Interventions to Promote Well-being and Social Relationships Among University Students

NCT ID: NCT07147712

Last Updated: 2025-08-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2025-12-31

Brief 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. 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

Conditions

Loneliness; Psychological Well Being; Social Relationship

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental - Psychological Group Intervention

Intervention Group (receives the program immediately)

Group Type: EXPERIMENTAL

Psychological Group Intervention

Intervention Type: BEHAVIORAL

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.

Control group - waitlist

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Psychological Group Intervention

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Padova

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Università degli Studi di Padova

Padua, Padova, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Sabrina Cipolletta, PhD

Role: CONTACT

sabrina.cipolletta@unipd.it

+39 049 827 7423

Facility Contacts

Sabrina Cipolletta, PhD

Role: primary

sabrina.cipolletta@unipd.it

+39 049 827 7423

References

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.

Reference Type: BACKGROUND

PMID: 39664633 (View on PubMed)

Other Identifiers

1232-b

Identifier Type: -

Identifier Source: org_study_id