[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100571777":3},{"organization":4,"outcomesModule":7,"designInfo":70,"detailedDescription":79,"studyPopulation":69,"armGroups":80,"interventions":91,"overallOfficials":96,"centralContacts":101,"locations":107,"responsibleParty":132,"collaborators":69,"id":136,"slug":69,"hasResults":137,"nctId":138,"briefTitle":139,"officialTitle":139,"acronym":140,"eligibilityCriteria":141,"healthyVolunteers":137,"sex":142,"minAge":143,"maxAge":144,"enrollmentInfo":145,"targetDuration":69,"studyType":148,"phases":149,"briefSummary":151,"conditions":152,"keywords":159,"overallStatus":128,"whyStopped":69,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":175},{"fullName":5,"class":6},"Babes-Bolyai University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":69},[9],{"measure":10,"description":11,"timeFrame":12},"Internalizing problems","Change from baseline in internalizing problems. Revised Children's Anxiety and Depression Scale (RCADS) completed by adolescents.","baseline, after 8 weeks of intervention, 6 months follow-up",[14,18,21,24,28,32,35,39,42,45,49,53,57,60,63,66],{"measure":15,"description":16,"timeFrame":17},"Clinical diagnosis","Change in DSM-5 Anxiety and Depressive Disorder Diagnoses in Accordance with Anxiety Disorders Interview Schedule for the DSM-5, Child and Parent Versions (ADIS-5-C\u002FP) Clinical Diagnosis","administered pre-baseline, post-baseline (after 8 week waitlist period), after 8 weeks of intervention",{"measure":19,"description":20,"timeFrame":12},"Global functioning","Children's Global Assessment Scale (C-GAS)",{"measure":22,"description":23,"timeFrame":12},"Severity","Clinical Global Impression Scale - Severity",{"measure":25,"description":26,"timeFrame":27},"Improvement","Clinical Global Impression Scale - Improvement","after 8 weeks of intervention, 6 months follow-up",{"measure":29,"description":30,"timeFrame":31},"Comorbid problems","Subscales of the Revised Children's Anxiety and Depression Scale (RCADS) completed by adolescents","baseline, after 8 weeks of intervention, 6 month follow-up",{"measure":33,"description":34,"timeFrame":12},"Life satisfaction","SWLS-C: Satisfaction with Life Scale for Children",{"measure":36,"description":37,"timeFrame":38},"Satisfaction with the Internet-delivered intervention","Client Satisfaction Questionnaire (CSQ-8)","after 8 weeks of intervention",{"measure":40,"description":41,"timeFrame":38},"Working alliance","Working alliance scale for Internet interventions",{"measure":43,"description":44,"timeFrame":31},"Automatic thoughts","Automatic thoughts questionnaire",{"measure":46,"description":47,"timeFrame":48},"Credibility and expectations","Credibility and expectations questionnaire","week 2",{"measure":50,"description":51,"timeFrame":52},"Credibility and expectations based on primary outcome measure","Credibility and expectations based on primary outcome scale","baseline",{"measure":54,"description":55,"timeFrame":56},"Anxiety and depressive symptoms","PHQ4","baseline, at each 2 weeks during treatment duration, after 8 weeks of intervention, 6 months follow-up",{"measure":58,"description":59,"timeFrame":31},"Avoidance","CAMS",{"measure":61,"description":62,"timeFrame":52},"Parental distress","DASS-21",{"measure":64,"description":65,"timeFrame":31},"Adolescent anxiety and depressive symptoms as reported by parents","RCADS-47 parent report",{"measure":67,"description":68,"timeFrame":52},"Parental accommodations","Family accommodation scale - parent report",null,{"allocation":71,"interventionModel":72,"interventionModelDescription":69,"primaryPurpose":73,"observationalModel":69,"timePerspective":69,"maskingInfo":74},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":75,"maskingDescription":69,"whoMasked":76},"DOUBLE",[77,78],"INVESTIGATOR","OUTCOMES_ASSESSOR","To the best of investigators' knowledge, this is the first clinical trial conducted with adolescents diagnosed with anxiety\u002Fand or depressive disorders that tests the accuracy of a prediction model based on fMRI to investigate participants' response to a transdiagnostic Internet-delivered intervention.",[81,87],{"label":82,"type":83,"description":84,"interventionNames":85},"Transdiagnostic Internet-delivered intervention","EXPERIMENTAL","The intervention consists of 8 modules delivered over 8 weeks. It is based on Rational Emotive