Telepsychiatry for Social Isolation in Youths (SOLITAIRE)

July 29, 2024 updated by: Azienda Ospedaliera Universitaria Integrata Verona

Digital Interventions for Social isOLation In youThs And theIR familiEs

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Brindisi, Italy, 72100
        • Recruiting
        • Unità per le Disabilità gravi dell'età Evolutiva e Giovane Adulta, IRCCS Eugenio Medea, Polo scientifico Puglia
        • Contact:
        • Principal Investigator:
          • Antonio Trabacca, PhD
        • Sub-Investigator:
          • Isabella Fanizza
      • Verona, Italy, 37134
        • Recruiting
        • UOC Psichiatria B, Azienda Ospedaliera Universitaria Integrata
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marcella Bellani, PhD
        • Sub-Investigator:
          • Cinzia Perlini, PhD
        • Sub-Investigator:
          • Maria Gloria Rossetti, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
Patients with SI treated with CBT+CR
Behavioral: Cognitive Behavioral Therapy (CBT)
CBT is a psychotherapeutic intervention that focuses on challenging and changing cognitive distortions (such as thoughts, beliefs, and attitudes) and their associated behaviours to improve emotional regulation and develop personal coping strategies that target solving current problems. In this study, patients with SI will undergo 8 sessions of CBT (45 min, once a week), remotely. Techniques and strategies of the intervention will be based on a short telepsychotherapy protocol previously published by our group (Biagianti et. al., 2021). Instead, the content of each session will be adapted to the psychopathology associated with social isolation and the age of the subject. The psychotherapeutic sessions of the patients will be audio-recorded in order to conduct retrospective analyzes of the patient's speech.
Behavioral: Cognitive Remediation (CR)
The cognitive training will consist of 10 hours (30 minutes/session) of computer-based exercises focusing on working memory, attention, executive functions and social cognition, which will be performed online using BrainHQ software. This software allows for the customization of the training based on the specific characteristics of each subject. For example, it allows automatic adjustment of the difficulty of the exercises, trial by trial and session by session, in order to guarantee an adequate level of attention and motivation for the entire duration of the training and therefore favor optimal learning rates.
Active Comparator: Control group
Patients with SI treated with CBT
Behavioral: Cognitive Behavioral Therapy (CBT)
CBT is a psychotherapeutic intervention that focuses on challenging and changing cognitive distortions (such as thoughts, beliefs, and attitudes) and their associated behaviours to improve emotional regulation and develop personal coping strategies that target solving current problems. In this study, patients with SI will undergo 8 sessions of CBT (45 min, once a week), remotely. Techniques and strategies of the intervention will be based on a short telepsychotherapy protocol previously published by our group (Biagianti et. al., 2021). Instead, the content of each session will be adapted to the psychopathology associated with social isolation and the age of the subject. The psychotherapeutic sessions of the patients will be audio-recorded in order to conduct retrospective analyzes of the patient's speech.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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].
Time Frame: up to 4 months
Response to treatment is defined as a post-pre treatment reduction ≥ 25% in the HQ-25 score
up to 4 months
Feasibility and acceptability of the digital interventions
Time Frame: up to 4 months
I) The completion rate of the baseline and follow-up assessments ii) the completion rate of the entire study (completers vs drop-outs).
up to 4 months
Usability of the digital interventions
Time Frame: up to 4 months
Scores obtained on a 7pt Likert scale created ad hoc
up to 4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the clinical and cognitive profile of socially isolated participants.
Time Frame: up to 4 months

Post-pre treatment mean change in the score of questionnaires/tests measuring depression, anxiety, alexithymia, behaviour, loneliness, social interaction, impulsivity, temperament and character, close relationships, quality of life, general health, functioning, psychological needs and parental bonding as well as attention, memory, executive functions and linguistic comprehension.

Depending on the questionnaire/test taken into consideration, higher scores can mean either a better or worse outcome. Therefore, the scores of the various questionnaires/tests will be standardized (e.g., z-transformed) to allow for comparisons.
up to 4 months
Change in psychological burden and well-being of family members as assessed by self-report questionnaires.
Time Frame: up to 4 months
Post-pre treatment mean change in the questionnaire scores. Depending on the questionnaire/test taken into consideration, higher scores can mean either a better or worse outcome. Therefore, the scores of the various questionnaires/tests will be standardized (e.g., z-transformed) to allow for comparisons.
up to 4 months
Change of SI-related depressive symptoms measured via speech analysis
Time Frame: up to 4 months
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 scores produced by the automatic algorithm will be compared during the 8 weeks of intervention. Since these are exploratory analyses, these scores will be defined during the research itself (there are no widely accepted standard methodologies for this type of innovative analysis).
up to 4 months
Identification of plasmatic biomarkers related to social isolation pathology and treatment
Time Frame: up to 4 months
Blood samples of the participants will be collected before (T0) and at the end of (T1) the treatments. Blood serum will be analyzed through a Luminex200 multiplex immunoassay to quantify the levels of selected proteins. These will include markers previously reported to be altered in psychiatric conditions, such as BDNF, EGF, RANTES, MMP-9, IL-1, IL-6, TGFalpha.
up to 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliera Universitaria Integrata Verona

Collaborators

IRCCS Eugenio Medea
University of Milan
Istituto di Neuroscienze Consiglio Nazionale delle Ricerche

Investigators

  • Principal Investigator: Prof Mirella Ruggeri, PhD, Section of Psychiatry, University of Verona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

September 4, 2023

First Submitted That Met QC Criteria

November 16, 2023

First Posted (Actual)

November 18, 2023

Study Record Updates

Last Update Posted (Actual)

July 30, 2024

Last Update Submitted That Met QC Criteria

July 29, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 4202CESC
  • PNRR-MAD-2022-12376834 (Other Grant/Funding Number: European Union - Next Generation EU - NRRP M6C2)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie behavioural results, after deidentification(text, tables, figures, and appendices)

IPD Sharing Time Frame

Immediately following publication.No end date.

IPD Sharing Access Criteria

Proposals should be directed to marcella.bellani@univr.it. To gain access, data requestors will need to sign a data access agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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