[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"anxiety-mild-to-moderate\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:anxiety-mild-to-moderate":60},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":4},"100659852","tiny-heroes-compared-to-treatment-as-usual-to-decrease-and-prevent-anxiety-problems-in-young-children---a-randomized-controlled-study-100659852",false,"NCT07870213","Tiny Heroes Compared to Treatment as Usual to Decrease and Prevent Anxiety Problems in Young Children - a Randomized Controlled Study","Inclusion Criteria:\n\n* parent or caretaker of child 3-6 years with primary problem of worries, fear, or anxiety, assessed by a licensed psychologist at MALINA\n* parent or caretaker can read Swedish\n* access to computer, tablet or mobile phone with internet connection.\n\nExclusion Criteria:\n\n* child having major developmental disorder (e.g., intellectual disability or severe autism spectrum disorder)\n* parent having significant intellectual impairment or mental health problems (likely to interfere with participation in the treatment)\n* social problems which the psychologist at MALINA appraise will hinder participation in Tiny Heroes (e.g., ongoing separation between parents, serious problems with the child's pre-school).","ALL","3 Years","6 Years",{"count":19,"type":20},350,"ESTIMATED","INTERVENTIONAL",[23],"NA","The aim of this randomized controlled trial is to evaluate the effectiveness and cost-effectiveness of Tiny Heroes, a parent-directed internet-delivered cognitive behavioral therapy (iCBT) program for anxiety problems in children aged 3 to 6 years within first-line mental health care in Region Stockholm, Sweden. The study will compare Tiny Heroes with treatment as usual at MALINA clinics and investigate whether the intervention leads to greater reductions in child anxiety symptoms. Secondary objectives include assessing effects on parental self-efficacy, family accommodation, life interference, treatment satisfaction, adverse events, and healthcare-related costs.",[26,27],"Anxiety Mild to Moderate","Inhibition (Psychology)",[29],"preschool anxiety","NOT_YET_RECRUITING","2026-10-06",{"date":33,"type":34},"2026-10-13","ACTUAL",{"date":36,"type":20},"2026-10-15",{"date":38,"type":20},"2029-06-01",{"name":40,"class":41},"Karolinska Institutet","OTHER",{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":50,"sex":15,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":56,"conditions":57,"keywords":61,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":75},"100597425","the-effects-of-chicory-root-derived-prebiotic-on-mood-and-stress-responsiveness-in-healthy-adults-with-mild-to-moderate-levels-of-stress-and-anxiety-100597425","NCT07058324","The Effects of Chicory Root-derived Prebiotic on Mood and Stress Responsiveness in Healthy Adults With Mild to Moderate Levels of Stress and Anxiety","The Effects of Chicory Root-derived Prebiotic on Mood and Stress Responsiveness in Healthy Adults With Mild to Moderate Levels of Stress and Anxiety: a Randomized, Placebo-controlled, Double-blind, Monocentric, Two-armed Parallel, Prospective Study - The PRIME Study","PRIME","Inclusion Criteria:\n\n1. Volunteer is healthy at the time of screening.\n2. TICS Screening Scale of Chronic Stress (SSCS) score ≥ 6.\n3. GAD total score ≥ 5 and ≤ 14 indicating mild to moderate anxiety.\n4. Male or female aged ≥18 and ≤ 70 years at the time of screening.\n5. Body-Mass-Index (BMI) ≥ 18.5 and ≤ 29.9 kg\u002Fm2.\n6. Volunteer is able and willing to comply with the study instructions.\n7. Volunteer is suitable for participation in the study according to the investigator\u002Fstudy personnel.\n8. Voluntary, written informed consent to participate in the study.\n\nExclusion Criteria:\n\n1. No command of local language.\n2. Previously or currently diagnosed neurological or psychiatric disorders.\n3. Previous history of renal, hepatic, cardiovascular disease or clinically significant diabetes.\n4. Gastrointestinal disorders including irritable bowel syndrome (IBS), inflammatory bowel disease (IBD) or other conditions that might affect the gut environment.\n5. Contraindication or allergy to any substance in the verum or placebo product incl. lactose or fructose intolerance.\n6. Use of drugs (e.g., antibiotics, aspirin, proton pump inhibitors) influencing gastrointestinal function in the previous 8 weeks before the beginning of intervention.\n7. Use of laxatives and labelled pre-and probiotics in the previous 4 weeks before the beginning of intervention.\n8. Participation in another study with any investigational product within 30 days of screening or during the study.\n9. History of drug (recreational) or alcohol abuse.\n10. Use of anti-depressants medication including selective serotonin receptor inhibitors or amitriptyline for 3 months prior to screening.\n11. Bowel preparation for investigative procedures in the 4 weeks prior to screening.\n12. Surgical resection of any part of the bowel.\n13. Pregnant or lactating.\n14. Regular smoking.\n15. Previous Trier Social Stress Test (TSST) participation.",true,"18 Years","70 Years",{"count":54,"type":20},204,[23],"Emerging evidence from preclinical research suggests that prebiotic fibres may play a beneficial role in supporting mental health through modulation of the gut-brain axis-a complex communication network linking the gastrointestinal tract and the central nervous system. Chicory root-derived prebiotic fibre, already well-established for its positive effects on glycaemic control and bowel regularity, has recently shown promise in this context. The present study aims to investigate the mental health benefits of chicory root fibre in a larger and more diverse population, thereby contributing to the growing body of evidence supporting nutritional strategies for mental well-being.",[58,59,60],"Stress","Healthy Subjects","Anxiety, Mild to Moderate",[62,63],"anxiety","prebiotics","RECRUITING","2025-08-04",{"date":67,"type":34},"2025-08-07",{"date":69,"type":34},"2025-06-02",{"date":71,"type":20},"2026-08",{"name":73,"class":74},"Beneo-Institute","INDUSTRY",1]