[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"severe-mental-disorder\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:severe-mental-disorder":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,48,81,112,151,181,219,247],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":32,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100053742","the-effect-of-comorbid-alcoholsubstance-use-100053742",false,"NCT07692984","The Effect of Comorbid Alcohol\u002FSubstance Use","The Effect of Comorbid Alcohol\u002FSubstance Use on Social Inclusion and Clinical Outcome in Individuals With Severe Mental Illness Enrolled in a Community Mental Health Center: A Cross-Sectional Case-Control Study","Inclusion Criteria:\n\n* Being 18 years of age or older,\n* Having a diagnosis of Schizophrenia Spectrum Disorder and Other Psychotic Disorders or Bipolar Disorder according to DSM-5 diagnostic criteria,\n* Being actively followed up at the TRSM for at least 6 months.\n\nExclusion Criteria:\n\n* Individuals diagnosed with organic brain damage or neurodevelopmental disorders (intellectual disability, etc.),\n* Individuals with severe cognitive impairment that prevents them from communicating adequately.","ALL","18 Years","65 Years",{"count":20,"type":21},297,"ESTIMATED","OBSERVATIONAL","Study Design This study was designed as a comparative, cross-sectional case-control study examining the effect of comorbid alcohol and substance use disorder (ASUD) on clinical course and social inclusion among individuals with severe mental illness followed at a Community Mental Health Center (CMHC). The study did not involve any interventions.\n\nAim The aim of this study is to examine the effect of comorbid alcohol and substance use on clinical course parameters-such as number of hospitalizations and medication dosages-and on social inclusion indicators-such as employment, social participation, and social adjustment-among individuals with severe mental illness followed at the CMHC, in comparison with a matched control group without substance use.\n\nResearch Questions\n\nWhat are the rates of comorbid alcohol and substance use among patients with severe mental illness followed at the CMHC? What are the current addiction symptoms, number of hospitalizations, and employment rates among individuals with severe mental illness and comorbid ASUD? What is the level of continuity of CMHC engagement and social participation among individuals with severe mental illness and comorbid ASUD, and what factors influence it? How does the level of social inclusion among individuals with severe mental illness and comorbid ASUD compare with that of individuals without ASUD?\n\nHypotheses\n\nH1: The average annual number of hospitalizations among individuals with a dual diagnosis (severe mental illness + ASUD) followed at the CMHC is significantly higher than among those without substance use.\n\nH2: Among individuals with a dual diagnosis, the daily medication doses (e.g., chlorpromazine equivalents) required to control psychotic or manic symptoms are higher than in the control group.\n\nH3: Social inclusion is lower among patients with substance use compared with the control group.\n\nH4: Employment rates among individuals with a dual diagnosis are significantly lower than among those with severe mental illness alone.\n\nH5: Substance use negatively affects patients' social participation, including involvement in activities and friendships.\n\nH6: Attendance rates at CMHC workshops and rehabilitation programs are lower among individuals with substance use compared with the control group.",[25,26,27,28,29,30,31],"Alcohol Abuse","Alcohol Use Disorder","Substance Use Disorders","Severe Mental Disorder","Schizophrenia","Bipolar Disorder","Ostracism",[33,27,28,34],"alcohol use disorder","ostracism","RECRUITING","2026-07-10",{"date":38,"type":39},"2026-07-13","ACTUAL",{"date":41,"type":39},"2026-06-20",{"date":43,"type":21},"2026-12-30",{"name":45,"class":46},"Abant Izzet Baysal University","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":65,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":47},"100564076","effectiveness-of-a-pragmatic-metabolic-care-clinic-for-patients-with-severe-mental-illness---the-meta-care-clinic-100564076","NCT06624462","Effectiveness of a Pragmatic, Metabolic Care Clinic for Patients With Severe Mental Illness - The Meta Care Clinic","Inclusion Criteria:\n\n* Patients with schizophrenia spectrum disorders (International classification of diseases; ICD-10: DF2x) or bipolar disorder (ICD-10: DF30.x or DF31.x)\n* Medical treatment with antipsychotics\n* Age 18-45 years\n* Legally competent\n* Able to give informed consent\n\nand either:\n\n\\- Body mass index (BMI) ≥30 kg\u002Fm2.