[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"severe-mental-illness\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:severe-mental-illness":312},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,48,81,107,131,162,197,226,264,286],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100640731",false,"NCT07597863","A Study to Investigate Health Related Quality of Life With a Pharmacist Intervention Compared to Treatment as Usual in Participants With Severe Mental Illness and Substance Use Disorder Receiving Treatment From FACT Teams.","Optimizing Pharmacotherapy in Severe Mental Illness and Substance Use Disorder; Integrating a Clinical Pharmacist Into FACT Teams","pharmaFACT","Inclusion Criteria:\n\n* Age over 18 years old\n* Included in and receiving treatment from a participating FACT team\n* Diagnosed with severe mental illness and\u002For substance use disorder\n* Prescribed one or more psychotropic medication\n* Signed informed consent\n\nExclusion Criteria:\n\n* Patients not being competent or have the decision-making capacity to consent\n* Planned discharge from the team within the first three months of period 1\n* Patients not able to communicate in Norwegian or English","ALL","18 Years",{"count":19,"type":20},160,"ESTIMATED","INTERVENTIONAL",[23],"NA","The study aims to evaluate the impact of integrating a clinical pharmacist into Flexible Assertive Community (FACT) teams on health-related quality of life and pharmacotherapy for individuals with severe mental illness and substance use disorders. This is a pragmatic effectiveness study using a stepped wedge cluster randomized trial design. Four FACT teams from FACT Innlandet will serve as clusters, transitioning from standard care (control) to intervention in a randomized sequence. The intervention involves integrating a clinical pharmacist into the interdisciplinary FACT teams. Participants will be adults (over 18 years old), receiving treatment from participating FACT teams, diagnosed with severe mental illness or substance use disorder and prescribed at least one psychotropic medication. Exclusion criteria include inability to provide informed consent, planned discharge within the first three months of period 1, or inability to communicate in Norwegian or English. The control group receives standard care provided by FACT teams. The intervention group will have a clinical pharmacist integrated into the FACT team performing medication reconciliation, comprehensive medication reviews, patient counselling, and interdisciplinary discussions to resolve medication-related problems. A sample size of 160 patients is estimated based on an effect size of 0.25, 80% power and alpha=0.05. The primary endpoint is change in patient-reported health related quality of life, measured using the EuroQoL-5 dimensions-5 levels (EQ-5D-5L) and Visual Analog Scale, EQ-VAS scores from baseline to the end of the intervention.",[26,27],"Severe Mental Illness","Substance Use Disorder (SUD)",[29,30,31,32,33,34],"FACT","Flexible assertive community treatment","Clinical pharmacist","Medication review","Patient counselling","Medication reconciliation","NOT_YET_RECRUITING","2026-05-13",{"date":38,"type":39},"2026-05-19","ACTUAL",{"date":41,"type":20},"2026-05-01",{"date":43,"type":20},"2031-02",{"name":45,"class":46},"Sykehuset Innlandet HF","OTHER",1,{"id":49,"slug":4,"hasResults":10,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":58,"conditions":59,"keywords":60,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":80},"100635168","NCT07549178","Care Coordination and Passive Mobile Data Monitoring to Improve Mental Health Care","Care Coordination and Passive Mobile Data Monitoring to Engage Veterans and Improve Mental Health Care","CCM","Inclusion Criteria:\n\n* a medical record diagnosis of Serious Mental Illness (SMI)\n\n  * defined as schizophrenia, schizoaffective disorder, or bipolar disorder\n* receipt of care at the VA site during the prior 9 months\n* a Care Assessment Need (CAN) score over the 75th percentile, indicating high risk for hospitalization or death in the upcoming year\n* ownership of a smart phone\n\nExclusion Criteria:\n\n* none",{"count":56,"type":20},400,[23],"Providing care to individuals with serious mental illness can be challenging, requiring ongoing monitoring, treatment adjustments, and coordination of various medical and social services. Rates of emergency service and hospital use are high due to unexpected social, medical, and mental health crises. Stressors and poor adherence with treatment are common and can lead to rapid worsening in symptoms, job loss, homelessness, incarceration, or