Social IsolationNCT05867758
Psychosocial Blended Group Intervention RCT
A study testing Psychosocial group intervention in people with Social Isolation, run by University of Padova at 1 site in Italy.
Trial summary
Extensive literature on social isolation and loneliness in young people points out that those conditions can negatively influence physical and psychological health, increasing the risks of loneliness-related health problems later in life. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Social Isolation
- What is being tested?
- Psychosocial group intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 9 Nov 2022to 31 Jul 2023
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age ≥18 years,
- being an international student enrolled to a full university course at the University of Padua
- living in Padua
- Being able to communicate in English
Who cannot join
- Participants were excluded if they were Erasmus students
- not resident in Padua at the time of the intervention
- not responding to the invitation to participate in the group activities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Addressing Social Isolation, Loneliness and Promoting Psychological Wellbeing in International Students
Extensive literature on social isolation and loneliness in young people points out that those conditions can negatively influence physical and psychological health, increasing the risks of loneliness-related health problems later in life. To date, especially after two years of the COVID-19 pandemic, the situation regarding loneliness and psychological frailties in young people has become even more urgent to address especially in populations at higher risks as for international students. This population in fact report to face greater social exclusion, discrimination, stigma, difficulties in cultural adaptation and more, compared to their peers, that can exacerbate loneliness and negatively impact on their psychological and physical health.
The pandemic delineated future directions for the development and implementation of digital interventions in the everyday clinical practice, many studies are starting to evaluate the efficacy and usability of blended (digital and in presence) psychological interventions within different populations. Thus, this study aims to assess the usability and efficacy of a blended psychosocial group intervention to tackle social isolation, loneliness and promoting well-being in this population.
Read the detailed description
Rationale \& background information:
Many studies have been conducted over the past two years regarding risks and challenges posed by the current situation towards youth frailties, psychological suffering, and social withdrawal derived from the pandemic. Some population are facing higher risks such as international college students that face difficulties such social isolation, loneliness and problems in getting in relationship with peers, with negative consequences on their wellbeing and mental health, as pointed out by different studies. Those difficulties have been enhanced by the pandemic as the social distancing, online classes and difficulties in adapting to a different context exacerbated many situations of vulnerability and resulted in severe clinical outcomes (anxiety, depression, mood disorders, loneliness health related outcomes, others).
Those scientific evidences underlined the importance of designing strategies of intervention to tackle those challenges fostering social inclusion, well-being empowerment and cultural adaptation in international students to prevent worse outcomes (such as immediate and long-term poor health outcomes, mental illnesses, increased suicidal risks) and to foster wellbeing and social connections.
Study goals:
The aim of this study is to investigate the impact and efficacy of a blended (in presence and online) psychosocial group intervention with peers in tackling social isolation, loneliness and empowering well-being in international college students.
Study design:
This study is a pilot randomized controlled trial of a blended (in presence and online) psychosocial group intervention.
Investigators anticipate recruiting a total of 30 participants that participated in the cross-sectional online survey and voluntarily left their email address to be recontacted to take part in the group activities. The participants will be randomly assigned into 2 groups with https://www.randomizer.org: experimental group (EG) composed of around 15 people and waiting list group (WG) composed of around 15 people. The participants of EG will take part in 8 psychosocial group sessions of 90 minutes each that will be held weekly between November 2022 and January 2023. The participants of WG will receive online self-help material regarding the same theme of the experimental group each week in the same period and will take part in the psychosocial group activities once the data collection will be over, approximately starting in March 2023. To evaluate the effects of the blended intervention and of the two conditions we will ask participants to fulfil clinical questionnaires (ULS-6, MSPSS, GAD-7, PHQ-9, SWLS, MLQ), before starting the intervention in presence and online (T0), at the end of that period (T1) and 2 months after (T2). The completion will take participants around 10 minutes.
Participants in the experimental group will fulfil the questionnaires pen-and-paper before the start of the group session, while participants in the control group will fulfil the questionnaires and the informed consent online through the use of qualtrics.com.
