Mental Health Issue Clinical Trial
Official title:
Effects of an Intervention on University Students' Mental Health and Learning During COVID-19: a Non-randomized Controlled Study
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.
Status | Not yet recruiting |
Enrollment | 200 |
Est. completion date | December 30, 2021 |
Est. primary completion date | December 20, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
France | Charbonnier | Nîmes |
Lead Sponsor | Collaborator |
---|---|
University of Nimes |
France,
Charbonnier E, Trémolière 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. JMIR Preprints. 09/04/2021:29505
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
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 (a between 0.68 and 0.92) and depression (a between 0.67 and 0.90; see the review of Bjelland et al., 2002). | between 5 and 10 minutes | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Learned helplessness | Units: "mean score". Learned helplessness is assessed using a French version of the LHQ which is specific to academic work. Only the subscale measuring learned helplessness was included. Participants rated each of the 12 items on a 5-point Likert scale ranging from Not true to Absolutely true. Higher scores reflected higher levels of an inability to learn. This scale has been validated with Italian students and has good internal reliability (a = .77). | between 5 and 10 minutes | |
Secondary | Coping strategies | Units: "mean score". Coping are assessed using a French validation of the situational version of the Brief-COPE. Participants were instructed to refer to a stressful situation related to COVID-19 pandemic. This self-report scale assesses fourteen coping strategies (2 items per strategy): active coping, planning, instrumental support, use of emotional support, venting, behavioural disengagement, self-distraction, self-blame, positive reframing, humour, denial, acceptance, religion, and substance use. Participants rated each of the 28 items on a 4-point Likert scale ranging from Never to Always. Higher scores reflected higher levels of strategy use. The French validation of this scale was performed with French students and has good psychometric properties. This scale has good external validity since correlations with instruments assessing psychological balance showed a consistent set of results. It also has good structural validity with the majority of items. | 10 minutes | |
Secondary | Intolerance of uncertainty | Units: "mean score". Intolerance of uncertainty is assessed using the French version of the IU Scale - Short Form (Carleton et al., 2007). This self-report scale measures responses to uncertainty, ambiguous situations, and the future. The 12 items are rated on a 5-point Likert scale ranging from 1 ("not at all characteristic of me") to 5 ("entirely characteristic of me"). This scale assesses one total score and two dimensions of the intolerance of uncertainty: the prospective anxiety subscale (with 7 items, e.g., "it frustrates me not having all the information I need"), and inhibitory anxiety subscale (with 5 items, e.g., "when it's time to act, uncertainty paralyses me".) Good convergent and discriminant validity, as well as internal consistency, have been demonstrated by the total score and both subscale scores. | between 5 and 10 minutes | |
Secondary | Social support | Units: "mean score". Social support is evaluated with the French validation of the Social Provisions Scale-10 item (Caron, 2013). The 10 items are rated on a 4-point Likert scale ranging from 1 ("strongly disagree") to 4 ("Strongly in agreement"). This self-report scale capturing five dimensions of social support (two items per dimension of support): emotional support or attachment (e.g., "I feel a strong emotional bond with at least one other person"), social integration (e.g., "there are people who enjoy the same social activities I do"), reassurance of worth (e.g., "there are people who admire my talents and skills"), tangible help (e.g., "there are people I can count on to help me when I really need it"), and orientation (e.g., "there is someone with whom I can discuss important decisions about my life"). This scale has good psychometric qualities, it is a reliable and valid instrument for measuring the availability of social support. | 5 minutes | |
Secondary | Well-being | Units: "mean score". Well-being is evaluated with the French validation (Cottraux, 2009) of the psychological Well-Being Scale (Ryff, 1989). The 18 items are rated on a 6-point Likert scale ranging from 1 ("Disagreement") to 6 ("Agreement"). This self-report scale capturing 6 components of well-being (3 items per components): autonomy ("I tend to be influenced by others when they have strong opinions", control of the environment (e.g., "often, the demands of daily life bring me down"), personal development ("For me, life is a continuous process of learning, change and personal change and personal growth"), positive relationships (e.g., I have not experienced many warm and trusting relationships with others), giving meaning to life (e.g., I live from day to day and don't really think about the future"), and self-acceptance (e.g., I like most aspects of my personality). This scale and its subscales have good psychometric qualities. | between 5 and 10 minutes | |
Secondary | Situational factors | Six situational factors were considered::
the extent to which participants felt that lockdown was compromising their future job prospects (scale ranging from 0 to 100) the extent to which university studies were essential to participants (scale ranging from 0 to 100) the presence or absence of COVID symptoms (dichotomous answer: Yes or No) the presence or absence of COVID symptoms in their relatives (dichotomous answer: Yes or No) participants' level of concern about their health owing to the COVID-19 crisis (scale ranging from 0 to 100) participants' level of concern about their relatives' health owing to the COVID-19 crisis (scale ranging from 0 to 100). |
3 minutes | |
Secondary | Socio-demographic factors | Four socio-demographic factors were considered:
Age Gender Level of education Field of study |
2 minutes |
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