NCT04978194

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 27, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

September 25, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2021

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

July 27, 2021

Status Verified

July 1, 2021

Enrollment Period

3 months

First QC Date

July 22, 2021

Last Update Submit

July 22, 2021

Conditions

Keywords

LearningMental healthYoung adults/ StudentUniversity-based Intervention

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

EXPERIMENTAL

Online 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

Other: University-based intervention to promote better management of emotions and learning

Hybrid group

EXPERIMENTAL

Hybrid 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

Other: University-based intervention to promote better management of emotions and learning

Control group

NO INTERVENTION

Control 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.

Hybrid groupOnline group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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: 35169655BACKGROUND
  • 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

    BACKGROUND
  • 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.

  • Charbonnier 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.

MeSH Terms

Conditions

Burnout, PsychologicalPsychological Well-Being

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehaviorPersonal Satisfaction

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Central Study Contacts

Elodie Charbonnier, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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).
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

Locations