[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100482869":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":39,"centralContacts":43,"locations":51,"responsibleParty":69,"collaborators":71,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":83,"acronym":30,"eligibilityCriteria":84,"healthyVolunteers":85,"sex":86,"minAge":87,"maxAge":30,"enrollmentInfo":88,"targetDuration":30,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":30,"overallStatus":54,"whyStopped":30,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Boston University Charles River Campus","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP)","EXPERIMENTAL","Digital, transdiagnostic, emotion-focused CBT intervention that consists of five \"core\" modules or components that have been shown to target temperamental characteristics (i.e., neuroticism) and resulting emotion dysregulation that are believed to underlie all anxiety, depressive, and emotional disorders. The core components of the program are psychoeducation, mindfulness, cognitive flexibility, behavioral strategies to counter emotion-driven behaviors, interoceptive, and emotion exposures.",[13],"Behavioral: The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP)",{"label":15,"type":16,"description":17,"interventionNames":18},"Space from Depression (SFD)","ACTIVE_COMPARATOR","Digital CBT program designed to minimize the impact of depressive symptoms. This program emphasizes the use of cognitive behavioral strategies as well as mindfulness through a series of seven structured modules. The core components of the program include psychoeducation around the relationship between thoughts, feelings, and behaviors; cognitive behavioral practices aimed at restructuring negative beliefs; behavioral strategies to improve self-esteem; and mindfulness techniques that focus attention on the present moment.",[19],"Behavioral: Space for depression",{"label":21,"type":16,"description":22,"interventionNames":23},"Space for Resilience (SFR)","Digital program based on positive psychology principles and designed to promote resilience and well-being through a series of seven modules. The core components of the program include psychoeducation, values exploration, building relationships, promoting self-esteem and self-efficacy, and building gratitude and optimism.",[24],"Behavioral: Space for resilience",[26,31,35],{"type":27,"name":9,"description":28,"armGroupLabels":29,"otherNames":30},"BEHAVIORAL","This is a cognitive behavioral treatment (CBT) for emotional disorders. This transdiagnostic intervention consists of eight modules and can be effectively applied to various disorders and problems.",[9],null,{"type":27,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"Space for depression","Digital CBT program designed to minimize the impact of depression symptoms. Emphasizes CBT strategies and mindfulness through a series of seven structured modules.",[15],{"type":27,"name":36,"description":37,"armGroupLabels":38,"otherNames":30},"Space for resilience","This program is built from positive psychology principles and is designed to promote resilience and well-being through seven modules.",[21],[40],{"name":41,"affiliation":5,"role":42},"Todd Farchione, Ph.D.","PRINCIPAL_INVESTIGATOR",[44,48],{"name":41,"role":45,"phone":46,"phoneExt":30,"email":47},"CONTACT","(617) 353-9610","tfarchio@bu.edu",{"name":49,"role":45,"phone":46,"phoneExt":30,"email":50},"Anthony Rosellini, Ph.D.","ajrosell@bu.edu",[52],{"facility":53,"status":54,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"Center for Anxiety and Related Disorders","RECRUITING","Boston","Massachusetts","02115","United States","US",{"type":61,"coordinates":62},"Point",[63,64],-71.05977,42.35843,{"lat":64,"lon":63},[67],{"name":41,"role":45,"phone":68,"phoneExt":30,"email":47},"617-353-9610",{"type":70,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR",[72,75,77],{"name":73,"class":74},"National Institute of Mental Health (NIMH)","NIH",{"name":76,"class":6},"Silver Cloud Health",{"name":78,"class":6},"Kaiser Permanente","100482869","using-machine-learning-to-optimize-user-engagement-and-clinical-response-to-digital-mental-health-interventions-100482869",false,"NCT05567640","Using Machine Learning to Optimize User Engagement and Clinical Response to Digital Mental Health Interventions","Inclusion Criteria:\n\n* English-speaking adults\n* Ages 18 or older\n* Have a device that can connect to the internet.",true,"ALL","18 Years",{"count":89,"type":90},1800,"ESTIMATED","INTERVENTIONAL",[93],"NA","Digital mental health interventions are a cost-effective and efficient approach to expanding the accessibility and impact of psychological treatments; however, little guidance exists for selecting the most effective program for a given individual. In the proposed study, decision rules will develop for selecting the digital program that is most likely to be the optimal intervention for each user. These treatment recommendations can be implemented in the context of large healthcare delivery systems to improve the delivery of digital mental health interventions at scale.\n\nThe overarching aim of the current study is to better understand for whom and how leading digital interventions work in a large healthcare setting. The study builds on the existing literature and follows expert recommendations by using machine learning (ML) methods to develop precision treatment rules (PTRs) for three leading digital interventions for emotional disorders (e.g., anxiety, depression, and related mental health disorders). Specifically, ML methods will be used to develop PTRs to optimize clinical outcomes and associated intervention engagement. This study will leverage a unique partnership between Boston University (BU), SilverCloud Health (SC)--a leading provider of digital mental health care--and Kaiser Permanente (KP)--one of America's leading health care providers.\n\nA clinical trial (RCT) will be conducted to evaluate the relative effectiveness of three distinct empirically supported digital mental health interventions (from SC's existing library of programs) in a sample recruited from KP primary care and other clinical settings. Data from this trial will be used to develop theoretically and empirically informed, reliable selection algorithms for managing treatment delivery decisions. Algorithms will be validated in a separate \"holdout\" dataset by examining whether allocation to predicted optimal treatment is associated with superior outcomes compared to allocation to a non-optimal treatment. The role of user engagement will be determined, and other mechanisms in treatment outcome.",[96,97],"Anxiety Disorders and Symptoms","Depressive Symptoms","2026-07-30",{"date":100,"type":101},"2026-07-31","ACTUAL",{"date":103,"type":101},"2023-04-12",{"date":105,"type":90},"2027-07",{"name":5,"class":6},1]