[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05371470":3,"trial-entities:NCT05371470":79,"trial-summary:NCT05371470":17},{"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":20,"study_type":22,"primary_purpose":14,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":35,"secondary_outcomes":52,"sex":53,"minimum_age":54,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":55,"std_ages":59,"locations":62,"central_contacts":72,"overall_officials":73,"references":77,"see_also_links":78},"NCT05371470","21-012982","Voice Analysis Technology to Detect and Manage Depression and Anxiety in Cardiac Rehabilitation","Evaluation of Voice Analysis Technology in Detecting and Managing Depression and Anxiety in Patients Undergoing Cardiac Rehabilitation","ENROLLING_BY_INVITATION","2026-11","2026-03","2026-03-19","2023-09-21","Mayo Clinic","OTHER",false,"The purpose of this study is to learn if a voice analysis smartphone app which detects anxiety and depression could be used along with cardiac rehabilitation to improve results compared to cardiac rehabilitation alone.",null,[19],"Myocardial Infarction",[21],"Cardiac Rehabilitation","INTERVENTIONAL",[24],"NA",{"count":26,"type":27},200,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DEVICE","Ellipsis Health Voice Application","Smartphone application that utilizes voice biomarkers to assess for potential presence and severity of depression and anxiety",[34],"Cardiac rehabilitation plus voice analysis",[36,40,43,46,49],{"measure":37,"description":38,"timeFrame":39},"Change in depressive symptoms","Measured using the self-reported Patient Health Questionnaire-9 (PHQ-9) to assess for major depressive disorder. Possible score range from 0 to 27, with higher scores indicating a worse outcome\u002Fgreater severity of depressive symptoms.","Baseline, 12 weeks",{"measure":41,"description":42,"timeFrame":39},"Change in anxiety symptoms","Measured using the self-reported Generalized Anxiety Disorder 7-Item Scale (GAD-7) that assesses anxiety symptoms. Possible score range from 0 to 21, with higher scores indicating a worse outcome\u002Fgreater severity of anxiety symptoms.",{"measure":44,"description":45,"timeFrame":39},"Change in perceived stress","Measured using the self-reported Perceived Stress Scale-14 (PSS-14), a 14 item questionnaire which assesses the degree to which situations in life are stressful within the last month. Each item is scored on a 5 point Likert scale from 0 (never) to 4 (very often), higher total scores indicate a worse outcome\u002Fgreater severity of perceived stress.",{"measure":47,"description":48,"timeFrame":39},"Change in quality of life","Measured using the self-reported abbreviated generic Quality of Life Scale developed through the World Health Organization (WHOQOL-BREF) questionnaire that assesses an individual's perceptions of their health and well-being within the last two weeks. Each item is scored on a 5 point Likert scale, higher scores indicate greater perceived quality of life.",{"measure":50,"description":51,"timeFrame":39},"Change in health behaviors","Measured using the self-reported Current Health Behaviors (HB) questionnaire, a 13 item questionnaire which assesses behaviors and life circumstances during the last month. Each item is scored on a 10 point Likert scale, higher scores indicate better outcome.",[],"ALL","18 Years",{"inclusion":56,"exclusion":57,"raw_text":58},[],[],"Inclusion Criteria:\n\n1. ≥ 18 years\n2. Enrolled in cardiac rehabilitation program to start within 3 months from hospital discharge\n3. Owns a smartphone\n4. Willing to download and use a smartphone app\n5. Able to read, write, and speak English\n\nExclusion Criteria:\n\n1. Cardiac transplant\n2. Active substance use\n3. Neurocognitive disorder\n4. Active psychosis\n5. Mania diagnosis\n6. Active suicidality\n7. Uncontrolled bipolar disorder",[60,61],"ADULT","OLDER_ADULT",[63],{"facility":64,"city":65,"state":66,"zip":67,"country":68,"geoPoint":69},"Mayo Clinic in Rochester","Rochester","Minnesota","55905","United States",{"lat":70,"lon":71},44.02163,-92.4699,[],[74],{"name":75,"affiliation":13,"role":76},"Virend Somers, MD, PhD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":80,"biomarkers":81},[21,19],[]]