[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"psychotic-disorders\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:psychotic-disorders":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,32,0,25,[9,44,72,105,135,156,183,205,235,263,287,311,341,375,405,446,480,504,535,557,585,607,628,652,678],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100513239","development-of-a-transdiagnostic-intervention-for-adolescents-at-risk-for-serious-mental-illness-100513239",false,"NCT05962879","Development of a Transdiagnostic Intervention for Adolescents at Risk for Serious Mental Illness","Inclusion Criteria:\n\n* Currently enrolled in 9th through 12th grade and between the ages of 14 and 19\n* Endorsed at least one psychotic experience\n* Provided contact information\n* Have a parent or legal guardian who is able and willing to provide written informed consent (if under the age of 18)\n* Have a parent or legal guardian who is able and willing to participate in a parent session\n* Competent and willing to provide written informed assent (if under the age of 18) or consent (if age 18 or older)\n* Able to communicate in English\n\nExclusion Criteria:\n\n* Currently prescribed psychotropic medication (not including medications for attention deficit\u002Fhyperactivity disorder), regardless of adherence\n* Currently obtaining psychotherapeutic intervention","ALL","14 Years","19 Years",{"count":20,"type":21},70,"ESTIMATED","INTERVENTIONAL",[24],"NA","This research study aims to develop a brief group-based treatment called Resilience Training for Teens, then to test how well it protects high school students with mild symptoms of depression, anxiety, or having unusual feelings from developing mental illnesses.",[27,28,29,30],"Anxiety Disorders","Psychotic Disorders","Depressive Disorder","Psychosocial Functioning","RECRUITING","2026-06-09",{"date":34,"type":35},"2026-06-11","ACTUAL",{"date":37,"type":35},"2024-03-22",{"date":39,"type":21},"2027-05-31",{"name":41,"class":42},"Massachusetts General Hospital","OTHER",1,{"id":45,"slug":46,"hasResults":12,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":12,"sex":16,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":71},"100489695","clinical-study-evaluating-pharmacogenomics-informed-pharmacotherapy-versus-dosing-as-usual-in-psychiatric-disorders-100489695","NCT05656469","Clinical Study Evaluating Pharmacogenomics-informed Pharmacotherapy Versus Dosing as Usual in Psychiatric Disorders","A New Intervention for Implementation of Pharmacogenetics in Psychiatry","PSY-PGx","Inclusion Criteria:\n\n1. Suffer from a depressive episode (major depressive disorder and bipolar disorder (currently depressive episode)) (as assessed by the MINI International Neuropsychiatric Interview (M.I.N.I.) in agreement with Diagnostic and Statistical Manual (DSM-5 criteria) of at least moderate severity (assessed using the Structured Interview Guide for the Hamilton Depression Scale (SIGH-D) with a score of 14 or higher) and\u002For suffer from an anxiety disorder (panic disorder, generalised anxiety disorder) (as assessed by the M.I.N.I. in agreement with DSM-5 criteria) of at least moderate severity (assessed using the Structured Interview Guide for the Hamilton Anxiety Scale (SIGH- A) with a score of 18 or higher) and\u002For suffer from a psychotic disorder (schizophrenia and schizoaffective disorder) (as assessed by the M.I.N.I. in agreement with DSM-5 criteria) of at least moderate severity (assessed using the Positive and Negative Symptom Scale (PANSS) with a score of 75 or higher).\n2. Have had an inadequate response to at least 1 psychotropic treatment during their life-time. Inadequate response is defined as insufficient efficacy of a psychotropic treatment when dosed high enough and maintained long enough, or discontinuation of a psychotropic treatment due to AEs or intolerability.\n3. Are about to switch (or have switched within the last 2 weeks prior to first contact with an investigator) to sertraline or escitalopram (for patients with mood or anxiety disorders), or to aripiprazole or risperidone (for patients with psychotic disorders) due to an inadequate response to or intolerance of the current\u002F previous medication.\n4. Currently receiving inpatient or outpatient psychiatric treatment.\n5. Be able to understand the requirements of the study and provide written informed consent to participate in this study; a signed and dated informed consent form (ICF) will be obtained from each patient before participation in the study.\n6. To give written consent to the use and disclosure of clinical data from their medical records for the purpose of this study.\n7. Age between ≥16 and \\\u003C70 years.\n8. Ownership of a mobile phone (Android or iOS operation system) for passive monitoring.\n\nExclusion Criteria:\n\n1. Patients with a history of prior pharmacogenomic testing\n2. Patients with no prior use of psychotropic medication (medication-naïve patients)\n3. Severe somatic comorbidities as reported in the subject's medical history or based on clinical chemistry\u002Felectrocardiography (ECG) results up to six months ago. If any of these comorbidities is detected on the basis of physical examination and\u002For clinical chemistry and\u002For ECG at the screening visit, participation is not possible.\n\n   * Liver disease defined as follows: Alanine-Aminotransferase (ALAT) \\>70u\u002FL\n   * Renal disease: Estimated glomerular filtration rate (eGFR) \\\u003C 60ml\u002Fmin\u002F1.73m2\n   * Diabetes: Blood glucose \\> 11.1 mmol\u002FL or twice a fasting glucose \\> 7.0 mmol\u002FL\n   * Cardiac disease: prolonged QT-interval.\n4. Alcohol and\u002For substance abuse and\u002For dependence (except nicotine)\n5. Polypharmacy defined as the routine use of five or more medications including over- the-counter, prescription and\u002For traditional and complementary medicines used by a patient (WHO 2019).\n6. Inability to use the mobile phone application\n7. Pregnant or breastfeeding women","16 Years","70 Years",{"count":55,"type":21},2500,[24],"A 24-week, patient- and rater-blinded, two-arm, parallel-group controlled, and multi-centre randomized clinical trial (RCT) to establish the benefits of pharmacogenetics-informed pharmacotherapy versus dosing as usual (DAU) in psychiatric patients suffering from mood, anxiety, or psychotic disorders.",[59,27,28],"Mood Disorders",[61],"Pharmacogenetics","2026-05-29",{"date":64,"type":35},"2026-06-02",{"date":66,"type":35},"2023-02-23",{"date":68,"type":21},"2026-09",{"name":70,"class":42},"Parnassia Groep",9,{"id":73,"slug":74,"hasResults":12,"nctId":75,"briefTitle":76,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":12,"sex":16,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":84,"conditions":85,"keywords":90,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":97,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":104},"100326055","semantic-and-syntactic-computerized-analysis-of-free-speech-100326055","NCT03525054","Semantic and Syntactic Computerized Analysis of Free Speech","ASESID","Inclusion Criteria:\n\n* Major and\u002For minor from 15 to 30 years old\n* Who alleged a suicidal gesture or idea or behavior that has repercussions in their emotional, social or professional life\n* If patients receive neuroleptic treatment that impairs cognitive abilities, a one-week wash-out period will be scheduled prior to assessment.\n* Affiliated with or beneficiary of a health insurance\u002Fsocial security system\n* Able and willing to provide written informed consent\n\nExclusion Criteria:\n\n* History of psychosis\n* Risk of self-harm or violence not compatible with outpatient treatment\n* QI\\\u003C70 (WAIS)\n* Neurological disorder or major health problem\n* Impossibility to interrupt neuroleptic treatment for one week\n* Refusal to participate","15 Years","30 Years",{"count":82,"type":21},215,"OBSERVATIONAL","Subtle speech disorganization could be predictive of a transition to schizophrenia of ultra-high-risk patients. The aim of our longitudinal multicenter cohort study is to identify specific linguistic markers of the psychotic transition to validate a french predictive model of this transition using computerized speech analysis techniques",[28,86,87,88,89],"Psychosis","Schizophrenia and Related Disorders","Schizophrenia Prodromal","Diagnosis, Psychiatric",[28,89,88,91,92,93,94,95,96],"Ultra High Risk","Prediction Of Psychosis","Machine Learning","Automated Language Analysis","Semantic Coherence","Syntaxic Complexity",{"date":64,"type":35},{"date":99,"type":35},"2018-05-18",{"date":101,"type":21},"2030-05-02",{"name":103,"class":42},"University Hospital, Brest",3,{"id":106,"slug":107,"hasResults":12,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":112,"sex":16,"minAge":52,"maxAge":113,"enrollmentInfo":114,"targetDuration":4,"studyType":22,"phases":116,"briefSummary":117,"conditions":118,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":43},"100473460","investigating-the-neural-correlates-of-cognitive-function-in-psychosis-patients-and-non-psychiatric-controls-with-cannabis-use-100473460","NCT05445180","Investigating the Neural Correlates of Cognitive Function in Psychosis Patients and Non-Psychiatric Controls With Cannabis Use","Investigating the Neural Correlates of Cognitive Function Associated With Cannabis Abstinence in Psychosis Patients and Non-Psychiatric Controls With Cannabis Use","Inclusion Criteria:\n\n* Able to provide informed consent in English or French\n* Heavy cannabis use (defined as weekly cannabis use for at six months) and\u002For DSM-5 diagnosis of CUD\n* Have a Full-Scale IQ ≥ 75\n* Meet DSM-5 criteria for a psychotic disorder (psychosis patient arm only)\n* Be an outpatient receiving a stable dose of medication(s) for at least two months (psychosis patient arm only)\n* Clinically stable (as measured by the PANSS-6, total score \\\u003C30) (psychosis patient arm