NCT06138301 Telepsychiatry for Social Isolation in Youths
| NCT ID | NCT06138301 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Azienda Ospedaliera Universitaria Integrata Verona |
| Condition | Social Isolation |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2023-09-01 |
| Primary Completion | 2024-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2023-09-01 with a primary completion date of 2024-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
Prof Mirella Ruggeri, PhD
PRINCIPAL INVESTIGATOR
Section of Psychiatry, University of Verona
Frequently Asked Questions
Who can join the NCT06138301 clinical trial?
This trial is open to participants of all sexes, aged 11 Years or older, up to 80 Years, studying Social Isolation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06138301 currently recruiting?
Yes, NCT06138301 is actively recruiting participants. Contact the research team at marcella.bellani@univr.it for enrollment information.
Where is the NCT06138301 trial being conducted?
This trial is being conducted at Brindisi, Italy, Verona, Italy.
Who is sponsoring the NCT06138301 clinical trial?
NCT06138301 is sponsored by Azienda Ospedaliera Universitaria Integrata Verona. The principal investigator is Prof Mirella Ruggeri, PhD at Section of Psychiatry, University of Verona. The trial plans to enroll 80 participants.