[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"The Mediterranean Institute for the Advance of Biotechnology and Health Research\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":70},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100607231","prevention-of-anxiety-and-depression-over-risk-assessment-100607231",false,"NCT07185867","Prevention of ANxiety and Depression Over Risk Assessment","Prevention of ANxiety and Depression Over Risk Assessment: a Randomized Controlled Trial (the PANDORA-Predict-Plus-Prevent Study)","Inclusion Criteria:\n\n* Informed consent acceptance\n* Having a valid telephone number\n* Ownership of an Apple-Android-operating smartphone with an internet connection\n* 18-65 years old\n* Habitually reside (\\> 6 months\u002Fyear) in Spain or Chile\n\nExclusion Criteria:\n\n* Difficulty reading and\u002For understanding Spanish\n* Suffer from disabling neurological conditions (dementia, blindness, etc.) that makes it difficult to use smartphone, terminal illness with a life expectancy \\\u003C 12 months, a history of severe mental disorders confirmed by a healthcare professional (schizophrenia or psychosis, bipolar, anoxeria, bulimia or personality disorders), having alcohol or substance use disorder within the past year\n* Currently receiving face to face or via internet psychological treatment (currently taking antidepressants or anxiolytics is not an exclusion criterion, but their use will be taken into account throughout the follow-up)\n* Presence of clinically relevant anxiouys (GAD-7 score ≥ 10 points) or depressive symptoms (PHQ-9 score ≥ 10 points).",true,"ALL","18 Years","65 Years",{"count":21,"type":22},2595,"ESTIMATED","INTERVENTIONAL",[25],"NA","The general goal is to design, develop and evaluate a personalized, self-guided and trans-diagnostic internet-based intervention to prevent anxiety and depression, based on predictive risk algorithms and decision support systems (DSS), in Spanish and Chilean adult population.\n\nMethods: We will conduct a three-arm parallel randomized controlled trial with one year of follow-up. A total of 2,595 depression- or\u002Fand anxiety-free participants (865 per group), aged 18-65, will be recruited and randomly assigned to one of two intervention groups or to the usual-care group (in a 1:1:1 ratio). Both interventions, Pandora-1 and Pandora-2, will be implemented via a smartphone application, the Pandora App. Pandora-1 is a self-guided and transdiagnostic intervention that includes 4 interactive intervention modules (move more, sleep better, improve relationships and emotional well-being), as well as predictive risk algorithms, decision support systems, and monitoring and feedback to implement personalized plans for the prevention of anxiety and depression. Pandora-2 is a psycho-educative intervention with predictive risk algorithms, minimally interactive and without personalization. The primary outcome is the combined rate of the onset of anxiety or depression (DSM-V diagnoses as measured by the CIDI interview) at 6 and 12 months. The secondary outcomes are the reduction of depressive (PHQ-9) and anxious (GAD-7) symptoms, risk of depression and anxiety (predictD and predictA risk algorithms), and the improvement of mental \\& physical quality of life (SF-12), as well as acceptation and satisfaction with Pandora apps (u-MARS) and adverse effects (ad hoc questionnaire), which will be assessed at 1, 6 and 12 months. As mediators will be measured social support (Duke-UNC-2 items), physical activity (BPAQ-2), sleep (AIS-5), and repetitive negative thinking (PTQ-9) evaluated at 1, 6 and 12 months. We will use ActiGraph-GT3X accelerometers to assess physical activity and sleep at 1 and 6 months, in a subsample of 404 sedentary study participants.",[28,29,30,31],"Depression","Anxiety","Prevention","m-Health",[28,29,30,33,31,34,35],"Randomized Controlled Trial","App","Predictive risk algorithms","NOT_YET_RECRUITING","2025-09-15",{"date":39,"type":40},"2025-09-22","ACTUAL",{"date":42,"type":22},"2026-02-15",{"date":44,"type":22},"2028-03-07",{"name":46,"class":47},"The Mediterranean Institute for the Advance of Biotechnology and Health Research","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":23,"phases":59,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":68,"leadSponsor":69,"locationsCount":4},"100543125","the-predictplusprevent-study-100543125","NCT06351800","The PredictPlusPrevent Study","Universal Prevention of Depression and Anxiety in the General Population Through a Personalized Intervention Based on Risk Algorithms, ICTs, and Decision Support Systems: Randomized Controlled Trial. The \"PredictPlusPrevent\" Study","Inclusion Criteria:\n\n* Age between 18 and 55 years.\n* Participants must have a smartphone for their own use in the next year.\n\nExclusion Criteria:\n\n* Not signing the informed consent.\n* Having depression and\u002For anxiety at baseline according to the PRIME-MD questionnaire.\n* Living outside of Spain.\n* Having a severe mental disorder (psychosis, bipolar disorder, addictions, etc.), a terminal illness or cognitive impairment (dementia).\n* Difficulties in understanding Spanish.","55 Years",{"count":58,"type":22},9000,[25],"Objective: To design, develop, and evaluate a personalized intervention for the universal prevention of depression and anxiety in the general population based on risk algorithms, ICTs, and decision support systems (DSS).\n\nMethods: A double-blind, parallel-group, randomized controlled trial with a twelve-month follow-up. The entire process of recruitment, random allocation, intervention, and follow-up will be conducted through the 'PredictPlusPrevent' platform and its associated apps. Following a media campaign, at least 9,000 Spanish participants aged 18 to 55 years without depression and\u002For anxiety at baseline will be randomly assigned to the intervention or active control group \"PredictPlusPrevent\". The \"PredictPlusPrevent\" intervention will be self-guided and implemented through participants' smartphones via an app; it will have a biopsychosocial and multi-component approach (8 modules: physical exercise, improving sleep, expanding relationships, problem-solving, improving communication, assertiveness, decision-making, and managing thoughts). The \"PredictPlusPrevent\" intervention is based on validated risk algorithms for depression and anxiety and a DSS that will help participants develop their own personalized depression prevention plans, which they will implement themselves while the platform monitors and provides feedback. The active control \"PredictPlusPrevent\" will include information from the risk algorithms and 24 self-help booklets. The primary outcome will be the incidence of new cases of depression and\u002For anxiety assessed using the PRIME-MD questionnaire, and secondary outcomes will include reductions in depression (PHQ-9) and anxiety symptoms (GAD-7), probability of depression and anxiety risk (predictD and predictA algorithms), and physical and mental quality of life (SF-12).",[28,62],"Anxiety Disorders",[28,62,30,64,34,33],"m-health",{"date":66,"type":40},"2025-09-19",{"date":42,"type":22},{"date":44,"type":22},{"name":46,"class":47},""]