\n\nOr\n\n* BMI ≥27 kg\u002Fm2 and at least one of the following:\n* Hypertension defined as treatment with ≥1 antihypertensive drug or out-of-office \u002F 24-hour, non-invasive ambulatory blood pressure ≥140\u002F90 mmHg within the previous 6 months\n* Dyslipidaemia defined as treatment with ≥1 lipid-lowering drug or elevated low-density lipoprotein (LDL) cholesterol (≥3.0 mmol\u002Fl), elevated triglycerides (≥1.7 mmol\u002Fl) or low high-density lipoprotein cholesterol (≥1.2 mmol\u002Fl in women and ≥1.0 mmol\u002Fl in men) within the previous 6 months\n* Sleep apnoea (ICD-10 DG473).\n* Prediabetes or diabetes defined as HbA1c ≥42 mmol\u002Fmol or impaired fasting glucose as defined by the International Diabetes Federation within the previous 6 months.\n\nOr\n\n\\- a history of rapid weight gain during antipsychotic therapy defined as increases of either ≥5% body weight or ≥5 cm waist circumference since initiation of antipsychotic therapy.\n\nExclusion Criteria:\n\n* Clinical or laboratory evidence of comorbid medical disease not compatible with participation as judged by the research team.\n* Unstable psychiatric disorder as judged by the research team.\n* Severe current drug or alcohol misuse as judged by the research team.\n* Acute suicidal risk.","45 Years",{"count":56,"type":21},84,"INTERVENTIONAL",[59],"NA","This study will examine the effectiveness of a Pragmatic, Metabolic Care Clinic for Patients With Severe Mental Illness",[28,62,63,64,30],"Metabolic Complication","Side-Effect;Medication","Schizophrenia Spectrum and Other Psychotic Disorders",[66,67,68,69,70,71],"Severe mental illness","Overweight and obesity","Antipsychotic medication","Dysmetabolism","Schizophrenia Spectrum Disorders","Bipolar disorder","2026-01-06",{"date":74,"type":39},"2026-01-08",{"date":76,"type":39},"2023-10-10",{"date":78,"type":21},"2026-12-31",{"name":80,"class":46},"Bjorn H. Ebdrup",{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":89,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":57,"phases":92,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":111},"100586380","real-time-experiences-physical-activity-and-biological-outcomes-in-personal-recovery-residents-empower-res-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.",true,{"count":91,"type":21},72,[59],"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.",[28,95],"Severe Mental Illness",[97,98,99,100,101],"mental health supported accommodation","personal recovery","severe mental disorder","bio-psychosocial","rehabilitation","2025-12-11",{"date":104,"type":39},"2025-12-18",{"date":106,"type":21},"2026-01-15",{"date":108,"type":21},"2028-12-31",{"name":110,"class":46},"IRCCS Centro San Giovanni di Dio Fatebenefratelli",3,{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":118,"eligibilityCriteria":119,"healthyVolunteers":89,"sex":16,"minAge":120,"maxAge":121,"enrollmentInfo":122,"targetDuration":4,"studyType":57,"phases":124,"briefSummary":125,"conditions":126,"keywords":133,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":47},"100599548","norwegian-mental-illness-heart-health-study-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":123,"type":21},70,[59],"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.",[127,128,28,129,130,131,132,95],"Cardio Vascular Disease","Metabolic Syndrome (MetS)","Schizophrenia and Schizophrenia Spectrum Psychosis","Bipolar Disease Type I","Overweight and\u002For Obesity","CVD Risk Factors",[95,134,135,136,137,138,29,139,30,140,141],"Cardiovascular Disease","Lifestyle Intervention","Healthy Diet","Exercise","CVD-risk","Antipsychotic Medication","Non-pharmacological intervention","Clinical Dietitian","2025-09-26",{"date":144,"type":39},"2025-10-02",{"date":146,"type":39},"2025-09-16",{"date":148,"type":21},"2028-06-30",{"name":150,"class":46},"Madeleine Elisabeth Angelsen",{"id":152,"slug":153,"hasResults":11,"nctId":154,"briefTitle":155,"officialTitle":155,"acronym":4,"eligibilityCriteria":156,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":157,"targetDuration":4,"studyType":57,"phases":159,"briefSummary":160,"conditions":161,"keywords":167,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":47},"100585570","prediction-and-intervention-effect-of-rehabilitation-status-for-severe-mental-disorder-patients-based-on-multimodal-analysis-and-ai-agents-100585570","NCT06904079","Prediction and Intervention Effect of Rehabilitation Status for Severe Mental Disorder Patients Based on Multimodal Analysis and AI Agents","Inclusion criteria:\n\n* Registered in the Shanghai Mental Health Information Management System,\n\n  * Diagnosed patients with one of the six severe mental disorders: schizophrenia, schizoaffective disorder, paranoid psychosis, bipolar (affective) disorder, mental disorder due to epilepsy, and mental retardation accompanied by mental disorder,\n\n    * Aged between 18 and 65 years old, ④ Normal vision or hearing, or within the normal range after correction, ⑤ Patients or their families have provided informed consent for this study and signed the informed consent form.