suicide. Clinician visits can be infrequent. Patient-clinician contact between visits is challenging and often nonexistent. As such, illness exacerbations usually occur with no clinician awareness in real time, leaving limited opportunity to provide services. Clinicians need interventions that are capable of monitoring and quickly detecting worsening behaviors and illness, to improve care coordination, outreach, and treatment. This project studies the effectiveness of enhanced care coordination using passive mobile data monitoring and support from peer specialists, with the goal of improving outcomes and reducing the need for acute care.",[26],[61,62,63,64,65,66,67,68,69],"Mental Disorders, Severe","Veterans","Remote Sensing Technology","Mobile Applications","Patient Care Team","Continuity of Patient Care","Disease Management","Peer Coaching","Health Care Utilization","2026-05-12",{"date":72,"type":39},"2026-05-15",{"date":74,"type":20},"2026-08-03",{"date":76,"type":20},"2030-04-30",{"name":78,"class":79},"VA Office of Research and Development","FED",2,{"id":82,"slug":4,"hasResults":10,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":88,"enrollmentInfo":89,"targetDuration":4,"studyType":21,"phases":91,"briefSummary":92,"conditions":93,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":106},"100639056","NCT07586150","Personalized Pharmaco-Lifestyle Interventions for Severe Mental Illnesses (LIFETRAIN)","Personalised Pharmaco-Lifestyle Interventions for Severe Mental Illnesses Enhanced by Digital Health and Immersive Technologies","LIFETRAIN","Inclusion Criteria:\n\n* Age 18 to 65 years\n* Able and willing to provide written informed consent\n* Diagnosis of schizophrenia, bipolar disorder, or major depressive disorder according to DSM-5-TR, confirmed by M.I.N.I.\n* Female participants of childbearing potential must agree to use an effective method of contraception\n* Stable psychopathology defined as BPRS less than or equal to 41, MADRS less than or equal to 34, and YMRS less than or equal to 25, with stable psychopharmacological treatment for at least 2 weeks\n* Reduced functioning at screening defined as SF-36 score less than or equal to 40\n* If using benzodiazepines, dose less than or equal to 2 mg lorazepam equivalent per day\n* Stable somatic condition for at least 4 weeks\n* For semaglutide treatment: overweight with BMI at least 27 and less than 30 kg\u002Fm² plus at least one weight-related risk condition, or obesity with BMI at least 30 kg\u002Fm²\n* For optional adaptive neurostimulation: MADRS score at least 19\n* Expected ability to comply with study procedures in the investigator's judgment\n\nExclusion Criteria:\n\n* Unable to provide informed consent\n* Current or past neurological disorder or structural brain pathology that may affect study procedures\n* Known intolerance or hypersensitivity to semaglutide\n* Pregnancy or lactation\n* Serious suicidal risk\n* Substance dependence within the last 3 months\n* BMI less than 18.5 kg\u002Fm²\n* eGFR less than 30 mL\u002Fmin\u002F1.73 m²\n* Type 1 diabetes, diabetic ketoacidosis, diabetic retinopathy, or poorly controlled diabetes with recurrent hypoglycemic episodes\n* Pancreatitis, history of pancreatitis, or pancreatic cancer\n* Multiple endocrine neoplasia type 2 or personal\u002Ffamily history of medullary thyroid cancer\n* Pre-existing significant gastrointestinal conditions such as inflammatory bowel disease or gastroparesis\n* Need for acute surgery\n* Other medical condition that may affect study procedures or participant safety\n* For optional adaptive neurostimulation: nonremovable metal in or around the head, known increased intracranial pressure due to infarcts or trauma, professional metal work or prior ocular metal injury, history of rTMS or ECT, or current (es)ketamine treatment","65 Years",{"count":90,"type":20},140,[23],"This randomized, rater-blind, multicenter clinical trial will evaluate whether a personalized pharmaco-lifestyle intervention improves mental functioning in adults with severe mental illness, including schizophrenia, bipolar disorder, or major depressive disorder. Participants will be randomized to either a modular individualized intervention program or a structured psychoeducation control condition. The individualized intervention may include physical exercise, an anti-inflammatory diet, sleep intervention, social prescribing, semaglutide for eligible participants with overweight or obesity, and optional closed-loop transcranial alternating current stimulation for participants with prominent depressive symptoms. The primary outcome is change in the SF-36 Mental Component