[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100593452":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":35,"responsibleParty":52,"collaborators":54,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":9,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":19,"enrollmentInfo":66,"targetDuration":19,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":82,"whyStopped":19,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Vrije Universiteit Brussel","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"CoMBI-SMI","EXPERIMENTAL","This study arm includes adults (aged 18-64 years) and older adults (aged 65 years and older) with a severe mental illness (SMI). Participants must meet the inclusion criteria of having a diagnosed SMI and exhibiting behavior that is not well understood by caregivers. Additional inclusion criteria are the willingness and ability to participate in the study procedures. Participants in this arm will receive the CoMBI-SMI intervention following a period of treatment as usual.",[13],"Behavioral: CoMBI-SMI",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"BEHAVIORAL","CoMBI-SMI (Cognitive Model for Behavioral Interventions - Severe Mental Illness) is a structured, team-based behavioral intervention for individuals with severe mental illness. It consists of four steps: (1) analyzing misunderstood behavior and identifying unmet core needs, (2) selecting the most relevant core need, (3) choosing appropriate nursing interventions, and (4) developing a CoMBI care plan. The model is based on cognitive-behavioral principles and personality-based formulations grounded in the DSM. It describes self-image, perception of others, triggers, and problematic behaviors. CoMBI-SMI is implemented by the entire team in a cyclical process, with periodic evaluation and a focus on consistent, team-aligned strategies.",[9],null,[21],{"name":22,"affiliation":23,"role":24},"van Alphen, Prof. dr.","Mondriaan","PRINCIPAL_INVESTIGATOR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":19,"email":30},"Saskia Bollen, MSc","CONTACT","0031643732363","saskia.bollen@vub.be",{"name":32,"role":28,"phone":33,"phoneExt":19,"email":34},"Gina Rossi, Prof. dr.","0032476721678","gina.rossi@vub.be",[36],{"facility":23,"status":19,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Heerlen","Limburg","6419PJ","Netherlands","NL",{"type":43,"coordinates":44},"Point",[45,46],5.98154,50.88365,{"lat":46,"lon":45},[49],{"name":50,"role":28,"phone":29,"phoneExt":19,"email":51},"Saskia Bollen","saskiabollen80@gmail.com",{"type":24,"investigatorFullName":50,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"Hoofdonderzoeker",[55],{"name":23,"class":56},"AMBIG","100593452","combi-smi-multicenter-study-a-person-centered-cognitive-behavioral-intervention-for-severe-mental-illness-100593452",false,"NCT07006623","\"CoMBI-SMI Multicenter Study: A Person-Centered Cognitive-Behavioral Intervention for Severe Mental Illness\"","A Multicenter Study of the Cognitive Model for Behavioral Interventions (CoMBI) as a Personalized Cognitive Behavioral Intervention for Patients With Severe Mental Illness","Inclusion Criteria:\n\n* Psychogeriatric inpatients aged 18 years and older\n* Clinical diagnosis of a severe mental illness (SMI)\n* Presence of behavioral problems not understood by caregivers\n* Willingness and ability to participate in the study\n\nExclusion Criteria:\n\n\\- Diagnosis of dementia","ALL","18 Years",{"count":67,"type":68},99,"ESTIMATED","INTERVENTIONAL",[71],"NA","This observational multicenter study aims to evaluate whether the Cognitive Model for Behavioral Interventions - Severe Mental Illness (CoMBI-SMI) can reduce challenging behaviors and psychological symptoms in adults (aged 18 and older) with severe mental illness (SMI). The study is conducted across multiple sites in the Netherlands, Belgium, and the Caribbean, using a stepped-wedge design. All participating departments initially continue their usual care. At different time points, each team receives training in the CoMBI-SMI approach and begins implementing the intervention. This design allows for a comparison between standard care and CoMBI-SMI-based care.\n\nParticipants first receive their usual treatment, during which baseline data are collected on their behavior and psychological symptoms. After the care team is trained in CoMBI-SMI, participants receive CoMBI-SMI-based care for four weeks. They complete questionnaires on behavior, psychological symptoms, and quality of life before and after the intervention. The study aims to assess whether CoMBI-SMI helps reduce challenging behaviors such as aggression or repetitive actions, improve quality of life, and reduce stress for both caregivers and treatment teams. Findings from this study may help improve care for individuals with severe mental illness and provide better support for mental health professionals managing complex behaviors.",[74],"Mental Illness Persistent",[76,77,78,79,80,81],"Severe mental illness","older adults","adults","mediationtherapie","Cognitive behavioral therapie","Nursing interventions","NOT_YET_RECRUITING","2025-06-11",{"date":85,"type":86},"2025-06-15","ACTUAL",{"date":88,"type":68},"2025-09-01",{"date":90,"type":68},"2029-09",{"name":5,"class":6},1]