[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658605":3},{"organization":4,"outcomesModule":7,"designInfo":26,"detailedDescription":25,"studyPopulation":25,"armGroups":32,"interventions":50,"overallOfficials":25,"centralContacts":56,"locations":62,"responsibleParty":76,"collaborators":80,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":25,"eligibilityCriteria":93,"healthyVolunteers":94,"sex":95,"minAge":96,"maxAge":97,"enrollmentInfo":98,"targetDuration":25,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":109,"overallStatus":111,"whyStopped":25,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"State University of New York at Buffalo","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":25,"otherOutcomes":25},[9,13,17,21],{"measure":10,"description":11,"timeFrame":12},"Accrual efficiency\u002FPre-treatment visits","Calculated from visit milestones. Percentage of screen-eligible participants who attend the Intake Visit after randomization to Remote vs In-Person Intake. Additional accrual metrics include 1) Intake-to-Treatment\u002FAssessment Visit 1 completion and 2) Overall pre-treatment accrual (Brief Screen to Treatment\u002FAssessment Visit 1","~1 month",{"measure":14,"description":15,"timeFrame":16},"Trial Quality: Retention","Retention will be assessed using visit milestone data to determine whether each participant achieved each T\u002FA Visit (Visits 2-5) following T\u002FA initiation at T\u002FA Visit 1. We will calculate a continuous metric of retention (0-4; the number of visits completed) for each participant, supplemented by visit-specific data to provide a detailed examination of the time course and overall amount of retention.","~3 months",{"measure":18,"description":19,"timeFrame":20},"Trial Quality: Treatment utilization","Participant engagement with the Moodivate mobile application pulled directly from the Moodivate analytics data. The primary outcome will be the number of sessions of app use. Additional secondary outcomes include: average time per session and total time using the app, as well as fidelity metrics (number of goals created and the number of activities created, scheduled, and completed).","~3 months (assessed from T\u002FA1 [when app is distributed] through T\u002FA5)",{"measure":22,"description":23,"timeFrame":24},"Trial quality: Biospecimen completion rates","The number of saliva samples completed\u002Freturned for Treatment\u002FAssessment visits 1-5 that each participant attended. Remote participants return samples by mail; to count as completed\u002Freturned, the mailed package must be postmarked within 7 days of the visit.","~3 months (assessed at T\u002FA Visits 1,2, 3, 4, and 5)",null,{"allocation":27,"interventionModel":28,"interventionModelDescription":29,"primaryPurpose":6,"observationalModel":25,"timePerspective":25,"maskingInfo":30},"RANDOMIZED","PARALLEL","Randomized, parallel-group design.\n\nThe study employs a two-stage adaptive biased-coin randomization technique. The initial randomization will be generated using a stratified biased coin design with an allocation probability of 0.75 and a randomization list within each stratum will be generated for both Stage I (randomization to remote vs in-person Intake) and Stage II (randomization to remote vs. in-person Treatment\u002FAssessment visits). To optimize the balance in cell sizes across the 4 treatment conditions, the allocation probabilities will be adjusted at 3 study milestones (once 25%, 50%, and 75% of the target sample of 100 participants attend Treatment\u002FAssessment Visit 1). Specifically, the allocation probability will be modified based on the imbalance in the number of participants across conditions who have attended Treatment\u002FAssessment Visit 1.",{"masking":31,"maskingDescription":25,"whoMasked":25},"NONE",[33,38,42,46],{"label":34,"type":6,"description":35,"interventionNames":36},"REMOTE intake AND REMOTE treatment\u002Fassessment","In this arm, ppts have been randomly assigned to a REMOTE INTAKE eligibility\u002Fbaseline visit, and subsequently randomized to 5 REMOTE treatment\u002Fassessment visits.",[37],"Behavioral: mobile health application (Moodivate)",{"label":39,"type":6,"description":40,"interventionNames":41},"REMOTE intake BUT IN-PERSON treatment\u002Fassessment","In this arm, ppts have been randomly