\n\nExclusion criteria:\n\nPatients with severe physical illnesses or organic brain diseases.",{"count":158,"type":21},82,[59],"Mental health issues represent a major public health and social problem that significantly impacts economic and social development. Compared to other diseases, mental disorders can impair various aspects of a patient' s life, including psychological, social, occupational, and educational functions, affecting their quality of life and daily living abilities. Particularly, severe mental disorders tend to have a chronic course, often resulting in diminished social functions and social withdrawal, making it difficult for patients to integrate into society. Repeated, systematic, and comprehensive rehabilitation training for patients with severe mental disorders can effectively control or delay disease recurrence, improve social functions, enhance quality of life, and facilitate patients' reintegration into society.\n\nIn recent years, the scope of mental disorder rehabilitation has expanded to include enhancing patients' social functions and promoting their integration into society. Vocational rehabilitation and social skills training are widely used in the rehabilitation treatment of patients with severe mental disorders, and some physical intervention methods, such as neurofeedback training, have also proven to be significantly effective in the rehabilitation process. However, traditional rehabilitation techniques often lack specificity and fail to meet individualized needs of patients. Additionally, the rehabilitation process lacks long-term monitoring, making it challenging to continuously assess and adjust patients' rehabilitation outcomes. Furthermore, the assessment of rehabilitation effectiveness mainly relies on patients' subjective feelings and clinical observations, lacking high-quality evidence. Therefore, there is an urgent need to introduce new rehabilitation technologies and scientifically evaluate their effectiveness to address the shortcomings of traditional methods and provide more personalized, precise, and effective rehabilitation support.\n\nWith the rise of digital health technologies, the field of mental health rehabilitation has encountered new opportunities. Compared to traditional therapies, digital health is revolutionizing the healthcare industry, moving away from traditional approaches to healthcare management to real-time personalized monitoring and therapeutic care.Technologies such as remote monitoring, virtual reality, and computer-assisted cognitive correction therapy are increasingly applied in rehabilitation. However, these methods still need improvements in data management and integration capabilities. A large amount of data accumulates in systems, recording only the training process and real-time effects of patients, without further evaluating their rehabilitation status, leading to resource waste. Therefore, there is an urgent need to develop a digital rehabilitation model that better meets the genuine needs of patients with severe mental disorders.\n\nThis study aims to integrate multimodal technology, reinforcement learning, and agent-based modeling (ABM) into the research of mental health rehabilitation to more accurately assess and predict the rehabilitation status of mental disorder patients and to more effectively guide and support decision-making in mental rehabilitation treatment.",[28,29,162,163,164,165,166],"Schizoaffective Disorder","Paranoid Psychosis","Bipolar Affective Disorder","Mental Disorders Due to Epilepsy","Mental Retardation Accompanied by Mental Disorders",[28,168,169,170,171],"Reinforcement Learning","Agent-based Modeling","Multimodal and Crossmodal AI framework","Digital rehabilitation","2025-08-12",{"date":174,"type":39},"2025-08-17",{"date":176,"type":39},"2024-03-12",{"date":178,"type":21},"2026-06-30",{"name":180,"class":46},"Shanghai Mental Health