National Survey of Mental Health After COVID-19 Outbreak

Mental Health Impairment Clinical Trial

— CoV2SoulRS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04896983
• Other study ID #: #7528289
• Secondary ID: #7528289 COVID-1
• Status: Recruiting
• Start date: June 2021
• Est. completion date: March 2022

Study information

• Verified date: June 2021
• Source: University of Belgrade
• Contact: Goran Knezevic, Professor
• Phone: +381113206141
• Email: gknezevi[@]f.bg.ac.rs
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: March 2022
• Est. primary completion date: November 2021
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Mental Health Impairment

Locations

Country	Name	City	State
Serbia	Faculty of Medicine, University of Belgrade	Belgrade
Serbia	Faculty of Philosophy, University of Belgrade	Belgrade
Serbia	Faculty of Philosophy, University of Novi Sad	Novi Sad

Sponsors (2)

Lead Sponsor	Collaborator
University of Belgrade	University of Novi Sad

Country where clinical trial is conducted

Serbia, 

References & Publications (6)

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. — View 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. — View 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. Review. — View Citation

Spitzer RL, Kroenke K, Williams JB, Löwe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 24 weeks
Primary	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)	Up to 24 weeks
Primary	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)	Up to 24 weeks
Primary	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.	Up to 24 weeks
Primary	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.	Up to 24 weeks
Primary	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.	Up to 24 weeks
Primary	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.	Up to 24 weeks

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