Condition category
Mental and Behavioural Disorders
Date applied
17/11/2020
Date assigned
19/11/2020
Last edited
20/11/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Virgínia Conceição

ORCID ID

http://orcid.org/0000-0002-3281-1508

Contact details

Rua Domingos Machado
102
Porto
4250-201
Portugal
+351 (0)222061820
up200501131@med.up.pt

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

PMHDS-1

Study information

Scientific title

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

Acronym

Study hypothesis

Depression and anxiety symptoms increased as a result of the COVID-19 pandemic.

Ethics approval

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

Study design

Observational cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Internet

Trial type

Screening

Patient information sheet

See additional files

Condition

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

Phase

Drug names

Primary outcome measure

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
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 measures

Help-seeking attitudes measured with the Attitudes Toward Seeking Professional Help scale in February, May and October 2019, June 2020, January and May 2021

Overall trial start date

01/02/2019

Overall trial end date

01/06/2021

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

500

Total final enrolment

623

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/04/2019

Recruitment end date

31/05/2019

Locations

Countries of recruitment

Portugal

Trial participating centre

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

Sponsor information

Organisation

University of Porto

Sponsor details

Institute of Public Health
Rua das Taipas
nº 135
Porto
4050-600
Portugal
+351 (0)912969687
secretaria@ispup.up.pt

Sponsor type

University/education

Website

https://ispup.up.pt/

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The 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 statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Virgínia Conceição (up200501131@med.up.pt).

Intention to publish date

01/03/2021

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

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.