[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100474338":3},{"organization":4,"armGroups":7,"interventions":33,"overallOfficials":52,"centralContacts":56,"locations":64,"responsibleParty":83,"collaborators":85,"id":95,"slug":96,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":51,"eligibilityCriteria":101,"healthyVolunteers":97,"sex":102,"minAge":103,"maxAge":51,"enrollmentInfo":104,"targetDuration":51,"studyType":107,"phases":108,"briefSummary":110,"conditions":111,"keywords":114,"overallStatus":67,"whyStopped":51,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"University of Rochester","OTHER",[8,14,20,25,29],{"label":9,"type":10,"description":11,"interventionNames":12},"Control","ACTIVE_COMPARATOR","Online Mood Monitoring for 12 weeks",[13],"Behavioral: Mood Monitoring",{"label":15,"type":16,"description":17,"interventionNames":18},"Single Insomnia Treatment","EXPERIMENTAL","Cognitive-behavioral therapy for insomnia delivered in a self-managed online format (computer or phone app) with access to a coach. Duration of access for 12 weeks.",[19],"Behavioral: Cognitive Behavioral Therapy for Insomnia",{"label":21,"type":16,"description":22,"interventionNames":23},"Single Depression Treatment","Cognitive-behavioral therapy for depression delivered in a self-managed online format (computer or phone app) with access to a coach. Duration of access for 12 weeks.",[24],"Behavioral: Cognitive Behavioral Therapy for Depression",{"label":26,"type":16,"description":27,"interventionNames":28},"Sequenced Depression and Insomnia Treatment","Cognitive-behavioral therapy for depression followed by cognitive-behavioral therapy for insomnia each delivered in a self-managed online format (computer or phone app) with access to a coach. Duration of access to the depression treatment only for 4 weeks after which the access to the insomnia treatment is also made available. Total duration of access for 12 weeks.",[19,24],{"label":30,"type":16,"description":31,"interventionNames":32},"Sequenced Insomnia and Depression Treatment","Cognitive-behavioral therapy for insomnia followed by cognitive-behavioral therapy for depression each delivered in a self-managed online format (computer or phone app) with access to a coach. Duration of access to the insomnia treatment only for 4 weeks after which the access to the depression treatment is also made available. Total duration of access for 12 weeks.",[19,24],[34,41,47],{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"BEHAVIORAL","Cognitive Behavioral Therapy for Insomnia","Cognitive Behavioral Therapy for Insomnia consists of the standard features of this well-established insomnia treatment that will be delivered in this study via a mobile optimized web app. Participants also have access to an intervention coach\u002Fguide as needed.",[26,30,15],[40],"CBT-I",{"type":35,"name":42,"description":43,"armGroupLabels":44,"otherNames":45},"Cognitive Behavioral Therapy for Depression","Cognitive Behavioral Therapy for Depression consists of the standard features of this well-established depression treatment that will be delivered in this study via a mobile optimized web app. Participants also have access to an intervention coach\u002Fguide as needed.",[26,30,21],[46],"CBT-D",{"type":35,"name":48,"description":49,"armGroupLabels":50,"otherNames":51},"Mood Monitoring","The mood monitoring intervention is based on mood tracking principles in broader mood management interventions, but without any psychoeducational content or cognitive-behavioral exercises. Instead, participants will get access to a mobile optimized web app that allows users to enter their mood, tag related events, and view trends over time to raise awareness of how activities influence certain mood states.",[9],null,[53],{"name":54,"affiliation":5,"role":55},"Wilfred Pigeon, PhD","PRINCIPAL_INVESTIGATOR",[57,61],{"name":54,"role":58,"phone":59,"phoneExt":51,"email":60},"CONTACT","(585) 275-2900","wilfred_pigeon@urmc.rochester.edu",{"name":62,"role":58,"phone":59,"phoneExt":51,"email":63},"Michelle Carr, PhD","michelle_carr@urmc.rochester.edu",[65],{"facility":66,"status":67,"city":68,"state":69,"zip":70,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":79},"University of Rochester Sleep Research Laboratory","RECRUITING","Rochester","New York","14642","United States","US",{"type":74,"coordinates":75},"Point",[76,77],-77.61556,43.15478,{"lat":77,"lon":76},[80],{"name":81,"role":58,"phone":82,"phoneExt":51,"email":60},"Wilfred Pigeon, Ph.D.","585-275-2900",{"type":55,"investigatorFullName":54,"investigatorTitle":84,"investigatorAffiliation":5,"oldNameTitle":51,"oldOrganization":51},"Professor of Psychiatry",[86,89,91,93],{"name":87,"class":88},"United States Department of Defense","FED",{"name":90,"class":6},"University of South Florida",{"name":92,"class":6},"Harvard University",{"name":94,"class":6},"University of California, Irvine","100474338","digital-cbt-for-insomnia-and-depression-100474338",false,"NCT05456607","Digital CBT for Insomnia and Depression","Optimizing Digital Behavioral Treatment for Co-occurring Insomnia and Depression","Inclusion Criteria:\n\n* English-speaking\n* U.S. Military Veterans\n* endorse depression (Patient Health Questionnaire-depression score \\> 10)\n* endorse insomnia (Insomnia Severity Index score \\> 10).\n\nExclusion Criteria are limited in accordance with real world effectiveness trials, but will include:\n\n* pregnancy\n* history of bipolar disorder\n* history of psychosis\n* current use of anti-psychotic medications or mood stabilizers (e.g., lithium)\n* current suicidal ideation with active intent","ALL","18 Years",{"count":105,"type":106},1200,"ESTIMATED","INTERVENTIONAL",[109],"NA","This study has two primary objectives, each of which addresses critical clinical and research gaps for individuals who have co-occurring insomnia and depression. The first objective is to address whether sequential treatment of insomnia and depression is superior to a single treatment for either depression or for insomnia, and if so, which treatment sequence is optimal. The second objective is to determine if there are heterogeneity of treatment effects; that is, variation in which interventions are best for which individuals, and if so, to develop and individualized intervention rule to better match individuals with the treatment that is most likely to lead to the best outcomes. A large randomized trial will be conducted to meet these objectives.",[112,113],"Depression","Insomnia",[115,116,117,118],"cognitive behavioral therapy","digital intervention","depression","insomnia","2026-05-05",{"date":121,"type":122},"2026-05-11","ACTUAL",{"date":124,"type":122},"2023-05-01",{"date":126,"type":106},"2027-09-18",{"name":5,"class":6},1]