The psychosocial group intervention will consist of 8 sessions (one per week, duration estimated 90 minutes) that will be held in presence at the university clinical services. The themes that will be discussed during the sessions are related to social isolation, loneliness, well-being, mental health, tools to support connection with other peers and more.
Safety considerations:
The intervention will be conducted ensuring participants' physical and psychological safety, and no risks are identified during the intervention. To furtherly limit those risks, no potentially dangerous tools will be taken and used in the group activities (e.g. scissors, other dangerous objects).
Follow-up:
This study will include a follow-up with participants that will consist in the filling out of the clinical measures previously presented 2 months after the end of the intervention (experimental in presence intervention and online waiting list for the control group) to evaluate the long term effects of the intervention on well-being, loneliness and social support.
Data management:
All outcome measures of the experimental group will be recorded with pen-and-paper during the group session; on the contrary all outcome measures of the control group will be collected online through the use of qualtrics.com that will record their answers digitally. A research assistant will enter the data into an electronic database. A second research assistant independent from this study will check the quality and accuracy. The paper data collection sheets and signed informed consents will be stored in a locked cabinet, and the electronic database will be password-protected. The data will be kept confidential with only limited access to research investigators and related research assistants and graduate students.
Statistical analysis:
Investigators expect to use the paired-t test and analysis of covariance (ANCOVA) to analyze differences in baseline characteristics, baseline outcome measures and follow-up between the groups and determine the intervention effect for the 2 groups.
Qualitative analysis:
The study includes a qualitative evaluation of the personal experience and contents of the group activities proposed that will be collected through semi-structured interviews with participants at the end of the group intervention. A qualitative evaluation of the digital self-help materials provided online to both groups will be carried out with an online survey with close and open-ended questions to assess usability, accessibility and personal experience with the provided self-help materials and exercises.
Quality assurance:
The study was approved by the Ethics Committee of the School of Psychology at the University of Padua, protocol number 4800 (unique number: 06592A5FCBBFA818A5676B611295D2FC). The Committee will ensure that research is conducted according to the Declaration of Helsinki.
Problems anticipated:
The challenge for the study is the difficulty in recruiting participants. Recruiting international students facing social isolation and/or loneliness could be challenging. To address this problem, we will try to collaborate with other university services such as tutoring and mentoring services to inform their international student mentees about this study, as well as we will try to target international students who have enrolled to the university during the pandemic period and ask them to invite other international students they know via direct contact. This could lead to the inclusion (even if we will randomize participants) of some people that already know each other and or that already receive a form of support (social, practical etc.) that could empower and foster their well-being and socialization.
Project management:
The first and corresponding authors contribute to the study design, coordination, and project management. The first and second authors participate in the recruitment of participants, in the creation and delivery of the psychosocial intervention in presence and online. The first, second, and corresponding authors perform the data analyses, interpret them, draft and revise the manuscript. The corresponding author provided consultation throughout the entire process.
Ethics:
The study has approvals to send email invitations to participants based on data provided by students responding to a cross-sectional online survey and from other university services (e.g. tutoring and mentoring services).
- Conditions
- Social Isolation
- Being tested
- Psychosocial group intervention
- Keywords
- social isolation, international college students, loneliness, psychosocial group intervention, blended intervention
- Medical subject headings
- Social Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychosocial group interventionOther
The psychosocial group intervention is composed of 8 weekly sessions of 90 minutes each and the receiving of self-help digital materials. Both organized as following: 2 on isolation, loneliness and social connection, 2 on well-being, 2 on the use of digital tools, 2 on the fostering of socialization with peers.
To evaluate the effects of the blended intervention and of the two conditions we will ask participants to fulfill the following clinical questionnaires: ULS-6 (Russell et al. 1980), MSPSS (Zimet et al., 1988), GAD-7 (Spitzer et al., 2006), PHQ-9 (Kroenke, Spitzer \& Williams, 2001), SWLS (Diener et al., 1985), MLQ (Steger et al., 2006) before starting the intervention in presence and online (T0), at the end of that period (T1) and 2 months after (T2).
