DepressionNCT04444336
Information Sources and Their Relationship to Depressive and Anxiety Symptoms During the COVID-19 Pandemic: A Network Study
An observational study of Depression and Anxiety, run by University of Oslo.
Trial summary
This study aims to investigate the association between the use different information sources to obtain information about the COVID-19 pandemic and symptoms of psychopathology (i.e., depression and anxiety). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- Cross-sectional study examining the impact of information sources to obtain information about COVID-19 on depression and anxiety symptoms
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 4,000 participants
- Where
- No sites listed yet
- Study dates
- 22 Jun 2020to 13 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All adults above 18 years residing in Norway and thus experiencing identical mitigation protocols are invited to participate the study, reached through a random digital sample, providing consent digitally.
Who may be able to join
- Eligible participants are all adults including those of 18 years and above,
- Who are currently living in Norway and thus experiencing identical NPIs, and
- Who will provide digital consent to partake in the study.
Who cannot join
- Children and adolescents (individuals below 18)
- Adults not residing in Norway during the measurement period
Trial locations and contacts
No sites are listed yet.
About this study
This study aims to investigate the association between the use different information sources to obtain information about the COVID-19 pandemic and symptoms of psychopathology (i.e., depression and anxiety).
Research Question:
How central are different sources of information used to obtain knowledge about the COVID-19 pandemic in network along with depressive and anxiety symptoms? Which sources of information are most strongly connected to different symptoms of depression and anxiety? Staying away from information will be measured in the present study. As avoidance is a type of safety behavior in anxiety disorders, we are further eager to investigate the centrality of this behavior in the network. Furthermore, multiple studies using latent-variable paradigms have established a relationship between sum-scores of depression and social anxiety use in general. We are further interested in examining this potential link more thoroughly and detailed in the present network study. The findings of this study, although they will be cross-sectional and require further examination in studies with temporal data structure, will be an important and interesting starting point giving initial ideas about potential mechanisms that may be involved in use of information sources in pandemics and mental health
Read the detailed description
Research Question 1:
How central are different sources of information used to obtain knowledge about the COVID-19 pandemic in network along with depressive and anxiety symptoms? Which sources of information are most strongly connected to different symptoms of depression and anxiety?
Staying away from information will be measured in the present study. As avoidance is a type of safety behavior in anxiety disorders, the investigators are further eager to investigate the centrality of this behavior in the network. Furthermore, multiple studies using latent-variable paradigms have established a relationship between sum-scores of depression and social anxiety use in general. The investigators are further interested in examining this potential link more thoroughly and detailed in the present network study. The findings of this study, although they will be cross-sectional and require further examination in studies with temporal data structure, will be an important and interesting starting point giving initial ideas about potential mechanisms that may be involved in use of information sources in pandemics and mental health.
Statistical analysis:
The estimated network will consist of 23 items (9: PHQ-9; 7: GAD-7; 7: information sources to obtain information about COVID-19). The network will be estimated using the R package qgraph (Epskamp et al., 2012). Network stability and accuracy tests will be conducted using R package bootnet (Epskamp, et al., 2018). An undirected partial correlation network will be estimated, resulting in associations between each pair of symptoms controlling for all other associations among symptoms. Centrality indices will be reported. The appropriate correlation method will be applied following an assessment of the data (e.g., with regards to possible skewness).
The network will further be regularized using Graphical Least Absolute Shrinkage and Selection Operator (GLASSO), with Extended Bayes Information Criterion (EBIC). The tuning parameter will be set to 0.5, as is recommended practice. Centrality table and plots will be depicted, and difference test of edges conducted.
Additionally, the investigators will investigate differences in network structure across major demographic subgroups in the sample (e.g., gender). All analyses and questions addressed in the forthcoming paper that are not pre-specified in this pre-registered protocol will be defined as exploratory.
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.
Inference criteria:
p < 0.05 to determine significance.
Sample size and power calculation:
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. The network to be constructed for this study consists of 7 anxiety items (GAD-7), 9 depression symptom items (PHQ-9), and the 7 pre-specified items above concerning medium of information and extent of use. Consequently, the network consists of 23 items. 23x(23-1)/2 x 3 = at least 759 participants (according to guidelines by Fried \& Cramer, 2017). Thus, following these two approaches respectively, between 759 to 2530 participants are required. Data will be collected for three weeks, and participants are based on a representative sample of Norwegian adults with equal opportunity to partake in the study following 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 any 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 analysis and investigate whether data is missing at random.
- Conditions
- Depression, Anxiety
- Being tested
- Cross-sectional study examining the impact of information sources to obtain information about COVID-19 on depression and anxiety symptoms
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cross-sectional study examining the impact of information sources to obtain information about COVID-19 on depression and anxiety symptomsBehavioural
Cross-sectional study examining the impact of information sources to obtain information about COVID-19 on depression and anxiety symptoms
What is being measured
The primary outcome is the main question the study is designed to answer.
The Patient Health Questionnaire 9
The Patient Health Questionnaire 9 (PHQ-9; Kroenke, Spitzer \& Williams, 2001) is used to measure symptoms of depression in accordance with the diagnostic criteria for major depressive disorder. The questionnaire consists of nine items where each is scored on a four-point Likert scale (0-3), with the range of scores from 0 to 27. Higher scores indicate greater depression severity, and scores above 10 are considered as the cut-off that indicating that the patient is within the depressive area.
