National Survey of Mental Health After COVID-19 Outbreak

• Conditions: Mental Health Impairment

• Registration Number: NCT04896983
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-12
• Study First Submitted QC: 2021-05-19
• Study First Posted: 2021-05-21
• Status Verified: 2021-06
• Study Start: 2021-06
• Last Update Submitted: 2021-06-30
• Last Update Posted: 2021-07-01
• Primary Completion: 2021-11
• Study Completion: 2022-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intensity of the pandemic-related stress	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.
Quality of life in relation to different MH conditions	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.
Severity of depressive symptoms	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)
Severity of anxiety symptoms	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)
Quality of life in general	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.
Prevalence of MH disorders	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.
Perception of COVID-19 pandemic consequences	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.

Trial Locations

Locations (3)

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, Serbia