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Group of participants (9 to 12) participating in the psychosocial group intervention (8 sessions, one per week) and receiving the self-help digital materials each week. Receives: Other: Psychosocial group intervention |
| Control group - waiting list | No intervention | Group of participants (9 to 12) receiving the self-help digital materials each week, who will take part in the psychosocial group intervention once the data collection will be over |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline before the group intervention (ULS-6)
Participants of both groups (EG and CG) will fulfill the following measures to assess their baselines before the starting of the group intervention, objectives and clinical tools are the following:
Loneliness will be assessed with ULS-6, short-form UCLA Loneliness Scale
Measured: the first week of intervention (T0)
Baseline before the group intervention (MSPSS)
Participants of both groups (EG and CG) will fulfill the following measures to assess their baselines before the starting of the group intervention, objectives and clinical tools are the following:
Perceived social support will be assessed with MSPSS, Multidimensional Scale of Perceived Social Support
Measured: the first week of intervention (T0)
Baseline before the group intervention (GAD-7)
Participants of both groups (EG and CG) will fulfill the following measures to assess their baselines before the starting of the group intervention, objectives and clinical tools are the following:
General Anxiety will be assessed with GAD-7, General Anxiety Disorder-7
Measured: the first week of intervention (T0)
Baseline before the group intervention (PHQ-9)
Participants of both groups (EG and CG) will fulfill the following measures to assess their baselines before the starting of the group intervention, objectives and clinical tools are the following:
General well-being will be assessed with PHQ-9, Patient Health Questionnaire-9
Measured: the first week of intervention (T0)
Baseline before the group intervention (SWLS)
Participants of both groups (EG and CG) will fulfill the following measures to assess their baselines before the starting of the group intervention, objectives and clinical tools are the following:
Psychological well-being will be assessed with SWLS, Satisfaction With Life Scale
Measured: the first week of intervention (T0)
Baseline before the group intervention (MLQ)
Participants of both groups (EG and CG) will fulfill the following measures to assess their baselines before the starting of the group intervention, objectives and clinical tools are the following:
Perception of personal well-being will be assessed with MLQ, Meaning in Life Questionnaire
Measured: the first week of intervention (T0)
Post intervention effect (from baseline to the last week of intervention)
Evaluation of change from the baseline (T0) to the last week of intervention (T1) in all the measures presented for (T0) baseline evaluation.
Participants of both groups (EG and CG), at the end of the intervention (T1), will fulfill previously presented measures to assess changes from baseline (T0).
Measured: the last week of the intervention (T1)
Follow up intervention effect (from baseline to follow up)
Evaluation of change from the baseline (T0) to the follow up measurement 2 months after the end of the intervention (T2) in all the measures presented for (T0) baseline evaluation.
Participants of both groups (EG and CG), at the follow up measurement 2 months after the end of the intervention (T2), will fulfill previously presented measures to assess changes from baseline (T0).
Measured: two months after the last week of the intervention (T2)
Follow up intervention effect (from last week of intervention to follow up)
Evaluation of change from the post intervention (T1) to the follow up measurement 2 months after the end of the intervention (T2) in all the measures presented for (T0) baseline evaluation.
Participants of both groups (EG and CG), at the follow up measurement 2 months after the end of the intervention (T2), will fulfill previously presented measures to assess changes from post intervention (T1).
Measured: two months after the last week of the intervention (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start9 Nov 2022
- Primary completion31 Jul 2023 (estimated)
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial of a Group intervention with international college students
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sabrina Cipolletta, PhD, Principal investigator, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05867758
- Sponsor's protocol ID
- 18-11-22
- Status last verified
- Nov 2022
- First submitted
- 21 Nov 2022
- Last updated
- 22 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bu F, Steptoe A, Fancourt D. Who is lonely in lockdown? Cross-cohort analyses of predictors of loneliness before and during the COVID-19 pandemic. Public Health. 2020 Sep;186:31-34. doi: 10.1016/j.puhe.2020.06.036. Epub 2020 Aug 5.
