Ignite Creation Date:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2025-12-31 @ 11:23 AM
Study NCT ID:
NCT07147712
Status:
RECRUITING
Last Update Posted:
2025-08-29
First Post:
2025-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interventions to Promote Well-being and Social Relationships Among University Students
Sponsor:
University of Padova
Organization:
Study Overview
Official Title:
Interventions to Promote Well-being and Social Relationships Among University Students
Status:
RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: