LonelinessNCT07147712
Interventions to Promote Well-being and Social Relationships Among University Students
A study testing Psychological Group Intervention in people with Loneliness and Psychological Well Being, run by University of Padova at 1 site in Italy.
Trial summary
This study evaluates the impact of a psychological group intervention aimed at promoting well-being and social connectedness among university students. The intervention is part of the UNIST-HEALTH (PRO-BEN) initiative and targets students enrolled at the University of Padua. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Loneliness, Psychological Well Being, Social Relationship
- What is being tested?
- Psychological Group Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- University students regularly enrolled at the University of Padua
- Aged 18 years or older
- Able to understand and complete the questionnaires in Italian or English
- Residing in Padova or its province during the study period
- Providing informed consent for participation
Who cannot join
- Presence of severe psychological conditions requiring immediate or specialized clinical care, as identified during the initial screening interview
- Inability or unavailability to attend group sessions for the full 6-week duration
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Università degli Studi di Padova
Padova, Padova, 35131
Sabrina Cipolletta, PhD, +39 049 827 7423, sabrina.cipolletta@unipd.it
About this study
This study evaluates the impact of a psychological group intervention aimed at promoting well-being and social connectedness among university students. The intervention is part of the UNIST-HEALTH (PRO-BEN) initiative and targets students enrolled at the University of Padua. Participants will be randomly assigned to either an intervention group or a waitlist control group. The intervention consists of six weekly group sessions focused on psychoeducation and experiential activities designed to enhance the quality of social relationships, reduce loneliness, and improve psychological well-being. Assessments will be conducted at baseline, post-intervention, and at a four-week follow-up.
Read the detailed description
University students are a population at heightened risk for psychological distress, with increasing levels of loneliness, anxiety, and depression reported globally. The university period represents a developmental transition characterized by academic, social, and emotional challenges.
Extensive research has shown that strong social relationships are critical to psychological well-being. High levels of social connectedness are associated with lower rates of anxiety and depression, and promote greater life satisfaction, emotional resilience, and academic adjustment. In contrast, loneliness and perceived social isolation are predictors of psychological distress and negative health outcomes.
To address these issues, the aim of this study is to evaluate the impact of a brief psychological group intervention designed to promote well-being and enhance the quality of social relationships among university students. The intervention is developed within the framework of the UNIST-HEALTH (PRO-BEN) project.
Assessment Phase The study begins with an initial screening phase. Participants are invited to attend a brief individual interview with a trained psychologist to assess their psychological health status, motivation to participate, and expectations regarding the intervention.
Following the interview, participants complete a baseline questionnaire collecting demographic information (e.g. age, gender, course of study, country of origin, type of housing - 10 questions) and measures from self-report instruments, including:
- Questions regarding health status and social life (e.g. social and sports activities practiced) - 11 questions.
- UCLA Loneliness Scale - 3-item version: 3 items to measure subjective feelings of loneliness and social isolation.
- Psychological Well-Being Scale: 18 items to measure psychological well-being.
- General Anxiety Disorder-7: 7 questions about the perception of anxious symptoms in the last two weeks.
- Patient Health Questionnaire-9: 9 questions about the frequency with which, in the last two weeks, different problems attributable to depressive symptoms have been faced.
- Work and Social Adjustment Scale: 5 questions about functioning in social and work life.
- Multidimensional Scale of Perceived Social Support: 12 questions to measure perceived support, in particular from friends, family and partners.
- Sense of community: brief scale developed ad hoc to evaluate perception of belongingness to different groups
Participants complete the same set of questionnaires at three time points:
- Baseline (pre-intervention)
- Post-intervention (after 6 weeks)
- Follow-up (4 weeks after the final session) Intervention Phase Eligible participants are randomly assigned to either the intervention group or the control group (waitlist). The intervention group will immediately take part in a 6-session group-based program (one session per week, for six consecutive weeks), while the control group will receive the same intervention only after the follow-up period has been completed. Sessions will include psychoeducational modules, experiential exercises, and guided group discussions.
The study aims:
- to assess the feasibility and acceptability of a 6-weeks intervention to promote psychological and general well-being on university students
- to assess the impact of the intervention compared to a control group who did not receive it
- Conditions
- Loneliness, Psychological Well Being, Social Relationship
- Being tested
- Psychological Group Intervention
- Keywords
- university students, well being, social relationships, socialization
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological Group InterventionBehavioural
6-session psychological group intervention, delivered once per week over six weeks. The intervention is designed to promote well-being and improve the quality of social relationships. It includes psychoeducational content, experiential exercises, and guided group discussions focused on emotional expression, social connection, and mutual support. A follow-up session will be offered after 4 weeks. Sessions will be led by trained psychologists and conducted in a university setting.