Summary score from baseline to Month 3.",[26,94,95,96],"Depression \u002F Major Depressive Disorder","Bipolar Disorder (BD)","Schizophrenia","2026-05-07",{"date":99,"type":39},"2026-05-14",{"date":101,"type":20},"2028-10",{"date":103,"type":20},"2030-12",{"name":105,"class":46},"Ludwig-Maximilians - University of Munich",5,{"id":108,"slug":4,"hasResults":10,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":21,"phases":116,"briefSummary":117,"conditions":118,"keywords":4,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":47},"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":115,"type":20},44,[23],"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.",[119,120,26],"Psychotic Disorders","Schizophrenia Spectrum Disorders (SSD)","RECRUITING","2026-04-28",{"date":124,"type":39},"2026-04-29",{"date":126,"type":39},"2026-01-01",{"date":128,"type":20},"2026-11-30",{"name":130,"class":46},"University of Trás-os-Montes and Alto Douro",{"id":132,"slug":4,"hasResults":10,"nctId":133,"briefTitle":134,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":136,"sex":16,"minAge":17,"maxAge":137,"enrollmentInfo":138,"targetDuration":4,"studyType":140,"phases":4,"briefSummary":141,"conditions":142,"keywords":145,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":47},"100573240","NCT06743711","Validation and Impact of Cardiorespiratory Fitness in Severe Mental Illness - the Heart in Mind Project","Inclusion Criteria:\n\n* 18-45 years\n* Diagnosis within schizophrenia spectrum or affective disorders (i.e. F2.x or F3.x according to ICD-10 classification)\n* current antipsychotic treatment for more than one month on a regular daily dose\n* Able to give informed consent.\n\nExclusion Criteria:\n\n* Clinical or laboratory evidence of uncompensated medical disease\n* Unstable psychiatric disorder\n* Acute suicidal risk\n* Planned hospitalization within the study period.",true,"45 Years",{"count":139,"type":20},75,"OBSERVATIONAL","This project aims to evaluate feasibility, validity and clinically applicability to systematically measure fitness in patients with severe mental illness.\n\nThe research project is a validation study using a cross-sectional design. The project will include 50 people with severe mental illness and 25 healthy controls without present or previous mental illness. The protocol includes a baseline visit where three different ways of measure fitness will be carried out, and a 14-day period of physical activity monitoring.",[26,143,144],"Schizophrenia Spectrum &Amp; Other Psychotic Disorders","Bipolar Affective Disorder",[146,147,148,149,150,151,152,153],"cardiorespiratory fitness","severe mental illness","cardiovascular disease","validation","physical activity","cardiopulmonary exercise test","non-exercise vo2max estimation","vo2max",{"date":155,"type":39},"2026-05-04",{"date":157,"type":39},"2025-01-01",{"date":159,"type":20},"2026-06-30",{"name":161,"class":46},"Bjorn H. Ebdrup",{"id":163,"slug":4,"hasResults":10,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":167,"eligibilityCriteria":168,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":169,"targetDuration":4,"studyType":21,"phases":171,"briefSummary":172,"conditions":173,"keywords":176,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":195,"locationsCount":80},"100617298","NCT07316803","Group Intervention for Romantic Relationships in Young Adults With Severe Mental Illness","Study on the Effectiveness of a Group Intervention on Romantic Relationships in Young Adults With Severe Mental Illness","A2C'estMieuxVE","Inclusion Criteria:\n\n* Adults aged 18 years and older\n* Diagnosis of a severe mental illness (e.g., schizophrenia, bipolar disorder, or major depressive disorder)\n* Currently single\n* Motivated to improve romantic and social relationships and to pursue a romantic relationship\n* Received mental health care within the past two years\n* Able and willing to provide informed consent\n\nExclusion Criteria:\n\n* Inability to speak or read French\n* Currently receiving acute or crisis-level psychiatric care\n* Unable to comply with study procedures or group rules (e.g., maintaining sobriety during sessions)",{"count":170,"type":20},20,[23],"This study evaluates a group-based intervention designed to improve romantic and social relationship skills in adults living with a severe mental illness (SMI), such as schizophrenia, bipolar disorder, or major depressive disorder.\n\nMany adults with SMI experience loneliness, social isolation, and difficulties forming romantic relationships, even though most express a strong desire for intimacy. These challenges may be related to social skill difficulties, stigma, low self-esteem, and limited opportunities to develop healthy relationships.