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临床试验/NCT04978194
NCT04978194Unknown不适用

Effects of an Intervention on University Students' Mental Health and Learning During COVID-19: a Non-randomized Controlled Study

University of Nimes2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年9月25日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
200
试验地点
2
主要终点
Academic burnout

研究概览

简要总结

Since the beginning of the pandemic, several authors (Lee, 2020; Sahu, 2020; Zhai & Du, 2020) have highlighted the various challenges faced by university students, as well as their negative effects on their mental health. A deterioration in their mental health was observed, particularly during lockdown, with very high levels of anxiety and depressive symptoms (Essadek & Rabeyron, 2020; Husky et al., 2020; Le Vigouroux et al., 2021; Odriozola-González et al., 2020). In addition, COVID-19 has brought about a digital revolution in higher education (Strielkowski, 2020). However, distance learning was not without consequences on student stress (IAU, 2020). The detrimental effects of distance education, in terms of stress and anxiety, could also have important consequences for students' learning and academic success.

Our research proposes to evaluate effects of an intervention focused on stress and learning on mental health and learning strategies. This intervention will be proposed to students from University of Nimes. Its primary objective is to prevent psychological health alterations and to improve students' learning strategies.

Three groups will be constituted: a group that will participate in an online program (online group), a group will participate in a hybrid program, i.e. with online content and face-to-face support (hybrid group) and a group that will not be receiving any interventions (control group). The investigators plan to include between 150 and 200 university students, between 40 and 70 in each group.

The levels of mental health and learning strategies of the two experimental group (online and hybrid group) will be compared to a control group with the realization of pre and post intervention measures. Sociodemographic (e.g., level education) and situational variables (e.g., diagnostic of COVID-19) will be considered in the analyses.

详细描述

In March 2020, the World Health Organization declared the coronavirus disease 2019 (COVID-19) as a global pandemic. In France, all universities have been closed on 16th March 2020. In September 2020, face-to-face teaching restarted in French universities, but with new constraints (e.g., reducing number of students in classrooms, wearing masks) and significant changes in teachings (e.g., distance and/or hybrid education). In October 2020, several French universities closed down again due to significant contamination among students. Finally, on 30th October 2020, the French government imposed a second lockdown and all universities have been closed. It is only in February 2021 that face-to-face teaching started again in French universities (within the limit of 50% of the universities' capacity and 20% of the teachings).

Since the beginning of the COVID-19, a deterioration in their mental health was observed, particularly during lockdown, with very high levels of anxiety and depressive symptoms (Essadek & Rabeyron, 2020; Husky et al., 2020; Le Vigouroux et al., 2021; Odriozola-González et al., 2020). This may be explained in part by the fact that people who were experiencing high levels of psychological distress prior to the pandemic are the most vulnerable (Druss, 2020; Yao et al., 2020), and before COVID-19, university students were already identified as a vulnerable population (see literature review: Paula et al., 2020). Before COVID-19, a central element of students' psychological distress was their difficulties coping with an accumulation of hassles, such as university pressure, schedule changes or financial difficulties (Réveillère et al., 2001). The pandemic confronts students with new and unprecedented events (e.g., online learning, online examinations, regular and significant changes to their schedule) that challenge their ability to adapt (Araújo et al., 2020; Zhai & Du, 2020). Recent research has shown that the more university students used avoidance strategies during lockdown, the more they had symptoms of anxiety and depression (Dawson & Golijani-Moghaddam, 2020; Le Vigouroux et al., 2021). In addition, the inability to tolerate uncertainty in the COVID-19 pandemic can trigger fear of virus (Schimmenti et al., 2020) and impact negatively on psychological well-being (Satici et al., 2020).

COVID-19 has brought about a digital revolution in higher education (Strielkowski, 2020). However, distance learning was not without consequences on student stress (IAU, 2020). This confronts students with new obstacles (e.g., technological, personal, family; Baticulon et al., 2020). The detrimental effects of distance education, in terms of stress and anxiety, could also have important consequences for students' learning and academic success. Indeed, the more depressive and anxiety symptoms learners have, the more their academic difficulties are exacerbated (Mills & Blankstein, 2000), and the less successful their learning strategies are (Warr & Downing, 2000). Furthermore, the fear of losing an academic year was the concern that most exacerbated students' lockdown anxiety (Hasan & Bao, 2020).

