COVID-19 pandemic effects on depression, anxiety and help-seeking attitudes in college students
| ISRCTN | ISRCTN63459073 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63459073 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | PMHDS-1 |
| Sponsor | University of Porto |
| Funder | Investigator initiated and funded |
- Submission date
- 17/11/2020
- Registration date
- 19/11/2020
- Last edited
- 03/01/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
For young people, just as in the general population, the COVID-19 pandemic has caused many changes in their lives. Research has shown an increased risk for mental illness symptoms as a consequence of the pandemic. The aim of this study is to evaluate the impact of the COVID-19 pandemic on university students' anxiety and depression symptoms. This is a follow up to the study described at https://www.isrctn.com/ISRCTN97093665.
Who can participate?
Students in their first year at the University of Porto who participated in the previous study
What does the study involve?
The study involves three follow-up evaluations besides the ones described in the previous study, taking place in June 2020, January and May 2021. Depression symptoms, anxiety symptoms and help-seeking attitudes are assessed using questionnaires.
What are the possible benefits and risks of participating?
Benefits include increasing knowledge about how changes brought by the COVID-19 influence depression and anxiety symptoms. Possible risks/inconvenience include the time invested in responding to the questionnaires.
Where is the study run from?
Institute of Public Health of the University of Porto (Portugal)
When is the study starting and how long is it expected to run for?
February 2019 to June 2021
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Virgínia Conceição
up200501131@med.up.pt
Contact information
Scientific
Rua Domingos Machado
102
Porto
4250-201
Portugal
 ORCID ID |
0000-0002-3281-1508 |
|---|---|
| Phone | +351 (0)222061820 |
| up200501131@med.up.pt |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational cohort study |
| Secondary study design | Cohort study |
| Participant information sheet | ISRCTN63459073_PIS.pdf |
| Scientific title | COVID-19 pandemic effects on depression, anxiety and help-seeking attitudes in college students: a cohort study |
| Study objectives | Depression and anxiety symptoms increased as a result of the COVID-19 pandemic. |
| Ethics approval(s) | Approved 01/08/2020, Institute of Public Health of the University of Porto ethics committee (Rua das Taipas 135, 4050-091 Porto; +351 (0)222061820; etica@ispup.up.pt), ref: CE18096 |
| Health condition(s) or problem(s) studied | Changes in depression and anxiety symptoms in college students |
| Intervention | This study is part of broader longitudinal research on university students' mental health with the Portuguese version of The Patient Health Questionnaire (PHQ-9) and the Portuguese version of the Generalised Anxiety Disorder (GAD-7) data with evaluations on January, May and October 2019 and June 2020, as well as socio-demographic information. Using the SurveyMonkey platform, in February 2019, the researchers contacted all 4493 first-year students from all 14 schools of the University of Porto through institutional email and invited them to participate in the study. A reminder email is sent a week after the first email. Participants are then also evaluated in May and October 2019 and again in June 2020. The researchers plan to repeat the evaluation in January and May 2021. The statistical analyses consist of two parts. The first part explores the results obtained in the last moment of evaluation, describing depression and anxiety symptomatology after the pandemic, and comparing mean scores and above cut-off proportions according to gender and by all the covariates. The researchers use Student's t-test to compare groups in continuous variables, and the Mann-Whitney test to compare proportions between two groups. The second phase explores the differences in PHQ-9 and GAD-7 scores across time, using one-way ANOVA repeated measures to assess changes in means, and Cochran's Q test with McNemar's post-hoc Bonferroni-adjusted alpha to evaluate the changes in cut-off proportions between the different evaluation moments. The researchers will fixed-effects regression to analyse the effect of the pandemic on changes within an individual's depression and anxiety symptomatology, and mean scores for the outcome measure, as opposed to fitting a fixed-effects model for a binary outcome indicator, in order to prevent the exclusion with concordant responses over time. The researchers will assess the effect of the pandemic within participants using fixed-effects regression and use mean scores for the outcome measure because a binary outcome in the fixed-effects model would further reduce the sample available for analysis as it would exclude concordant responses over time, thus affecting statistical power. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Depression symptoms measured with the Portuguese version of The Patient Health Questionnaire (PHQ-9) in February, May and October 2019, June 2020, January and May 2021 |
| Key secondary outcome measure(s) |
Help-seeking attitudes measured with the Attitudes Toward Seeking Professional Help scale in February, May and October 2019, June 2020, January and May 2021 |
| Completion date | 01/06/2021 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 500 |
| Total final enrolment | 623 |
| Key inclusion criteria | 1. Participated in the RCT "Mental health stigma: a video‐based randomized controlled trial to reduce depression stigma among university students" (https://www.isrctn.com/ISRCTN97093665) 2. Responded to all evaluation moments described in the above study |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/04/2019 |
| Date of final enrolment | 31/05/2019 |
Locations
Countries of recruitment
- Portugal
Study participating centre
Porto
Porto
4050-600
Portugal
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Virgínia Conceição (up200501131@med.up.pt). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 14/12/2021 | 03/01/2023 | Yes | No | |
| Participant information sheet | 20/11/2020 | No | Yes | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- ISRCTN63459073_PIS.pdf
- Uploaded 20/11/2020
Editorial Notes
03/01/2023: Publication reference added.
20/11/2020: The participant information sheet has been uploaded.
19/11/2020: Trial's existence confirmed by Institute of Public Health of the University of Porto ethics committee.
