[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07130734":3,"trial-entities:NCT07130734":95,"trial-summary:NCT07130734":99},{"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":22,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":41,"secondary_outcomes":50,"sex":51,"minimum_age":52,"maximum_age":53,"healthy_volunteers":15,"eligibility_criteria":54,"std_ages":66,"locations":68,"central_contacts":84,"overall_officials":92,"references":93,"see_also_links":94},"NCT07130734","00000675","Digital Intervention for Physical Activity","Digitally-Delivered Intervention to Prompt Physical Activity","RECRUITING","2026-05","2025-09","2025-09-18","2025-09-22","Auburn University","OTHER",false,"The present study will assess the effects of a four-week digitally delivered intervention on physical activity and depressive symptoms among adults experiencing at least moderate depressive symptoms. The main questions this research aims to answer are:\n\n* Does a digitally-delivered intervention increase physical activity levels?\n* Does a digitally-delivered intervention reduce symptoms of depression?\n\nResearchers will compare an intervention promoting physical activity to a passive control (does not receive the intervention) group to see if the intervention reduces depressive symptoms and increases physical activity levels.\n\nParticipants will:\n\n* Visit the laboratory at two separate time points before group assignment, separated by one week of physical activity monitoring\n* Be randomly assigned to complete four weeks of a digital intervention prompting engagement in physical activity or have their mental health symptoms monitored over four weeks (i.e., passive control group)\n* Visit the laboratory at two separate time points after the intervention, separated by one week of physical activity monitoring","Procedures include four laboratory visits: two visits before the intervention and two visits after the intervention.\n\nParticipants will be randomly assigned to either four weeks of a digital intervention that prompts participants to engage in physical activity or a waitlist (passive) control condition. Participants will be randomized using a stratified approach using depressive symptoms and physical activity measured at pre-intervention as strata.\n\nThe digital intervention group will be instructed to download a Pathverse mobile application on their Apple or Android smartphone device. The Pathverse mobile application will be used as a research delivery platform that can send participants daily push notifications to engage in physical activity of their choice. During the second pre-intervention visit, each participant will select approximately five types of physical activity they find enjoyable that they would like to engage in over the four-week intervention. Participants will report on the physical activity they completed, along with the duration and intensity of each activity. Participants will have the choice of time of day as to when they would like to receive daily notifications on their device.\n\nMembers of the passive control group will be informed that their mental health will be monitored over four weeks as a control condition. After the study, they will be offered the digital PA intervention, if desired.",[19,20,21],"Depression - Major Depressive Disorder","Anxiety","Stress",[23,24,25,26],"Physical Activity","Digital Intervention","Depression","Mobile Application","INTERVENTIONAL","TREATMENT",[30],"NA",{"count":32,"type":33},50,"ESTIMATED",[35],{"type":36,"name":37,"description":38,"armGroupLabels":39},"BEHAVIORAL","Digital Physical Activity","The Pathverse mobile application platform will be downloaded on each participant's smartphone. Participants will be guided on how to download and use the application, as well as how to interact with the application during the intervention period. Participants will choose approximately five types of physical activity they enjoy before the intervention and will be prompted to complete these physical activities throughout the intervention. Participants will also self-report the duration and type of physical activity performed each day of the intervention.",[40],"Digital Intervention Group",[42,46],{"measure":43,"description":44,"timeFrame":45},"Depressive Symptoms","Depression, Anxiety, and Stress Scale (DASS-21) will be used to assess changes in symptoms of depression. The DASS-21 includes 7 items that assess for depression. Total scores for depression range from 0-42, with higher scores indicating greater depression severity.","pre-intervention, at the two-week time point during the intervention, and immediately after the intervention",{"measure":47,"description":48,"timeFrame":49},"Moderate-to-vigorous physical activity","Physical activity will be assessed using a wrist-worn accelerometer before and after the intervention. Physical activity outcomes will be calculated as amount of time spent in a specific intensity.","pre-intervention and immediately after the intervention",[],"ALL","19 Years","40 Years",{"inclusion":55,"exclusion":64,"raw_text":65},[56,57,58,59,60,61,62,63],"Between the ages of 19 and 40 years","Verbally fluent in English (i.e., must be able to speak or understand English)","No uncorrected visual or hearing impairment","Moderate depressive symptoms or greater of at least 10 or higher on the Patient Health Questionnaire-8 screening instrument","Eligible to participate in physical activity","Physically inactive (i.e., engaging in less than 150 min of weekly moderate-to-vigorous physical activity)","Owns an Apple or Android mobile device, willing to download the Pathverse app , and willing to keep the device on during the study period","Not currently pregnant",[],"Inclusion Criteria:\n\n* Between the ages of 19 and 40 years\n* Verbally fluent in English (i.e., must be able to speak or understand English)\n* No uncorrected visual or hearing impairment\n* Moderate depressive symptoms or greater of at least 10 or higher on the Patient Health Questionnaire-8 screening instrument\n* Eligible to participate in physical activity\n* Physically inactive (i.e., engaging in less than 150 min of weekly moderate-to-vigorous physical activity)\n* Owns an Apple or Android mobile device, willing to download the Pathverse app , and willing to keep the device on during the study period\n* Not currently pregnant\n\nExclusion Criteria:\n\n\\- Participants will not qualify for the current study if they do not meet the above inclusion criteria.",[67],"ADULT",[69],{"facility":70,"status":8,"city":71,"state":72,"zip":73,"country":74,"contacts":75,"geoPoint":81},"Kinesiology Building","Auburn","Alabama","36849","United States",[76],{"name":77,"role":78,"phone":79,"email":80},"Administrator, Business & Admin Services School of Kinesiology","CONTACT","334-844-1450","lse0001@auburn.edu",{"lat":82,"lon":83},32.60986,-85.48078,[85,89],{"name":86,"role":78,"phone":87,"email":88},"Christopher J Brush, Ph.D.","334-844-4483","cjbrush@auburn.edu",{"name":90,"role":78,"email":91},"Karly A Knudson, B.S.","kak0146@auburn.edu",[],[],[],{"nct_id":4,"conditions":96,"biomarkers":98},[20,21,97],"Unipolar Depression",[],{"nct_id":4,"found":100,"summary":101,"prompt_version":111},true,{"design":102,"status":103,"heading":104,"summary":105,"follow_up":106,"word_count":107,"commitments":108,"compensation":109,"drugs_mentioned":110},"This study will randomly assign 50 participants to either use the Pathverse mobile application for four weeks or be in a control group that doesn't use the app. This is an interventional study, meaning participants will receive a specific intervention.","completed","Digital Intervention for Physical Activity in Depression and Anxiety","This study is testing if a digital intervention called \"Pathverse mobile application\" can help adults aged 19-40 who are experiencing moderate depressive symptoms. The researchers want to see if using this app to encourage physical activity can increase how much you move and reduce symptoms of depression. You would be eligible if you are physically inactive, fluent in English, and don't have uncorrected vision or hearing problems. The study aims to enroll 50 participants and is currently unclear on its recruitment status. Success would mean participants show increased physical activity and reduced depressive symptoms after using the app.","Depressive symptoms will be measured at pre-intervention, during the intervention (at two weeks), and immediately after the intervention. Physical activity will be measured at pre-intervention and immediately after the intervention.",98,"Participants will have four laboratory visits: two before the intervention and two after. If in the intervention group, you will download and use the Pathverse mobile application on your smartphone for four weeks, reporting on your chosen physical activities.","Not stated in the trial record.",[],"v2"]