| Study group | Role | What they receive |
|---|---|---|
| Experimental - Psychological Group Intervention | Experimental | Intervention Group (receives the program immediately) Receives: Behavioral: Psychological Group Intervention |
| Control group - waitlist | No intervention | Participants in the waitlist control group will not take part in the intervention during the initial phase of the study. They will complete all assessments at the same time points as the experimental group (pre, post, and follow-up) and will be offered the same 6-session intervention after the follow-up data collection is complete. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Between group differences (experimental vs control group) in wellbeing levels
Psychological Well-Being Scale (PWS; min=18, max=108; higher scores indicate greater wellbeing)
Measured: baseline, 6-weeks, 4-weeks follow-up
Between group differences (experimental vs control group) in loneliness levels
UCLA Loneliness Scale - 3-item version (min=3, max=9; higher scores indicate higher levels of loneliness)
Measured: baseline, 6-weeks, 4-weeks follow-up
Adherence to the intervention
Participants' attendance rates to the sessions
Measured: 6-weeks, 4-weeks follow-up
Acceptability of the intervention
Participants' rates to the satisfaction questionnaire, developed ad hoc for the present study (min=8, max= 56; higher scores indicate higher satisfaction)
Measured: 6-weeks
Secondary outcomes (2)
Between group differences (experimental vs control group) in symptoms of anxiety
General Anxiety Disorder-7 (GAD-7). Higher scores indicate greater anxiety severity (min=0, max=21)
Measured: baseline, 6-weeks, 4-weeks follow-up
Between group differences (experimental vs control group) in symptoms of depression
Patient Health Questionnaire-9 (PHQ-9). A higher score means more severe symptoms (min=0, max=27)
Measured: baseline, 6-weeks, 4-weeks follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start1 May 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LonelinessStudies 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
- Model description
- This study will use a randomized controlled design to test the impact of a brief psychological group intervention on university students' psychological well-being and social connectedness. Participants will be randomly assigned to either the intervention group (immediate participation in the 6-session program) or the control group (waitlist, intervention after follow-up).
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07147712
- Sponsor's protocol ID
- 1232-b
- Status last verified
- May 2025
- First submitted
- 18 Jul 2025
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: A plan will be established by the research team for data sharing following publication of the first manuscript
Publications
Cipolletta S, Tedoldi I, Tomaino SCM. A blended group intervention to promote social connectedness and wellbeing among international university students: an exploratory study. Front Psychol. 2024 Nov 27;15:1497544. doi: 10.3389/fpsyg.2024.1497544. eCollection 2024.
PubMed 39664633
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventions to Promote Well-being and Social Relationships Among University Students
- ClinicalTrials.gov ID
- NCT07147712
- Acronym / sponsor ID
- 1232-b
- Conditions
- Loneliness, Psychological Well Being, Social Relationship
- Keywords
- university students, well being, social relationships, socialization
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 29 Aug 2025 (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 study evaluates the impact of a psychological group intervention aimed at promoting well-being and social connectedness among university students. The intervention is part of the UNIST-HEALTH (PRO-BEN) initiative and targets students enrolled at the University of Padua. Participants will be randomly assigned to either an intervention group or a waitlist control group. The intervention consists of six weekly group sessions focused on psychoeducation and experiential activities designed to enhance the quality of social relationships, reduce loneliness, and improve psychological well-being. Assessments will be conducted at baseline, post-intervention, and at a four-week follow-up.
Detailed description
University students are a population at heightened risk for psychological distress, with increasing levels of loneliness, anxiety, and depression reported globally. The university period represents a developmental transition characterized by academic, social, and emotional challenges.
Extensive research has shown that strong social relationships are critical to psychological well-being. High levels of social connectedness are associated with lower rates of anxiety and depression, and promote greater life satisfaction, emotional resilience, and academic adjustment. In contrast, loneliness and perceived social isolation are predictors of psychological distress and negative health outcomes.
To address these issues, the aim of this study is to evaluate the impact of a brief psychological group intervention designed to promote well-being and enhance the quality of social relationships among university students. The intervention is developed within the framework of the UNIST-HEALTH (PRO-BEN) project.
Assessment Phase The study begins with an initial screening phase. Participants are invited to attend a brief individual interview with a trained psychologist to assess their psychological health status, motivation to participate, and expectations regarding the intervention.
Following the interview, participants complete a baseline questionnaire collecting demographic information (e.g. age, gender, course of study, country of origin, type of housing - 10 questions) and measures from self-report instruments, including:
- Questions regarding health status and social life (e.g. social and sports activities practiced) - 11 questions.
- UCLA Loneliness Scale - 3-item version: 3 items to measure subjective feelings of loneliness and social isolation.
