An observational study in Mental Health Impairment, sponsored by University of Belgrade. Status unknown at 3 sites in Serbia. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-07-01.
Sponsored by University of Belgrade · Observational
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's planned enrollment of 1,200 is above the median of 261 across 3,136 observational studies indexed under COVID-19.
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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.
Exclusion criteria:
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.
Time frame: Up to 24 weeks
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)
Time frame: Up to 24 weeks
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)
Time frame: Up to 24 weeks
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.
Time frame: Up to 24 weeks
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.
Time frame: Up to 24 weeks
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.
Time frame: Up to 24 weeks
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.
Time frame: Up to 24 weeks
Plan to share: Yes — Collected data will be completely anonymized and used in subsequent analyses at the group level. Anonymized dataset will be uploaded to a repository following all good scientific practices.
This study is status unknown, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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University of Belgrade