The effects of the COVID-19 pandemic on mental health
| ISRCTN | ISRCTN14652655 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14652655 |
| ClinicalTrials.gov number | U1111-1262-3753 |
- Submission date
- 09/12/2020
- Registration date
- 18/12/2020
- Last edited
- 14/01/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
On 11 March 2020, the WHO declared the novel coronavirus (SARS-CoV-2) infection pandemic. Along with the increased pressure on the medical system, the spread of SARS-Cov2 infection has generated multiple economic and social effects on society. Fear of being infected, the measures of social distancing (reducing social contact, limiting recreation, etc) imposed to limit the transmission of the virus, along with financial instability generated by job loss, are the main causes of mental health damage during the COVID-19 pandemic.
In this context, family physicians, along with other medical professionals, play an important role in managing psycho-emotional changes as part of the pandemic response.
In clinical practice during the pandemic, the monitoring of psychosocial needs and the support provided to patients during direct (face to face) meetings have been greatly reduced due to isolation/quarantine measures at home and due to restricted access to services. caused by the rapid spread of SARS-CoV-2 virus infection. In this context, it is necessary to develop methods for remote evaluation of patients by family doctors through telephone consultations and/or communication via the Internet.
The aim of this study is to assess the impact of the COVID-19 pandemic on mental health among the adult population using social networks.
Who can participate?
Adults (aged over 18) who use social networks
What does the study involve?
Recruitment of the participants is voluntary and is made through social media platforms. Participants are invited to complete a questionnaire. The online questionnaire (created with Google Forms) consists of 31 questions and is accessible on social networks such as Facebook and Twitter.
What are the possible benefits and risks of participating?
The study does not involve any additional risk in terms of physical and mental health. This study will provide information on the effects of the COVID-19 pandemic on society. Participants do not receive any reward for participating in this research
Where does the study run from?
Grigore T. Popa University of Medicine and Pharmacy (Romania)
When is the study starting and how long is it expected to run for?
November 2020 to December 2020
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Mrs Elena Popa, MD, PhD
elena.popa@umfiasi.ro
Contact information
Scientific
Strada Ion Creanga nr 73A
Iasi
700737
Romania
 ORCID ID |
0000-0003-2207-5129 |
|---|---|
| Phone | +40 (0)723635745 |
| elena.popa@umfiasi.ro |
Scientific
Ion Creanga Street nr 73A
Iasi
700737
Romania
| teodora.tetia@email.umfiasi.ro |
Scientific
University Street no 16
Iasi
700115
Romania
| elena.coman@umfiasi.ro |
Scientific
University Street no 16
Iasi
700115
Romania
| boanca.mihaela@umfiasi.ro |
Scientific
University Street no 16
Iasi
700115
Romania
| monica.ungureanu@umfiasi.ro |
Scientific
University Street no 16
Iasi
700115
Romania
| ana.slanina@umfiasi.ro |
Scientific
University Street no 16
Iasi
700115
Romania
| carmen.barbacariu@umfiasi.ro |
Scientific
University Street no 16
Iasi
700115
Romania
| antoneta.petroaie@umfiasi.ro |
Scientific
University Street no 16
Iasi
700115
Romania
| agnes.bacusca@umfiasi.ro |
Scientific
University Street no 16
Iasi
700115
Romania
| dana.anton@umfiasi.ro |
Scientific
University Street no 16
Iasi
700115
Romania
| irina.manoilescu@umfiasi.ro |
Scientific
Univerity Street no 16
Iasi
700115
Romania
| mihaela.manole@umfiasi.ro |
Study information
| Study design | Observational cross sectional study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Internet/virtual |
| Study type | Screening |
| Participant information sheet | No participant information sheet available |
| Scientific title | The effects of the COVID-19 pandemic on mental health: a web-based study among Romanian adults |
| Study objectives | The prevalence of anxiety and depression increased in the adult population during the COVID-19 pandemic. |
| Ethics approval(s) | Approved 21/12/2020, Ethics Committee of the Grigore T. Popa University of Medicine and Pharmacy (Universitatea de Medicină și Farmacie “Grigore T. Popa”, 6 Universitatii Street, 700115, Iași, România; +40 (0)232 301 603 / +40 (0)232 267 801 / +40 (0)232 267 623; rectorat@umfiasi.ro), ref: 25/21.12.2020 |
| Health condition(s) or problem(s) studied | Anxiety and depression |
| Intervention | The researchers are conducting an anonymous cross-sectional web-based survey on anxiety and depression among Romanian adult Internet users. They developed a questionnaire including open-ended and closed questions. The questionnaire includes questions regarding the presence of anxiety or depression. Recruitment to the study is done on a voluntary basis, and the participants fill in a questionnaire available on a Google drive link. To assess the presence of anxiety and depression, the researchers use two well-recognized and validated tools: the GAP-7 scale for the diagnosis of anxiety and the PHQ-9 scale (nine-item Patient Health Questionnaire) for the diagnosis of depression. This questionnaire is sent to volunteers in an electronic format through a social network (Facebook, Twitter). As this is a survey study, consent is inferred from the provision of information about participants at the beginning of the survey. All data collected is anonymous and confidential. The study is conducted in accordance with the Helsinki-updated statement. Participants are not remunerated and do not incur any financial costs related to participating in the study. |
| Intervention type | Other |
| Primary outcome measure | Prevalence of anxiety and depression evaluated using the Patient Health Questionnaire -9 (PHQ-9) scale and the General Anxiety Disorders-7 (GAD-7) scale at a single timepoint |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 29/11/2020 |
| Completion date | 16/12/2020 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 500 |
| Total final enrolment | 1254 |
| Key inclusion criteria | Romanian adult Internet users |
| Key exclusion criteria | History of mental illness |
| Date of first enrolment | 03/12/2020 |
| Date of final enrolment | 16/12/2020 |
Locations
Countries of recruitment
- Romania
Study participating centre
Iasi
700737
Romania
Sponsor information
University/education
University Street no 16
Iasi
700115
Romania
| Phone | +40 (0)232 301 603 / +40 (0)232 267 801 / +40 (0)232 267 623 |
|---|---|
| rectorat@umfiasi.ro | |
| Website | http://www.umfiasi.ro/Pages/Default.aspx |
"ROR" |
https://ror.org/03hd30t45 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 03/01/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication of one original paper |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Miss Teodora Tetia (teodora.tetia@email.umfiasi.ro) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 04/01/2021 | No | No | ||
| Statistical Analysis Plan | 04/01/2021 | No | No | ||
| Preprint results | 30/12/2020 | 14/01/2022 | No | No |
Additional files
- ISRCTN14652655_PROTOCOL.docx
- Uploaded 04/01/2021
- ISRCTN14652655_SAP.docx
- Uploaded 04/01/2021
Editorial Notes
14/01/2022: Preprint reference added.
05/01/2021: Ethics approval details added.
04/01/2021: Uploaded protocol (not peer reviewed). Uploaded statistical analysis plan.
17/12/2020: Trial's existence confirmed by Grigore T. Popa University of Medicine and Pharmacy.