Center",{"id":182,"slug":183,"hasResults":11,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":187,"eligibilityCriteria":188,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":189,"targetDuration":4,"studyType":57,"phases":191,"briefSummary":192,"conditions":193,"keywords":202,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":218},"100540305","a-transdiagnostic-mentalization-based-intervention-for-parents-with-mental-disorders-100540305","NCT06315114","A Transdiagnostic Mentalization-based Intervention for Parents With Mental Disorders","A Transdiagnostic Mentalization-based Intervention (LIGHTHOUSE Parenting Program) Versus Care as Usual for Parents With Mental Disorders in Adult Mental Health Service: a Randomised Clinical Trial","LIGHTHOUSE","Inclusion Criteria exclusive to the Outpatient Clinic\n\n* Age \\>18 years\n* Seeking treatment for one of the following non-psychotic disorders according to ICD-10: obsessive-compulsive disorder and anxiety disorders (F40-42), posttraumatic stress disorder (DF43), personality disorders (F60-61), or one of the previous disorders and a drug-or alcohol related disorder (F10-19) (i.e. 'dual diagnosis disorder')\n\nInclusion Criteria exclusive to the trial:\n\n* Parent of at least one child aged 0-17 years of age at baseline\n* Fluent i.e., sufficient Danish language skills\n* Parent is living with child or is in regular contact (min. 5 days monthly)\n* Written informed consent\n\nExclusion Criteria exclusive to the Outpatient Clinic:\n\n* Possibility of a learning disability (IQ\\\u003C75)\n* A diagnosis of schizotypal personality disorder or antisocial personality disorder\n* Presence of a comorbid psychiatric disorder that requires specialist treatment elsewhere\n* Concurrent psychotherapeutic treatment outside the clinic\n\nExclusion Criteria exclusive to the trial:\n\n* Acute suicidal risk or state of crises\n* Lack of informed consent\n* Acute child endangerment\n* Participation in another parenting focused intervention simultaniously",{"count":190,"type":21},170,[59],"The aim of this randomised clinical trial is to evaluate the short and longterm effects of a transdiagnostic mentalization-based intervention (Lighthouse MBT Parenting Program) compared to care as usal (CAU) for parents with a mental disorder in adult mental health service.",[194,195,196,197,28,198,199,200,201],"Mental Disorder","Behavior Disorders","Diagnosis, Psychiatric","Diagnosis Dual","Mental Illness","Psychiatric Disorder","Psychiatric Disease","Psychiatric Illness",[203,204,205,206,207,208],"Mental disorder","Parent","Child","Preventive intervention","Prevention","Intergenerational transmission","2025-05-09",{"date":211,"type":39},"2025-05-14",{"date":213,"type":39},"2024-03-11",{"date":215,"type":21},"2028-04-01",{"name":217,"class":46},"Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital",2,{"id":220,"slug":221,"hasResults":11,"nctId":222,"briefTitle":223,"officialTitle":224,"acronym":225,"eligibilityCriteria":226,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":227,"targetDuration":4,"studyType":57,"phases":229,"briefSummary":230,"conditions":231,"keywords":232,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":47},"100564348","digital-follow-up-of-aerobic-interval-training-in-outpatients-with-mental-disorders-100564348","NCT06628011","Digital Follow-up of Aerobic Interval Training in Outpatients With Mental Disorders","Digital Follow-up of Exercise Training in Outpatients With Mental Disorders","DIG-EX","Inclusion Criteria:\n\n* Individuals receiving outpatient mental health treatment at the clinics of mental health at St. Olavs Hospital,.\n\n  .-18-65 years old\n* Both men and women able to carry out exercise training.\n* Participants must be capable of giving informed consent and use HelsaMi.\n\nExclusion Criteria:\n\n* Contraindications for exercise training and testing according to the ACSM specifications; life-threatening or terminal medical conditions; unable to carry out intervention or test procedures; pregnancy; mothers \\<6 months post-partum.\n* Inpatients at an acute psychiatric ward or have any planned surgery that would interfere with the intervention.",{"count":228,"type":21},40,[59],"This randomized-controlled trial (RCT) will investigate if digital follow-up of exercise, i.e. followup through the new citizen portal HelsaMi, coupled with an exercise app can result in exercise adherence and improved oxygen uptake in individuals with mental disorders (MD). Secondary, the project will provide information regarding effects on cardiovascular disease risk-factors, functional capacity, quality of life, satisfaction, and cost through a randomized-controlled trial (RCT) including individuals with MDs.