PubMed 32768621Cipolletta S, Gris F. Older People's Lived Perspectives of Social Isolation during the First Wave of the COVID-19 Pandemic in Italy. Int J Environ Res Public Health. 2021 Nov 11;18(22):11832. doi: 10.3390/ijerph182211832.
PubMed 34831586Cipolletta, S., Mercurio, A., & Pezzetta, R. (2022). Perceived Social Support and Well-Being of International Students at an Italian University, Journal of International Students, 12(3). https://doi.org/10.32674/jis.v12i3.3954
Cuijpers P, Auerbach RP, Benjet C, Bruffaerts R, Ebert D, Karyotaki E, Kessler RC. The World Health Organization World Mental Health International College Student initiative: An overview. Int J Methods Psychiatr Res. 2019 Jun;28(2):e1761. doi: 10.1002/mpr.1761. Epub 2019 Jan 6.
PubMed 30614123Haikalis M, Doucette H, Meisel MK, Birch K, Barnett NP. Changes in College Student Anxiety and Depression From Pre- to During-COVID-19: Perceived Stress, Academic Challenges, Loneliness, and Positive Perceptions. Emerg Adulthood. 2022 Apr;10(2):534-545. doi: 10.1177/21676968211058516.
PubMed 35382515Karyotaki E, Cuijpers P, Albor Y, Alonso J, Auerbach RP, Bantjes J, Bruffaerts R, Ebert DD, Hasking P, Kiekens G, Lee S, McLafferty M, Mak A, Mortier P, Sampson NA, Stein DJ, Vilagut G, Kessler RC. Sources of Stress and Their Associations With Mental Disorders Among College Students: Results of the World Health Organization World Mental Health Surveys International College Student Initiative. Front Psychol. 2020 Jul 30;11:1759. doi: 10.3389/fpsyg.2020.01759. eCollection 2020.
PubMed 32849042Song B, Zhao Y, Zhu J. COVID-19-related Traumatic Effects and Psychological Reactions among International Students. J Epidemiol Glob Health. 2021 Mar;11(1):117-123. doi: 10.2991/jegh.k.201016.001. Epub 2020 Oct 24.
PubMed 33605116
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Social Isolation, Loneliness and Promoting Psychological Wellbeing in International Students
- ClinicalTrials.gov ID
- NCT05867758
- Acronym / sponsor ID
- 18-11-22
- Conditions
- Social Isolation
- Keywords
- social isolation, international college students, loneliness, psychosocial group intervention, blended intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- 9 Nov 2022 (actual)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 22 May 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.
Extensive literature on social isolation and loneliness in young people points out that those conditions can negatively influence physical and psychological health, increasing the risks of loneliness-related health problems later in life. To date, especially after two years of the COVID-19 pandemic, the situation regarding loneliness and psychological frailties in young people has become even more urgent to address especially in populations at higher risks as for international students. This population in fact report to face greater social exclusion, discrimination, stigma, difficulties in cultural adaptation and more, compared to their peers, that can exacerbate loneliness and negatively impact on their psychological and physical health.
The pandemic delineated future directions for the development and implementation of digital interventions in the everyday clinical practice, many studies are starting to evaluate the efficacy and usability of blended (digital and in presence) psychological interventions within different populations. Thus, this study aims to assess the usability and efficacy of a blended psychosocial group intervention to tackle social isolation, loneliness and promoting well-being in this population.
Detailed description
Rationale \& background information:
Many studies have been conducted over the past two years regarding risks and challenges posed by the current situation towards youth frailties, psychological suffering, and social withdrawal derived from the pandemic. Some population are facing higher risks such as international college students that face difficulties such social isolation, loneliness and problems in getting in relationship with peers, with negative consequences on their wellbeing and mental health, as pointed out by different studies. Those difficulties have been enhanced by the pandemic as the social distancing, online classes and difficulties in adapting to a different context exacerbated many situations of vulnerability and resulted in severe clinical outcomes (anxiety, depression, mood disorders, loneliness health related outcomes, others).