only)\n\nExclusion Criteria:\n\n* current SUD (other than CUD)\n* MRI contraindications\n* Positive urine screen for psychoactive substances other than cannabis, nicotine, or caffeine\n* Current suicidal or homicidal ideation\n* Head injury requiring hospitalization or loss of consciousness \\> 5 minutes\n* Current medical diseases that requires hospitalization or regular monitoring\n* Being pregnant\n* DSM-5 Axis 1 diagnosis (other than CUD) (non-psychiatric controls only)\n* Taking psychotropic medication",true,"80 Years",{"count":115,"type":21},134,[24],"Cognitive impairment is well established in people with psychosis and is associated with cannabis use. The current study will investigate the neurobiological basis of cognitive change associated with 28-days of cannabis abstinence in people with psychosis and non-psychiatric controls with cannabis use. Participants will be randomized to a cannabis abstinent group or a non-abstinent control group and will undergo magnetic resonance imaging at baseline and following 28-days of abstinence. This study will help characterize the neuropathophysiological processes underlying cognitive dysfunction associated with cannabis use and its recovery which may guide the development of novel interventions for problematic cannabis use.",[28,119,120,121,122,123,124,125],"Cannabis Use Disorder","Cannabis Dependence","Cannabis Use","Schizophrenia; Psychosis","Cognitive Dysfunction","Memory Impairment","Neuroimaging","2026-05-19",{"date":128,"type":35},"2026-05-22",{"date":130,"type":35},"2022-04-21",{"date":132,"type":21},"2027-05",{"name":134,"class":42},"Douglas Mental Health University Institute",{"id":136,"slug":137,"hasResults":12,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":4,"eligibilityCriteria":141,"healthyVolunteers":12,"sex":16,"minAge":142,"maxAge":80,"enrollmentInfo":143,"targetDuration":4,"studyType":22,"phases":145,"briefSummary":146,"conditions":147,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":43},"100587519","a-preventive-behavioral-intervention-for-young-adults-with-psychotic-experiences-100587519","NCT06929442","A Preventive Behavioral Intervention for Young Adults With Psychotic Experiences","A Randomized Controlled Trial of a Preventive Behavioral Intervention for Young Adults With Psychotic Experiences","Inclusion criteria:\n\n1. 18-30 years old\n2. Enrolled as a first or second year student (i.e., freshman or sophomore) in an undergraduate program at the college or university where the intervention takes place\n3. Students who endorse some psychotic experiences (Peter's et al. Delusion Inventory (PDI) score \\> 3)\n\nExclusion criteria:\n\n1. Inability to provide informed consent\n2. Not proficient in English\n3. Current self-reported Diagnostic Statistical Manual 5 (DSM-5) diagnosis with active symptoms (such as active psychotic symptoms, current suicidality, serious active alcohol or substance use, marked deterioration in functioning over the prior month) determined by clinical interview with participant, or self-report of a psychiatric diagnosis that necessitates close monitoring or individual therapy and\u002For inpatient or partial hospitalization\n4. Current enrollment in psychological or behavioral health treatment.\n5. Current use of psychotropic medications (other than stimulants) prescribed by a physician.\n6. A diagnosis of a serious, chronic mental illness as determined by the Mini-International Neuropsychiatric Interview (MINI)","18 Years",{"count":144,"type":21},192,[24],"This is a randomized controlled trial testing the efficacy of Resilience Training in college students with elevated transdiagnostic risk for developing a serious mental illness.",[28,59,27],"2026-05-07",{"date":150,"type":35},"2026-05-11",{"date":152,"type":35},"2025-02-10",{"date":154,"type":21},"2029-06",{"name":41,"class":42},{"id":157,"slug":158,"hasResults":12,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":4,"eligibilityCriteria":162,"healthyVolunteers":112,"sex":16,"minAge":142,"maxAge":4,"enrollmentInfo":163,"targetDuration":4,"studyType":22,"phases":165,"briefSummary":166,"conditions":167,"keywords":169,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":43},"100628347","racial-disparities-in-the-expression-of-paranoia-100628347","NCT07460453","Racial Disparities in the Expression of Paranoia","Study of Life Challenges, Personality, and Emotional Experiences","Inclusion Criteria\n\n* 18 years of age or older\n* Self-identify as non-Hispanic Black or African American\n* Currently reside in the United States\n* Speak and read English\n* Registered as a survey participant on the Prolific platform\n\nExclusion Criteria\n\n* Younger than 18 years of age\n* Do not self-identify as non-Hispanic Black or African American\n* Do not currently reside in the United States\n* Do not speak or read English\n* Not registered as a survey participant on the Prolific platform",{"count":164,"type":21},480,[24],"Paranoia is a pattern of thinking in which people feel suspicious or believe others may want to harm them. It can occur in many people, not only those with a mental health diagnosis, and it can affect daily life, relationships, and overall well-being. Research has consistently shown that Black Americans report higher levels of paranoia than White Americans, even when they do not have a clinical diagnosis. However, the reasons for this difference are not well understood.\n\nThe goal of this study is to better understand why these differences exist. In the experimental part of the study, researchers will use a randomized design to test whether exposure to stressful experiences related to race leads to higher levels of paranoia among Black American participants. The study will also examine factors that may strengthen or weaken this effect, such as individual experiences and personal characteristics.\n\nBy identifying how stressful experiences related to race influence paranoia, this research aims to improve how paranoia is measured and understood across different groups. These findings may help researchers and clinicians use more accurate and culturally appropriate tools to assess psychosis-related experiences in diverse populations.",[168,28],"Paranoia",[168,170,171,172,173],"Psychosis-Spectrum","Adverse Experiences","Experimental Paradigm","General Population","2026-04-28",{"date":176,"type":35},"2026-04-29",{"date":178,"type":35},"2026-04-13",{"date":180,"type":21},"2026-06-30",{"name":182,"class":42},"Indiana University",{"id":184,"slug":185,"hasResults":12,"nctId":186,"briefTitle":187,"officialTitle":188,"acronym":189,"eligibilityCriteria":190,"healthyVolunteers":12,"sex":16,"minAge":142,"maxAge":4,"enrollmentInfo":191,"targetDuration":4,"studyType":22,"phases":193,"briefSummary":194,"conditions":195,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":198,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":43},"100620672","multimodal-physical-exercise-program-physical-exercise-for-psychosis-for-people-with-psychosis-treated-with-long-acting-injectable-antipsychotics-100620672","NCT07360665","Multimodal Physical Exercise Program (Physical Exercise for Psychosis) for People With Psychosis Treated With Long-Acting Injectable Antipsychotics","PEP - Physical Exercise for Psychosis: A Study Protocol","PEP","Inclusion Criteria:\n\n* Age 18 years or older;\n* Clinical diagnosis of psychosis;\n* Currently undergoing treatment with long-acting injectable antipsychotics (LAIs);\n* Follow-up at the Antipsychotic Clinic of ULSTMAD;\n* Certificate of autonomy issued by the treating psychiatrist, confirming the participant's capacity to engage in the study procedures;\n* Ability to provide written informed consent, either personally or through a legal representative;\n* (Experimental group only) Residence within a reasonable distance from the physical exercise intervention site to allow attendance at supervised sessions.\n\nExclusion Criteria:\n\n* Attendance below 85% of the supervised exercise sessions (experimental group);\n* Failure to complete the four main assessment time points;\n* Withdrawal or lack of informed consent at any stage of the study;\n* Not prescribed long-acting injectable antipsychotics (LAIs);\n* Not affiliated with or followed at the Antipsychotic Clinic of ULSTMAD.",{"count":192,"type":21},44,[24],"People with psychotic disorders, such as schizophrenia, often experience significant difficulties in daily functioning, physical health, and quality of life. Long-acting injectable antipsychotics are an important part of treatment, but they can be associated with metabolic side effects and reduced physical fitness. Physical exercise has shown potential benefits for mental and physical health in this population; however, structured exercise programs implemented in real-world psychiatric services are still limited.\n\nThe purpose of this study is to evaluate the feasibility and clinical impact of a structured, multimodal physical exercise program for adults with psychosis who are receiving long-acting injectable antipsychotic treatment. The study aims to determine whether participation in a supervised exercise program can improve physical functioning, psychological well-being, and selected biological markers related to brain health and metabolism.\n\nThis study will be conducted in an outpatient psychiatric setting in Portugal and will include adults diagnosed with psychosis who are currently treated with long-acting injectable antipsychotics. Participants will be allocated to either an exercise group or a control group receiving usual care. The exercise program will last 24 weeks and will include aerobic, strength, mobility, and flexibility exercises, with supervised sessions conducted by qualified professionals.\n\nParticipants will be assessed at baseline, during the intervention, after completion of the program, and at follow-up. Assessments will include measures of physical function, body composition, psychological well-being, quality of life, and blood-based biomarkers such as brain-derived neurotrophic factor, dopamine, serotonin, and metabolic indicators.