Telepsychiatry for Social Isolation in Youths

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age11-80
SponsorAzienda Ospedaliera Universitaria Integrata Verona

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

primary medical conditions or vision/hearing deficits that interfere with the ability to participate in the project

suicidal Ideation

IQ < 70

Trial design

Treatments tested in this trial

  • Cognitive Behavioral Therapy (CBT)
  • Cognitive Remediation (CR)

Treatment groups

80 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Azienda Ospedaliera Universitaria Integrata Verona

Lead sponsor

IRCCS Eugenio Medea

Collaborator

University of Milan

Collaborator

Istituto di Neuroscienze Consiglio Nazionale delle Ricerche

Collaborator