behaviour and internal experience), and two for avolition (behaviour and internal experience). Each item is rated from 0 to 6 in a clinical interview by a blinded rater. The total score ranges from 0 to 42, and higher scores mean more severe apathy. The post-intervention score is compared between the PEPS and treatment-as-usual groups, adjusted for the baseline score.","Baseline, and within 2 weeks after the end of the 8-week intervention or treatment-as-usual period",[14,18,21,24,27,30,33,36],{"measure":15,"description":16,"timeFrame":17},"Ventral striatal activation during reward anticipation","Brain activity (fMRI BOLD signal) in the ventral striatum during reward anticipation in the Monetary Incentive Delay task. Post-intervention activation is compared between the PEPS and treatment-as-usual groups, adjusted for baseline activation.","Baseline, and within 2 weeks after the end of the 8-week intervention or treatment-as-usual period.",{"measure":19,"description":20,"timeFrame":17},"Association between change in ventral striatal activation and change in apathy","Relationship between post-intervention ventral striatal activation during reward anticipation (Monetary Incentive Delay task) and post-intervention apathy (BNSS apathy composite score). Both are adjusted for their baseline values.",{"measure":22,"description":23,"timeFrame":17},"Fronto-limbic connectivity during emotion processing","Task-related functional connectivity (psychophysiological interaction) between the dorsolateral prefrontal cortex, caudate nucleus, anterior cingulate cortex and amygdala during the Variable Affective Attention Task. Post-intervention connectivity is compared between groups, adjusted for baseline.",{"measure":25,"description":26,"timeFrame":17},"Prefrontal activation and fronto-striatal connectivity during social decision-making","Prefrontal activation and prefrontal-striatal functional connectivity (fMRI) during a social-context decision-making task. Post-intervention values are compared between groups, adjusted for baseline.",{"measure":28,"description":29,"timeFrame":17},"Resting-state functional connectivity","Functional connectivity between brain regions measured with resting-state fMRI, including network (graph-theory) measures. Post-intervention connectivity is compared between groups, adjusted for baseline.",{"measure":31,"description":32,"timeFrame":17},"Positive symptoms on the Positive and Negative Syndrome Scale (PANSS)","PANSS positive factor score, the sum of six items (delusions, hallucinatory behaviour, grandiosity, suspiciousness, unusual thought content, lack of judgement and insight). The post-intervention score is compared between groups, adjusted for baseline.",{"measure":34,"description":35,"timeFrame":17},"Self-rated negative symptoms (Self-evaluation of Negative Symptoms, SNS)","Total score on the SNS, a 20-item self-report questionnaire covering anhedonia, avolition, social withdrawal, blunted affect and alogia. The post-intervention score is compared between groups, adjusted for baseline.",{"measure":37,"description":38,"timeFrame":17},"Cognition (Brief Assessment of Cognition in Schizophrenia, BACS)","BACS composite score across verbal memory, working memory, motor speed, verbal fluency, attention and processing speed, and executive function. The post-intervention score is compared between groups, adjusted for baseline.",null,{"allocation":41,"interventionModel":42,"interventionModelDescription":39,"primaryPurpose":43,"observationalModel":39,"timePerspective":39,"maskingInfo":44},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":45,"maskingDescription":39,"whoMasked":46},"SINGLE",[47],"OUTCOMES_ASSESSOR","Background: Negative symptoms of schizophrenia, particularly apathy (avolition, asociality, anhedonia), are a major cause of poor functional outcome, and no pharmacological treatment adequately improves them. The Positive Emotions Program for Schizophrenia (PEPS) is a group psychotherapy that targets deficits in anticipating and maintaining positive emotions. It has reduced apathy and anhedonia compared with treatment as usual in a previous randomized trial (Favrod et al., 2019). The neural mechanisms of this effect are unknown. Ventral striatal hypoactivation during reward anticipation, which is associated with apathy, is a candidate response biomarker.\n\nObjectives: The primary objective is to test the efficacy of PEPS on apathy compared with treatment as usual (TAU). Secondary objectives are to test whether PEPS changes ventral striatal activation during reward anticipation, whether neural changes are associated with clinical improvement, and whether PEPS affects emotion processing, social decision-making and resting-state networks.\n\nDesign: This is a single-centre, rater-blinded randomized controlled trial at the Geneva University Hospitals. Eighty-eight outpatients with schizophrenia, schizoaffective disorder or unspecified nonorganic psychosis (aged 18-60, clinically stable, with at least one moderate negative symptom) are randomized 1:1, stratified by sex, to PEPS or TAU. PEPS consists of eight weekly 1-hour group sessions, with about four participants per group. TAU is routine outpatient care, and TAU participants are offered PEPS after completing the study. Thirty healthy controls are also recruited, without randomization or intervention, to provide test-retest benchmarks. All participants undergo clinical assessment and fMRI at baseline and within 2 weeks after the 8-week intervention or waiting period.",[50,56],{"label":51,"type":52,"description":53,"interventionNames":54},"Positive