\n\nOutcomes assessed in this project, such as maximal oxygen uptake, functional capacity, and quality of life, are strongly related to the ability to carry out activities of daily living. These outcomes are associated with benefits such as reduced sick leave, extended life expectancy, independence, and improved health status with increasing age. Economically, with the world population growing older and health care resources being stretched, there is clearly a need to apply and evaluate effective alternative methods to improve somatic health on a broader scale in a sustainable fashion, preferably utilizing existing platforms and exercise apps.",[28],[233,234,235,236,237],"Peak oxygen uptake","Aerobic high-intensity interval training","Digital follow-up","Mental health disorder","Exercise physiology","2025-03-31",{"date":240,"type":39},"2025-04-01",{"date":242,"type":39},"2025-01-01",{"date":244,"type":21},"2030-09-01",{"name":246,"class":46},"Norwegian University of Science and Technology",{"id":248,"slug":249,"hasResults":11,"nctId":250,"briefTitle":251,"officialTitle":252,"acronym":253,"eligibilityCriteria":254,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":255,"targetDuration":4,"studyType":57,"phases":257,"briefSummary":258,"conditions":259,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":264,"lastUpdatePostDateStruct":265,"startDateStruct":267,"completionDateStruct":269,"leadSponsor":271,"locationsCount":47},"100480266","evaluating-the-effectiveness-of-the-gill-ehealth-intervention-to-improve-physical-health-and-lifestyle-behaviours-in-patients-with-severe-mental-illness-100480266","NCT05533749","Evaluating the Effectiveness of the GILL eHealth Intervention to Improve Physical Health and Lifestyle Behaviours in Patients With Severe Mental Illness","Improving Physical Health and Lifestyle Behaviors in Patients With Serious Mental Illness: a Cluster Randomized Controlled Trial on the Effectiveness of the Nurse-led GILL eHealth Intervention","GILL","Inclusion Criteria:\n\n* Meet the criteria of severe mental illness\n* Aged from 18 to 65 years\n* Body mass index (BMI) ≥ 27\n* Access and ability to use internet\n* Able and willing to sign informed consent\n\nExclusion Criteria:\n\n* Contra-indications (to be assessed by the treating physician\u002Fpsychiatrist) for participation due to acute psychiatric crisis or severe somatic diseases\n* Subjects with a cognitive impairment sufficient to interfere with their ability to provide informed consent, complete study questionnaires, or participate in the intervention\n* Pregnant or breastfeeding women at the time of inclusion\n* Subject not able to communicate in the Dutch language",{"count":256,"type":21},258,[59],"The aim of this study is to evaluate the effectiveness of the nurse-led GILL (Gezondheid in Lichaam en Leefstijl) eHealth intervention in patients with serious mental illness (SMI), compared to usual care. Expected is that the GILL eHealth intervention will be more effective than usual care in improving physical health and lifestyle behaviors. To evaluate this, we will perform a cluster randomized controlled trial with an embedded process evaluation of the implementation of the GILL intervention. 258 adult patients with serious mental illness and a body mass index of 27 or higher (overweight\u002Fobesity) will be included. The GILL eHealth intervention consists of two complementary modules for (a) somatic screening and (b) lifestyle promotion, resulting in a personalized somatic treatment and lifestyle plan. Trained mental health nurses and clinical nurse specialists will implement the intervention within the multidisciplinary treatment context, and will guide and support the patients in the promotion of their somatic health, including cardiometabolic risk management. The intervention will be compared to usual care, which includes treatment according to national guidelines. The outcome measures will be metabolic syndrome severity (primary), fitness, physical activity, lifestyle behaviors, quality of life, recovery, psychosocial functioning, health related self-efficacy and health care utilization after 1 year. The process evaluation focuses on the feasibility of the eHealth intervention, its acceptability for patients and health care providers (mainly mental health nurses and clinical nurse specialists), and barriers\u002Ffacilitators to implementation.",[28,260,261,262,263],"Metabolic Syndrome","Lifestyle","Somatic Screening","eHealth","2024-06-13",{"date":266,"type":39},"2024-06-14",{"date":268,"type":39},"2024-05-30",{"date":270,"type":21},"2025-12-31",{"name":272,"class":46},"Amsterdam UMC, location VUmc"]