Social IsolationSOLITAIRENCT06138301
Telepsychiatry for Social Isolation in Youths
A study testing Cognitive Behavioral Therapy (CBT) and Cognitive Remediation (CR) in people with Social Isolation and Psychosocial Problem, run by Azienda Ospedaliera Universitaria Integrata Verona at 2 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 11 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Social Isolation, Psychosocial Problem
- What is being tested?
- Cognitive Behavioral Therapy (CBT) and Cognitive Remediation (CR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Sep 2023to May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- Caregivers:
- Age ≤ 80
- no history of psychotic spectrum disorders
- have a first-degree relative with moderate-to-severe SI
- have an internet connection
Who cannot join
- All participants:
- primary medical conditions or vision/hearing deficits that interfere with the ability to participate in the project
- suicidal Ideation
- IQ < 70
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Recruiting
Unità per le Disabilità gravi dell'età Evolutiva e Giovane Adulta, IRCCS Eugenio Medea, Polo scientifico Puglia
Brindisi, 72100
Isabella Fanizza, +393394245184, isabella.fanizza@lanostrafamiglia.it
Antonio Trabacca, PhD
- Recruiting
UOC Psichiatria B, Azienda Ospedaliera Universitaria Integrata
Verona, 37134
Marcella Bellani, PhD, +390458126691, marcella.bellani@univr.it
Maria Gloria Rossetti, PhD, +390458124038, mariagloria.rossetti@univr.it
About this study
Official title: Digital Interventions for Social isOLation In youThs And theIR familiEs
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:
Read more
- 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.
Read the 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.
- Conditions
- Social Isolation, Psychosocial Problem
- Being tested
- Cognitive Behavioral Therapy (CBT), Cognitive Remediation (CR)
- Keywords
- Social Isolation, Telepsychiatry, Digital health, Cognitive remediation, CBT, Psychotherapy, Loneliness
- Medical subject headings
- Social Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy (CBT)Behavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Patients with SI treated with CBT+CR Receives: Behavioral: Cognitive Behavioral Therapy (CBT); Behavioral: Cognitive Remediation (CR) |
| Control group | Active comparator | Patients with SI treated with CBT Receives: Behavioral: Cognitive Behavioral Therapy (CBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 4 months
Feasibility and acceptability of the digital interventions
- The completion rate of the baseline and follow-up assessments ii) the completion rate of the entire study (completers vs drop-outs).
Measured: up to 4 months
Usability of the digital interventions
Scores obtained on a 7pt Likert scale created ad hoc
Measured: up to 4 months
Secondary outcomes (4)
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.
Measured: up to 4 months
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.
Measured: up to 4 months
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).
Measured: up to 4 months
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.
Measured: up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Sep 2023
- Primary completionNov 2024 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Social IsolationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata Verona
- Sponsor type
- University, hospital or other
- Collaborators
- IRCCS Eugenio Medea, University of Milan, Istituto di Neuroscienze Consiglio Nazionale delle Ricerche
- Responsible party
- Sponsor
- Investigators
- Prof Mirella Ruggeri, PhD, Principal investigator, Section of Psychiatry, University of Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06138301
- Sponsor's protocol ID
- 4202CESC
- Other IDs
- PNRR-MAD-2022-12376834
- Acronym
- SOLITAIRE
- Status last verified
- Jul 2024
- First submitted
- 4 Sep 2023
- Last updated
- 30 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie behavioural results, after deidentification(text, tables, figures, and appendices)
Publications
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.
PubMed 28382237Biagianti 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.
PubMed 34925187Cacioppo 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.
PubMed 25222636De 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.
PubMed 34110880Domenici 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.
PubMed 20161799Faurholt-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.
PubMed 27434490Garcia-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.
PubMed 32499729Gershkovich 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.
PubMed 28776431Low 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.
PubMed 32128436McEvoy 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.
PubMed 17826734Merikangas 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.
PubMed 21156268Nagata 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.
PubMed 21997765Nordh 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.
PubMed 29247101Kim 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.
PubMed 30337888Ramdhani, 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Interventions for Social isOLation In youThs And theIR familiEs
- ClinicalTrials.gov ID
- NCT06138301
- Acronym / sponsor ID
- SOLITAIRE / 4202CESC
- Conditions
- Social Isolation, Psychosocial Problem
- Keywords
- Social Isolation, Telepsychiatry, Digital health, Cognitive remediation, CBT, Psychotherapy, Loneliness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata VeronaUniversity, hospital or other
- Collaborators
- IRCCS Eugenio Medea, University of Milan, Istituto di Neuroscienze Consiglio Nazionale delle Ricerche
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Cognitive Behavioral Therapy (CBT), Behavioral: Cognitive Remediation (CR)Patients with SI treated with CBT+CR |
| Control group | Active comparator | Behavioral: Cognitive Behavioral Therapy (CBT)Patients with SI treated with CBT |
Who may qualify
- Ages
- 11 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (4 listed)
- primary medical conditions or vision/hearing deficits that interfere with the ability to participate in the project
- suicidal Ideation
- IQ < 70
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Control group, Experimental group |
| 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. | Behavioural | Experimental group |
Primary outcome
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].
Time frame: 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
Time frame: 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
Time frame: up to 4 months
Scores obtained on a 7pt Likert scale created ad hoc
4 secondary outcomes
Change in the clinical and cognitive profile of socially isolated participants.
Time frame: up to 4 months
Change in psychological burden and well-being of family members as assessed by self-report questionnaires.
Time frame: up to 4 months
Change of SI-related depressive symptoms measured via speech analysis
Time frame: up to 4 months
Identification of plasmatic biomarkers related to social isolation pathology and treatment
Time frame: up to 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Background: PubMed 28382237Bhatti 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.
- Background: PubMed 34925187Biagianti 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.
- Background: PubMed 25222636Cacioppo 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.
- Background: PubMed 34110880De 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.
- Background: PubMed 20161799Domenici 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.
- Background: PubMed 27434490Faurholt-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.
- Background: PubMed 32499729Garcia-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.
- Background: PubMed 28776431Gershkovich 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.
- Background: PubMed 32128436Low 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.
- Background: PubMed 17826734McEvoy 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.
- Background: PubMed 21156268Merikangas 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.
- Background: PubMed 21997765Nagata 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.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie behavioural results, after deidentification(text, tables, figures, and appendices)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof Mirella Ruggeri, PhD principal investigator
Section of Psychiatry, University of Verona
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy (CBT) and Cognitive Remediation (CR) in people with Social Isolation and Psychosocial Problem, run by Azienda Ospedaliera Universitaria Integrata Verona at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Prof Marcella Bellani, PhD (+390458126691, marcella.bellani@univr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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]. (time frame: up to 4 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06138301, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024.