Telepsychiatry for Social Isolation in Youths

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. The main questions that this project aims to answer are: * What is the general feasibility and applicability of the proposed digital interventions? * 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? Participants will be asked to undergo: * A detailed clinical and neuropsychological evaluation (pre-post treatment) * A blood sample (pre-post treatment) * A telepsychiatry intervention (cognitive behavioural therapy (CBT) and/or cognitive remediation (CR) for SI participants and psychoeducation (PE) for family members) The 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. The same PE intervention will be offered to the family members of all recruited SI participants.

NCT Number	NCT06138301
Lead Sponsor	Azienda Ospedaliera Universitaria Integrata Verona Collaborators: IRCCS Eugenio Medea, University of Milan, Istituto di Neuroscienze Consiglio Nazionale delle Ricerche
Conditions	Social Isolation, Psychosocial Problem
Enrollment	80 participants
Start Date	2023-09-01
Primary Completion	2024-11 (estimated)
Study Completion	2025-05 (estimated)
Updated on ClinicalTrials.gov	2024-07-30