\n\nThe \"À deux, c'est mieux\" (Better Together) program is a structured 12-session group intervention focused on developing communication skills, emotional regulation, social understanding, and healthy romantic relationship behaviors. Sessions are led by trained mental health professionals and take place in small groups.\n\nParticipants will complete assessments before starting the program, at the end of the 12 sessions, and three months later. The study will examine changes in romantic relationship skills, quality of life, loneliness, self-esteem, self-stigma, and recovery.\n\nThe purpose of this study is to determine whether this intervention improves romantic and social functioning and overall well-being, and whether it is acceptable and relevant for adults living with severe mental illness.",[26,96,174,175],"Bipolar Disorder","Major Depressive Disorder",[147,177,178,179,180,181,182,183,184,185,186,187,188],"omantic relationships","intimate relationships","social functioning; loneliness","self-esteem","self-stigma","recovery","group intervention","psychosocial intervention","social skills training","relationship skills","mental health rehabilitation","adults with mental illness","2025-12-19",{"date":191,"type":39},"2026-01-05",{"date":193,"type":39},"2025-11-03",{"date":128,"type":20},{"name":196,"class":46},"Centre hospitalier de Ville-Evrard, France",{"id":198,"slug":4,"hasResults":10,"nctId":199,"briefTitle":200,"officialTitle":201,"acronym":202,"eligibilityCriteria":203,"healthyVolunteers":136,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":204,"targetDuration":4,"studyType":21,"phases":206,"briefSummary":207,"conditions":208,"keywords":210,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":217,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":223,"locationsCount":225},"100586380","NCT06914622","Real-time Experiences, Physical Activity and Biological Outcomes in Personal Recovery Residents (EMPOWER-RES)","Real-Time Experiences, Physical Activity And Biological Outcomes In Personal Recovery Of Residents With Mental Disorders (EMPOWER-RES): A Non-Randomized Multicentric Clinical Trial","EMPOWER-RES","The study population will include:\n\nPatients with a mental disorder inclusion criteria:\n\n* diagnosis of a mental disorder according to DSM5TR,\n* receiving treatment at an SRP of the recruiting centers,\n* over 18 years old, willing to participate exclusion criteria:\n* moderate\u002Fsevere intellectual disability,\n* inability to speak and write in Italian.\n\nInformal caregivers of patients inclusion criteria:\n\n* over 18 years old,\n* willing to participate, exclusion criteria:\n* inability to speak and write in Italian.\n\nMental health professionals inclusion criteria:\n\n* working in SRPs of the recruiting centers as a psychiatrist, educator, nurse, social worker, OSS, ASA, or TeRP,\n* if part of the \"personal recovery-oriented treatment\" group, having specific training, exclusion criteria:\n* unwillingness to participate.",{"count":205,"type":20},72,[23],"The project focuses on patients with severe mental disorders (SMD) residing in Italian mental health supported accommodation (SA). Although the goal of SA is to promote personal recovery - that is, living life to the fullest of one's potential - international literature on this topic is scarce, and traditional treatments in the Italian residential system show limitations in adopting such approaches.\n\nThe research hypothesis is that activating personal recovery pathways could improve the biopsychosocial outcomes of patients, caregivers, and professionals. To test this hypothesis, a non-pharmacological, non-randomized interventional trial will compare two groups: one group of individuals with SMD receiving recovery-oriented treatment, using the Mental Health Recovery Star, and another group of individuals with SMD receiving standard treatment.