Telepsychiatry for Social Isolation in Youths
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age11-80
SponsorAzienda Ospedaliera Universitaria Integrata Verona
About this trial
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
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
primary medical conditions or vision/hearing deficits that interfere with the ability to participate in the project
suicidal Ideation
IQ < 70
Trial design
Design model
Parallel
Treatments tested in this trial
Cognitive Behavioral Therapy (CBT)
BehavioralCBT 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.
Cognitive Remediation (CR)
BehavioralThe 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.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Experimental groupExperimental treatment 2 interventions
Group B: Control groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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].
Response to treatment is defined as a post-pre treatment reduction ≥ 25% in the HQ-25 score
Time frame
up to 4 months2
Feasibility and acceptability of the digital interventions
I) The completion rate of the baseline and follow-up assessments ii) the completion rate of the entire study (completers vs drop-outs).
Time frame
up to 4 months3
Usability of the digital interventions
Scores obtained on a 7pt Likert scale created ad hoc
Time frame
up to 4 monthsSecondary outcomes
1
Change in the clinical and cognitive profile of socially isolated participants.
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.
Time frame
up to 4 months2
Change in psychological burden and well-being of family members as assessed by self-report questionnaires.
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.
Time frame
up to 4 months3
Change of SI-related depressive symptoms measured via speech analysis
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).
Time frame
up to 4 months4
Identification of plasmatic biomarkers related to social isolation pathology and treatment
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.
Time frame
up to 4 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Azienda Ospedaliera Universitaria Integrata Verona
Lead sponsor
IRCCS Eugenio Medea
Collaborator
University of Milan
Collaborator
Istituto di Neuroscienze Consiglio Nazionale delle Ricerche
Collaborator
Source ClinicalTrials.gov