\n\nThe main hypothesis of this study is that individuals who participate in the physical exercise program will show improvements in physical function, mood, and overall well-being compared with those receiving usual care alone. The results of this study are expected to provide practical evidence to support the integration of structured physical exercise as an adjunct to routine psychiatric care for people with psychosis.",[28,196,197],"Schizophrenia Spectrum Disorders (SSD)","Severe Mental Illness",{"date":176,"type":35},{"date":200,"type":35},"2026-01-01",{"date":202,"type":21},"2026-11-30",{"name":204,"class":42},"University of Trás-os-Montes and Alto Douro",{"id":206,"slug":207,"hasResults":12,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":211,"eligibilityCriteria":212,"healthyVolunteers":12,"sex":16,"minAge":142,"maxAge":4,"enrollmentInfo":213,"targetDuration":4,"studyType":22,"phases":215,"briefSummary":216,"conditions":217,"keywords":220,"overallStatus":224,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":234},"100635637","testing-a-peer-support-group-for-veterans-who-hear-voices-100635637","NCT07555275","Testing a Peer-Support Group for Veterans Who Hear Voices","A Multisited Efficacy Trial of Veteran Voices and Visions","VVV RCT","Inclusion Criteria:\n\n* Has been experiencing auditory hallucinations at least weekly within the past 6 months that are not exclusively due to substance use\n* English fluency sufficient for participating in groups\n* Able to provide consent\n\nExclusion Criteria:\n\n* Psychosis exclusively due to substance use\n* Clinically significant seizure disorder, traumatic brain injury, dementia, developmental disorder\u002Fintellectual disability\n* Inability to provide informed consent for any reason, including due to acute psychosis, mania, or dementia, or active guardianship or durable power of attorney\n* Plan to transfer or terminate care in the next 3 months\n* Has previously attended a VVV group",{"count":214,"type":21},160,[24],"Veterans with schizophrenia spectrum disorders who experience psychosis struggle with social integration- e.g., participation in work, housing, and citizenship-due to symptoms, stigma, and psychosocial functioning deficits. Veteran Voices and Visions (VVV) is a psychosocial, peer-led group intervention for Veterans with psychosis based that reduces distress related to psychosis and fosters a sense of belonging for Veterans living with psychosis. VVV destigmatizes psychosis; reframes symptoms; and introduces personalized, meaningful coping strategies enabling social interaction. The investigators will assess VVV's efficacy in a trial comparing recipients of VVV to another peer-led group, Wellness Recovery Action Planning (WRAP), on outcomes of distress from psychosis, sense of belonging, and social functioning while identifying contextual factors regarding implementation at two sites. The investigators hypothesize that proximal reduction in distress and increased sense of belonging results in improvements in social functioning.",[28,218,219],"Hallucinations, Auditory","Social Isolation",[28,221,222,223],"hallucinations, auditory","social isolation","Veterans","NOT_YET_RECRUITING","2026-04-21",{"date":176,"type":35},{"date":228,"type":21},"2027-04-01",{"date":230,"type":21},"2030-09-30",{"name":232,"class":233},"VA Office of Research and Development","FED",2,{"id":236,"slug":237,"hasResults":12,"nctId":238,"briefTitle":239,"officialTitle":239,"acronym":4,"eligibilityCriteria":240,"healthyVolunteers":12,"sex":16,"minAge":142,"maxAge":241,"enrollmentInfo":242,"targetDuration":4,"studyType":22,"phases":244,"briefSummary":245,"conditions":246,"keywords":249,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":255,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":261,"locationsCount":43},"100514025","examining-the-efficacy-of-a-virtual-reality-cognitive-remediation-program-for-people-living-with-psychosis-100514025","NCT05973110","Examining the Efficacy of a Virtual Reality Cognitive Remediation Program for People Living With Psychosis","Inclusion Criteria:\n\n* Diagnosis of a psychosis-spectrum disorder\n* Equal or between 18 to 60 years old\n* Ability to read and speak English\n* Be clinically stable, as defined as a total Positive And Negative Severity Symptoms score equal or between 30 - 95\n* No changes to their medication dosage, starting a new medication, or stopping a medication within the past month before signing the consent form\n\nExclusion Criteria:\n\n* Neurological or medical disorders that may produce cognitive impairment (including head injury with more than 1 minute of loss of consciousness)\n* Intellectual disability or a score equal or below 70 on the Wechsler Abbreviated Scale of Intelligence.\n* Any vision conditions that cannot be corrected with contact lenses or glasses that can fit in the virtual reality googles.\n* Past history of seizures, fit, and epilepsy\n* Any severe medical condition related to the eyes, ears, and balance\n* History of substance use disorder within the last 3 months","60 Years",{"count":243,"type":21},52,[24],"Individuals living with a psychotic disorder often experience changes to their thinking and social skills that can lead to challenges with work, school, relationships and living independently. One intervention to target these areas is cognitive remediation therapy, which can be delivered in virtual reality to help apply the skills and strategies learned to day-to-day life. Over the past few years, our team has co-developed a cognitive remediation program in virtual reality with healthcare professionals and people with lived experiences of psychosis. The current trial tests the feasibility and efficacy of this cognitive remediation program in virtual reality at improving thinking skills, social skills, and daily life functioning.",[28,247,248],"Schizophrenia","Schizo Affective Disorder",[28,250,251,252,253,254],"Cognitive Remediation","Virtual Reality","Neurocognition","Social Cognition","Community Functioning",{"date":256,"type":35},"2026-04-16",{"date":258,"type":35},"2023-07-31",{"date":260,"type":21},"2026-12",{"name":262,"class":42},"The Royal Ottawa Mental Health Centre",{"id":264,"slug":265,"hasResults":12,"nctId":266,"briefTitle":267,"officialTitle":268,"acronym":269,"eligibilityCriteria":270,"healthyVolunteers":12,"sex":16,"minAge":142,"maxAge":271,"enrollmentInfo":272,"targetDuration":4,"studyType":22,"phases":274,"briefSummary":275,"conditions":276,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":279,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":43},"100627999","feasibility-acceptability-and-preliminary-efficacy-of-yoga-based-group-intervention-for-outpatients-with-schizophrenia-spectrum-disorders-100627999","NCT07455929","Feasibility, Acceptability, and Preliminary Efficacy of Yoga-based Group Intervention for Outpatients With Schizophrenia Spectrum Disorders","Feasibility, Acceptability, and Preliminary Efficacy of Yoga-based Group Intervention for Outpatients With Schizophrenia Spectrum Disorders (YOGIA Study) - a Three-arm, Single-blind Randomized Controlled Pilot Study","YOGIA","Inclusion Criteria:\n\n* Diagnosis of Schizophrenia Spectrum Disorder by previous (medical) reports according to ICD-10\u002F DSM-V\n* Treated as psychiatric outpatients\n* Age between 18 and 65 years\n* Ability to give informed consent\n* Willingness and ability to engage in psychotherapeutic group therapy\n* Low to moderate psychotic state indicated with a score of ≤ 6 for each item at the Positive scale of the Positive and Negative Syndrome Scale (PANSS, Peralta \\& Cuesta, 1994)\n\nExclusion Criteria:\n\n* Neurological disorders and history of severe traumatic brain injury in the past that may affect cognitive functioning\n* Acute substance dependence, excluding nicotine and prescribed medication\n* PANSS-P score on one item \\> 6 (= very severe)\n* Ineligibility for group participation\n* Acute suicidality, indicated by a score \\> 1 on item 8 of the Calgary Depression Scale for Schizophrenia (Addington, Addington, Maticka-Tyndale, \\& Joyce, 1992)\n* Conflicting co-therapy such as electroconvulsive therapy or ketamine treatment as well as intensive psychotherapy","65 Years",{"count":273,"type":21},60,[24],"A three-arm pilot rater-blinded randomized controlled trial is conducted, comprising Yoga-based Group Intervention (YoGI + TAU) as the experimental condition, a strength and flexibility training (SFT + TAU) group, and treatment as usual (TAU). Participants in all conditions receive the respective intervention in addition to treatment as usual (TAU) in outpatient settings in Germany. The interventions are designed for patients with schizophrenia spectrum disorders. To examine feasibility, acceptability, and preliminary efficacy, self-report measures and blinded rater-based assessments are administered at baseline (T0), after 12 weeks of participation (T1), and at a 3-month follow-up (T2). Before each intervention session, acute stress (general stress and symptom-related distress) is measured using a visual analogue scale. After each intervention session, acute stress (general stress and symptom-related distress; visual analogue scale), perceived effort (BORG-RPE-Scale), and the occurrence of unpleasant experiences are recorded via self-report, while instructors rate exercise performance and overall participation quality. In addition, semi-structured interviews are conducted at T0 and T1 to assess subjective mechanisms of change and relevant processes.