The Impact of Information Sources on Mental Health During the COVID-19 Pandemic
NCT ID: NCT04442360
Last Updated: 2020-06-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
4000 participants
OBSERVATIONAL
2020-06-22
2020-07-13
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The present study seeks to investigate the impact of various sources of information on psychopathology, and specifically health anxiety, depression, and general anxiety, during the COVID-19 pandemic. The study will investigate the divergent impact of various information sources on these psychopathological symptoms during the pandemic.
Hypotheses and research questions:
Hypothesis 1: Media consumption across all information sources will significantly be associated with depression and anxiety symptoms, with increased media consumption in general associated with higher levels of health anxiety, depression, and general anxiety.
Hypothesis 2: Using social media and online interactive platforms to obtain news about the pandemic in comparison to using traditional media (e.g., TV, radio, and newspapers) will be associated with higher levels of health anxiety, depression, and general anxiety. Actively staying away from information will further significantly be associated with higher levels of higher levels of health anxiety, depression, and general anxiety.
Research Question 1: Is there a differential effect among different information sources on health anxiety, depression and general anxiety? To what extend and how are different information sources related to symptoms of health anxiety, depression, and general anxiety.
Exploratory:
Additionally, we will exploratory investigate to what extent the amount of use of different information sources impact health anxiety, depression, and general anxiety. We will also examine effect sizes with part correlations, to investigate information sources with the most and least detrimental impact on health anxiety, depression, and general anxiety.
Furthermore, we will report which information platforms participants reported as most useful with regards to information concerning how to best deal with the pandemic.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Predictors of Mental Well-being During the COVID-19 Pandemic
NCT04443699
COVID-19 - No Health Without Mental Health
NCT04421612
Loneliness During Strict and Lifted Social Distancing Protocols Against the COVID-19 Pandemic
NCT04444115
Investigating Differential Effects of Online Mental Training Interventions on Mental Well-being and Social Cohesion
NCT04889508
Mental Health and Its Correlates Among Chinese Adolescents Exposed to the Novel Coronavirus Disease 2019
NCT04299711
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Hypothesis 1: Media consumption across all information sources will significantly be associated with depression and anxiety symptoms, with increased media consumption in general associated with higher levels of health anxiety, depression, and general anxiety.
Hypothesis 2: Using social media and online interactive platforms to obtain news about the pandemic in comparison to using traditional media (e.g., TV, radio, and newspapers) will be associated with higher levels of health anxiety, depression, and general anxiety. Actively staying away from information will further significantly be associated with higher levels of higher levels of health anxiety, depression, and general anxiety.
Research Question 1: Is there a differential effect among different information sources on health anxiety, depression and general anxiety? To what extend and how are different information sources related to symptoms of health anxiety, depression, and general anxiety.
Exploratory:
Additionally, the investigators will exploratory investigate to what extent the amount of use of different information sources impact health anxiety, depression, and general anxiety. The investigators will also examine effect sizes with part correlations, to investigate information sources with the most and least detrimental impact on health anxiety, depression, and general anxiety.
Furthermore, the investigators will report which information platforms participants reported as most useful with regards to information concerning how to best deal with the pandemic.
Statistical analysis:
Three multiple regression analyses will be conducted. 1) with PHQ-9 as the dependent variable; and 2) the second with GAD-7 at as the dependent variable; and 3) the third with Health Anxiety as the dependent variable. All analyses will include the different sources of information as predictor variables, while controlling for the effects of pre-existing mental health condition, gender, age, and education. Part correlations will be reported for each regression analysis, presenting the effect size of the hypothesized predictors associated with health anxiety, depression and general anxiety. A part (semi-partial) correlation gives the least biased and easiest interpretable estimate of the strength of a predictive relationship (Dudgeon, 2016). It is the correlation between the outcome and the aspects of the predictor unique from all the other predictors. As a type of correlation, its size can be evaluated according to Cohen's (1988) criteria: small \>=0.10, medium \>=0.30, large \>=0.50.
The sources of information include: 1) National television and radio channels; 2) national and regional, and local newspapers; 3) Use of social media for information; 4) use of blogs, podcasts, forums or other Internet sources; 5) information obtained from peers (i.e., friends and family); 6) Other sources of information; 7) actively staying away from information.
