Clinical trial NCT06138301: Telepsychiatry for Social Isolation in Youths
Official title: Digital Interventions for Social isOLation In youThs And theIR familiEs
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Social Isolation
Psychosocial Problem
Keywords: Social Isolation
Telepsychiatry
Digital health
Cognitive remediation
CBT
Psychotherapy
Loneliness
Lead sponsor: Azienda Ospedaliera Universitaria Integrata Verona
Sponsor class: OTHER
Collaborators: name: IRCCS Eugenio Medea
name: University of Milan
name: Istituto di Neuroscienze Consiglio Nazionale delle Ricerche
First posted: 2023-11-18
Enrollment: 80
Sex: ALL
Minimum age (years): 11
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: SI is a condition that can lead to complete withdrawal from society, especially concerning the most fragile subgroups, such as youth and elderly populations. It is often a core (often prodromal) symptom of severe psychiatric disorders such as Hikikomori syndrome, social anxiety disorder, psychosis, depression, post-traumatic disorders stress disorder, obsessive-compulsive disorder, mood dysregulation, and autism spectrum disorders. If left untreated, SI can escalate into complete withdrawal from society. Therefore, early interventions for the treatment of SI could lead to a more favourable outcome for young patients. However, due to the social interaction barrier inherent to the condition, current treatments alone are problematic and only partially effective in treating SI. SOLITAIRE aims to implement a multi-component digital psychiatric intervention to help adolescents and young adults with SI based on CBT and/or CR for socially isolated participants and PE for their family members. All interventions will be delivered remotely, thus overcoming most of the barriers and limitations of standard face-to-face clinical interventions. In particular, a randomized controlled trial (RCT) will be conducted on participants with SI to test the feasibility and acceptability of the interventions and to evaluate the difference in efficacy between CBT+CR (experimental group) and CBT alone (control group). The CBT sessions will be audio-recorded. The recordings will then be analyzed using machine learning algorithms to build an automatic system for the evaluation of SI-related depressive symptoms starting from the voice. The digital interventions will last about 2-3 months. The investigators hypothesized that participants in the experimental group would show more durable and generalizable cognitive and behavioural improvements due to the neuroplasticity processes associated with CR. Furthermore, plasma samples of the socially isolated participants will be collected before and after the interventions and biochemically analyzed to explore the neurobiological basis of SI and treatment-related biomarkers.

Family members will be invited to undergo video calls with a psychotherapist (8 sessions, ≈1 hour/week) in which cognitive-behavioural and PE techniques will be combined to provide them with knowledge about the clinical aspects and treatments of SI. The content of the sessions will be adapted to the age and specific psychopathological profile of the socially isolated relatives.

Participants with SI can be included in the study even if their family members choose not to participate.

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

Primary outcomes:
measure: Change in SI-related symptoms in socially isolated participants, as assessed by the Hikikomori Questionnaire (HQ-25); [score range 0-100; higher scores mean worse outcome].
timeFrame: up to 4 months
measure: Feasibility and acceptability of the digital interventions
timeFrame: up to 4 months
measure: Usability of the digital interventions
timeFrame: up to 4 months
Secondary outcomes:
measure: Change in the clinical and cognitive profile of socially isolated participants.
timeFrame: up to 4 months
measure: Change in psychological burden and well-being of family members as assessed by self-report questionnaires.
timeFrame: up to 4 months
measure: Change of SI-related depressive symptoms measured via speech analysis
timeFrame: up to 4 months
measure: Identification of plasmatic biomarkers related to social isolation pathology and treatment
timeFrame: up to 4 months
Other outcomes:
Locations:
city: Brindisi
country: Italy
facility: Unità per le Disabilità gravi dell'età Evolutiva e Giovane Adulta, IRCCS Eugenio Medea, Polo scientifico Puglia
city: Verona
country: Italy
facility: UOC Psichiatria B, Azienda Ospedaliera Universitaria Integrata
Study officials:
affiliation: Section of Psychiatry, University of Verona
name: Prof Mirella Ruggeri, PhD
role: PRINCIPAL_INVESTIGATOR
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