- Psychological Well-Being Scale: 18 items to measure psychological well-being.
- General Anxiety Disorder-7: 7 questions about the perception of anxious symptoms in the last two weeks.
- Patient Health Questionnaire-9: 9 questions about the frequency with which, in the last two weeks, different problems attributable to depressive symptoms have been faced.
- Work and Social Adjustment Scale: 5 questions about functioning in social and work life.
- Multidimensional Scale of Perceived Social Support: 12 questions to measure perceived support, in particular from friends, family and partners.
- Sense of community: brief scale developed ad hoc to evaluate perception of belongingness to different groups
Participants complete the same set of questionnaires at three time points:
- Baseline (pre-intervention)
- Post-intervention (after 6 weeks)
- Follow-up (4 weeks after the final session) Intervention Phase Eligible participants are randomly assigned to either the intervention group or the control group (waitlist). The intervention group will immediately take part in a 6-session group-based program (one session per week, for six consecutive weeks), while the control group will receive the same intervention only after the follow-up period has been completed. Sessions will include psychoeducational modules, experiential exercises, and guided group discussions.
The study aims:
- to assess the feasibility and acceptability of a 6-weeks intervention to promote psychological and general well-being on university students
- to assess the impact of the intervention compared to a control group who did not receive it
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study will use a randomized controlled design to test the impact of a brief psychological group intervention on university students' psychological well-being and social connectedness. Participants will be randomly assigned to either the intervention group (immediate participation in the 6-session program) or the control group (waitlist, intervention after follow-up).
| Arm | Type | Receives |
|---|---|---|
| Experimental - Psychological Group Intervention | Experimental | Behavioral: Psychological Group InterventionIntervention Group (receives the program immediately) |
| Control group - waitlist | No intervention | –Participants in the waitlist control group will not take part in the intervention during the initial phase of the study. They will complete all assessments at the same time points as the experimental group (pre, post, and follow-up) and will be offered the same 6-session intervention after the follow-up data collection is complete. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- University students regularly enrolled at the University of Padua
- Aged 18 years or older
- Able to understand and complete the questionnaires in Italian or English
- Residing in Padova or its province during the study period
- Providing informed consent for participation
Key exclusion criteria (2 listed)
- Presence of severe psychological conditions requiring immediate or specialized clinical care, as identified during the initial screening interview
- Inability or unavailability to attend group sessions for the full 6-week duration
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 |
|---|---|---|
| Psychological Group Intervention6-session psychological group intervention, delivered once per week over six weeks. The intervention is designed to promote well-being and improve the quality of social relationships. It includes psychoeducational content, experiential exercises, and guided group discussions focused on emotional expression, social connection, and mutual support. A follow-up session will be offered after 4 weeks. Sessions will be led by trained psychologists and conducted in a university setting. | Behavioural | Experimental - Psychological Group Intervention |
Primary outcome
Between group differences (experimental vs control group) in wellbeing levels
Time frame: baseline, 6-weeks, 4-weeks follow-up
Psychological Well-Being Scale (PWS; min=18, max=108; higher scores indicate greater wellbeing)
Between group differences (experimental vs control group) in loneliness levels
Time frame: baseline, 6-weeks, 4-weeks follow-up
UCLA Loneliness Scale - 3-item version (min=3, max=9; higher scores indicate higher levels of loneliness)
Adherence to the intervention
Time frame: 6-weeks, 4-weeks follow-up
Participants' attendance rates to the sessions
Acceptability of the intervention
Time frame: 6-weeks
Participants' rates to the satisfaction questionnaire, developed ad hoc for the present study (min=8, max= 56; higher scores indicate higher satisfaction)
2 secondary outcomes
Between group differences (experimental vs control group) in symptoms of anxiety
Time frame: baseline, 6-weeks, 4-weeks follow-up
Between group differences (experimental vs control group) in symptoms of depression
Time frame: baseline, 6-weeks, 4-weeks follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Background: PubMed 39664633Cipolletta S, Tedoldi I, Tomaino SCM. A blended group intervention to promote social connectedness and wellbeing among international university students: an exploratory study. Front Psychol. 2024 Nov 27;15:1497544. doi: 10.3389/fpsyg.2024.1497544. eCollection 2024.
- Individual participant dataSharing planned: No. A plan will be established by the research team for data sharing following publication of the first manuscript
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychological Group Intervention in people with Loneliness and Psychological Well Being, 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 5 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 29 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sabrina Cipolletta, PhD (+39 049 827 7423, sabrina.cipolletta@unipd.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Between group differences (experimental vs control group) in wellbeing levels (time frame: baseline, 6-weeks, 4-weeks follow-up). The study lists 4 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 NCT07147712, which also lists 1 linked publication.
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 29 Aug 2025.