Study Results
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Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2023-09-01
2025-05-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Experimental group
Patients with SI treated with CBT+CR
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.
Control group
Patients with SI treated with CBT
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* primary medical conditions or vision/hearing deficits that interfere with the ability to participate in the project
* suicidal Ideation
* IQ \< 70
11 Years
80 Years
ALL
Yes
Sponsors
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IRCCS Eugenio Medea
OTHER
University of Milan
OTHER
Istituto di Neuroscienze Consiglio Nazionale delle Ricerche
NETWORK
Azienda Ospedaliera Universitaria Integrata Verona
OTHER
Responsible Party
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Principal Investigators
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Prof Mirella Ruggeri, PhD
Role: PRINCIPAL_INVESTIGATOR
Section of Psychiatry, University of Verona
Locations
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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, , Italy
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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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.
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.
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.
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.
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.
Other Identifiers
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PNRR-MAD-2022-12376834
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
4202CESC
Identifier Type: -
Identifier Source: org_study_id
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