COVID-19 pandemic effects on depression, anxiety and help-seeking attitudes in college students

ISRCTN ISRCTN63459073
DOI https://doi.org/10.1186/ISRCTN63459073
Secondary identifying numbers PMHDS-1
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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

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

Mrs Virgínia Conceição
Scientific

Rua Domingos Machado
102
Porto
4250-201
Portugal

ORCiD logoORCID ID 0000-0002-3281-1508
Phone +351 (0)222061820
Email up200501131@med.up.pt

Study information

Study designObservational cohort study
Primary study designObservational
Secondary study designCohort study
Study setting(s)Internet/virtual
Study typeScreening
Participant information sheet ISRCTN63459073_PIS.pdf
Scientific titleCOVID-19 pandemic effects on depression, anxiety and help-seeking attitudes in college students: a cohort study
Study objectivesDepression 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) studiedChanges in depression and anxiety symptoms in college students
InterventionThis 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 typeOther
Primary outcome measure1. 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
2. Anxiety symptoms measured with the Portuguese version of the Generalised Anxiety Disorder (GAD-7) in February, May and October 2019, June 2020, January and May 2021
Secondary outcome measuresHelp-seeking attitudes measured with the Attitudes Toward Seeking Professional Help scale in February, May and October 2019, June 2020, January and May 2021
Overall study start date01/02/2019
Completion date01/06/2021

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
SexBoth
Target number of participants500
Total final enrolment623
Key inclusion criteria1. 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 criteriaDoes not meet inclusion criteria
Date of first enrolment01/04/2019
Date of final enrolment31/05/2019

Locations

Countries of recruitment

  • Portugal

Study participating centre

Institute of Public Health of the University of Porto
Rua das Taipas nº135
Porto
Porto
4050-600
Portugal

Sponsor information

University of Porto
University/education

Institute of Public Health
Rua das Taipas
nº 135
Porto
4050-600
Portugal

Phone +351 (0)912969687
Email secretaria@ispup.up.pt
Website https://ispup.up.pt/
ROR logo "ROR" https://ror.org/043pwc612

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date01/03/2021
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planThe researchers plan to publish the study protocol in a peer-reviewed journal.

The researchers are planning to publish three results papers:
1. Depression and anxiety consequences of the COVID-19 pandemic: a longitudinal cohort study with university students - to be submitted to peer-review in November 2020
2. The effects of the COVID-19 pandemic in help-seeking attitudes in people with anxiety and depression symptoms - to be submitted to peer-review in June 2021
IPD sharing planThe 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?
Participant information sheet 20/11/2020 No Yes
Results article 14/12/2021 03/01/2023 Yes No

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.