\n\nThe primary outcomes of this trial are the feasibility and acceptability of YoGI and the SFT, assessed through recruitment and retention rates, adherence, and participant feedback. Based on recommendations for pilot studies of 20-50 participants, a conservative target sample size of 60 patients was determined. Further, the trial will evaluate secondary outcomes, including (body) mindfulness (SMQ, BMQ), symptoms of depression, anxiety, and stress (DASS, CDSS), positive and negative symptomatology (PANSS), psychological flexibility (CFQ), psychological well-being (WHO-QoL-BREF), social functioning (PSP), subjectively perceived cognitive functioning (SSTICS), and physical activity (SIMPAQ). This study aims to provide preliminary evidence for the efficacy of YoGI in comparison to both SFT and a TAU, and to establish a foundation for a future fully powered randomized controlled trial.",[28,277],"Schizophrenia Spectrum Disorders","2026-03-09",{"date":280,"type":35},"2026-03-11",{"date":282,"type":21},"2026-03",{"date":284,"type":21},"2028-03",{"name":286,"class":42},"Charite University, Berlin, Germany",{"id":288,"slug":289,"hasResults":12,"nctId":290,"briefTitle":291,"officialTitle":292,"acronym":293,"eligibilityCriteria":294,"healthyVolunteers":12,"sex":16,"minAge":142,"maxAge":271,"enrollmentInfo":295,"targetDuration":4,"studyType":22,"phases":296,"briefSummary":297,"conditions":298,"keywords":301,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":304,"lastUpdatePostDateStruct":305,"startDateStruct":307,"completionDateStruct":309,"leadSponsor":310,"locationsCount":43},"100623328","acceptability-feasibility-and-preliminary-outcomes-of-the-kiso-mind-app-for-outpatients-with-schizophrenia-spectrum-disorders-100623328","NCT07395206","Acceptability, Feasibility and Preliminary Outcomes of the Kiso Mind App for Outpatients With Schizophrenia Spectrum Disorders","Acceptability, Feasibility and Preliminary Outcomes of the Kiso Mind App for Outpatients With Schizophrenia Spectrum Disorders: A Randomized Controlled Pilot Trial","KISO","Inclusion Criteria:\n\n* ICD-10: F20 Schizophrenia, F25 Schizoaffective Disorder\n* Age: 18 - 65 years\n* Sufficient German Language Proficiency\n* Ability to Use a Smartphone\n\nExclusion Criteria:\n\n* Intensive Psychotherapy Protocols (more than one psychotherapy session a month)\n* CGI-Score \\\u003C 3; \\> 6\n* No smartphone\n* Neurological Disorders or Brain Damage\n* Acute Suicidality\n* Acute Heavy Substance Abuse or Addiction\n* Current Electroconvulsive Therapy",{"count":273,"type":21},[24],"The Kiso pilot study is a randomized controlled trial to test the acceptability and feasibility of a novel digital intervention, namely the Kiso Mind smartphone app. A parallel-group design is utilized. Participants either receive access to the Kiso Mind intervention and treatment-as-usual (TAU) in the experimental condition or receive treatment as usual (TAU) in the control condition. The intervention is designed for participants diagnosed with either schizophrenia (F20.0) or schizoaffective disorder (F25.0) according to the ICD-10.\n\nTo examine acceptability, feasibility, and preliminary effectiveness, both self-report and rater-based assessments are administered at baseline (T0) and at the end of the 12-week intervention period (post-intervention T1). Lastly, a qualitative interview will be conducted with participants from the experimental condition. The primary outcome of the present study is the acceptability and feasibility of the Kiso Mind app. The secondary outcome consists of general psychopathology, and positive-, negative-, depressive symptoms, as well as social functioning and self-efficacy ratings.",[86,28,299,277,247,300],"Primary Psychotic Disorders","Schizoaffective Disorder",[86,28,299,247,300,277,302,303],"Digital Intervention","E-Health","2026-02-28",{"date":306,"type":35},"2026-03-03",{"date":308,"type":35},"2026-01-30",{"date":180,"type":21},{"name":286,"class":42},{"id":312,"slug":313,"hasResults":12,"nctId":314,"briefTitle":315,"officialTitle":316,"acronym":317,"eligibilityCriteria":318,"healthyVolunteers":12,"sex":16,"minAge":142,"maxAge":4,"enrollmentInfo":319,"targetDuration":4,"studyType":22,"phases":321,"briefSummary":322,"conditions":323,"keywords":327,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":334,"startDateStruct":336,"completionDateStruct":338,"leadSponsor":340,"locationsCount":43},"100574371","cbt-cp-for-veterans-with-smi-100574371","NCT06758414","CBT-CP for Veterans With SMI","Exploring the Efficacy of Cognitive Behavioral Therapy for Chronic Pain in Veterans With Serious Mental Illness","CP-SMI","Inclusion Criteria:\n\n* Have chronic back pain, per medical record\n* Have a PEG-3 rating of 4 or greater for pain severity or interference\n* Meet criteria for an SMI diagnosis (schizophrenia, schizoaffective disorder, bipolar disorder, major depression with psychosis) per medical record\n* 18 years of age or older\n* Enrolled in outpatient programming within a VISN 5 health care facility at time of consent\n* Have regular access to a telephone\n* Capacity to sign informed consent\n\nExclusion Criteria:\n\n* Are engaging in moderate-to-severe substance use that would impact their ability to participate and\u002For would require a higher level of care (as determined by treating provider)\n* Engagement in individual Cognitive Behavioral Therapy for Chronic Pain (CBT-CP), whether currently or in the past 12 months\n* Have a current acute pain condition, medical condition, or limited mobility (i.e., unable to walk one city block) that would interfere with their ability to engage in CBT-CP interventions (e.g., activity pacing\u002Fwalking program)",{"count":320,"type":21},190,[24],"Chronic musculoskeletal pain has a highly negative impact on Veterans, especially those with serious mental illness (SMI). Chronic musculoskeletal pain leads to poorer mental and physical health-related functioning, representing a critical obstacle to rehabilitation and recovery for SMI Veterans. Despite known high prevalence rates of chronic pain in SMI populations, there is little research to evaluate nonpharmacological pain management strategies in this population. This study aims to address this research and clinical gap by testing the efficacy of Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) - a VA evidence-based psychotherapy for chronic pain - in Veterans with SMI and chronic low back pain. The study will primarily evaluate the impact of CBT-CP on pain-related functioning, quality of life, and pain severity. This study will also examine relationships between pain and mental health symptoms, and how these relationships may change with CBT-CP completion.",[324,247,28,325,326],"Chronic Pain","Bipolar Disorder","Affective Disorders, Psychotic",[223,328,329,330,331,332],"chronic pain","psychotic disorders","affective disorders, psychotic","cognitive behavioral therapy","ecological momentary assessment","2026-02-04",{"date":335,"type":35},"2026-02-09",{"date":337,"type":35},"2026-02-01",{"date":339,"type":21},"2029-09-30",{"name":232,"class":233},{"id":342,"slug":343,"hasResults":12,"nctId":344,"briefTitle":345,"officialTitle":346,"acronym":347,"eligibilityCriteria":348,"healthyVolunteers":112,"sex":16,"minAge":349,"maxAge":350,"enrollmentInfo":351,"targetDuration":4,"studyType":22,"phases":353,"briefSummary":354,"conditions":355,"keywords":356,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":365,"lastUpdatePostDateStruct":366,"startDateStruct":368,"completionDateStruct":370,"leadSponsor":372,"locationsCount":374},"100390959","dimensional-and-developmental-profiles-of-psychosis-in-children-and-adolescents-100390959","NCT04370730","Dimensional and Developmental Profiles of Psychosis in Children and Adolescents","Dimensional and Developmental Approach to Psychotic Episodes in Children and Adolescents: Impact on Clinical Management","PSYDEV","Inclusion Criteria for the Patient:\n\n1. Children and young adults ages 7-20 years with age of onset of psychotic disorder between 7-17 years.\n2. Hospitalized or seen for out-patient treatment for a psychotic episode, acute or chronic.\n3. DSM-V diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, psychotic disorder not otherwise specified, or major depressive episode with psychotic features.\n4. Written informed consent signed by the parents or the individual(s) with legal parental authority, and by the minor patient if his\u002Fher condition permits.\n5. Written informed consent signed by the patient if he\u002Fshe is a major, after clinical stabilization (not delusional).\n6. Has health insurance coverage from Social Security (France) (not AME coverage).\n\nInclusion Criteria for parents or siblings wishing to participate in the genetic part of the study :\n\n1. Parents : no specific criteria.\n2. Siblings : siblings are eligible to participate if there are at least two first-degree relatives with psychotic disorders (including the patient) in the family.\n3. Written informed consent for the genetic part of the study signed by any participating parents and siblings.\n4. Has health insurance coverage from Social Security (France) (not AME coverage).\n\nExclusion Criteria:\n\n1. Moderate or severe intellectual deficiency (IQ \\\u003C 50).\n2. Psychoses judged to be secondary to medical illness, medication effects or drugs of abuse.\n3. Diagnosis of bipolar disorder.\n4. Patients who are under legal guardianship.