[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100526711":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":46,"responsibleParty":86,"collaborators":88,"id":96,"slug":97,"hasResults":98,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":104,"sex":105,"minAge":106,"maxAge":107,"enrollmentInfo":108,"targetDuration":26,"studyType":111,"phases":112,"briefSummary":114,"conditions":115,"keywords":118,"overallStatus":49,"whyStopped":26,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},{"fullName":5,"class":6},"Azienda Ospedaliera Universitaria Integrata Verona","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental group","EXPERIMENTAL","Patients with SI treated with CBT+CR",[13,14],"Behavioral: Cognitive Behavioral Therapy (CBT)","Behavioral: Cognitive Remediation (CR)",{"label":16,"type":17,"description":18,"interventionNames":19},"Control group","ACTIVE_COMPARATOR","Patients with SI treated with CBT",[13],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","Cognitive Behavioral Therapy (CBT)","CBT is a psychotherapeutic intervention that focuses on challenging and changing cognitive distortions (such as thoughts, beliefs, and attitudes) and their associated behaviours to improve emotional regulation and develop personal coping strategies that target solving current problems. In this study, patients with SI will undergo 8 sessions of CBT (45 min, once a week), remotely. Techniques and strategies of the intervention will be based on a short telepsychotherapy protocol previously published by our group (Biagianti et. al., 2021). Instead, the content of each session will be adapted to the psychopathology associated with social isolation and the age of the subject. The psychotherapeutic sessions of the patients will be audio-recorded in order to conduct retrospective analyzes of the patient's speech.",[16,9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Cognitive Remediation (CR)","The cognitive training will consist of 10 hours (30 minutes\u002Fsession) of computer-based exercises focusing on working memory, attention, executive functions and social cognition, which will be performed online using BrainHQ software. This software allows for the customization of the training based on the specific characteristics of each subject. For example, it allows automatic adjustment of the difficulty of the exercises, trial by trial and session by session, in order to guarantee an adequate level of attention and motivation for the entire duration of the training and therefore favor optimal learning rates.",[9],[32],{"name":33,"affiliation":34,"role":35},"Prof Mirella Ruggeri, PhD","Section of Psychiatry, University of Verona","PRINCIPAL_INVESTIGATOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Prof Marcella Bellani, PhD","CONTACT","+390458126691","marcella.bellani@univr.it",{"name":43,"role":39,"phone":44,"phoneExt":26,"email":45},"Maria Gloria Rossetti, PhD","+390458124038","mariagloria.rossetti@univr.it",[47,69],{"facility":48,"status":49,"city":50,"state":26,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Unità per le Disabilità gravi dell'età Evolutiva e Giovane Adulta, IRCCS Eugenio Medea, Polo scientifico Puglia","RECRUITING","Brindisi","72100","Italy","IT",{"type":55,"coordinates":56},"Point",[57,58],17.93607,40.63215,{"lat":58,"lon":57},[61,65,67],{"name":62,"role":39,"phone":63,"phoneExt":26,"email":64},"Isabella Fanizza","+393394245184","isabella.fanizza@lanostrafamiglia.it",{"name":66,"role":35,"phone":26,"phoneExt":26,"email":26},"Antonio Trabacca, PhD",{"name":62,"role":68,"phone":26,"phoneExt":26,"email":26},"SUB_INVESTIGATOR",{"facility":70,"status":49,"city":71,"state":26,"zip":72,"country":52,"countryCode":53,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"UOC Psichiatria B, Azienda Ospedaliera Universitaria Integrata","Verona","37134",{"type":55,"coordinates":74},[75,76],10.9938,45.43854,{"lat":76,"lon":75},[79,81,82,83,85],{"name":80,"role":39,"phone":40,"phoneExt":26,"email":41},"Marcella Bellani, PhD",{"name":43,"role":39,"phone":44,"phoneExt":26,"email":45},{"name":80,"role":35,"phone":26,"phoneExt":26,"email":26},{"name":84,"role":68,"phone":26,"phoneExt":26,"email":26},"Cinzia Perlini, PhD",{"name":43,"role":68,"phone":26,"phoneExt":26,"email":26},{"type":87,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[89,91,93],{"name":90,"class":6},"IRCCS Eugenio Medea",{"name":92,"class":6},"University of Milan",{"name":94,"class":95},"Istituto di Neuroscienze Consiglio Nazionale delle Ricerche","NETWORK","100526711","telepsychiatry-for-social-isolation-in-youths-100526711",false,"NCT06138301","Telepsychiatry for Social Isolation in Youths","Digital Interventions for Social isOLation In youThs And theIR familiEs","SOLITAIRE","Inclusion Criteria:\n\nPatients with SI:\n\n* age11-17 years (adolescents) 18-45 years (adults)\n* moderate-to-high levels of SI as detected by clinical evaluation and confirmed by the HQ-25 score\n* stable pharmacotherapy and symptomatology in the last 3 months\n* not being in psychotherapy or being willing to interrupt it during the study\n* have an internet connection\n\nCaregivers:\n\n* Age ≤ 80\n* no history of psychotic spectrum disorders\n* have a first-degree relative with moderate-to-severe SI\n* have an internet connection\n\nExclusion Criteria:\n\nAll participants:\n\n* primary medical conditions or vision\u002Fhearing deficits that interfere with the ability to participate in the project\n* suicidal Ideation\n* IQ \\\u003C 70",true,"ALL","11 Years","80 Years",{"count":109,"type":110},80,"ESTIMATED","INTERVENTIONAL",[113],"NA","This clinical trial aims to implement multimodal digital interventions for adolescents and young adults with social isolation (SI) and their family members. Furthermore, the neurobiological basis of SI will be explored by analyzing blood neuroinflammation biomarkers in socially isolated participants.\n\nThe main questions that this project aims to answer are:\n\n* What is the general feasibility and applicability of the proposed digital interventions?\n* What is the effect of the proposed digital interventions on the SI-related clinical symptoms and the cognitive and global functioning of participants with SI?\n\nParticipants will be asked to undergo:\n\n* A detailed clinical and neuropsychological evaluation (pre-post treatment)\n* A blood sample (pre-post treatment)\n* A telepsychiatry intervention (cognitive behavioural therapy (CBT) and\u002For cognitive remediation (CR) for SI participants and psychoeducation (PE) for family members)\n\nThe researchers will compare SI participants treated with CBT+CR (experimental group) with SI patients treated only with CBT (control group) to see if the combined intervention of the experimental group leads to more durable and generalizable effects.\n\nThe same PE intervention will be offered to the family members of all recruited SI participants.",[116,117],"Social Isolation","Psychosocial Problem",[116,119,120,121,122,123,124],"Telepsychiatry","Digital health","Cognitive remediation","CBT","Psychotherapy","Loneliness","2024-07-29",{"date":127,"type":128},"2024-07-30","ACTUAL",{"date":130,"type":128},"2023-09-01",{"date":132,"type":110},"2025-05",{"name":5,"class":6},2]