Clinical trial NCT04978194: Effects of an Intervention on University Students' Mental Health and Learning During COVID-19
Official title: Effects of an Intervention on University Students' Mental Health and Learning During COVID-19: a Non-randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mental Health Issue
Learning Problem
Student Burnout
Motivation
Young Adults/ Students
University-based Intervention
Keywords: Learning
Mental health
Young adults/ Student
University-based Intervention
Lead sponsor: University of Nimes
Sponsor class: OTHER
First posted: 2021-07-27
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: During the first academic semester of the academic year 2021/2022, baseline assessments were carried out using an online questionnaire (made on qualtrics secure software) in three groups (online group, hybrid group, control group): measures of mental health (e.g., academic burnout, anxiety and depression), psychological processes (e.g., intolerance of uncertainty, coping, learned helplessness), learning (e.g., cognitive and metacognitive strategies, motivational strategies and beliefs about learning), situational factors (e.g., levels of concern about their health, the health of their loved ones) and socio-demographic factors (e.g., age, level of education, gender, field of study) These assessments were performed in October 2021 (First Time - T1) and December 2021 (Second time - T2).

During the first academic semester, a university-based intervention to promote better management of emotions and learning was realised in two Experimental group (online group and hybrid group).
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

To fill these gaps, our research proposes to evaluate the effects on mental health and learning of a program focused on stress and learning. Our program has been pre-tested during the 2019-2020 academic year. It included nine modules (that take place over 9 weeks) composed of video capsules, with the following themes: stress information, learning information, emotion and stress regulation strategies, cognitive and metacognitive learning strategies, motivation for learning, physical activity, diet, sleep, and managing worry and uncertainty. Particular attention will be paid to the communication tools in order to provide graphic coherence, facilitating the understanding and appropriation of the different media. Our program is based on modules from previous online student mental health intervention studies. It presents, however, two innovative aspects: 1) elements and examples specific to the COVID-19 pandemic and 2) the addition of modules focused on learning strategies. It is therefore an original program, designed within the framework of this research, and adapted to the context of the COVID-19 pandemic (notably concerning the themes of concern, the stressors, or the distance learning courses). The different modules were designed by five associate professors: two specialized in cognitive psychology, experts in learning, two specialized in clinical psychology and cognitive and behavioral therapy, experts in stress and emotion regulation, and one specialized in health psychology, expert in acceptance and commitment therapy. Two Master students in clinical psychology and two undergraduate students in psychology were involved in the process. All the modules are the result of a collaborative effort between the associate professors who contributed their expertise and the students who pre-tested the modules and help improve their design to make them attractive to other students.

For the control group, the videos will be posted every week on a You Tube channel and broadcast on a private discord group. After each video, an associate professor will invite the students to share their feelings, comments, or questions, about the videos in this group. In addition, this researcher will moderate the exchanges. For the hybrid group, student will have to attend 10 lessons of 2 hours. These courses include the viewing of videos and a time for discussion between students and the teacher.

Participants were repeatedly reminded that the program was not a substitute for medical and/or psychotherapeutic care. They were also informed of the services offered by the university (in particular, preventive medicine and health promotion services) which could accompany should they need it. Each participant was identified by a code to aggregate the data between the different measurement times and preserve anonymity. The recruitment was based on voluntary participation and no compensation was offered to participants. The latter signed a consent form and were informed that their information will remain anonymous and their participation was voluntary and could be withdrawn at any time. Measurements are made before and after the intervention, using an online questionnaire (made on qualtrics secure software).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Anxiety and depressive symptoms
timeFrame: between 5 and 10 minutes
measure: Academic burnout
timeFrame: between 5 and 10 minutes
measure: Cognitive and metacognitive strategies
timeFrame: 5 minutes
measure: Motivational strategies and beliefs
timeFrame: 3 minutes
Secondary outcomes:
measure: Learned helplessness
timeFrame: between 5 and 10 minutes
measure: Coping strategies
timeFrame: 10 minutes
measure: Intolerance of uncertainty
timeFrame: between 5 and 10 minutes
measure: Social support
timeFrame: 5 minutes
measure: Well-being
timeFrame: between 5 and 10 minutes
measure: Situational factors
timeFrame: 3 minutes
measure: Socio-demographic factors
timeFrame: 2 minutes
Other outcomes:
Locations:
city: Nîmes
country: France
facility: Charbonnier
Study officials:
References:
citation: Charbonnier E, Tremoliere B, Baussard L, Goncalves A, Lespiau F, Philippe AG, Le Vigouroux S. Effects of an online self-help intervention on university students' mental health during COVID-19: A non-randomized controlled pilot study. Comput Hum Behav Rep. 2022 Mar;5:100175. doi: 10.1016/j.chbr.2022.100175. Epub 2022 Feb 10.
citation: Charbonnier, E., Le Vigouroux, S., & Goncalves, A. (2021). Etudiants en temps de confinement et au-delà. La Presse Médicale Formation. https://doi.org/10.1016/j.lpmfor.2021.06.011
citation: Le Vigouroux S, Goncalves A, Charbonnier E. The Psychological Vulnerability of French University Students to the COVID-19 Confinement. Health Educ Behav. 2021 Apr;48(2):123-131. doi: 10.1177/1090198120987128. Epub 2021 Jan 20.