\n5. For the neuroimaging part of the study only : any contraindications to Magnetic Resonance Imaging.","7 Years","20 Years",{"count":352,"type":21},200,[24],"Five collaborating sites in France will study the broad spectrum of schizophrenia in children and adolescents. Patients will be studied with diagnostic interviews, developmental histories, dimensional clinical ratings, comprehensive cognitive assessments, neuroimaging and DNA (copy number variant) analyses (in families and patients who agree), and follow-up of course of illness, cognitive status and treatment response to specific antipsychotic drugs. The goal of the study is to test a prior hypothesis about clinical subgroups in this population and to test whether these subgroups predict antipsychotic medication response.",[247,28],[357,358,359,360,361,362,363,364],"schizophrenia","schizophrenia spectrum","psychosis","early-onset","cognition","magnetic resonance imaging","course of illness","treatment response","2026-01-21",{"date":367,"type":35},"2026-01-23",{"date":369,"type":35},"2021-06-02",{"date":371,"type":21},"2026-10-01",{"name":373,"class":42},"Assistance Publique - Hôpitaux de Paris",6,{"id":376,"slug":377,"hasResults":12,"nctId":378,"briefTitle":379,"officialTitle":380,"acronym":381,"eligibilityCriteria":382,"healthyVolunteers":12,"sex":16,"minAge":52,"maxAge":383,"enrollmentInfo":384,"targetDuration":4,"studyType":22,"phases":386,"briefSummary":388,"conditions":389,"keywords":392,"overallStatus":224,"whyStopped":4,"lastUpdateSubmitDate":395,"lastUpdatePostDateStruct":396,"startDateStruct":398,"completionDateStruct":400,"leadSponsor":402,"locationsCount":404},"100575921","phase-3-stratification-and-treatment-in-early-psychosis-study---enhance-100575921","NCT06778564","Stratification and Treatment in Early Psychosis Study - ENHANCE","Augmentation With Cannabidiol in First Episode Psychosis: a Double-blind, Randomised Controlled Trial","STEP-ENHANCE","Inclusion criteria:\n\n1. The participant is 16 to 40 years of age, willing and able to provide written informed consent\u002Fassent.\n2. The participant is currently being treated with an antipsychotic for at least 3 weeks but no longer than 16 weeks.\n3. The participant should be receiving at least the minimum dose of this antipsychotic for FEP according to modified Maudsley guidelines, as listed in Appendix B. The clinician should judge the participant to be a non-responder to this treatment and that increasing the dose further is unacceptable to the clinician and\u002For participant.\n4. The compliance score associated with this antipsychotic medication is 4 or more on the Clinician Rating Scale (CRS).\n5. The participant meets DSM-5 criteria for schizophrenia, schizoaffective disorder or schizophreniform disorder, as confirmed through the SCID-5-RV.\n6. The participant does not meet modified Andreasen criteria for symptomatic remission (time requirement does not apply).\n7. Participants of childbearing potential (\\*) must be willing to ensure that they use highly effective contraception during the trial and as per the requirements in the protocol\\*\\*.\n8. In the Investigator's opinion, is able and willing to comply with all trial requirements.\n9. Willing to allow their General Practitioner and\u002For consultant, if required by local guidelines\u002Fregulations, to be notified of participation in the trial.\n10. For participants who take part in the optional MRI scans: they must be eligible for MRI scanning as per local requirements, for example concerning e.g. implants, braces etc.\n\nThere is inadequate information on the effects of cannabidiol on the foetus in humans. Participants of childbearing potential\\* should use a highly effective method of contraception\\*\\* for the duration of the trial and for 3 months after the last time the trial intervention was used.\n\n\\*A person is considered of childbearing potential, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.\n\n\\*\\* Methods that can achieve a failure rate of less than 1% per year when used consistently and correctly are considered as highly effective birth control methods. Such methods include: 1) combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral; intravaginal; transdermal); 2) progestogen-only hormonal contraception associated with inhibition of ovulation (oral; injectable; implantable); 3) intrauterine device (IUD); 4) intrauterine hormone-releasing system (IUS); 5) bilateral tubal occlusion; 6) vasectomised partner; 7) sexual abstinence (abstinence should only be used as a contraceptive method if it is in line with the participants' usual and preferred lifestyle).\n\nPeriodic abstinence (calendar, symptothermal, post-ovulation methods) is not an acceptable method of contraception. The participant agrees to use an acceptable method of contraception\\* for the duration of the study and for 3 months after any study drug administration, unless surgically sterile or postmenopausal (no menses for 12 months without an alternative medical cause).\n\nThe age range for eligibility has been applied as this corresponds to the usual age range for first episode psychosis; individual cases outside of this age range may have a different aetiology and\u002For prognosis which could impact on the study outcomes.\n\nExclusion criteria:\n\n1. Having been previously treated with a different antipsychotic (to the current one) at an adequate dose\\* for 4 weeks or longer.\n2. Current or previous treatment with clozapine and\u002For current treatment with sodium valproate, valproate semisodium, or clobazam. In cases of current use of these medicines, participation is only permitted if they can and will be discontinued or switched to a suitable alternative medication prior to randomisation.\n3. Hypersensitivity to the active substance, sesame oil, sesame seed or any of the excipients of the intervention.\n4. Known hepatic insufficiency and\u002For transaminase elevations levels exceeding the upper limit of normal 2 times or more and bilirubin greater than 1.5 times the upper limit of normal.\n5. Previous neurosurgery or neurological disorder, including epilepsy, which may affect the study procedures\\*\\*.\n6. IQ \\\u003C70.\n7. Pregnancy or breastfeeding.\n8. The patient has a current diagnosis of 'Substance or medication induced psychotic disorder' or 'Psychotic disorder due to another medical condition' as determined through the SCID-5-RV.\n9. Current active suicidal ideation within the last 2 weeks, defined as a score of 1 or higher on CDSS question 8, followed by an assessment by the treating clinician who determines it is not safe for the patient to participate in the study\\*\\*\\*.\n10. Meeting DSM-V criteria for substance use disorder, with the exception of nicotine use disorder (mild, moderate, and severe allowed). Mild cannabis use disorder is allowed (i.e. can meet up to but no more than 3 criteria on the SCID) as long as the subject patient has not consumed cannabis on average more than three times a week in the past 30 days. Mild alcohol use disorder is also allowed.\n11. Patient has participated in another clinical trial in which they received an experimental or investigational drug or agent within 3 months before Visit 0. Patients who have participated in Type A studies (e.g. trials of standard and within-label treatments including antipsychotic medication) or non CTIMP studies (e.g. studies of exercise therapy) must have completed the intervention but may be included if permitted by the protocol of the other trial.\n12. The participant refuses any mandatory safety checks during the trial, specifically, refusal of: urine pregnancy test (those of child-bearing potential only); safety blood test; reporting of adverse events; and assessment of suicidality.\n13. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.\n\n    * Adequate doses are provided in Appendix B. \\*\\*Minor neurological disorders such as migraine, other minor headache disorders, sleep disorders or nerve palsies which are unlikely to affect study outcomes including neuroimaging measures are permitted.\n\n      * The decision to include the patient is at clinician's discretion. The clinician can conclude that it is safe for the patient to participate after the patient is evaluated, in which case this exclusion criterion does not apply and the patient can participate. Either way, the treating clinician needs to record his\u002Fher evaluation of suicidal risk in the source documentation or medical file, including his\u002Fher considerations, and notify the site PI of the decision.","40 Years",{"count":385,"type":21},250,[387],"PHASE3","The purpose of this study is:\n\n* To investigate whether the response to antipsychotic treatment can be enhanced by adding cannabidiol (CBD) to the existing treatment, compared to placebo, in participants with a first episode of psychosis, who have had a suboptimal or no response to their first antipsychotic treatment.\n* To confirm the safety of CBD in people with psychosis.\n\nThe study is a randomized, double-blind, placebo-controlled, multi-centre, clinical trial. Individuals with a diagnosis of first-episode psychosis, who have had a suboptimal or no response to their first antipsychotic treatment will be recruited. These participants are randomised to treatment with CBD oral solution 500mg twice daily, or a matching placebo for 6 weeks, as an adjunct to their existing antipsychotic treatment. By using a battery of clinical outcome assessments, the trial will also assess several biomarkers to determine if they can be used to predict clinical outcomes and response to treatment with CBD. Biomarkers are being assessed as an exploratory outcome measure. Participants will be invited to provide blood and stool samples, and may be asked to complete neuroimaging assessments at certain eligible sites.",[86,390,28,391],"First Episode Psychosis","Psychotic Episode",[393,394],"Cannabidiol","first episode psychosis","2025-12-04",{"date":397,"type":35},"2025-12-12",{"date":399,"type":21},"2026-02",{"date":401,"type":21},"2029-02",{"name":403,"class":42},"University of Oxford",17,{"id":406,"slug":407,"hasResults":12,"nctId":408,"briefTitle":409,"officialTitle":409,"acronym":410,"eligibilityCriteria":411,"healthyVolunteers":12,"sex":16,"minAge":142,"maxAge":412,"enrollmentInfo":413,"targetDuration":4,"studyType":22,"phases":415,"briefSummary":416,"conditions":417,"keywords":427,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":395,"lastUpdatePostDateStruct":440,"startDateStruct":441,"completionDateStruct":443,"leadSponsor":445,"locationsCount":43},"100409377","cognitive-remediation-in-forensic-mental-health-care-100409377","NCT04610697","Cognitive Remediation in Forensic Mental Health Care","CRFMHC","Inclusion Criteria:\n\ni1. Age 18 - 55; i2. Ability to read and speak in fluent English; i3. Current status as inpatient on the Forensic Treatment Unit.