Those scientific evidences underlined the importance of designing strategies of intervention to tackle those challenges fostering social inclusion, well-being empowerment and cultural adaptation in international students to prevent worse outcomes (such as immediate and long-term poor health outcomes, mental illnesses, increased suicidal risks) and to foster wellbeing and social connections.
Study goals:
The aim of this study is to investigate the impact and efficacy of a blended (in presence and online) psychosocial group intervention with peers in tackling social isolation, loneliness and empowering well-being in international college students.
Study design:
This study is a pilot randomized controlled trial of a blended (in presence and online) psychosocial group intervention.
Investigators anticipate recruiting a total of 30 participants that participated in the cross-sectional online survey and voluntarily left their email address to be recontacted to take part in the group activities. The participants will be randomly assigned into 2 groups with https://www.randomizer.org: experimental group (EG) composed of around 15 people and waiting list group (WG) composed of around 15 people. The participants of EG will take part in 8 psychosocial group sessions of 90 minutes each that will be held weekly between November 2022 and January 2023. The participants of WG will receive online self-help material regarding the same theme of the experimental group each week in the same period and will take part in the psychosocial group activities once the data collection will be over, approximately starting in March 2023. To evaluate the effects of the blended intervention and of the two conditions we will ask participants to fulfil clinical questionnaires (ULS-6, MSPSS, GAD-7, PHQ-9, SWLS, MLQ), before starting the intervention in presence and online (T0), at the end of that period (T1) and 2 months after (T2). The completion will take participants around 10 minutes.
Participants in the experimental group will fulfil the questionnaires pen-and-paper before the start of the group session, while participants in the control group will fulfil the questionnaires and the informed consent online through the use of qualtrics.com.
The psychosocial group intervention will consist of 8 sessions (one per week, duration estimated 90 minutes) that will be held in presence at the university clinical services. The themes that will be discussed during the sessions are related to social isolation, loneliness, well-being, mental health, tools to support connection with other peers and more.
Safety considerations:
The intervention will be conducted ensuring participants' physical and psychological safety, and no risks are identified during the intervention. To furtherly limit those risks, no potentially dangerous tools will be taken and used in the group activities (e.g. scissors, other dangerous objects).
Follow-up:
This study will include a follow-up with participants that will consist in the filling out of the clinical measures previously presented 2 months after the end of the intervention (experimental in presence intervention and online waiting list for the control group) to evaluate the long term effects of the intervention on well-being, loneliness and social support.
Data management:
All outcome measures of the experimental group will be recorded with pen-and-paper during the group session; on the contrary all outcome measures of the control group will be collected online through the use of qualtrics.com that will record their answers digitally. A research assistant will enter the data into an electronic database. A second research assistant independent from this study will check the quality and accuracy. The paper data collection sheets and signed informed consents will be stored in a locked cabinet, and the electronic database will be password-protected. The data will be kept confidential with only limited access to research investigators and related research assistants and graduate students.
Statistical analysis:
Investigators expect to use the paired-t test and analysis of covariance (ANCOVA) to analyze differences in baseline characteristics, baseline outcome measures and follow-up between the groups and determine the intervention effect for the 2 groups.
Qualitative analysis:
The study includes a qualitative evaluation of the personal experience and contents of the group activities proposed that will be collected through semi-structured interviews with participants at the end of the group intervention. A qualitative evaluation of the digital self-help materials provided online to both groups will be carried out with an online survey with close and open-ended questions to assess usability, accessibility and personal experience with the provided self-help materials and exercises.
Quality assurance:
The study was approved by the Ethics Committee of the School of Psychology at the University of Padua, protocol number 4800 (unique number: 06592A5FCBBFA818A5676B611295D2FC). The Committee will ensure that research is conducted according to the Declaration of Helsinki.
Problems anticipated:
The challenge for the study is the difficulty in recruiting participants. Recruiting international students facing social isolation and/or loneliness could be challenging. To address this problem, we will try to collaborate with other university services such as tutoring and mentoring services to inform their international student mentees about this study, as well as we will try to target international students who have enrolled to the university during the pandemic period and ask them to invite other international students they know via direct contact. This could lead to the inclusion (even if we will randomize participants) of some people that already know each other and or that already receive a form of support (social, practical etc.) that could empower and foster their well-being and socialization.
