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Mental Health ImpairmentCoV2SoulRSNCT04896983

National Survey of Mental Health After COVID-19 Outbreak

An observational study of Mental Health Impairment, run by University of Belgrade at 3 sites in Serbia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Mental Health Impairment
How many people
1,200 participants
Where
3 sitesSerbia
Study dates
Jun 2021to Mar 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

Goran Knezevic, Professor contact

+381113206141

gknezevi@f.bg.ac.rs

Jovana Todorovic, M.D, Assist. contact

+381112659533

jovana.todorovic@med.bg.ac.rs

Serbia3 sites, 3 recruiting

  • Faculty of Medicine, University of Belgrade

    Belgrade, 11000

    Nadja P Maric, MD PhD, +381113307548, nadja.maric-bojovic@med.bg.ac.rs

    Jovana Todorovic, MD PhD, +381112659533, jovana.todorovic@med.bg.ac.rs

    Recruiting

  • Faculty of Philosophy, University of Belgrade

    Belgrade, 11000

    Ljiljana P Lazarevic, PhD, ljiljana.lazarevic@f.bg.ac.rs

    Recruiting

  • Faculty of Philosophy, University of Novi Sad

    Novi Sad, 21000

    Ljiljana P Mihic, PhD, lmihic@ff.uns.ac.rs

    Recruiting

Other trials in Serbia

About this study

Official title: National Survey of Mental Health in the Second Year After COVID-19 Outbreak: Multilevel Analysis of Individual and Societal Factors

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.

Keywords
COVID-19, Prevalence, Mental health disorders, Stress, Personality, Multilevel modelling, National survey, Quality of life
Medical subject headings
COVID-19

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prevalence of MH disorders

    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.

    Measured: Up to 24 weeks

  2. Severity of depressive symptoms

    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)

    Measured: Up to 24 weeks

  3. Severity of anxiety symptoms

    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)

    Measured: Up to 24 weeks

  4. Intensity of the pandemic-related stress

    Covid Stress Scale (Taylor et al., 2020) will be used. Score range 0-4. Higher score means worse pandemic-related psychological problems.

    Measured: Up to 24 weeks

  5. Perception of COVID-19 pandemic consequences

    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.

    Measured: Up to 24 weeks

  6. Quality of life in relation to different MH conditions

    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.

    Measured: Up to 24 weeks

  7. Quality of life in general

    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.

    Measured: Up to 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2021
  2. Study startJun 2021 (estimated)
  3. Primary completionNov 2021 (estimated)
  4. Study completionMar 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Ecologic or community
Time perspective
Cross-sectional
Enrolment
1,200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04896983
Sponsor's protocol ID
#7528289
Other IDs
#7528289 COVID-19 CoV2Soul.RS
Acronym
CoV2SoulRS
Status last verified
Jun 2021
First submitted
12 May 2021
Last updated
1 Jul 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Taylor S, Landry CA, Paluszek MM, Fergus TA, McKay D, Asmundson GJG. Development and initial validation of the COVID Stress Scales. J Anxiety Disord. 2020 May;72:102232. doi: 10.1016/j.janxdis.2020.102232. Epub 2020 May 4.

    PubMed 32408047

  • Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

    PubMed 11556941

  • Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

    PubMed 16717171

  • Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59 Suppl 20:22-33;quiz 34-57.

    PubMed 9881538

  • Priebe S, Huxley P, Knight S, Evans S. Application and results of the Manchester Short Assessment of Quality of Life (MANSA). Int J Soc Psychiatry. 1999 Spring;45(1):7-12. doi: 10.1177/002076409904500102.

    PubMed 10443245

  • Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.

    PubMed 8628042

  • Maric NP, Lazarevic LB, Mihic L, Pejovic Milovancevic M, Terzic Z, Toskovic O, Todorovic J, Vukovic O, Knezevic G. Mental health in the second year of the COVID-19 pandemic: protocol for a nationally representative multilevel survey in Serbia. BMJ Open. 2021 Sep 21;11(9):e053835. doi: 10.1136/bmjopen-2021-053835.

    PubMed 34548371

Questions about this trial

What is this clinical trial studying?

An observational study of Mental Health Impairment, run by University of Belgrade at 3 sites in Serbia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Goran Knezevic, Professor (+381113206141, gknezevi@f.bg.ac.rs), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of MH disorders (time frame: Up to 24 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04896983, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2021.

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