Telepsychiatry for Social Isolation in Youths

Summary

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.

Conditions

• Social Isolation
• Psychosocial Problem

Interventions

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.

BEHAVIORAL

Cognitive Remediation (CR)

The cognitive training will consist of 10 hours (30 minutes/session) 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.

Sponsors & Collaborators

• IRCCS Eugenio Medea

  collaborator OTHER

• University of Milan

  collaborator OTHER

• Istituto di Neuroscienze Consiglio Nazionale delle Ricerche

  collaborator NETWORK

• Azienda Ospedaliera Universitaria Integrata Verona

  lead OTHER

Principal Investigators

• Prof Mirella Ruggeri, PhD · Section of Psychiatry, University of Verona

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

11 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-09-01

Primary Completion

2024-11-30

Completion

2025-05-31

Countries

• Italy

Study Locations