Behavioral Therapy (REBT).",[86],"Behavioral: Transdiagnostic Internet-delivered intervention",{"label":88,"type":89,"description":90,"interventionNames":69},"Control group","NO_INTERVENTION","Participants in the control group are a delayed intervention group (waiting list control). They will access the intervention after 8 weeks.",[92],{"type":93,"name":82,"description":94,"armGroupLabels":95,"otherNames":69},"BEHAVIORAL","The intervention consists of 8 modules based on Rational emotive therapy, delivered via 8 weeks.",[82],[97],{"name":98,"affiliation":99,"role":100},"Costina Poetar, PhD","Babeș-Bolyai University","STUDY_CHAIR",[102],{"name":103,"role":104,"phone":105,"phoneExt":69,"email":106},"Kristoffer Mansson, PhD","CONTACT","+46705803267","nils.mansson@ubbcluj.ro",[108,127],{"facility":5,"status":109,"city":110,"state":69,"zip":111,"country":112,"countryCode":113,"cosmosGeoPoint":114,"geoPoint":119,"contacts":120},"NOT_YET_RECRUITING","Cluj-Napoca","400015","Romania","RO",{"type":115,"coordinates":116},"Point",[117,118],23.6,46.76667,{"lat":118,"lon":117},[121,125],{"name":122,"role":104,"phone":123,"phoneExt":69,"email":124},"Costina R Poetar, Ph.D","+ 40743589465","costinapoetar@psychology.ro",{"name":122,"role":126,"phone":69,"phoneExt":69,"email":69},"SUB_INVESTIGATOR",{"facility":99,"status":128,"city":110,"state":69,"zip":111,"country":112,"countryCode":113,"cosmosGeoPoint":129,"geoPoint":131,"contacts":69},"RECRUITING",{"type":115,"coordinates":130},[117,118],{"lat":118,"lon":117},{"type":133,"investigatorFullName":134,"investigatorTitle":135,"investigatorAffiliation":5,"oldNameTitle":69,"oldOrganization":69},"PRINCIPAL_INVESTIGATOR","Costina-Ruxandra Poetar","Assistant professor","100571777",false,"NCT06724666","Transdiagnostic Internet-delivered Intervention for Adolescents With Anxiety and Depression","NEURO4C","Inclusion Criteria:\n\n* elevated symptoms of anxiety or depression\u002F internalizing problems (T score\\> 60) at intake (based on Youth self-report completed by adolescents)\n* primary diagnosis of an anxiety\u002Fdepressive disorder based on DSM-5 criteria according to ADIS-5-C\u002FP interview\n* age 13-17\n* able to read and understand Romanian language\n* Currently unmedicated or on stable and adequate doses of medication for at least 6 weeks before treatment onset\n* Internet access\n\nExclusion Criteria:\n\n* severe mental disorder (psychosis, severe depression, bipolar disorder, based on clinical interview)\n* any condition that interferes with the protocol implementation (e.g., physical illness or sensory impairment that interferes with behavioral tasks such as exposure, behavioral activation, unavailable for the next 3 months),\n* active suicidal ideation (assessed by child psychiatrist during clinical interview) in the last month\n* currently following CBT\u002F psychotherapy for anxiety\u002Fdepression, in the last 6 months\n* fMRI incompatible (based on safety questionnaire)\n* Being diagnosed with an intellectual disability, pervasive developmental disorder, an alcohol and\u002For substance dependence disorder, reading disabilities (based on clinical interview).\n* Current treatment with benzodiazepines","ALL","13 Years","17 Years",{"count":146,"type":147},198,"ESTIMATED","INTERVENTIONAL",[150],"NA","The goal of this clinical trial is to test the efficacy of a transdiagnostic Internet-delivered interventions for Romanian adolescents with anxiety and\u002F or depression. The main questions it aims to answer are:\n\n* What is the clinical efficacy of the Internet-delivered intervention?\n* How accurate is the prediction model in predicting who will respond to treatment? Participants will undergo non-invasive fMRI to measure variability in brain signal as a proxy of the neural systems' adaptability before receiving the intervention, then they will be allocated either to the Internet-delivered intervention or control group.",[153,154,155,156,157,158],"Anxiety Disorders","Depressive Disorder","Social Anxiety Disorder","Major Depressive Disorder","Dysthymia","Generalized Anxiety Disorder",[160,161,162,163,164,165],"Internet-delivered intervention","transdiagnostic","adolescents","internalizing","anxiety","depression","2025-04-02",{"date":168,"type":169},"2025-04-04","ACTUAL",{"date":171,"type":169},"2025-04-01",{"date":173,"type":147},"2026-06-30",{"name":5,"class":6},2]