National Survey of Mental Health After COVID-19 Outbreak (CoV2SoulRS)
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|ClinicalTrials.gov Identifier: NCT04896983|
Recruitment Status : Recruiting
First Posted : May 21, 2021
Last Update Posted : July 1, 2021
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.
|Condition or disease|
|Mental Health Impairment|
|Study Type :||Observational|
|Estimated Enrollment :||1200 participants|
|Observational Model:||Ecologic or Community|
|Official Title:||National Survey of Mental Health in the Second Year After COVID-19 Outbreak: Multilevel Analysis of Individual and Societal Factors|
|Estimated Study Start Date :||June 2021|
|Estimated Primary Completion Date :||November 2021|
|Estimated Study Completion Date :||March 2022|
- Prevalence of MH disorders [ Time Frame: 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.
- Severity of depressive symptoms [ Time Frame: 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 [ Time Frame: 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)
- Intensity of the pandemic-related stress [ Time Frame: 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.
- Perception of COVID-19 pandemic consequences [ Time Frame: 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.
- Quality of life in relation to different MH conditions [ Time Frame: 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.
- Quality of life in general [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04896983
|Contact: Goran Knezevic, Professoremail@example.com|
|Contact: Jovana Todorovic, M.D, Assist.||+firstname.lastname@example.org|
|Faculty of Medicine, University of Belgrade||Recruiting|
|Belgrade, Serbia, 11000|
|Contact: Nadja P Maric, MD PhD +381113307548 email@example.com|
|Contact: Jovana Todorovic, MD PhD +381112659533 firstname.lastname@example.org|
|Faculty of Philosophy, University of Belgrade||Recruiting|
|Belgrade, Serbia, 11000|
|Contact: Ljiljana P Lazarevic, PhD email@example.com|
|Faculty of Philosophy, University of Novi Sad||Recruiting|
|Novi Sad, Serbia, 21000|
|Contact: Ljiljana P Mihic, PhD firstname.lastname@example.org|