\n\nExclusion Criteria:\n\ne1. Intellectual disability; e2. TBI with loss of consciousness followed by known severe neurological sequelae requiring hospitalisation and rehabilitation.","55 Years",{"count":414,"type":21},30,[24],"Forensic patients often display cognitive deficits, particularly in the domain of executive functions, that represent a challenge to forensic rehabilitation.\n\nOne empirically-validated method to train executive functions is cognitive remediation, which consists of cognitive exercises combined with coaching.\n\nThis trial investigates whether cognitive remediation can improve cognitive, functional, and clinical outcomes in forensic inpatients.",[28,418,419,420,421,422,123,423,424,247,425,426],"ADHD","TBI (Traumatic Brain Injury)","Aggression","Substance Use Disorders","Violence","Anxiety","Depression","Offenders","Antisocial",[250,428,429,430,431,432,433,434,435,436,437,438,439],"Cognitive Training","Cognitive Enhancement","Cognitive Rehabilitation","Neuropsychological Rehabilitation","Executive Function","Forensic Mental Health","Forensic Psychology","Forensic Neuropsychology","Forensic Neuroscience","Forensic Rehabilitation","Cognition","Executive Functioning",{"date":397,"type":35},{"date":442,"type":35},"2020-02-10",{"date":444,"type":21},"2026-02-10",{"name":262,"class":42},{"id":447,"slug":448,"hasResults":12,"nctId":449,"briefTitle":450,"officialTitle":451,"acronym":452,"eligibilityCriteria":453,"healthyVolunteers":12,"sex":16,"minAge":142,"maxAge":4,"enrollmentInfo":454,"targetDuration":4,"studyType":22,"phases":456,"briefSummary":457,"conditions":458,"keywords":459,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":470,"lastUpdatePostDateStruct":471,"startDateStruct":473,"completionDateStruct":475,"leadSponsor":477,"locationsCount":374},"100576169","improving-heart-and-metabolic-health-in-people-with-severe-mental-illness-through-a-long-term-clinical-trial-100576169","NCT06781801","Improving Heart and Metabolic Health in People With Severe Mental Illness Through a Long-term Clinical Trial","Longitudinal Approach to Generate Positive Cardiometabolic Health Outcomes in Severe Mental Illness","LAGOM","Inclusion criteria\n\n1. Adults ≥18 years of age meeting the International Classification of Diseases, Tenth Revision (ICD-10) diagnostic criteria for any one of the schizophrenia spectrum disorders (F20-F25 or F28-F29)\n2. Ability to provide informed consent\n\nExclusion criteria\n\n1. Having an electrical medical implant such as a pacemaker or other mechanical implants\n2. Pregnancy\n3. Deemed unsuitable by the investigator (a person may be deemed unsuitable for participation in the trial by the clinical investigation team member based on factors that may affect the ability to participate safely and reliably. These factors may include, but are not limited to, physical disabilities that hinder participation or practical challenges such as long travel distances to the trial site. The assessment is made on an individual basis and aims to ensure both patient safety and trial integrity).\n4. Prior participation in the LAGOM trial during a previous inclusion cycle (i.e., participants can only be included once during the trial period).\n5. Currently under compulsory care.",{"count":455,"type":21},644,[24],"Cardiometabolic diseases are prevalent among individuals with psychotic disorders, significantly contributing to their shorter lifespan, reduced quality of life, and economic impact on individuals and society. To improve cardiometabolic health, effective and individualized interventions are crucial. Psychosis outpatient clinics are ideal for these interventions due to regular patient visits and the availability of diverse health professionals. The investigators have developed and want to test a comprehensive intervention program to improve cardiometabolic health, enhance quality of life, and promote healthy lifestyles specifically for people with psychotic disorders at psychiatric outpatient clinics in Gothenburg.\n\nThis clinical trial aims to include 644 individuals with psychotic disorders from six outpatient clinics in the Department of Psychotic Disorders at Sahlgrenska University Hospital in Gothenburg. Two outpatient clinics will provide the LAGOM-intervention, while the other clinics will serve as controls, offering \"care as usual\". The intervention group will receive multidisciplinary support integrated into the routine clinical procedures. The intervention includes regular follow-ups and use of motivational tools, including body composition analyzer and cardiovascular risk prediction algorithm (QRISK3).\n\nIf the intervention effectively improves cardiometabolic health, enhances quality of life for this vulnerable group, and proves cost-effective, it can serve as a model program for implementation in Region Västra Götaland.",[28],[460,461,462,463,464,465,466,467,468,469],"Psychotic disorders","Quality of life","Cost-effectiveness","Cardiometabolic risk factors","Cardiovascular disease prevention","Metabolic syndrome","Pragmatic clinical trial","Integrated health care","Multicomponent intervention","Behavior change intervention","2025-12-01",{"date":472,"type":35},"2025-12-09",{"date":474,"type":35},"2025-02-27",{"date":476,"type":21},"2029-12-31",{"name":478,"class":479},"Vastra Gotaland Region","OTHER_GOV",{"id":481,"slug":482,"hasResults":12,"nctId":483,"briefTitle":484,"officialTitle":485,"acronym":4,"eligibilityCriteria":486,"healthyVolunteers":12,"sex":16,"minAge":142,"maxAge":412,"enrollmentInfo":487,"targetDuration":4,"studyType":22,"phases":489,"briefSummary":490,"conditions":491,"keywords":492,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":495,"lastUpdatePostDateStruct":496,"startDateStruct":498,"completionDateStruct":500,"leadSponsor":502,"locationsCount":234},"100560757","magnetic-seizure-therapy-for-psychotic-disorders-100560757","NCT06581302","Magnetic Seizure Therapy for Psychotic Disorders","Accelerated 100Hz Magnetic Seizure Therapy for Psychotic Disorders","Inclusion Criteria:\n\n* (1) meets the diagnostic criteria for schizophrenia or other primary psychotic disorders according to DSM-5;\n* (2) age range between 18 and 55 years;\n* (3) Positive And Negative Syndrome Scale (PANSS) score≥60;\n* (4) to provide informed consent.\n\nExclusion Criteria:\n\n* (1) have a concomitant severe medical illness;\n* (2) are pregnant or intend to get pregnant during the study;\n* (3) have a history of DSM-5 diagnosis of substance dependence or abuse within the past three months;\n* (4) history of traumatic brain injury (with a screening scale score of 7 or above);\n* (5) history of poor response to electroconvulsive therapy or MST;\n* (6) have probable dementia based on study investigator assessment; have any significant neurological disorder or condition likely to be associated with increased intracranial pressure or a space occupying brain lesion, e.g., cerebral aneurysm;\n* (7) presenting with a medical condition, medication, or laboratory anomaly deemed by the investigator to potentially induce psychotic symptoms, or significant cognitive impairment. (e.g., hypothyroidism with low TSH, rheumatoid arthritis requiring high dose prednisone, or Cushing's disease);\n* (8) have an intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed;\n* (9) a score of 18 or more on the 24-item Hamilton Depression Rating Scale (HAM-D);\n* (10) needing ECT treatment immediately due to such dangerous symptoms as suicide, stupor or psychomotor agitation, etc.",{"count":488,"type":21},50,[24],"This trial aims to evaluate the efficacy and safety of Magnetic Seizure Therapy (MST) as an augmentation of antipsychotic medications for psychosis.",[28],[493,329,494],"Magnetic Seizure Therapy (MST)","longitudinal study","2025-11-24",{"date":497,"type":35},"2025-11-25",{"date":499,"type":35},"2024-09-01",{"date":501,"type":21},"2025-12-30",{"name":503,"class":42},"Shanghai Jiao Tong University School of Medicine",{"id":505,"slug":506,"hasResults":12,"nctId":507,"briefTitle":508,"officialTitle":508,"acronym":4,"eligibilityCriteria":509,"healthyVolunteers":12,"sex":16,"minAge":510,"maxAge":511,"enrollmentInfo":512,"targetDuration":4,"studyType":22,"phases":514,"briefSummary":515,"conditions":516,"keywords":519,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":525,"lastUpdatePostDateStruct":526,"startDateStruct":528,"completionDateStruct":530,"leadSponsor":532,"locationsCount":534},"100477671","supporting-patients-by-family-education-in-psychotic-illness-a-prospective-cohort-study-100477671","NCT05500001","Supporting Patients by Family Education in Psychotic Illness: A Prospective Cohort Study","Inclusion Criteria:\n\n* Young adult service user is aged 17-27 at time of recruitment\n* Young adult service user has had an admission or discharge from an Alberta Health Services or Covenant Health psychiatric unit for psychosis in the Edmonton Zone within previous 12-months\n\nExclusion Criteria:\n\n* Not proficient in English\n* Young adult service user has NOT had an admission or discharge from an Alberta Health Services or Covenant Health psychiatric unit for psychosis in the Edmonton Zone within previous 12-months","17 Years","27 Years",{"count":513,"type":21},113,[24],"Background: A lack of education, resources, and support for family carers of young adults with psychotic illnesses leaves them ill-equipped to support their loved one. Although family support groups exist, few groups offer evidence-based, skills-focused, psychoeducation taught by certified professionals and provided on a public-health level. By equipping families with skills and knowledge, public healthcare harnesses a powerful ally to maintain community stabilization.