Actively Recruiting

Phase Not Applicable
Age: 11Years - 80Years
All Genders
Healthy Volunteers
NCT06138301

Telepsychiatry for Social Isolation in Youths

Led by Azienda Ospedaliera Universitaria Integrata Verona · Updated on 2024-07-30

80

Participants Needed

2

Research Sites

86 weeks

Total Duration

On this page

Sponsors

A

Azienda Ospedaliera Universitaria Integrata Verona

Lead Sponsor

I

IRCCS Eugenio Medea

Collaborating Sponsor

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

Telepsychiatry for Social Isolation in Youths

Who Can Participate

Age: 11Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with social isolation aged 11-17 years (adolescents) or 18-45 years (adults)
  • Moderate-to-high levels of social isolation confirmed by clinical evaluation and HQ-25 score
  • Stable medication and symptoms for the past 3 months
  • Not currently in psychotherapy or willing to stop psychotherapy during the study
  • Access to an internet connection
  • Caregivers aged 80 years or younger
  • Caregivers with no history of psychotic spectrum disorders
  • Caregivers who have a first-degree relative with moderate-to-severe social isolation
  • Caregivers with access to an internet connection
Not Eligible

You will not qualify if you...

  • Primary medical conditions or vision/hearing problems that prevent participation
  • Suicidal ideation
  • IQ below 70

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Unità per le Disabilità gravi dell'età Evolutiva e Giovane Adulta, IRCCS Eugenio Medea, Polo scientifico Puglia

Brindisi, Italy, 72100

Actively Recruiting

2

UOC Psichiatria B, Azienda Ospedaliera Universitaria Integrata

Verona, Italy, 37134

Actively Recruiting

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Research Team

P

Prof Marcella Bellani, PhD

CONTACT

M

Maria Gloria Rossetti, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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