Multicollinearity and other statistical assumptions will be checked using examined. Multicollinearity will be assessed with common guidelines (VIF \< 5 and Tolerance \> 0.2; Hocking, 2003; O'Brian, 2007).
All analyses and questions addressed in the forthcoming paper that are not pre-specified in this pre-registered protocol will be defined as exploratory.
Sensitivity analyses and random subsample replications of the main findings will be conducted following selection of a random sample of participants that ensure a proportionate ratio between the collected sample and the adult population of Norway.
Possible transformations:
All variables will be assessed in their original and validated format as is recommended practice, as long as this is possible with regards to statistical assumptions underlying the pre-defined analyses (i.e., multiple regression). However, if this is not possible with regards to the statistical assumptions behind the analyses, transformation (e.g., square root or log-transformations) may be needed to apply interval-based methods. The investigators will examine the degree of skewness and evaluate this against the assumptions and analyses before choosing the appropriate analysis. The pre-registered and planned analyses include multiple regression as long as assumptions are met. Alternatively a non-parametric test will be used.
Inference criteria Given the large sample size in this study, the investigators pre-define their significance level: p \< 0.01 to determine significance.
Sample size and power calculation:
The present study is part of a larger project with the first part aiming to investigate information source predictors of mental health through regression analyses, and the second part aiming to examine directional relations amongst specific sources of information and their centrality through complex systems approaches (i.e., network analysis). Consequently, power calculations are based on power required for network analyses. Following power analysis guidelines by Fried \& Cramer (2017), it is recommended that the number of participants are three times larger than the number of estimated parameters. However, more conservative recommendations by Roscoe (1975) for multivariate research, recommends sample size that is ten times larger than the number of estimated parameters. Thus, following these two approaches respectively, between 1053 to 3510 participants are required. Data will be collected for three weeks, and participants are based on a representative and random sample of Norwegian adults, randomly selected and provided equal opportunity to partake in the study, providing digital consent.
Missing data:
The TSD system (Services for Sensitive Data), a platform used in Norway to store person-sensitive data verifies participants officially through a kind of national ID number to give them full right to withdraw their data at any time, following the European GDPR (General Data Protection Regulation) laws. Accordingly, participants are allowed to withdraw their own data at any time. The survey includes mandatory fields of response. Participation is voluntarily, and withdrawal of provided data is possible at any moment. The investigators do not expect participants to withdraw their data and thus expect no missing data. However, if participants do withdraw their data, the investigators will conduct state-of-art missing data analyses and investigate whether data is missing at random.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
OTHER
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Prospective study with two measurement points investigating the impact of viral mitigation protocols on mental health
Prospective study with two measurement points investigating the impact of viral mitigation protocols on mental health
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Who are currently living in Norway and thus experiencing identical NPIs, and
* Who will provide digital consent to partake in the study.
Exclusion Criteria
* Adults not residing in Norway during the measurement period
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Modum Bad
OTHER
University of Oslo
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Omid V. Ebrahimi
Mr.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Omid V. Ebrahimi, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Oslo
Asle Hoffart, PhD
Role: PRINCIPAL_INVESTIGATOR
Modum Bad
Sverre Urnes Johnson, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Oslo
Ole Myklebust Amundsen, Cand.Psychol Student
Role: PRINCIPAL_INVESTIGATOR
University of Bergen
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
Johnson SU, Ulvenes PG, Oktedalen T, Hoffart A. Psychometric Properties of the General Anxiety Disorder 7-Item (GAD-7) Scale in a Heterogeneous Psychiatric Sample. Front Psychol. 2019 Aug 6;10:1713. doi: 10.3389/fpsyg.2019.01713. eCollection 2019.
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.
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.
Salkovskis PM, Rimes KA, Warwick HM, Clark DM. The Health Anxiety Inventory: development and validation of scales for the measurement of health anxiety and hypochondriasis. Psychol Med. 2002 Jul;32(5):843-53. doi: 10.1017/s0033291702005822.
Amundsen OM, Hoffart A, Johnson SU, Ebrahimi OV. Pandemic Information Dissemination and Its Associations With the Symptoms of Mental Distress During the COVID-19 Pandemic: Cross-sectional Study. JMIR Form Res. 2021 Dec 3;5(12):e28239. doi: 10.2196/28239.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
REK125510-13
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.