[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594648":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":12,"centralContacts":28,"locations":37,"responsibleParty":82,"collaborators":84,"id":97,"slug":98,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":99,"sex":105,"minAge":106,"maxAge":12,"enrollmentInfo":107,"targetDuration":12,"studyType":110,"phases":111,"briefSummary":113,"conditions":114,"keywords":117,"overallStatus":40,"whyStopped":12,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":136},{"fullName":5,"class":6},"Radboud University Medical Center","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Care As Usual (CAU)","NO_INTERVENTION","The control group, receiving care as usual, will use a version of the Patient Journey App that only displays study questionnaires and sends reminders to complete them at the start of the study, and again at 3 and 6 months. Every 6 weeks, depression symptoms are measured. Patients can view their depression questionnaire results (PHQ-9; Patient Health Questionnaire-9) in a graph within the app. General practitioners and mental health nurses will not have access to the app. At 12 months, all participants will be invited to complete an optional final questionnaire about (cost-)effectiveness to assess the long-term impact of the intervention.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Personalized Lifestyle Intervention","EXPERIMENTAL","The intervention group will receive the personalized lifestyle intervention (PLI) in addition to care as usual. The PLI consists of the combined use of the Patient Journey App and regular treatment provided by the general practitioner or mental health nurse in general practice. Patients, general practitioners and mental health nurses will have access to the app to monitor patient progress and outcomes (symptoms of depression and anxiety). Study questionnaires will be completed at the start of the study (baseline), and again at 3, 6, and optionally 12 months after enrollment. Every 6 weeks, depression symptoms are measured.",[18],"Device: Personalized Lifestyle Intervention",[20],{"type":21,"name":14,"description":22,"armGroupLabels":23,"otherNames":24},"DEVICE","The personalized lifestyle intervention (PLI) consists of the combined use of the Patient Journey App (PJA) alongside care provided by the general practitioner or mental health nurse.\n\nThe Patient Journey App integrates four digital health tools within a single smartphone application:\n\n1. A brief lifestyle questionnaire covering six key areas: mental wellbeing, minimizing harmful substance use, social relationships, healthy eating, sleep, and physical activity.\n2. A personalized summary of the questionnaire results, which supports the formulation of two personal lifestyle goals.\n3. Tailored information and advice about lifestyle, including suggested interventions, based on the patient's personal goals.\n4. Monitoring of depression symptoms over time to support measurement-based care.\n\nGeneral practitioners and mental health nurses will have access to the app to monitor patient progress and outcomes.",[14],[25,26,27],"Patient Journey App","Lifestyle App","PLI",[29,34],{"name":30,"role":31,"phone":32,"phoneExt":12,"email":33},"Eline Jagtenberg","CONTACT","0652902132","eline.jagtenberg@radboudumc.nl",{"name":35,"role":31,"phone":12,"phoneExt":12,"email":36},"Suzanne Ligthart","suzanne.ligthart@radboudumc.nl",[38,54,68],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Radboudumc","RECRUITING","Nijmegen","Gelderland","6525GA","Netherlands","NL",{"type":47,"coordinates":48},"Point",[49,50],5.85278,51.8425,{"lat":50,"lon":49},[53],{"name":30,"role":31,"phone":32,"phoneExt":12,"email":33},{"facility":55,"status":40,"city":56,"state":57,"zip":58,"country":44,"countryCode":45,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"Amsterdam UMC","Amsterdam","North Holland","1105 AZ",{"type":47,"coordinates":60},[61,62],4.88969,52.37403,{"lat":62,"lon":61},[65],{"name":66,"role":31,"phone":12,"phoneExt":12,"email":67},"Otto Maarsingh","o.maarsingh@amsterdamumc.nl",{"facility":69,"status":40,"city":70,"state":71,"zip":72,"country":44,"countryCode":45,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"UMC Groningen","Groningen","Provincie Groningen","9713 GZ",{"type":47,"coordinates":74},[75,76],6.56667,53.21917,{"lat":76,"lon":75},[79],{"name":80,"role":31,"phone":12,"phoneExt":12,"email":81},"Huib Burger","h.burger@umcg.nl",{"type":83,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR",[85,88,90,92,93,95],{"name":86,"class":87},"Ixta Noa","UNKNOWN",{"name":89,"class":87},"Hogeschool van Arnhem en Nijmegen (HAN)",{"name":91,"class":6},"Pro Persona Mental Health Care Foundation",{"name":55,"class":6},{"name":94,"class":87},"Interactive Studios",{"name":96,"class":6},"University Medical Center Groningen","100594648","lifestyle-intervention-for-symptoms-of-depression-with-app-support-in-general-practice-100594648",false,"NCT07022184","Lifestyle Intervention for Symptoms of Depression wIth App Support in General Practice","A Personalized Lifestyle Intervention for Depression Symptomatology in General Practice - a Cluster Randomized Multicenter Trial","LIDIAS","Inclusion Criteria:\n\n* Currently experiencing an episode of symptoms of depression and receiving treatment for this episode from their GP or GP-MHW for less than six months\n* Have a smartphone\n* Be proficient in Dutch\n\nExclusion Criteria:\n\n* Severe mental illness (such as psychosis or bipolar disorder)\n* Severe alcohol or drug addiction requiring specialized secondary care\n* High suicide risk\n* moderate to severe cognitive impairment (as determined by the GP)\n\nPatients who visit their GP for depressive symptoms but with a PHQ-9 of \\\u003C5 at baseline are allowed to use the PLI, but will not be included in the primary analysis.","ALL","18 Years",{"count":108,"type":109},216,"ESTIMATED","INTERVENTIONAL",[112],"NA","The goal of this clinical trial is to find out whether a smartphone app can help reduce symptoms of depression by supporting healthy lifestyle changes and encouraging self-monitoring in adults who visit their general practitioner with symptoms of depression.\n\nThe main questions this study aims to answer are:\n\nDoes a personalized lifestyle intervention delivered through the app, in addition to regular care, reduce depression symptoms more effectively than regular care alone? Is this approach more cost-effective than regular care alone?\n\nResearchers will compare patients who use the app alongside their regular care to patients who receive regular care without the app, to see whether the app leads to better outcomes.\n\nParticipants who use the app will:\n\nComplete a lifestyle questionnaire focused on six themes: mental wellbeing, use of harmful substances, social relationships, healthy eating, sleep, and physical activity.\n\nSet personal goals based on their results and receive tailored lifestyle advice.\n\nTrack their depression symptoms regularly within the app to support ongoing care.\n\nHave follow-up conversations with their general practitioner or mental health nurse to discuss their progress.\n\nFill out questionnaires about their symptoms and experiences during the study.",[115,116],"Depressive\u002FAnxiety Symptoms","Depressive Disorder",[118,119,120,121,122,123,124,125,126],"Personalized lifestyle intervention","eHealth","Measurement-based care","Depression symptomatology","Cluster randomized trial","General practice","Lifestyle changes","Mental health support","Primary care","2025-12-19",{"date":129,"type":130},"2025-12-22","ACTUAL",{"date":132,"type":130},"2025-06-17",{"date":134,"type":109},"2027-02",{"name":5,"class":6},3]