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Search / Trial NCT06138301

Telepsychiatry for Social Isolation in Youths

Launched by AZIENDA OSPEDALIERA UNIVERSITARIA INTEGRATA VERONA · Nov 16, 2023

Trial Information

Current as of July 24, 2025

Recruiting

Keywords

Social Isolation Telepsychiatry Digital Health Cognitive Remediation Cbt Psychotherapy Loneliness

ClinConnect Summary

This clinical trial is looking at how digital tools can help teens and young adults who feel socially isolated. Social isolation can be a big problem, and the researchers want to see if combining different types of online therapy, like cognitive behavioral therapy (CBT) and cognitive remediation (CR), can make a difference. They will also take blood samples to understand the biological factors behind social isolation. The study will compare two groups: one group will receive the combined therapy, while the other will just get CBT. This will help determine if the extra therapy is more effective in helping participants feel better and function better in their daily lives.

To join this study, participants need to be aged 11 to 45 years and show moderate to high levels of social isolation. They should also have a stable treatment plan in the last three months and be okay with stopping any ongoing psychotherapy during the trial. Family members of the participants will also have the chance to take part in a supportive educational program. Everyone involved will need to have internet access, and there are specific health criteria that must be met to ensure safety. Overall, this study aims to find new ways to support young people feeling isolated and their families.

Gender

ALL

Eligibility criteria

  • 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

About Azienda Ospedaliera Universitaria Integrata Verona

Azienda Ospedaliera Universitaria Integrata Verona is a leading academic hospital institution in Italy, dedicated to advancing healthcare through innovative clinical research and patient care. With a strong emphasis on collaboration between its medical staff and academic partners, the institution integrates comprehensive clinical services with cutting-edge research initiatives. This multidisciplinary approach ensures the delivery of high-quality healthcare while contributing to the development of new medical knowledge and therapies. The organization is committed to improving patient outcomes and fostering evidence-based practices in the medical community.

Locations

Brindisi, , Italy

Verona, , Italy

Patients applied

0 patients applied

Trial Officials

Prof Mirella Ruggeri, PhD

Principal Investigator

Section of Psychiatry, University of Verona

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported