Telepsychiatry for Social Isolation in Youths

Social Isolation Clinical Trial

— SOLITAIRE  

Official title:

Digital Interventions for Social isOLation In youThs And theIR familiEs

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06138301
• Other study ID #: 4202CESC
• Secondary ID: PNRR-MAD-2022-12
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: May 2025

Study information

• Verified date: November 2023
• Source: Azienda Ospedaliera Universitaria Integrata Verona
• Contact: Prof Marcella Bellani, PhD
• Phone: +390458126691
• Email: marcella.bellani[@]univr.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: May 2025
• Est. primary completion date: November 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Psychosocial Problem
• Social Isolation

Intervention

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.
• 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.

Locations

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

Sponsors (4)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria Integrata Verona	IRCCS Eugenio Medea, Istituto di Neuroscienze Consiglio Nazionale delle Ricerche, University of Milan

Country where clinical trial is conducted

Italy, 

References & Publications (22)

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Biagianti B, Zito S, Fornoni C, Ginex V, Bellani M, Bressi C, Brambilla P. Developing a Brief Tele-Psychotherapy Model for COVID-19 Patients and Their Family Members. Front Psychol. 2021 Dec 2;12:784685. doi: 10.3389/fpsyg.2021.784685. eCollection 2021. — View Citation

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Domenici E, Wille DR, Tozzi F, Prokopenko I, Miller S, McKeown A, Brittain C, Rujescu D, Giegling I, Turck CW, Holsboer F, Bullmore ET, Middleton L, Merlo-Pich E, Alexander RC, Muglia P. Plasma protein biomarkers for depression and schizophrenia by multi analyte profiling of case-control collections. PLoS One. 2010 Feb 11;5(2):e9166. doi: 10.1371/journal.pone.0009166. — View Citation

Faurholt-Jepsen M, Busk J, Frost M, Vinberg M, Christensen EM, Winther O, Bardram JE, Kessing LV. Voice analysis as an objective state marker in bipolar disorder. Transl Psychiatry. 2016 Jul 19;6(7):e856. doi: 10.1038/tp.2016.123. — View Citation

Garcia-Gutierrez MS, Navarrete F, Sala F, Gasparyan A, Austrich-Olivares A, Manzanares J. Biomarkers in Psychiatry: Concept, Definition, Types and Relevance to the Clinical Reality. Front Psychiatry. 2020 May 15;11:432. doi: 10.3389/fpsyt.2020.00432. eCollection 2020. — View Citation

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McEvoy PM. Effectiveness of cognitive behavioural group therapy for social phobia in a community clinic: a benchmarking study. Behav Res Ther. 2007 Dec;45(12):3030-40. doi: 10.1016/j.brat.2007.08.002. Epub 2007 Aug 8. — View Citation

Merikangas KR, He JP, Burstein M, Swendsen J, Avenevoli S, Case B, Georgiades K, Heaton L, Swanson S, Olfson M. Service utilization for lifetime mental disorders in U.S. adolescents: results of the National Comorbidity Survey-Adolescent Supplement (NCS-A). J Am Acad Child Adolesc Psychiatry. 2011 Jan;50(1):32-45. doi: 10.1016/j.jaac.2010.10.006. Epub 2010 Dec 3. — View Citation

Nagata T, Yamada H, Teo AR, Yoshimura C, Nakajima T, van Vliet I. Comorbid social withdrawal (hikikomori) in outpatients with social anxiety disorder: clinical characteristics and treatment response in a case series. Int J Soc Psychiatry. 2013 Feb;59(1):73-8. doi: 10.1177/0020764011423184. Epub 2011 Oct 13. — View Citation

Nordh M, Vigerland S, Ost LG, Ljotsson B, Mataix-Cols D, Serlachius E, Hogstrom J. Therapist-guided internet-delivered cognitive-behavioural therapy supplemented with group exposure sessions for adolescents with social anxiety disorder: a feasibility trial. BMJ Open. 2017 Dec 14;7(12):e018345. doi: 10.1136/bmjopen-2017-018345. — View Citation

Ramdhani, N., Widjaja, J. D., & Rahmawati, N. (2015). Internet supported cognitive behavior therapy to help students with shy-socially isolated problems. Procedia-Social and Behavioral Sciences, 165, 179-188.

Rohr S, Wittmann F, Engel C, Enzenbach C, Witte AV, Villringer A, Loffler M, Riedel-Heller SG. Social factors and the prevalence of social isolation in a population-based adult cohort. Soc Psychiatry Psychiatr Epidemiol. 2022 Oct;57(10):1959-1968. doi: 10.1007/s00127-021-02174-x. Epub 2021 Sep 17. — View Citation

Sarkhel S, Singh OP, Arora M. Clinical Practice Guidelines for Psychoeducation in Psychiatric Disorders General Principles of Psychoeducation. Indian J Psychiatry. 2020 Jan;62(Suppl 2):S319-S323. doi: 10.4103/psychiatry.IndianJPsychiatry_780_19. Epub 2020 Jan 17. No abstract available. — View Citation

Strawbridge R, Young AH, Cleare AJ. Biomarkers for depression: recent insights, current challenges and future prospects. Neuropsychiatr Dis Treat. 2017 May 10;13:1245-1262. doi: 10.2147/NDT.S114542. eCollection 2017. — View Citation

Taylor HO, Taylor RJ, Nguyen AW, Chatters L. Social Isolation, Depression, and Psychological Distress Among Older Adults. J Aging Health. 2018 Feb;30(2):229-246. doi: 10.1177/0898264316673511. Epub 2016 Oct 17. — View Citation

Teo AR. Social isolation associated with depression: a case report of hikikomori. Int J Soc Psychiatry. 2013 Jun;59(4):339-41. doi: 10.1177/0020764012437128. Epub 2012 Mar 8. — View Citation

Wang J, Zhang L, Liu T, Pan W, Hu B, Zhu T. Acoustic differences between healthy and depressed people: a cross-situation study. BMC Psychiatry. 2019 Oct 15;19(1):300. doi: 10.1186/s12888-019-2300-7. — View Citation

Zovetti N, Rossetti MG, Perlini C, Brambilla P, Bellani M. Neuroimaging studies exploring the neural basis of social isolation. Epidemiol Psychiatr Sci. 2021 Apr 6;30:e29. doi: 10.1017/S2045796021000135. — View Citation

* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	up to 4 months
Primary	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).	up to 4 months
Primary	Usability of the digital interventions	Scores obtained on a 7pt Likert scale created ad hoc	up to 4 months
Secondary	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.	up to 4 months
Secondary	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.	up to 4 months
Secondary	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).	up to 4 months
Secondary	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.	up to 4 months