National Survey of Mental Health After COVID-19 Outbreak

NCT ID: NCT04896983

Last Updated: 2021-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-30

Study Completion Date

2022-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Mental Health Impairment

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Novi Sad

OTHER

Sponsor Role collaborator

University of Belgrade

OTHER

Sponsor Role lead

Responsible Party

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Nadja P Maric

Principal Research Fellow & Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Medicine, University of Belgrade

Belgrade, , Serbia

Site Status RECRUITING

Faculty of Philosophy, University of Belgrade

Belgrade, , Serbia

Site Status RECRUITING

Faculty of Philosophy, University of Novi Sad

Novi Sad, , Serbia

Site Status RECRUITING

Countries

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Serbia

Central Contacts

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Goran Knezevic, Professor

Role: CONTACT

+381113206141

Jovana Todorovic, M.D, Assist.

Role: CONTACT

+381112659533

Facility Contacts

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Nadja P Maric, MD PhD

Role: primary

+381113307548

Jovana Todorovic, MD PhD

Role: backup

+381112659533

Ljiljana P Lazarevic, PhD

Role: primary

Ljiljana P Mihic, PhD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 32408047 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11556941 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16717171 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9881538 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10443245 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8628042 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34548371 (View on PubMed)

Related Links

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Other Identifiers

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#7528289 COVID-19 CoV2Soul.RS

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

#7528289

Identifier Type: -

Identifier Source: org_study_id

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