Telepsychiatry for Social Isolation in Youths

NCT06138301 | Recruiting

• 2 other identifiers: 4202CESCPNRR-MAD-2022-12376834
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

Social Isolation; Psychosocial Problem

Keywords

Social Isolation; Telepsychiatry; Digital health; Cognitive remediation; CBT; Psychotherapy; Loneliness

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• Usability of the digital interventions

  Scores obtained on a 7pt Likert scale created ad hoc

  up to 4 months

Secondary Outcomes (4)

• Change in the clinical and cognitive profile of socially isolated participants.

  up to 4 months

• Change in psychological burden and well-being of family members as assessed by self-report questionnaires.

  up to 4 months

• Change of SI-related depressive symptoms measured via speech analysis

  up to 4 months

• Identification of plasmatic biomarkers related to social isolation pathology and treatment

  up to 4 months

Study Arms (2)

Experimental group

EXPERIMENTAL

Patients with SI treated with CBT+CR

Behavioral: Cognitive Behavioral Therapy (CBT); Behavioral: Cognitive Remediation (CR)

Control group

ACTIVE COMPARATOR

Patients with SI treated with CBT

Behavioral: Cognitive Behavioral Therapy (CBT)

Interventions

Cognitive Behavioral Therapy (CBT) BEHAVIORAL

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.

Control group; Experimental group

Cognitive Remediation (CR) BEHAVIORAL

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.

Experimental group

Eligibility Criteria

• Age: 11 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• All participants:
• primary medical conditions or vision/hearing deficits that interfere with the ability to participate in the project
• suicidal Ideation
• IQ \< 70

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Integrata Verona: lead
• IRCCS Eugenio Medea: collaborator
• University of Milan: collaborator
• Istituto di Neuroscienze Consiglio Nazionale delle Ricerche: collaborator

Study Sites (2)

Unità per le Disabilità gravi dell'età Evolutiva e Giovane Adulta, IRCCS Eugenio Medea, Polo scientifico Puglia

Brindisi, 72100, Italy

RECRUITING

UOC Psichiatria B, Azienda Ospedaliera Universitaria Integrata

Verona, 37134, Italy

RECRUITING

Related Publications (22)

• Bhatti AB, Haq AU. The Pathophysiology of Perceived Social Isolation: Effects on Health and Mortality. Cureus. 2017 Jan 24;9(1):e994. doi: 10.7759/cureus.994.

  PMID: 28382237 BACKGROUND

• 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.

  PMID: 34925187 BACKGROUND

• Cacioppo S, Capitanio JP, Cacioppo JT. Toward a neurology of loneliness. Psychol Bull. 2014 Nov;140(6):1464-504. doi: 10.1037/a0037618. Epub 2014 Sep 15.

  PMID: 25222636 BACKGROUND

• De France K, Hancock GR, Stack DM, Serbin LA, Hollenstein T. The mental health implications of COVID-19 for adolescents: Follow-up of a four-wave longitudinal study during the pandemic. Am Psychol. 2022 Jan;77(1):85-99. doi: 10.1037/amp0000838. Epub 2021 May 24.

  PMID: 34110880 BACKGROUND

• 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.

  PMID: 20161799 BACKGROUND

• 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.

  PMID: 27434490 BACKGROUND

• 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.

  PMID: 32499729 BACKGROUND

• Gershkovich M, Herbert JD, Forman EM, Schumacher LM, Fischer LE. Internet-Delivered Acceptance-Based Cognitive-Behavioral Intervention for Social Anxiety Disorder With and Without Therapist Support: A Randomized Trial. Behav Modif. 2017 Sep;41(5):583-608. doi: 10.1177/0145445517694457. Epub 2017 Mar 8.

  PMID: 28776431 BACKGROUND

• Low DM, Bentley KH, Ghosh SS. Automated assessment of psychiatric disorders using speech: A systematic review. Laryngoscope Investig Otolaryngol. 2020 Jan 31;5(1):96-116. doi: 10.1002/lio2.354. eCollection 2020 Feb.

  PMID: 32128436 BACKGROUND

• 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.

  PMID: 17826734 BACKGROUND

• 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.

  PMID: 21156268 BACKGROUND

• 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.

  PMID: 21997765 BACKGROUND

• 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.

  PMID: 29247101 BACKGROUND

• Kim EJ, Bahk YC, Oh H, Lee WH, Lee JS, Choi KH. Current Status of Cognitive Remediation for Psychiatric Disorders: A Review. Front Psychiatry. 2018 Oct 1;9:461. doi: 10.3389/fpsyt.2018.00461. eCollection 2018.

  PMID: 30337888 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 34533607 BACKGROUND

• 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.

  PMID: 32055073 BACKGROUND

• 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.

  PMID: 28546750 BACKGROUND

• 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.

  PMID: 28553785 BACKGROUND

• 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.

  PMID: 22408115 BACKGROUND

• 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.

  PMID: 31615470 BACKGROUND

• 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.

  PMID: 33820592 BACKGROUND

MeSH Terms

Conditions

Social Isolation

Interventions

Cognitive Behavioral Therapy; Cognitive Remediation

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Prof Mirella Ruggeri, PhD

  Section of Psychiatry, University of Verona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Prof Marcella Bellani, PhD

CONTACT

+390458126691; marcella.bellani@univr.it

Maria Gloria Rossetti, PhD

CONTACT

+390458124038; mariagloria.rossetti@univr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2023
• First Posted: November 18, 2023
• Study Start: September 1, 2023
• Primary Completion: November 1, 2024
• Study Completion: May 1, 2025
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: Immediately following publication.No end date.
• Access Criteria: Proposals should be directed to marcella.bellani@univr.it. To gain access, data requestors will need to sign a data access agreement.

Locations

IT (2)