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临床试验/NCT07147712
NCT07147712招募中不适用

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

University of Padova1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
1
主要终点
Between group differences (experimental vs control group) in wellbeing levels

研究概览

简要总结

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.

详细描述

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:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

Experimental - Psychological Group Intervention

Experimental

Intervention Group (receives the program immediately)

干预措施: Psychological Group Intervention (Behavioral)

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.

结局指标

主要结局

Between group differences (experimental vs control group) in wellbeing levels

时间窗: 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

时间窗: 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

时间窗: 6-weeks, 4-weeks follow-up

Participants' attendance rates to the sessions

Acceptability of the intervention

时间窗: 6-weeks

Participants' rates to the satisfaction questionnaire, developed ad hoc for the present study (min=8, max= 56; higher scores indicate higher satisfaction)

次要结局

  • Between group differences (experimental vs control group) in symptoms of depression(baseline, 6-weeks, 4-weeks follow-up)
  • Between group differences (experimental vs control group) in symptoms of anxiety(baseline, 6-weeks, 4-weeks follow-up)

研究者

发起方
University of Padova
申办方类型
Other
责任方
Sponsor

研究点 (1)

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