\n\nAims: The primary study goal is to implement a psychoeducation intervention for family carers supporting young adults with psychosis to reduce family burden and foster community stabilization of service users.\n\nMethods: A longitudinal pre-post design will be used to assess the long-term effectiveness of the psychoeducation intervention for family carers supporting a young adult with psychosis on service utilization and functional indexes. Nine expert-reviewed, and family peer-informed psychoeducation modules are administered in 2-hour sessions over 9 weeks to family carers.\n\nConclusion: Presenting the novel approach of an expert-reviewed, peer-informed psychoeducation intervention for family carers, with a focus on knowledge and skill development, the researchers contribute to literature and best practice in patient and family-centered care.",[28,517,518,168],"Family Members","Anosognosia",[520,86,521,522,523,524],"Young Adult","Family Psychoeducation","Family Burden","Acceptance and Commitment Therapy","LEAP","2025-11-14",{"date":527,"type":35},"2025-11-18",{"date":529,"type":35},"2022-09-01",{"date":531,"type":21},"2026-09-01",{"name":533,"class":42},"University of Alberta",4,{"id":536,"slug":537,"hasResults":12,"nctId":538,"briefTitle":539,"officialTitle":540,"acronym":541,"eligibilityCriteria":542,"healthyVolunteers":12,"sex":16,"minAge":142,"maxAge":271,"enrollmentInfo":543,"targetDuration":4,"studyType":22,"phases":545,"briefSummary":546,"conditions":547,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":548,"lastUpdatePostDateStruct":549,"startDateStruct":551,"completionDateStruct":553,"leadSponsor":555,"locationsCount":234},"100495455","outcomes-from-remediation-and-behavioural-intervention-techniques-100495455","NCT05731414","Outcomes From Remediation and Behavioural Intervention Techniques","Cognitive Behavioural Therapy Compared to Cognitive Remediation for Schizophrenia-Spectrum Disorders","ORBIT","Inclusion Criteria:\n\n* Aged 18-65 years\n* Diagnosed with schizophrenia-spectrum disorders\n* Can read, write, and speak English\n\nExclusion Criteria:\n\n* Neurodevelopmental disability or neurocognitive disorder\n* CBT or CR in the past 6 months",{"count":544,"type":21},360,[24],"It is currently unknown what factors predict response to Cognitive Behavioural Therapy for Psychosis (CBTp) or Cognitive Remediation Therapy (CR) among individuals with schizophrenia-spectrum disorders, thus the current trial will examine predictors of response to determine who requires the combined intervention and who might respond sufficiently to either monotherapy.",[247,86,28,122],"2025-08-13",{"date":550,"type":35},"2025-08-19",{"date":552,"type":35},"2023-03-01",{"date":554,"type":21},"2027-01-31",{"name":556,"class":42},"University of Toronto",{"id":558,"slug":559,"hasResults":12,"nctId":560,"briefTitle":561,"officialTitle":562,"acronym":4,"eligibilityCriteria":563,"healthyVolunteers":12,"sex":16,"minAge":142,"maxAge":564,"enrollmentInfo":565,"targetDuration":4,"studyType":22,"phases":567,"briefSummary":568,"conditions":569,"keywords":571,"overallStatus":224,"whyStopped":4,"lastUpdateSubmitDate":577,"lastUpdatePostDateStruct":578,"startDateStruct":579,"completionDateStruct":581,"leadSponsor":583,"locationsCount":234},"100602888","effects-of-a-peer-facilitated-acceptance-based-self-learning-for-illness-management-pasim-program-100602888","NCT07129369","Effects of a Peer-facilitated, Acceptance-based Self-learning for Illness Management (PASIM) Program","Evaluating the Effects of a Peer-facilitated, Acceptance-based Self-learning for Illness Management (PASIM) Program for Adults With Recent-onset Psychosis: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Primarily diagnosed with psychosis (or ROP with \\\u003C5 years of illness as defined in recent literature), including brief, first-episode and other psychotic disorders according to the criteria of the DSM-5 \\[American Psychiatric Association 2013\\];\n* H.K. Chinese residents, aged 18-64 years;\n* Global Assessment of Functioning scores ≥51, indicating mild to moderate symptoms and difficulties in psychosocial\u002Foccupational functioning \\[American Psychiatric Association 2013\\], being mentally stable to comprehend APSI or psychoeducation and outcome measures;\n* Able to read and understand Cantonese\u002F Mandarin.\n\nExclusion Criteria:\n\n* Have received or are receiving other psychotherapies;\n* Comorbidity with other mental (learning disability, cognitive, or personality disorder) or significant medical disease(s);\n* And\u002For communication, visual or hearing difficulty.","64 Years",{"count":566,"type":21},186,[24],"Psychosis is a very disabling mental illness with a wide range of dysregulations and disruptions in cognition, emotions, and behaviors, resulting in poor functioning and frequent relapses, especially in the first five years of the illness. There is a knowledge gap about whether Peer-facilitated, Acceptance-based Self-learning for Illness Management (PASIM) can have longer-term and more significant benefits than current professional-led psychoeducation in diverse health outcomes of these psychotic patients such as functioning, problem-solving, and recovery. This multi-center randomized controlled trial with repeated measures, 3-arm design is proposed to test and compare the effects between two alternative interventions (PASIM and Psychoeducation Group program) and a usual-care-only group over an 18-month follow-up.",[28,570],"Recent-Onset Psychosis",[572,573,574,575,576],"Randomized controlled trial","Acceptance-based intervention","Peer support","Self help","Recent-onset psychosis","2025-08-11",{"date":550,"type":35},{"date":580,"type":21},"2026-01-02",{"date":582,"type":21},"2028-10-31",{"name":584,"class":42},"Chinese University of Hong Kong",{"id":586,"slug":587,"hasResults":12,"nctId":588,"briefTitle":589,"officialTitle":589,"acronym":4,"eligibilityCriteria":590,"healthyVolunteers":12,"sex":16,"minAge":142,"maxAge":4,"enrollmentInfo":591,"targetDuration":4,"studyType":22,"phases":593,"briefSummary":594,"conditions":595,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":599,"lastUpdatePostDateStruct":600,"startDateStruct":602,"completionDateStruct":604,"leadSponsor":606,"locationsCount":43},"100480545","a-novel-peer-delivered-recovery-focused-suicide-prevention-intervention-for-veterans-with-serious-mental-illness-100480545","NCT05537376","A Novel Peer-Delivered Recovery-Focused Suicide Prevention Intervention for Veterans With Serious Mental Illness","Inclusion Criteria:\n\nVeteran Inclusion Criteria:\n\n1. Veterans who report present suicidal ideation (i.e., Columbia-Suicide Severity Rating Scale (C-SSRS) \\> 2 (\"Active thoughts of killing oneself\") in past 1 month and\u002For a suicide attempt in the prior 3 months as identified by the C-SSRS\n2. Current SMI diagnosis (i.e., schizophrenia and other psychotic disorders, mood disorders with psychotic features, bipolar disorders)\n3. Capable of informed consent via the University of California San Diego Brief Assessment of Capacity to Consent (UBACC)\n\nPeer Specialist Inclusion Criteria:\n\n1. Certified Peer Specialist employed at VA San Diego Healthcare System (VASDHS) in the Mental Health Care Line (individuals must demonstrate competency in basic suicide screening and referral procedures to be certified)\n2. 2-3 years of experience post certification as a Certified Peer Specialist\n3. Interest in being trained in SUPPORT\n4. Provide verbal or written consent for the research staff to discuss ability to participate in the study with the Peer Specialist's direct clinical supervisor\n5. Direct clinical supervisor agreement to allow the Peer Specialist to participate. This includes the Peer Specialist's direct clinical supervisor agreement to allow the Peer Specialist time as part of their current scope of practice to 1) participate in the full day (8-hour) SUPPORT training, 2) participate in weekly 1-hour group supervision for the duration of the Peer Specialist's time in the study, and 3) take on a case load of at least one SUPPORT Veteran at a given time.\n\nExclusion Criteria:\n\nVeteran Exclusion Criteria:\n\n1. Cannot complete the assessment battery\n2. Current intoxication requiring immediate detoxification or outpatient plan directed specifically to residential substance use disorder (not mental health) services\n3. Imminent psychiatric hospitalization",{"count":592,"type":21},69,[24],"Suicide is a major public health concern, particularly among Veterans with serious mental illness (SMI, i.e., psychotic disorders or bipolar disorders). Wellness Recovery Action Plan (WRAP) is a well-established evidence-based practice for those with SMI that centers on identifying warning signs of mental illness, developing wellness tools for functional independence, planning for day-to-day effective living within one's community, and building an action plan to create a valued life worth living. This proposed study will refine and pilot SUicide Prevention by Peers Offering Recovery Tactics (SUPPORT), a novel integrated recovery program that is an adaptation of peer-delivered WRAP for Veterans with SMI. In SUPPORT, a Peer Specialist leads a Veteran at increased risk for suicide through recovery planning that is tailored to the Veteran's suicidal experiences with cognitive learning strategies to enhance safety plan recall and improve functioning.",[28,596,597,598],"Bipolar Disorders","Suicidal Ideation","Suicide, Attempted","2025-08-05",{"date":601,"type":35},"2025-08-07",{"date":603,"type":35},"2023-09-12",{"date":605,"type":21},"2027-10-31",{"name":232,"class":233},{"id":608,"slug":609,"hasResults":12,"nctId":610,"briefTitle":611,"officialTitle":612,"acronym":613,"eligibilityCriteria":614,"healthyVolunteers":12,"sex":16,"minAge":142,"maxAge":615,"enrollmentInfo":616,"targetDuration":4,"studyType":22,"phases":618,"briefSummary":619,"conditions":620,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":621,"lastUpdatePostDateStruct":622,"startDateStruct":624,"completionDateStruct":626,"leadSponsor":627,"locationsCount":43},"100418577","yoga-based-group-intervention-yogi-for-in-patients-with-schizophrenia-spectrum-disorders-100418577","NCT04730518","Yoga-based