\n\nThe Mental Health Recovery Star is a ten-pointed star-shaped tool that represents various life dimensions. Patients, together with their key professional, are expected to negotiate a score for each domain on the five-stage 'Scale of Change,' capturing and monitoring the different phases of the recovery process.",[209,26],"Severe Mental Disorder",[211,212,213,214,215],"mental health supported accommodation","personal recovery","severe mental disorder","bio-psychosocial","rehabilitation","2025-12-11",{"date":218,"type":39},"2025-12-18",{"date":220,"type":20},"2026-01-15",{"date":222,"type":20},"2028-12-31",{"name":224,"class":46},"IRCCS Centro San Giovanni di Dio Fatebenefratelli",3,{"id":227,"slug":4,"hasResults":10,"nctId":228,"briefTitle":229,"officialTitle":230,"acronym":231,"eligibilityCriteria":232,"healthyVolunteers":136,"sex":16,"minAge":233,"maxAge":234,"enrollmentInfo":235,"targetDuration":4,"studyType":21,"phases":237,"briefSummary":238,"conditions":239,"keywords":246,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":256,"startDateStruct":258,"completionDateStruct":260,"leadSponsor":262,"locationsCount":47},"100599548","NCT07085923","Norwegian Mental Illness Heart Health Study","Dietary Counselling And Exercise To Combat Cardiovascular Disease Risk In Norwegian Patients With A Severe Mental Illness","NORMI-Heart","Inclusion Criteria:\n\n* Diagnosis of F20-29 (schizophrenia spectrum) or F31 (bipolar affective disorder)\n* Current use of antipsychotic medication (first- or second generation) or lithium\n* Body Mass Index \\> or = 27 kg\u002Fm\\^2\n\nExclusion Criteria:\n\nPsychiatric condition:\n\n* Inability to provide informed consent\\*\n* Acute psychiatric crisis\\*\n* Significant cognitive impairment\\* \\*These criteria will be evaluated and confirmed by the participant's primary mental health care provider before enrollment\n\nMedication initiated during the intervention period:\n\n* GLP-1 receptor agonists\n* Antihypertensive medication\n* Antidiabetic medication\n* Lipid-lowering medication\n\nAlcohol consumption:\n\n-More than 14 units per week (men) or more than 7 units per week (women)\n\nSomatic conditions:\n\n* Type 1 diabetes\n* Established cardiovascular disease\n* Body Mass Index (BMI) \\\u003C27 kg\u002Fm²\n* Pregnancy\n* Inability to perform physical exercise\n\nSomatic risk findings at baseline:\n\n* HbA1c \\>57 mmol\u002Fmol (7.4%)\n* LDL cholesterol \\>5.0 mmol\u002FL\n* Blood pressure \\>180\u002F100 mmHg\n* Active malignant disease","25 Years","70 Years",{"count":236,"type":20},70,[23],"Norwegian patients with severe mental illnesses (SMI), such as schizophrenia spectrum or bipolar disorder, lose on average 10 years of life compared to mentally healthy individuals. Much of this gap is due to heart disease. Unhealthy lifestyle habits, including poor diet and physical inactivity, contribute to higher levels of metabolic risk factors for heart disease in this population.\n\nThe goal of this clinical trial is to find out if a lifestyle program including dietary counselling and regular physical exercise can help people with SMI to improve their physical and mental health.\n\nThe main questions it aims to answer are:\n\n* Does adherence to a healthy lifestyle program lead to reduced estimated risk of heart disease?\n* Does it change lifestyle habits, body weight and composition, and metabolic risk markers over six months?\n* Can participants with severe mental illness complete a healthy lifestyle program, and do they find it acceptable?\n\nResearchers will compare two groups: one that receives the lifestyle program in addition to regular mental health care, and one that receives regular care only.\n\nDuring the six month program, participants in the lifestyle group will:\n\n* Meet with a clinical dietitian once a month for dietary counselling\n* Take part in group-based physical activity sessions once a month, and receive support to follow a personal training plan\n\nAround 70 adults will take part in the study. The results may help improve the way lifestyle support is offered to people living with severe mental illness and inform health care providers about strategies to improve physical health in this vulnerable group.",[240,241,209,242,243,244,245,26],"Cardio Vascular Disease","Metabolic Syndrome (MetS)","Schizophrenia and Schizophrenia Spectrum Psychosis","Bipolar Disease Type I","Overweight and\u002For Obesity","CVD Risk Factors",[26,247,248,249,250,251,96,252,174,253,254],"Cardiovascular Disease","Lifestyle Intervention","Healthy Diet","Exercise","CVD-risk","Antipsychotic Medication","Non-pharmacological intervention","Clinical Dietitian","2025-09-26",{"date":257,"type":39},"2025-10-02",{"date":259,"type":39},"2025-09-16",{"date":261,"type":20},"2028-06-30",{"name":263,"class":46},"Madeleine Elisabeth Angelsen",{"id":265,"slug":4,"hasResults":10,"nctId":266,"briefTitle":267,"officialTitle":268,"acronym":4,"eligibilityCriteria":269,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":270,"enrollmentInfo":271,"targetDuration":4,"studyType":21,"phases":273,"briefSummary":274,"conditions":275,"keywords":276,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":279,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":284,"locationsCount":47},"100566748","NCT06659211","Effectiveness of Mentalization-based Therapy (MBT)","Effectiveness of Mentalization-based Therapy (MBT) as Part of a Stepped Mental Health Care in Finland - a Pilot Study","Inclusion Criteria:\n\nMBT Group:\n\n* Age 18-64 years.