Emotions Program for Schizophrenia (PEPS) group psychotherapy","EXPERIMENTAL","Patients receive the Positive Emotions Program for Schizophrenia (PEPS) in addition to their usual outpatient care. PEPS consists of eight weekly 1-hour group sessions led by a psychologist. Sessions train skills to anticipate, savour, express and share positive emotions, and to challenge defeatist beliefs, with home exercises between sessions.",[55],"Behavioral: Positive Emotion Program for Schizophrenia (PEPS), a psychotherapeutic intervention,",{"label":57,"type":58,"description":59,"interventionNames":39},"Treatment as usual (TAU)","NO_INTERVENTION","Patients continue their usual outpatient care for 8 weeks without PEPS. Usual care includes regular follow-up by their psychiatrist and nurse, antipsychotic medication, and non-specific group activities. None of these specifically targets negative symptoms. Patients are offered PEPS after completing the study.",[61],{"type":62,"name":63,"description":64,"armGroupLabels":65,"otherNames":39},"BEHAVIORAL","Positive Emotion Program for Schizophrenia (PEPS), a psychotherapeutic intervention,","PEPS is a manualized group intervention delivered over eight weekly sessions. Groups include four to eight participants and each session lasts approximately one hour.\n\nThe intervention focuses on four main domains:\n\n* identifying and savouring positive experiences;\n* emotional expression;\n* challenging negative beliefs related to performance; and maximise positive experiences\n* anticipating and recognizing positive moments in daily life. The intervention uses standardized materials and home exercises to ensure consistency and encourage real-life application.",[51],[67,72],{"name":68,"role":69,"phone":70,"phoneExt":39,"email":71},"Stefan Kaiser, MD","CONTACT","+41 (0)22 305 51 04","stefan.kaiser@hug.ch",{"name":73,"role":69,"phone":74,"phoneExt":39,"email":75},"Rachel Goldstein, MA","+41 (0)22 379 0958","Rachel.Goldstein@unige.ch",{"type":77,"investigatorFullName":78,"investigatorTitle":79,"investigatorAffiliation":5,"oldNameTitle":39,"oldOrganization":39},"PRINCIPAL_INVESTIGATOR","Stefan Kaiser","Sponsor- Investigator",[81,83],{"name":82,"class":6},"Swiss National Science Foundation",{"name":84,"class":6},"University Hospital, Geneva","100658508","motivational-intervention-for-patients-with-schizophrenia-100658508",false,"NCT07853079","Motivational Intervention for Patients With Schizophrenia","Effects of a Motivational Intervention on the Neural Mechanisms of Apathy in Patients With Schizophrenia - a Randomized Controlled Trial","Inclusion Criteria:\n\n* 18-60 years old\n* Capacity to give informed consent\n* Clinically diagnosis of schizophrenia, schizoaffective disorder or unspecified nonorganic psychosis\n* Clinically stable as judged by the treating psychiatrist and no hospitalization or change of medication two weeks prior to study entry\n* At least on negative symptom at a moderate level (3 on the BNSS) based on the clinician's judgment.\n\nExclusion Criteria:\n\n* Current major depressive episode\n* Psychotic symptoms with major impact on the daily life of the patient based on the clinician's judgment.\n* Current diagnosis of neurological disease,\n* Extrapyramidal symptoms with major impact on the daily life of the patient based on the clinician's judgment\n* Stimulant, opiate or alcohol use disorder\n* Contra-indication for MRI (e.g. Pregnancy, Pacemaker)","ALL","18 Years","60 Years",{"count":96,"type":97},88,"ESTIMATED","INTERVENTIONAL",[100],"NA","The goal of this clinical trial is to learn if a group therapy called the Positive Emotions Program for Schizophrenia (PEPS) can reduce apathy in adults aged 18 to 60 who have schizophrenia or a related psychotic disorder. Apathy means having little motivation or drive and getting less pleasure from daily life. The trial will also look at how the brain responds to this therapy.\n\nThe main questions it aims to answer are:\n\nDo people who take part in PEPS have less apathy after the therapy than people who continue with their usual care? Does PEPS increase activity in a brain areas important for motivation? Are changes in brain activity linked to changes in apathy?\n\nResearchers will compare PEPS with usual care (regular visits with the treating psychiatrist and nurse, without PEPS) to see if PEPS reduces apathy. They will also compare brain scans of people with schizophrenia to those of healthy volunteers, to see whether brain activity after PEPS becomes more similar to that of people without the illness.\n\nParticipants with schizophrenia will:\n\n* Be placed by chance into one of two groups: PEPS or usual care\n* Have an interview and questionnaires about their symptoms\n* Have an MRI brain scan while doing computer tasks\n* In the PEPS group, attend 8 weekly group sessions of 1 hour led by a psychologist. They will learn skills to notice, enjoy and look forward to pleasant moments, to question discouraging thoughts, and to share positive feelings with others. They will also do short exercises at home.\n* In the usual-care group, continue their usual care for 8 weeks. They will be offered PEPS after the study ends.\n* Repeat the interview and the brain scan within 2 weeks after the 8-week period",[103,104,105],"Schizo-affective Disorder","Non Organic Psychosis","Schizophenia Disorder",[107,108,109,110,111,112],"Schizophrenia","PEPS","fMRI","Negative symptoms","Apathy","Group psychotherapy","NOT_YET_RECRUITING","2026-09-27",{"date":116,"type":117},"2026-10-01","ACTUAL",{"date":116,"type":97},{"date":120,"type":97},"2029-09-30",{"name":5,"class":6}]