[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05703412":3,"trial-entities:NCT05703412":92,"trial-summary:NCT05703412":96},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":45,"secondary_outcomes":50,"sex":51,"minimum_age":52,"maximum_age":17,"healthy_volunteers":53,"eligibility_criteria":54,"std_ages":66,"locations":69,"central_contacts":78,"overall_officials":79,"references":86,"see_also_links":91},"NCT05703412","2208-001","Effectiveness of mHealth Post-discharge Intervention for Patients With Severe Mental Illness","Effectiveness of a Multi-component mHealth Intervention to Improve Post-hospital Transitions of Care for Patients With SMI","ENROLLING_BY_INVITATION","2027-07-31","2025-06","2025-06-06","2023-02-14","Butler Hospital","OTHER",true,"The overall aim of this program of research is to improve the continuity of care for patients with serious mental illness (SMI) by supporting a safer and more efficient bridge from hospital to outpatient care using a mobile device-delivered app called Transition-FOCUS (tFOCUS), which has previously been tested in community samples. The purpose of the proposed project is to establish the effectiveness of our empirically-supported, multi-component mHealth intervention.",null,[19,20,21],"Bipolar Disorder","Major Depression","Schizophrenia",[23,24,25],"mHealth","psychiatric hospitalization","transitions of care","INTERVENTIONAL","TREATMENT",[29],"NA",{"count":31,"type":32},180,"ESTIMATED",[34,41],{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"BEHAVIORAL","Transition-FOCUS mHealth Intervention","tFOCUS integrates evidence-based strategies for self-management of severe mental illness (SMI) into a comprehensive mobile assessment and treatment system that is grounded in theoretical SMI models. The application promotes self-management strategies aimed at improving medication adherence to manage biologically driven psychiatric symptoms, increase social support to reduce the negative impact of social withdrawal, improve sleep hygiene to reduce levels of fatigue, and promote strategies for coping with persistent symptoms. tFOCUS application strategies are linked to participants' specific assessment responses, allowing for a highly personalized self-management intervention experience",[36],[40],"tFOCUS",{"type":35,"name":42,"description":43,"armGroupLabels":44},"Check-In","Check-in includes a discharge and safety plan (with medication instructions, crisis services, etc.), a timely follow-up appointment with a mental health provider, and phone check-ins by case managers immediately following post-discharge for care coordination purposes.",[42],[46],{"measure":47,"description":48,"timeFrame":49},"Brief Psychiatric Rating Scale (BPRS)","The interviewer-rated Brief Psychiatric Rating Scale is a measure of psychiatric symptom severity. The total score (sum of items) will be used to assess overall severity with scores ranging from 18 to 126 and higher scores indicating greater severity.","24 weeks",[],"ALL","18 Years",false,{"inclusion":55,"exclusion":61,"raw_text":65},[56,57,58,59,60],"psychiatric inpatient\u002Fpartial hospitalization","diagnosis of schizophrenia-spectrum disorder or major mood disorder","planned ongoing mental health treatment post-discharge in the community","18 years or older","ability to speak and read English",[62,63,64],"lack of smartphone","homelessness or housing instability that would prevent reliable follow-up","discharge to a long-term restricted living setting","Inclusion Criteria:\n\n* psychiatric inpatient\u002Fpartial hospitalization\n* diagnosis of schizophrenia-spectrum disorder or major mood disorder\n* planned ongoing mental health treatment post-discharge in the community\n* 18 years or older\n* ability to speak and read English\n\nExclusion Criteria:\n\n* lack of smartphone\n* homelessness or housing instability that would prevent reliable follow-up\n* discharge to a long-term restricted living setting",[67,68],"ADULT","OLDER_ADULT",[70],{"facility":13,"city":71,"state":72,"zip":73,"country":74,"geoPoint":75},"Providence","Rhode Island","02916","United States",{"lat":76,"lon":77},41.82399,-71.41283,[],[80,83],{"name":81,"affiliation":13,"role":82},"Brandon Gaudiano, PhD","PRINCIPAL_INVESTIGATOR",{"name":84,"affiliation":85,"role":82},"Ethan Moitra, PhD","Brown University",[87],{"pmid":88,"type":89,"citation":90},"38431134","DERIVED","Moitra E, Amaral TM, Benz MB, Cambow S, Elwy AR, Kunicki ZJ, Lu Z, Rafferty NS, Rabasco A, Rossi R, Schatten HT, Gaudiano BA. A Hybrid Type 1 trial of a multi-component mHealth intervention to improve post-hospital transitions of care for patients with serious mental illness: Study protocol. Contemp Clin Trials. 2024 Apr;139:107481. doi: 10.1016\u002Fj.cct.2024.107481. Epub 2024 Mar 1.",[],{"nct_id":4,"conditions":93,"biomarkers":95},[19,21,94],"Unipolar Depression",[],{"nct_id":4,"found":53,"summary":17,"prompt_version":17}]