\n* Severe psychological symptoms, decreased functioning ability for long-term\n* Challenges with interpersonal relationships and emotional regulation\n* Patients willing to receive MBT\n* At least two of the following:\n\n  * Depression (diagnosis codes: F31.3-F31.5, F32.0-F32.9, F33.3-F33.9, F34.1) or anxiety disorder (diagnosis codes: F40-F48)\n  * Trauma background either as diagnosis or as need for treatment\n  * Signs of personality disorder (suspected or diagnosed)\n\nTAU group:\n\n* Age 18-64 years.\n* Severe psychological symptoms, decreased functioning ability for long-term\n* Challenges with interpersonal relationships and emotional regulation\n* At least two of the following\n\n  * Depression (diagnosis codes: F31.3-F31.5, F32.0-F32.9, F33.3-F33.9, F34.1) or anxiety disorder (diagnosis codes: F40-F48)\n  * Trauma background either as diagnosis or as need for treatment\n  * Signs of personality disorder (suspected or diagnosed)\n\nExclusion Criteria:\n\nMBT Group:\n\n* Active substance use disorder (i.e., intoxication F1x.0, active dependence F1x.24, Continuous use F1x.25), a physiological withdrawal state F1x.3 and F1x.4, or psychotic disorder F1x.5).\n* Acute psychosis (defined as the recent onset of severe psychotic symptoms that interfere with functioning and are not yet in a therapeutic state. Non-acute psychotic symptoms are not exclusionary)\n* Disorder requiring inpatient treatment\n* Previously received MBT\n* Currently receiving psychotherapeutic treatment (previous psychotherapeutic treatment is not an exclusion)\n\nThe exclusion criteria, therefore, do not exclude psychotic disorders or any other psychiatric illness (except substance abuse disorders).\n\nTAU group:\n\n* Active substance use disorder (i.e., intoxication F1x.0, active dependence F1x.24, Continuous use F1x.25), a physiological withdrawal state F1x.3 and F1x.4, or psychotic disorder F1x.5).\n* Acute psychosis (defined as the recent onset of severe psychotic symptoms that interfere with functioning and are not yet in a therapeutic state. Non-acute psychotic symptoms are not exclusionary)\n* Disorder requiring inpatient treatment\n* Previously received MBT\n* Intensive psychotherapy (e.g. rehabilitative psychotherapy or similar weekly long-term psychotherapy)","64 Years",{"count":272,"type":20},128,[23],"The effects of psychological treatment, mentalization-based therapy, will be studied among persons with mental disorders seeking help from mental health care services.",[26],[277],"mentalization, MBT, severe mental disorder, therapy, psychotherapeutic","2025-04-22",{"date":280,"type":39},"2025-04-25",{"date":282,"type":39},"2024-09-25",{"date":159,"type":20},{"name":285,"class":46},"Oulu University Hospital",{"id":287,"slug":4,"hasResults":10,"nctId":288,"briefTitle":289,"officialTitle":290,"acronym":4,"eligibilityCriteria":291,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":292,"enrollmentInfo":293,"targetDuration":4,"studyType":21,"phases":295,"briefSummary":297,"conditions":298,"keywords":299,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":304,"startDateStruct":306,"completionDateStruct":308,"leadSponsor":310,"locationsCount":47},"100472454","NCT05432089","The Effects of Oxytocin Administration to Patients and Therapists on Physiological Synchronization","The Effects of Oxytocin Administration to Patients and Therapists on Physiological Synchronization: a Randomized Controlled Pilot Study","Patients Inclusion Criteria:\n\n* age above 18.\n* any type of psychiatric illness.\n* hospitalization in one of the inpatients wards.\n\nPatients Exclusion Criteria:\n\n* current severe psychotic episode\n* pregnancy according to self-report.\n\nTherapist Inclusion Criteria:\n\n* psychologists, psychiatrists, and social workers, in different stages of seniority and training.\n\nTherapist Exclusion Criteria:\n\n* pregnancy according to self-report.","80 Years",{"count":294,"type":20},120,[296],"PHASE2","Introduction: Oxytocin (OT) is a nine-amino acid neuropeptide, known to have a fundamental role in social communication. In a recent randomized, double-blind, placebo-controlled study carried out in Shalvata Mental Health Center, OT was administrated to patients suffering from severe mental health illness. The results indicated that OT has a clear beneficial effect on therapeutic outcomes. However, to our knowledge, the effect of OT administration to both patients and therapists on the therapeutic process was never tested. Substance administration to caregivers is therefore possible, and could, in some cases, provide further knowledge about the caregiving dynamics. Since we know the therapist's characteristics effect the therapeutic alliance and that OT is associated with the therapeutic alliance, patient-therapist bond, and therapy outcome, we are led to ask if OT administration to patients and therapists could allow for a deeper understanding of OT's effects on the therapeutic process.