Telepsychiatry intervention for socially isolated youth
Digital Interventions for Social isOLation In youThs And theIR familiEs
This study is testing whether a combination of therapy and brain exercises delivered online can help socially isolated young people feel better and think more clearly compared to just therapy alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 11 Years to 80 Years |
| Sex | All |
| Sponsor | Azienda Ospedaliera Universitaria Integrata Verona Academic / other |
| Locations | 2 sites (Brindisi and 1 other locations) |
| Trial ID | NCT06138301 on ClinicalTrials.gov |
What this trial studies
This clinical trial implements multimodal digital interventions for adolescents and young adults experiencing social isolation, alongside their family members. Participants will undergo clinical evaluations, blood tests to analyze neuroinflammation biomarkers, and receive telepsychiatry interventions including cognitive behavioral therapy (CBT) and cognitive remediation (CR). The study aims to assess the feasibility and effectiveness of these interventions in improving social isolation-related symptoms and cognitive functioning. A randomized controlled trial will compare the outcomes of participants receiving combined CBT and CR against those receiving CBT alone.
Who should consider this trial
Good fit: Ideal candidates include adolescents aged 11-17 and young adults aged 18-45 with moderate-to-high levels of social isolation.
Not a fit: Patients with primary medical conditions, severe suicidal ideation, or those unable to participate due to cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the mental health and social functioning of youths suffering from social isolation.
How similar studies have performed: Other studies have shown promise in using digital interventions for mental health, but this specific approach targeting social isolation in youth is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Brindisi and 1 other locations
- Unità per le Disabilità gravi dell'età Evolutiva e Giovane Adulta, IRCCS Eugenio Medea, Polo scientifico Puglia — Brindisi, Italy (Recruiting)
- UOC Psichiatria B, Azienda Ospedaliera Universitaria Integrata — Verona, Italy (Recruiting)
Study contacts
- Principal investigator: Prof Mirella Ruggeri, PhD — Section of Psychiatry, University of Verona
- Study coordinator: Prof Marcella Bellani, PhD
- Email: marcella.bellani@univr.it
- Phone: +390458126691
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.