Project management:
The first and corresponding authors contribute to the study design, coordination, and project management. The first and second authors participate in the recruitment of participants, in the creation and delivery of the psychosocial intervention in presence and online. The first, second, and corresponding authors perform the data analyses, interpret them, draft and revise the manuscript. The corresponding author provided consultation throughout the entire process.
Ethics:
The study has approvals to send email invitations to participants based on data provided by students responding to a cross-sectional online survey and from other university services (e.g. tutoring and mentoring services).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial of a Group intervention with international college students
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: Psychosocial group interventionGroup of participants (9 to 12) participating in the psychosocial group intervention (8 sessions, one per week) and receiving the self-help digital materials each week. |
| Control group - waiting list | No intervention | –Group of participants (9 to 12) receiving the self-help digital materials each week, who will take part in the psychosocial group intervention once the data collection will be over |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age ≥18 years,
- being an international student enrolled to a full university course at the University of Padua
- living in Padua
- Being able to communicate in English
Key exclusion criteria (3 listed)
- Participants were excluded if they were Erasmus students
- not resident in Padua at the time of the intervention
- not responding to the invitation to participate in the group activities
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 |
|---|---|---|
| Psychosocial group interventionThe psychosocial group intervention is composed of 8 weekly sessions of 90 minutes each and the receiving of self-help digital materials. Both organized as following: 2 on isolation, loneliness and social connection, 2 on well-being, 2 on the use of digital tools, 2 on the fostering of socialization with peers. To evaluate the effects of the blended intervention and of the two conditions we will ask participants to fulfill the following clinical questionnaires: ULS-6 (Russell et al. 1980), MSPSS (Zimet et al., 1988), GAD-7 (Spitzer et al., 2006), PHQ-9 (Kroenke, Spitzer \& Williams, 2001), SWLS (Diener et al., 1985), MLQ (Steger et al., 2006) before starting the intervention in presence and online (T0), at the end of that period (T1) and 2 months after (T2). | Other | intervention group |
Primary outcome
Baseline before the group intervention (ULS-6)
Time frame: the first week of intervention (T0)
Participants of both groups (EG and CG) will fulfill the following measures to assess their baselines before the starting of the group intervention, objectives and clinical tools are the following: Loneliness will be assessed with ULS-6, short-form UCLA Loneliness Scale
Baseline before the group intervention (MSPSS)
Time frame: the first week of intervention (T0)
Participants of both groups (EG and CG) will fulfill the following measures to assess their baselines before the starting of the group intervention, objectives and clinical tools are the following: Perceived social support will be assessed with MSPSS, Multidimensional Scale of Perceived Social Support
Baseline before the group intervention (GAD-7)
Time frame: the first week of intervention (T0)
Participants of both groups (EG and CG) will fulfill the following measures to assess their baselines before the starting of the group intervention, objectives and clinical tools are the following: General Anxiety will be assessed with GAD-7, General Anxiety Disorder-7
Baseline before the group intervention (PHQ-9)
Time frame: the first week of intervention (T0)
Participants of both groups (EG and CG) will fulfill the following measures to assess their baselines before the starting of the group intervention, objectives and clinical tools are the following: General well-being will be assessed with PHQ-9, Patient Health Questionnaire-9
Baseline before the group intervention (SWLS)
Time frame: the first week of intervention (T0)
Participants of both groups (EG and CG) will fulfill the following measures to assess their baselines before the starting of the group intervention, objectives and clinical tools are the following: Psychological well-being will be assessed with SWLS, Satisfaction With Life Scale
Baseline before the group intervention (MLQ)
Time frame: the first week of intervention (T0)
Participants of both groups (EG and CG) will fulfill the following measures to assess their baselines before the starting of the group intervention, objectives and clinical tools are the following: Perception of personal well-being will be assessed with MLQ, Meaning in Life Questionnaire
Post intervention effect (from baseline to the last week of intervention)
Time frame: the last week of the intervention (T1)
Evaluation of change from the baseline (T0) to the last week of intervention (T1) in all the measures presented for (T0) baseline evaluation. Participants of both groups (EG and CG), at the end of the intervention (T1), will fulfill previously presented measures to assess changes from baseline (T0).
