Effects of an Intervention on University Students' Mental Health and Learning During COVID-19
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 22, 2021
CompletedFirst Posted
Study publicly available on registry
July 27, 2021
CompletedStudy Start
First participant enrolled
September 25, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2021
CompletedJuly 27, 2021
July 1, 2021
3 months
July 22, 2021
July 22, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Anxiety and depressive symptoms
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).
between 5 and 10 minutes
Academic burnout
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.
between 5 and 10 minutes
Cognitive and metacognitive strategies
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
5 minutes
Motivational strategies and beliefs
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.
3 minutes
Secondary Outcomes (7)
Learned helplessness
between 5 and 10 minutes
Coping strategies
10 minutes
Intolerance of uncertainty
between 5 and 10 minutes
Social support
5 minutes
Well-being
between 5 and 10 minutes
- +2 more secondary outcomes
Study Arms (3)
Online group
EXPERIMENTALOnline group: online university-based 9-weeks intervention to promote better management of emotions and learning. This intervention included: 1. 9- video capsules (one per week) 2. An exchange room on each video on a private discord group
Hybrid group
EXPERIMENTALHybrid group: hybrid university-based 9-weeks intervention to promote better management of emotions and learning. This intervention included: 10 lessons of 2 hours including 1. The viewing of the videos 2. A time of exchange between students, and with the teacher
Control group
NO INTERVENTIONControl group: No intervention, only two measurement times of 9 weeks apart. Nothing has changed.
Interventions
It included 9 video capsules (that take place over 9 weeks), 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. It is based on previous online student mental health intervention studies. It presents two innovative aspects: elements and examples specific to the COVID-19 pandemic and the addition of modules focused on learning strategies. The different modules were designed by 5 associate professors, 2 Master students in clinical psychology and 2 undergraduate students in psychology. For the control group, the videos will be posted every week on a You Tube channel and broadcast on a private discord group. 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.
Eligibility Criteria
You may qualify if:
- Students at the University of Nimes (males and females) aged over 18 years old
You may not qualify if:
- not to be a student of the University of Nîmes
- not signing the consent form to participate in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Charbonnier
Nîmes, 30000, France
Related Publications (4)
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.
PMID: 35169655BACKGROUNDCharbonnier, 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
BACKGROUNDLe 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.
PMID: 33472453RESULTCharbonnier E, Le Vigouroux S, Puechlong C, Montalescot L, Goncalves A, Baussard L, Gisclard B, Philippe AG, Lespiau F. The Effect of Intervention Approaches of Emotion Regulation and Learning Strategies on Students' Learning and Mental Health. Inquiry. 2023 Jan-Dec;60:469580231159962. doi: 10.1177/00469580231159962.
PMID: 36998220DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
July 22, 2021
First Posted
July 27, 2021
Study Start
September 25, 2021
Primary Completion
December 20, 2021
Study Completion
December 30, 2021
Last Updated
July 27, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share