[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05180344":3,"trial-entities:NCT05180344":111,"trial-summary:NCT05180344":114},{"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":23,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":37,"secondary_outcomes":61,"sex":68,"minimum_age":69,"maximum_age":70,"healthy_volunteers":15,"eligibility_criteria":71,"std_ages":81,"locations":83,"central_contacts":105,"overall_officials":108,"references":109,"see_also_links":110},"NCT05180344","1710-001","Feasibility, Acceptability, and Preliminary Efficacy of a Novel Personalized Mobile Intervention for Suicide - Open Trial (2)","Feasibility, Acceptability, and Preliminary Efficacy of a Novel Personalized Mobile Intervention for Suicide","RECRUITING","2025-10-01","2025-07","2025-07-17","2024-07-25","Butler Hospital","OTHER",false,"The primary aim of this grant is to conduct pilot testing on a novel personalized mobile intervention for suicide - Mobile Application to Prevent Suicide (MAPS) - and to establish feasibility, acceptability, safety, and primary outcomes (i.e., suicidal ideation and behavior; re-hospitalization).",null,[19,20,21,22],"Suicide","Suicide and Self-harm","Suicide, Attempted","Suicidal Ideation",[],"INTERVENTIONAL","TREATMENT",[27],"NA",{"count":29,"type":30},10,"ESTIMATED",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36},"BEHAVIORAL","Mobile Application to Prevent Suicide (MAPS)","Safety Planning Intervention, ecological momentary intervention smartphone app system, and bidirectional communication with study clinician.",[34],[38,42,45,48,51,54,58],{"measure":39,"description":40,"timeFrame":41},"Acceptability of Research (Recruitment)","Measured by recruitment rate.","Baseline",{"measure":39,"description":43,"timeFrame":44},"Measured by dropout rate.","1 month",{"measure":46,"description":47,"timeFrame":44},"Acceptability of Research Procedures","Feedback on qualitative interview",{"measure":49,"description":50,"timeFrame":44},"Patient Satisfaction","Measured using the Client Satisfaction Questionnaire, a self-report measure of satisfaction with treatment. Scores range from 8 to 32, with higher scores representing higher satisfaction.",{"measure":52,"description":53,"timeFrame":44},"Acceptability of MAPS Intervention","Feedback on qualitative interview.",{"measure":55,"description":56,"timeFrame":57},"Satisfaction with MAPS Intervention","Measured by protocol completion rate.","4 weeks",{"measure":59,"description":60,"timeFrame":57},"Ecological Momentary Assessment (EMA) Adherence","Number of assessments completed out of total.",[62,65],{"measure":63,"description":64,"timeFrame":44},"Suicidal Ideation and Behavior","Will be assessed using the Columbia Suicide Severity Rating Scale, items from the Modified Scale for Suicidal Ideation, and ecological momentary assessment of suicidal ideation and behavior. The Columbia Suicide Severity Rating Scale can provide presence\u002Fabsence of suicidal ideation and suicidal behavior, as well as a suicidal ideation score ranging from 0 to 5 with higher scores representing more severe ideation, and a suicidal ideation intensity rating from 0-25 with higher scores representing more intense ideation.",{"measure":66,"description":67,"timeFrame":44},"Rehospitalization","Will be assessed using the Treatment History Interview and medical records review.","ALL","18 Years","26 Years",{"inclusion":72,"exclusion":78,"raw_text":80},[73,74,75,76,77],"Suicidal ideation and\u002For suicidal behavior in the past month verified by the C-SSRS","Between the ages of 18 and 26","English proficiency","Comfortable with smartphone technology","Deemed by the treatment team to be stable enough to complete study procedures",[79],"Current psychotic or manic symptoms severe enough to interfere with study procedures","Inclusion Criteria:\n\n* Suicidal ideation and\u002For suicidal behavior in the past month verified by the C-SSRS\n* Between the ages of 18 and 26\n* English proficiency\n* Comfortable with smartphone technology\n* Deemed by the treatment team to be stable enough to complete study procedures\n\nExclusion Criteria:\n\n* Current psychotic or manic symptoms severe enough to interfere with study procedures",[82],"ADULT",[84],{"facility":13,"status":8,"city":85,"state":86,"zip":87,"country":88,"contacts":89,"geoPoint":102},"Providence","Rhode Island","02906","United States",[90,94,97,100],{"name":91,"role":92,"email":93},"Cheryl Cordeiro","CONTACT","ccordeiro@butler.org",{"name":95,"role":96},"Heather Schatten, PhD","PRINCIPAL_INVESTIGATOR",{"name":98,"role":99},"Michael Armey, PhD","SUB_INVESTIGATOR",{"name":101,"role":99},"Ivan Miller, PhD",{"lat":103,"lon":104},41.82399,-71.41283,[106],{"name":91,"role":92,"phone":107,"email":93},"401-455-6654",[],[],[],{"nct_id":4,"conditions":112,"biomarkers":113},[22,19],[],{"nct_id":4,"found":115,"summary":116,"prompt_version":126},true,{"design":117,"status":118,"heading":119,"summary":120,"follow_up":121,"word_count":122,"commitments":123,"compensation":124,"drugs_mentioned":125},"This is an interventional study, meaning you will receive the MAPS app. It is an open trial, so you and the researchers will know what treatment you are receiving. The study plans to include 10 participants.","completed","Mobile Application to Prevent Suicide (MAPS) Study","This study is testing a new personalized mobile app called Mobile Application to Prevent Suicide (MAPS). This app aims to help prevent suicide by offering safety planning, real-time support, and communication with a study clinician. You might be able to join if you are between 18 and 26 years old, have had suicidal thoughts or behaviors in the past month, are comfortable with smartphones, and speak English. The study wants to see if the MAPS app is practical to use, acceptable to participants, safe, and if it can help reduce suicidal thoughts and behaviors or re-hospitalization. This is a small study planning to enroll 10 people, and its current recruitment status is unclear.","The study measures acceptability of research at baseline and at 1 month.",113,"Not specified in the trial record.","Not stated in the trial record.",[34],"v2"]