Follow up intervention effect (from baseline to follow up)
Time frame: two months after the last week of the intervention (T2)
Evaluation of change from the baseline (T0) to the follow up measurement 2 months after the end of the intervention (T2) in all the measures presented for (T0) baseline evaluation. Participants of both groups (EG and CG), at the follow up measurement 2 months after the end of the intervention (T2), will fulfill previously presented measures to assess changes from baseline (T0).
Follow up intervention effect (from last week of intervention to follow up)
Time frame: two months after the last week of the intervention (T2)
Evaluation of change from the post intervention (T1) to the follow up measurement 2 months after the end of the intervention (T2) in all the measures presented for (T0) baseline evaluation. Participants of both groups (EG and CG), at the follow up measurement 2 months after the end of the intervention (T2), will fulfill previously presented measures to assess changes from post intervention (T1).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2023.
- Background: PubMed 32768621Bu F, Steptoe A, Fancourt D. Who is lonely in lockdown? Cross-cohort analyses of predictors of loneliness before and during the COVID-19 pandemic. Public Health. 2020 Sep;186:31-34. doi: 10.1016/j.puhe.2020.06.036. Epub 2020 Aug 5.
- Background: PubMed 34831586Cipolletta S, Gris F. Older People's Lived Perspectives of Social Isolation during the First Wave of the COVID-19 Pandemic in Italy. Int J Environ Res Public Health. 2021 Nov 11;18(22):11832. doi: 10.3390/ijerph182211832.
- BackgroundCipolletta, S., Mercurio, A., & Pezzetta, R. (2022). Perceived Social Support and Well-Being of International Students at an Italian University, Journal of International Students, 12(3). https://doi.org/10.32674/jis.v12i3.3954
- Background: PubMed 30614123Cuijpers P, Auerbach RP, Benjet C, Bruffaerts R, Ebert D, Karyotaki E, Kessler RC. The World Health Organization World Mental Health International College Student initiative: An overview. Int J Methods Psychiatr Res. 2019 Jun;28(2):e1761. doi: 10.1002/mpr.1761. Epub 2019 Jan 6.
- Background: PubMed 35382515Haikalis M, Doucette H, Meisel MK, Birch K, Barnett NP. Changes in College Student Anxiety and Depression From Pre- to During-COVID-19: Perceived Stress, Academic Challenges, Loneliness, and Positive Perceptions. Emerg Adulthood. 2022 Apr;10(2):534-545. doi: 10.1177/21676968211058516.
- Background: PubMed 32849042Karyotaki E, Cuijpers P, Albor Y, Alonso J, Auerbach RP, Bantjes J, Bruffaerts R, Ebert DD, Hasking P, Kiekens G, Lee S, McLafferty M, Mak A, Mortier P, Sampson NA, Stein DJ, Vilagut G, Kessler RC. Sources of Stress and Their Associations With Mental Disorders Among College Students: Results of the World Health Organization World Mental Health Surveys International College Student Initiative. Front Psychol. 2020 Jul 30;11:1759. doi: 10.3389/fpsyg.2020.01759. eCollection 2020.
- Background: PubMed 33605116Song B, Zhao Y, Zhu J. COVID-19-related Traumatic Effects and Psychological Reactions among International Students. J Epidemiol Glob Health. 2021 Mar;11(1):117-123. doi: 10.2991/jegh.k.201016.001. Epub 2020 Oct 24.
- Individual participant dataSharing planned: No
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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.
Sabrina Cipolletta, PhD principal investigator
University of Padova
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychosocial group intervention in people with Social Isolation, run by University of Padova at 1 site 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 4 inclusion and 3 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 22 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline before the group intervention (ULS-6) (time frame: the first week of intervention (T0)). The study lists 9 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 NCT05867758, which also lists 7 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 22 May 2023.