Clinical trial NCT04896983: National Survey of Mental Health After COVID-19 Outbreak
Official title: National Survey of Mental Health in the Second Year After COVID-19 Outbreak: Multilevel Analysis of Individual and Societal Factors
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mental Health Impairment
Keywords: COVID-19
Prevalence
Mental health disorders
Stress
Personality
Multilevel modelling
National survey
Quality of life
Lead sponsor: University of Belgrade
Sponsor class: OTHER
Collaborators: name: University of Novi Sad
First posted: 2021-05-21
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of MH disorders
timeFrame: Up to 24 weeks
measure: Severity of depressive symptoms
timeFrame: Up to 24 weeks
measure: Severity of anxiety symptoms
timeFrame: Up to 24 weeks
measure: Intensity of the pandemic-related stress
timeFrame: Up to 24 weeks
measure: Perception of COVID-19 pandemic consequences
timeFrame: Up to 24 weeks
measure: Quality of life in relation to different MH conditions
timeFrame: Up to 24 weeks
measure: Quality of life in general
timeFrame: Up to 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Belgrade
country: Serbia
facility: Faculty of Medicine, University of Belgrade
city: Belgrade
country: Serbia
facility: Faculty of Philosophy, University of Belgrade
city: Novi Sad
country: Serbia
facility: Faculty of Philosophy, University of Novi Sad
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.