Group Intervention (YoGI) for In-patients With Schizophrenia Spectrum Disorders","Yoga-based Group Intervention for In-Patients With Schizophrenia Spectrum Disorder - a Rater-Blinded Randomized Controlled Trial","YING","Inclusion Criteria:\n\n* male and female participants\n* treated as psychiatric inpatients at the psychosis ward or in the social-psychiatric day clinic\n* ≥18 years\n* diagnosis of a schizophrenia-spectrum disorder according to the Diagnostical and Statistical Manual 5th edition) and the International Statistical Classification of Diseases and Related Health Problems(ICD-10) code F2\n* ability to give informed consent\n* willingness and ability to engage in psychotherapeutic group therapy\n* low to moderate psychotic state indicated with a score of ≤ 6 for each item at the Positive scale of the Positive and Negative Syndrome Scale (PANSS, Peralta \\& Cuesta, 1994)\n\nExclusion Criteria:\n\n* a score \\> 6, suggesting an acute psychotic episode with severe psychotic symptoms (Peralta\\& Cuesta, 1994)\n* acute suicidality, assessed by item eight of the Calgary Depression Scale for Schizophrenia \\> 1 (Addington, Addington, Maticka-Tyndale, \\& Joyce, 1992)\n* any neurological disorders that may affect cognitive functioning\n* acute substance abuse other than nicotine and prescribed medication\n* conflicting co-therapy such as electroconvulsive therapy or ketamine treatment","90 Years",{"count":617,"type":21},77,[24],"A rater-blinded randomized controlled trial with a parallel-group design is utilized, comprised of yoga-based group intervention (YoGI) in the experimental condition, and treatment as usual (TAU) in the control condition. The participants in the experimental condition participate in YoGI beside their regular psychiatric treatment (TAU). The intervention is designed for in-patients with schizophrenia spectrum disorders. With the aim of examining the feasibility, acceptability and effectiveness, self-report and blinded rater-based assessments are evaluated before the YoGI (T0), and after four weeks of taking part in intervention (T1).\n\nBuilding on the results of the feasibility and acceptability trial, the study is now progressing to a full randomized controlled trial. The primary outcome for the full trial will be positive symptoms of schizophrenia spectrum disorders, assessed by a blinded rater using the Positive and Negative Syndrome Scale (PANSS). The target sample size has been adjusted to ensure sufficient statistical power, and the trial will evaluate secondary outcomes, including (body) mindfulness, negative symptoms, cognitive functioning, and quality of life, and stress. This study aims to provide robust evidence for the effectiveness of YoGI in comparison to treatment as usual (TAU).",[28],"2025-02-20",{"date":623,"type":35},"2025-02-24",{"date":625,"type":35},"2021-01-28",{"date":501,"type":21},{"name":286,"class":42},{"id":629,"slug":630,"hasResults":12,"nctId":631,"briefTitle":632,"officialTitle":632,"acronym":633,"eligibilityCriteria":634,"healthyVolunteers":12,"sex":16,"minAge":142,"maxAge":271,"enrollmentInfo":635,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":637,"conditions":638,"keywords":640,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":643,"lastUpdatePostDateStruct":644,"startDateStruct":646,"completionDateStruct":648,"leadSponsor":650,"locationsCount":43},"100580642","sensory-profile-and-early-clinical-signs-of-calm-room-users-100580642","NCT06839950","Sensory Profile and Early Clinical Signs of Calm Room Users","EVAL-APAISE","Inclusion Criteria:\n\n* Gender and Age: Male or female, aged 18 to 65\n* Hospitalization: Admitted to the closed hospitalization unit for less than 10 days\n* Social security: Affiliated or beneficiary of a social security system\n* Consent: Free, informed, and written consent, signed by the participant and\u002For their legal representative (for participants under protection measures) and the investigator (at the latest on the day of inclusion and before any research-related examination).\n\nExclusion Criteria:\n\n* Inability to understand information related to the study\n* Proven sensory disability\n* Dementia\n* Pregnancy\n* Lack of social protection\n* Previous Participation in this research protocol (in the case of a new hospitalization)\n* Expression abilities incompatible with completing the AASP Scale (e.g., french language comprehension issues, mute individuals, patients in restraint and\u002For therapeutic isolation)",{"count":636,"type":21},80,"This descriptive study aims primarily to characterize the sensory profile of patients in a closed psychiatric hospital unit who use a calming room.\n\nThe main questions it aims to answer are :\n\n* Could sensory information processing disorders be the cause of distress and tension in these patients?\n* Could users of the calming room present extreme sensory processing profiles, characterized by either hypersensitivity or hyposensitivity ?\n\nParticipants will answer a survey to determine their the sensory profile. Participants can already use the calming room as part of their regular medical care and they will answer surveys before and after each use.",[28,639,59],"Personality Disorders",[641,28,642,59,639],"Calm room","Sensory Profile","2025-02-17",{"date":645,"type":35},"2025-02-21",{"date":647,"type":35},"2023-12-19",{"date":649,"type":21},"2028-05-19",{"name":651,"class":42},"Centre Hospitalier Esquirol",{"id":653,"slug":654,"hasResults":12,"nctId":655,"briefTitle":656,"officialTitle":656,"acronym":657,"eligibilityCriteria":658,"healthyVolunteers":112,"sex":16,"minAge":142,"maxAge":241,"enrollmentInfo":659,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":661,"conditions":662,"keywords":665,"overallStatus":224,"whyStopped":4,"lastUpdateSubmitDate":669,"lastUpdatePostDateStruct":670,"startDateStruct":672,"completionDateStruct":674,"leadSponsor":676,"locationsCount":43},"100576236","investigation-of-objective-cognitive-effort-in-neuropsychological-evaluation-of-psychotic-disorders-100576236","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.",{"count":660,"type":21},100,"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.",[247,28,663,664],"Cognitive Impairment","Motivation",[666,667,668],"memory","effort","cardiovascular reactivity","2025-01-17",{"date":671,"type":35},"2025-01-20",{"date":673,"type":21},"2025-01-27",{"date":675,"type":21},"2026-07-01",{"name":677,"class":42},"University Hospital, Montpellier",{"id":679,"slug":680,"hasResults":12,"nctId":681,"briefTitle":682,"officialTitle":683,"acronym":684,"eligibilityCriteria":685,"healthyVolunteers":12,"sex":16,"minAge":142,"maxAge":4,"enrollmentInfo":686,"targetDuration":4,"studyType":22,"phases":688,"briefSummary":689,"conditions":690,"keywords":692,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":699,"lastUpdatePostDateStruct":700,"startDateStruct":702,"completionDateStruct":704,"leadSponsor":706,"locationsCount":43},"100514719","avatar-mediated-therapy-versus-cognitive-behavioural-therapy-for-persisting-experiences-of-hearing-voices-100514719","NCT05982158","Avatar-mediated Therapy Versus Cognitive Behavioural Therapy for Persisting Experiences of Hearing Voices","Remotely Delivered Avatar-mediated Therapy Versus Cognitive Behavioural Therapy for Persisting Auditory Hallucinations: Randomised Controlled Superiority Trial","AMETHYST","Inclusion Criteria:\n\n* Schizophrenia-related disorder or a mood disorder with psychotic symptoms diagnosis confirmed using the Structured Clinical Interview for DSM (SCID)\n* Experiencing current auditory verbal hallucinations as measured by the Positive and Negative Syndrome Scale (PANSS) item P3 ≥ 4\n* Auditory verbal hallucinations present for at least one year\n* AVHs include significant negative content (PSYRATS item 6 ≥ 2) and\u002For AVHs are distressing (PSYRATS item item 9 ≥ 2)\n* Current treatment with antipsychotic medication, or has been treated with antipsychotic medication in the past, with at least two different antipsychotic compounds, and these have been discontinued due to insufficient treatment response and\u002For poor tolerability.\n* Access to the internet and a computer or other device on which videoconferencing software can be used\n* Sufficient fluency in English for meaningful participation\n* Age 18 or over\n* Ability to give informed consent\n\nExclusion Criteria:\n\n* Auditory verbal hallucinations attributable to a primary substance use disorder or organic disorder\n* Estimated full scale IQ \\\u003C 70 (using the Test of Premorbid Functioning, TOPF)\n* Within the last month or planned at the time of intake: a change of antipsychotic medication,\n* Current or within the past 3 months receipt of individual psychological therapy for hearing voices, or receipt of electro-convulsive therapy or other brain stimulation treatment;\n* AVHs in a language not spoken by the therapists.",{"count":687,"type":21},212,[24],"The aim of this study is to compare the effects of a new psychological therapy, Avatar Therapy, to the current standard therapy, Cognitive Behavioural Therapy (CBT), in improving outcomes in people living with psychotic disorders who have persisting experiences of hearing voices (auditory verbal hallucinations, AVHs).",[691,28,87],"Auditory Hallucination",[693,86,247,694,695,696,697,698],"Auditory verbal hallucinations","Psychological therapy","Cognitive behavior therapy","Avatar therapy","Virtual reality","Telehealth","2024-11-19",{"date":701,"type":35},"2024-11-22",{"date":703,"type":35},"2023-08-08",{"date":705,"type":21},"2027-06",{"name":707,"class":42},"Swinburne University of Technology"]