assigned to a REMOTE INTAKE eligibility\u002Fbaseline visit, and subsequently randomized to 5 IN-PERSON treatment\u002Fassessment visits.",[37],{"label":43,"type":6,"description":44,"interventionNames":45},"IN-PERSON intake, BUT REMOTE treatment\u002Fassessment","In this arm, ppts have been randomly assigned to an IN-PERSON INTAKE eligibility\u002Fbaseline visit, and subsequently randomized to 5 REMOTE treatment\u002Fassessment visits.",[37],{"label":47,"type":6,"description":48,"interventionNames":49},"IN-PERSON intake AND IN-PERSON treatment\u002Fassessment","In this arm, ppts have been randomly assigned to an IN-PERSON INTAKE eligibility\u002Fbaseline visit, and subsequently randomized to 5 IN-PERSON treatment\u002Fassessment visits.",[37],[51],{"type":52,"name":53,"description":54,"armGroupLabels":55,"otherNames":25},"BEHAVIORAL","mobile health application (Moodivate)","All participants receive the mobile health application \"Moodivate\".",[47,43,34,39],[57],{"name":58,"role":59,"phone":60,"phoneExt":25,"email":61},"Larry W. Hawk, PhD","CONTACT","716-645-0192","lhawk@buffalo.edu",[63],{"facility":64,"status":25,"city":65,"state":66,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":25},"Medical University of South Carolina","Charleston","South Carolina","29425","United States","US",{"type":71,"coordinates":72},"Point",[73,74],-79.93275,32.77632,{"lat":74,"lon":73},{"type":77,"investigatorFullName":78,"investigatorTitle":79,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Larry Hawk, Ph.D.","professor",[81,82,85],{"name":64,"class":6},{"name":83,"class":84},"National Center for Advancing Translational Sciences (NCATS)","NIH",{"name":86,"class":6},"Wake Forest University Health Sciences","100658605","remote-vs-in-person-study-evaluation-rise-trials-rise-above-depression-trial-2-of-3-100658605",false,"NCT07854301","Remote vs. In-Person Study Evaluation (RISE) Trials: RISE Above Depression (Trial 2 of 3)","Remote vs. In-Person Study Evaluation (RISE) Above Depression","INCLUSION CRITERIA:\n\nCommon to all 3 RCTs:\n\n1. age18+ years\n2. stable mailing address (for mailing study packets if assigned to Remote Intake and\u002For Remote Treatment\u002FAssessment) within accessible range (1.5 hours) of each study site (per self report)\n3. able to read, speak \\& verbally comprehend English\n4. currently own an iOS- or Android-compatible smartphone\n5. have a valid e-mail address that is checked regularly (at least once per day) or have regular access to text messages (to access follow-up assessments)\n\nSpecific to RCT 2:\n\ne) Elevated depressive symptoms, defined as a score of \\> 10 on the Patient Health Questionnaire-9 (PHQ-9) f) Report willingness to utilize a mobile app for the treatment for depressed mood (response of \"yes\" on yes\u002Fno item)\n\nEXCLUSION CRITERIA:\n\nCommon to All 3 RCTs:\n\n1. consumption of \\>28 alcohol-containing drinks per week\n2. suicide attempt with at least some wish to die in past 3 months\n3. mental illness (such as schizophrenia, bipolar disorder, or major depression) that led to hospitalization in the past 30 days\n4. unable\u002Funwilling to provide informed consent or follow directions, inappropriately responsive, based on staff observations\n\n   Specific to RCT2:\n5. Current suicidal ideation at study screening, defined as a response of ≥ 1 on item nine (\"Thoughts that you would be better off dead, or of hurting yourself\") of the PHQ-9",true,"ALL","18 Years","99 Years",{"count":99,"type":100},100,"ESTIMATED","INTERVENTIONAL",[103],"NA","The study will employ a randomized, parallel-group design with two-stage randomization. After an initial brief screen for basic eligibility, participants will be randomized (within site) to either Remote (R) or In-Person (IP) Intake Groups. During the Intake, detailed consent and eligibility assessment will be completed. Participants who are eligible at the Intake will be randomized (within site and Intake Group) to R or IP Treatment and Assessment Groups. Participants will be followed for 3 months.",[106,107,108],"Remote vs. In-Person","Remote Visits","In-person Visits",[110],"Remote vs. In-Person methods","NOT_YET_RECRUITING","2026-10-07",{"date":114,"type":115},"2026-10-09","ACTUAL",{"date":117,"type":100},"2026-10",{"date":119,"type":100},"2028-05",{"name":5,"class":6},1]