\n\nAnother variable found to be associated with the therapeutic process is Physiological Synchronization. Physiological Synchronization (PS) is a primarily interpersonal phenomenon which includes coordination of physiological signals between two or more interacting individuals. Despite the rising number of studies examining PS, its physiological and psychological mechanisms are yet to be fully understood. Based on literature indicating associations between OT and PS, and associations each of them has with the therapeutic process and its facilitators, in this study we wish to examine the influence of OT on PS through intranasal OT administration to patients alone and to patients and therapists together.\n\nResearch Hypotheses:\n\n1. Patients receiving OT will demonstrate higher levels of PS during the measured session compared to patients receiving placebo.\n2. Patients receiving OT will report higher levels of perceived therapist empathy as compared to patients receiving placebo.\n3. These associations will be stronger when both patient and therapist receive OT in comparison to patient alone.\n4. Changed in PS and empathy will be associated with OT even after controlling for patient rated alliance and session impact.\n5. These findings will sustain after controlling for severity of symptoms and attachment patterns.\n\nMethod:\n\nParticipants. Sixty patients and their therapists will be recruited for the pilot study. Patients will be recruited from the inpatient adult psychiatric wards at Shalvata Mental Health Center. Therapists in this study will be comprised of psychologists, psychiatrists, and social workers, in different stages of seniority and training.\n\nInstruments. Attachment patterns, symptom severity, side effects and therapeutic process measurements - working alliance, perceived empathy and session impact - will be assessed using self-report questionnaires. PS will be measured by recordings of the electrodermal activity (EDA) measured by skin conductance signals, using a galvanic skin response (GSR) device. Oxytocin Administration will be performed intranasally using a spray containing 24U.\n\nProcedure. Sixty patients meeting inclusion criteria and their therapists will be recruited for the pilot study. Dyads will be randomized and double-blindly allocated to receive intra-nasal oxytocin or placebo. Dyads will be followed for two consecutive sessions, approximately at their fourth and fifth sessions. After signing informed consent forms, patients and therapists will complete therapeutic process measurements, and patients will be assessed for the severity of their symptoms and attachment patterns. Prior to the first session, patients will be administrated with either IN-OT or PLC and will wait for 30 minutes before the beginning of the session. Skin conductance synchrony will be measured during the session. At the end of the session, therapeutic process measurements will be assessed in both patients and therapists, and patients will complete a side-effect questionnaire. Prior to the second session, both patients and therapists will receive either IN-OT or PLC (each dyad will receive the same substance) and will wait for 30 minutes before the beginning of the session. Skin conductance synchrony will then be measured during the session. At the end of the session, therapeutic process measurements will be assessed in both patients and therapists alongside with a side-effect questionnaire.\n\nThe uniqueness of the proposed study is rooted in the view of the psychotherapy dyad as undetached, by focusing on the dyad and not on the patient alone. Focusing on patient-therapist synchronization lies on the understanding of the patient-therapist bond as co-dependent and co-affected. Such research could increase our understanding of PS between patient and therapist and its meaning in psychotherapy research and practice.",[26],[300,301,302],"Oxytocin","Physiological Synchronization","Psychotherapy","2024-06-27",{"date":305,"type":39},"2024-06-28",{"date":307,"type":39},"2023-03-30",{"date":309,"type":20},"2026-07-01",{"name":311,"class":46},"Shalvata Mental Health Center",""]