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Telepsychiatry for Social Isolation in Youths

Sponsored by Azienda Ospedaliera Universitaria Integrata Verona

About this trial

Last updated 2 years ago

Study ID

4202CESC

Status

Recruiting

Type

Interventional

Phase

N/A

Placebo

No

Accepting

11 to 80 Years
All Sexes

Trial Timing

Ended a year ago

What is this trial about?

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.

What are the participation requirements?

Inclusion Criteria

Patients with SI: * age11-17 years (adolescents) 18-45 years (adults) * moderate-to-high levels of SI as detected by clinical evaluation and confirmed by the HQ-25 score * stable pharmacotherapy and symptomatology in the last 3 months * not being in psychotherapy or being willing to interrupt it during the study * have an internet connection Caregivers: * Age ≤ 80 * no history of psychotic spectrum disorders * have a first-degree relative with moderate-to-severe SI * have an internet connection

Exclusion Criteria

All participants: * primary medical conditions or vision/hearing deficits that interfere with the ability to participate in the project * suicidal Ideation * IQ < 70