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临床试验/NCT05867758
NCT05867758进行中(未招募)不适用

Addressing Social Isolation, Loneliness and Promoting Psychological Wellbeing in International Students

University of Padova2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年11月9日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
40
试验地点
2
主要终点
Baseline before the group intervention (GAD-7)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
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

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Baseline before the group intervention (GAD-7)

时间窗: 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

Follow up intervention effect (from baseline to follow up)

时间窗: 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).

Baseline before the group intervention (PHQ-9)

时间窗: 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 (ULS-6)

时间窗: 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 (MLQ)

时间窗: 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

Baseline before the group intervention (MSPSS)

时间窗: 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

Post intervention effect (from baseline to the last week of intervention)

时间窗: 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 last week of intervention to follow up)

时间窗: 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).

Baseline before the group intervention (SWLS)

时间窗: 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

次要结局

未报告次要终点

研究者

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

研究点 (2)

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