We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

National Survey of Mental Health After COVID-19 Outbreak (CoV2SoulRS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04896983
Recruitment Status : Recruiting
First Posted : May 21, 2021
Last Update Posted : July 1, 2021
University of Novi Sad
Information provided by (Responsible Party):
Nadja P Maric, University of Belgrade

Brief Summary:

The Serbian national survey - acronym CoV2Soul.RS - has been launched to document mental health (MH) status and understand needs of the population in relation to the prolonged global public health crisis.

This cross-sectional study will collect a representative national sample (18-65 years) by multi-stage probabilistic household sampling method. Trained staff will conduct face-to-face diagnostic interviews (M.I.N.I.). Battery of self-report instruments will be used to measure quality of Life (QoL), level of distress, and associated protective and harmful psychological and societal factors. The investigators aim to assess prevalence rates of MH disorders and associated QoL in the nationally representative sample, to explore how MH conditions and QoL vary with respect to socio-demographic variables, personality, health status and traumatic events during pandemics, and to find how these relationships depend on societal factors characterising municipalities in which they live. Moreover, this study will address perception of pandemic consequences and associated distress in relation to personality and different types of possible mediators. The prevalence rates of MH disorders will be calculated as percentages of participants with a positive diagnosis. The hierarchical structure of the data will be analyzed using Multilevel Random Coefficient Modeling,

CoV2Soul.RS will contribute to an international evidence base about prevalence rates of psychiatric conditions during different phases of the pandemic in different regions and will identify protective and harmful psychological and societal factors for MH and QoL.

Condition or disease
Mental Health Impairment

Layout table for study information
Study Type : Observational
Estimated Enrollment : 1200 participants
Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Official Title: National Survey of Mental Health in the Second Year After COVID-19 Outbreak: Multilevel Analysis of Individual and Societal Factors
Estimated Study Start Date : June 2021
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Prevalence of MH disorders [ Time Frame: Up to 24 weeks ]
    Prevalence of 16 most common mental health disorders assessed by M.I.N.I 7.0.2, Standard Adult version (Sheehan et al, 1998) / Seven categories of MH conditions: (1) Mood disorders (Major depressive episode, Manic episode and Hypomanic episode); (2) Psychotic disorders; (3) Anxiety disorders (panic disorder, agoraphobia, social phobia, and generalized anxiety disorder); (4) Obsessive-compulsive disorder; (5) Trauma-related disorders (Post-traumatic stress disorder); (6) Eating disorders, and (7) Substance-related and addictive disorders.

  2. Severity of depressive symptoms [ Time Frame: Up to 24 weeks ]
    Depressive symptom severity will be measured by Patient Health Questionnaire - PHQ-9 (Kroenke et al., 2001); Score range 0-27 (higher scores inidicate more severe symptoms)

  3. Severity of anxiety symptoms [ Time Frame: Up to 24 weeks ]
    Anxiety symptom severity will be measured by General Anxiety Disorder - GAD-7 (Spitzer et al., 2006). Score range 0-21 (higher scores indicate more severe symptoms)

  4. Intensity of the pandemic-related stress [ Time Frame: Up to 24 weeks ]
    Covid Stress Scale (Taylor et al., 2020) will be used. Score range 0-4. Higher score means worse pandemic-related psychological problems.

  5. Perception of COVID-19 pandemic consequences [ Time Frame: Up to 24 weeks ]

    Perception of the pandemic consequences on various aspects of life will be measured using 6 items, allowing for positive Covid-19 related consequences. Score range 1-5.

    Lower score means more negative perception of the pandemic consequences.

  6. Quality of life in relation to different MH conditions [ Time Frame: Up to 24 weeks ]
    QoL assumes focusing on satisfaction with life as a whole (to be assessed by Manchester Short Assessment of Quality of Life - MANSA (Priebe et al., 1999). Score range: 1-7. Higher score means better QoL.

  7. Quality of life in general [ Time Frame: Up to 24 weeks ]
    Short Form survey scale - SF-12 (Ware et al., 1996) - to measure two specific QoL outcomes: 1) physical health-related quality of life (scores range: 6-20), and b) mental health-related quality of life (scores range: 6-27). Higher score means better QoL.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
The sample will be collected via multi-stage probabilistic household sampling (face-to-face, computer-assisted, or paper-pencil method). The first stage includes a random sampling of municipalities as clusters, while the second stage includes a random sampling of local communities in each municipality. Municipalities and local communities are sampled from four regions (Capital Belgrade and suburbs, Vojvodina, West, and Southeast Serbia) based on the random selection from the database created by the Serbian Institute of Statistics (database includes information on the name of the settlement, municipality, region, and the number of inhabitants). The third, final stage, deals with the selection of the respondents using a random walk technique.

Inclusion criteria:

  • Age between 18 and 65 years
  • Speaks Serbian fluently
  • Able to give informed consent

Exclusion criteria:

  • Cognitive impairment leading to a disability to understand questions
  • Severe neurological impairment
  • People with impaired hearing and deaf persons

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04896983

Layout table for location contacts
Contact: Goran Knezevic, Professor +381113206141 gknezevi@f.bg.ac.rs
Contact: Jovana Todorovic, M.D, Assist. +381112659533 jovana.todorovic@med.bg.ac.rs

Layout table for location information
Faculty of Medicine, University of Belgrade Recruiting
Belgrade, Serbia, 11000
Contact: Nadja P Maric, MD PhD    +381113307548    nadja.maric-bojovic@med.bg.ac.rs   
Contact: Jovana Todorovic, MD PhD    +381112659533    jovana.todorovic@med.bg.ac.rs   
Faculty of Philosophy, University of Belgrade Recruiting
Belgrade, Serbia, 11000
Contact: Ljiljana P Lazarevic, PhD       ljiljana.lazarevic@f.bg.ac.rs   
Faculty of Philosophy, University of Novi Sad Recruiting
Novi Sad, Serbia, 21000
Contact: Ljiljana P Mihic, PhD       lmihic@ff.uns.ac.rs   
Sponsors and Collaborators
University of Belgrade
University of Novi Sad
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Nadja P Maric, Principal Research Fellow & Professor, University of Belgrade
ClinicalTrials.gov Identifier: NCT04896983    
Other Study ID Numbers: #7528289
#7528289 COVID-19 CoV2Soul.RS ( Other Grant/Funding Number: Science Fund of the Republic of Serbia )
First Posted: May 21, 2021    Key Record Dates
Last Update Posted: July 1, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Collected data will be completely anonymized and used in subsequent analyses at the group level. Anonymized dataset will be uploaded to a repository following all good scientific practices.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nadja P Maric, University of Belgrade:
Mental health disorders
Multilevel modelling
National survey
Quality of life
Additional relevant MeSH terms:
Layout table for MeSH terms
Respiratory Tract Infections
Pneumonia, Viral
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases