SOLITAIRE: Telepsychiatry for Social Isolation in Youths

Sponsor

Azienda Ospedaliera Universitaria Integrata Verona (Other)

Overall Status

Recruiting

CT.gov ID

NCT06138301

Collaborator

IRCCS Eugenio Medea (Other), University of Milan (Other), Istituto di Neuroscienze Consiglio Nazionale delle Ricerche (Other)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Social Isolation Psychosocial Problem	Behavioral: Cognitive Behavioral Therapy (CBT) Behavioral: Cognitive Remediation (CR)	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Digital Interventions for Social isOLation In youThs And theIR familiEs

Actual Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Nov 1, 2024

Anticipated Study Completion Date :

May 1, 2025

Arms and Interventions

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.

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)

Outcome Measures

Primary Outcome Measures

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]. [up to 4 months]
Response to treatment is defined as a post-pre treatment reduction ≥ 25% in the HQ-25 score
Feasibility and acceptability of the digital interventions [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).
Usability of the digital interventions [up to 4 months]
Scores obtained on a 7pt Likert scale created ad hoc

Secondary Outcome Measures

Change in the clinical and cognitive profile of socially isolated participants. [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.
Change in psychological burden and well-being of family members as assessed by self-report questionnaires. [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.
Change of SI-related depressive symptoms measured via speech analysis [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).
Identification of plasmatic biomarkers related to social isolation pathology and treatment [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

11 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Unità per le Disabilità gravi dell'età Evolutiva e Giovane Adulta, IRCCS Eugenio Medea, Polo scientifico Puglia	Brindisi		Italy	72100
2	UOC Psichiatria B, Azienda Ospedaliera Universitaria Integrata	Verona		Italy	37134