Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04978194
Study type Interventional
Source University of Nimes
Contact Elodie Charbonnier, PhD
Email elodie.charbonnier@unimes.fr
Status Not yet recruiting
Phase N/A
Start date September 25, 2021
Completion date December 30, 2021

See also
  Status Clinical Trial Phase
Active, not recruiting NCT05777044 - The Effect of Hatha Yoga on Mental Health N/A
Recruiting NCT05064293 - Assisted Identification and Navigation of Early Mental Health Symptoms in Children N/A
Not yet recruiting NCT05886595 - Being Young : My Mental Health
Active, not recruiting NCT05903638 - A Pilot RCT: the Impact of a Virtual MBSR Course on Women With Primary Infertility N/A
Not yet recruiting NCT04030858 - The INFINITE Study: A Prospective Investigation of a Nutrient-dense Diet in Early Addiction Recovery N/A
Recruiting NCT04926675 - Development of a Money Advice Intervention Within IAPT N/A
Recruiting NCT06105970 - Chinese Community Sample of Hierarchical Model of Psychopathology
Recruiting NCT06038721 - Unified Protocol: Community Connections N/A
Completed NCT05056428 - Effects of Mindfulness Training on Emotional Care Strategies N/A
Recruiting NCT06144905 - Norwegian Microbiota Study in Anorexia Nervosa
Completed NCT06080685 - Efficacy of Character Strengths Intervention in Enhancing Character Strengths and Self-esteem Among Adolescents N/A
Not yet recruiting NCT06266936 - Smart Life Smart Living Intercontinental - Medical Students' Cohort
Not yet recruiting NCT06430853 - Psychobiological Interventions in Pregnancy N/A
Not yet recruiting NCT06187701 - Co-Active Therapeutic Theatre (Co-ATT) for Dual-Diagnosis Patients N/A
Not yet recruiting NCT05979649 - An Internet-Based Intervention With Peer Support for the Mental Health of Youths N/A
Not yet recruiting NCT06006936 - Testing an Evidence-Based Self-Help Program for Infertility-Related Distress in Women N/A
Recruiting NCT05492305 - Glucagon-like Peptide 1 (GLP1) Receptor Agonists and Mental Health
Not yet recruiting NCT05316948 - Mental Health and Sexuality in Adolescents and Young Adults
Completed NCT05598697 - Economic Evaluation of the MEWE Intervention N/A
Recruiting NCT05563285 - Effect of Exercise and MBI on Female Students' Emotion Regulation and Inhibitory Control of Smartphone Addiction N/A