The deleterious effects of the pandemic on students' health are now evident. However, some areas of research are still under-explored.

  1. Most of the research is largely descriptive and do not identify the factors involved in the deterioration in mental health and learning
  2. To date, no interventional studies have been conducted to prevent these deteriorations during the pandemic.

研究设计

研究类型
Interventional
分配方式
Non 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

  • Students at the University of Nimes (males and females) aged over 18 years old

排除标准

  • not to be a student of the University of Nîmes
  • not signing the consent form to participate in the study
  • Participants must be in only one group. For example, being in the hybrid group is an exclusion criterion for the online and control group.

结局指标

主要结局

Academic burnout

时间窗: between 5 and 10 minutes

Units: "mean score". Academic burnout is measured with the French version of the Maslach Burnout Inventory-General Survey for Students (MBI-GSS; Used with the approval of Mind Garden Inc). This 15-item self-report questionnaire captures 3 dimensions of academic burnout: emotional exhaustion (e.g., "I feel exhausted at the end of a day at the university"), efficacy related to academic work (e.g., "I feel fulfilled when I achieve my academic goals") and cynicism (e.g., "I feel less enthusiastic about my studies"). Each item was assessed using a 7-point Likert-type scale, with responses ranging from 0 (never) to 6 (always). After reverse scoring six items corresponding to the efficacy related to academic work, a high score indicated high academic burnout. Schaufeli et al. (2002) examined the factorial validity and invariance of the MBI-SS with European students and show that the three-factor structure (i.e., exhaustion, cynicism, and efficacy) of the MBI-SS fits to the data.

Anxiety and depressive symptoms

时间窗: between 5 and 10 minutes

Units: "mean score". These symptoms are assessed using a French version of the HADS (Lepine et al., 1985). This 14-item self-report questionnaire assesses anxiety symptoms and depressive symptoms (7 items for each dimension) with labels varying from one item to the next. Scores range from 0 to 21 for each dimension, with higher scores reflecting higher levels of anxiety or depressive symptoms. Although this scale has not been specifically validated with students, it is used in many epidemiological studies in the general population to identify the existence of a symptomatology and to assess its severity. This scale presents satisfactory correlations with other scales of depression and anxiety. Internal consistency of the scale is good for anxiety (α between 0.68 and 0.92) and depression (α between 0.67 and 0.90; see the review of Bjelland et al., 2002).

Cognitive and metacognitive strategies

时间窗: 5 minutes

Units: "mean score" and "reported elements". These strategies are measured with visual analog scales ranging from (never) to 100 (all the time) with items asking for the frequency of use in learning practices (e.g., "How well do you plan your study sessions?"), as well as with an open-ended question to assess the methods used by the participant to study in a more qualitative way

Motivational strategies and beliefs

时间窗: 3 minutes

Units: "mean score". This dimension is assessed through 8 items related to participants' motivation to learn (2 items; e.g. "How much do you want to start working on your classes?"), their beliefs about learning and intelligence (3 items; e.g. "How much do you consider that making mistakes is a good thing when studying?) and their perceived cognitive load (3 items inspired by Leppink et al. 2013; e.g. "How much do you agree with the following sentence: I will have to concentrate a lot to complete my university studies?). Response labels varied by question but were all in the form of visual analog scales from 0 to 100.

次要结局

  • Learned helplessness(between 5 and 10 minutes)
  • Social support(5 minutes)
  • Intolerance of uncertainty(between 5 and 10 minutes)
  • Socio-demographic factors(2 minutes)
  • Situational factors(3 minutes)
  • Coping strategies(10 minutes)
  • Well-being(between 5 and 10 minutes)

研究者

发起方
University of Nimes
申办方类型
Other
责任方
Principal Investigator
主要研究者

elodie charbonnier

Associate Professor

University of Nimes

研究点 (2)

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