Measured: Data is set to be collected starting from 22nd of June until enough data has been collected. The data collection period will last no longer than three weeks.
Generalized Anxiety Disorder 7
The Generalized Anxiety Disorder 7 (GAD-7; Spitzer, Kroenke, Williams \& Löwe, 2006) is a questionnaire consisting of seven items measuring symptoms of anxiety and worry. The items are scored on a four-point Likert scale (0-3), with the scores ranging from 0 to 21. Specific cut-off for Norwegian samples have been found yielding a cut-off of 8 and above for high sensitivity and specificity (Johnson, Ulvenes, Øktedalen \& Hoffart, 2019).
Measured: Data is set to be collected starting from 22nd of June until enough data has been collected. The data collection period will last no longer than three weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study start22 Jun 2020 (estimated)
- Primary completion13 Jul 2020 (estimated)
- Study completion13 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Collaborators
- Modum Bad
- Responsible party
- Principal investigator, Omid V. Ebrahimi, University of Oslo
- Investigators
- Omid Ebrahimi, Double PhD Candidate, Principal investigator, University of OsloAsle Hoffart, PhD, Principal investigator, Modum BadSverre Urnes Johnson, PhD, Principal investigator, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04444336
- Sponsor's protocol ID
- REK125510-16
- Status last verified
- Jun 2020
- First submitted
- 21 Jun 2020
- Last updated
- 24 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fried EI, Cramer AOJ. Moving Forward: Challenges and Directions for Psychopathological Network Theory and Methodology. Perspect Psychol Sci. 2017 Nov;12(6):999-1020. doi: 10.1177/1745691617705892. Epub 2017 Sep 5.
PubMed 28873325Kroenke 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.
PubMed 11556941Spitzer 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.
PubMed 16717171
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Information Sources and Their Relationship to Depressive and Anxiety Symptoms During the COVID-19 Pandemic: A Network Study
- ClinicalTrials.gov ID
- NCT04444336
- Acronym / sponsor ID
- REK125510-16
- Conditions
- Depression, Anxiety
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Collaborators
- Modum Bad
- Study start
- 22 Jun 2020 (estimated)
- Primary completion
- 13 Jul 2020 (estimated)
- Study completion
- 13 Jul 2020 (estimated)
- First posted
- 23 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate the association between the use different information sources to obtain information about the COVID-19 pandemic and symptoms of psychopathology (i.e., depression and anxiety).
Research Question:
How central are different sources of information used to obtain knowledge about the COVID-19 pandemic in network along with depressive and anxiety symptoms? Which sources of information are most strongly connected to different symptoms of depression and anxiety? Staying away from information will be measured in the present study. As avoidance is a type of safety behavior in anxiety disorders, we are further eager to investigate the centrality of this behavior in the network. Furthermore, multiple studies using latent-variable paradigms have established a relationship between sum-scores of depression and social anxiety use in general. We are further interested in examining this potential link more thoroughly and detailed in the present network study. The findings of this study, although they will be cross-sectional and require further examination in studies with temporal data structure, will be an important and interesting starting point giving initial ideas about potential mechanisms that may be involved in use of information sources in pandemics and mental health
Detailed description
Research Question 1:
How central are different sources of information used to obtain knowledge about the COVID-19 pandemic in network along with depressive and anxiety symptoms? Which sources of information are most strongly connected to different symptoms of depression and anxiety?
Staying away from information will be measured in the present study. As avoidance is a type of safety behavior in anxiety disorders, the investigators are further eager to investigate the centrality of this behavior in the network. Furthermore, multiple studies using latent-variable paradigms have established a relationship between sum-scores of depression and social anxiety use in general. The investigators are further interested in examining this potential link more thoroughly and detailed in the present network study. The findings of this study, although they will be cross-sectional and require further examination in studies with temporal data structure, will be an important and interesting starting point giving initial ideas about potential mechanisms that may be involved in use of information sources in pandemics and mental health.
Statistical analysis:
The estimated network will consist of 23 items (9: PHQ-9; 7: GAD-7; 7: information sources to obtain information about COVID-19). The network will be estimated using the R package qgraph (Epskamp et al., 2012). Network stability and accuracy tests will be conducted using R package bootnet (Epskamp, et al., 2018). An undirected partial correlation network will be estimated, resulting in associations between each pair of symptoms controlling for all other associations among symptoms. Centrality indices will be reported. The appropriate correlation method will be applied following an assessment of the data (e.g., with regards to possible skewness).
The network will further be regularized using Graphical Least Absolute Shrinkage and Selection Operator (GLASSO), with Extended Bayes Information Criterion (EBIC). The tuning parameter will be set to 0.5, as is recommended practice. Centrality table and plots will be depicted, and difference test of edges conducted.
Additionally, the investigators will investigate differences in network structure across major demographic subgroups in the sample (e.g., gender). All analyses and questions addressed in the forthcoming paper that are not pre-specified in this pre-registered protocol will be defined as exploratory.
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.
Inference criteria:
p < 0.05 to determine significance.
Sample size and power calculation:
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. The network to be constructed for this study consists of 7 anxiety items (GAD-7), 9 depression symptom items (PHQ-9), and the 7 pre-specified items above concerning medium of information and extent of use. Consequently, the network consists of 23 items. 23x(23-1)/2 x 3 = at least 759 participants (according to guidelines by Fried \& Cramer, 2017). Thus, following these two approaches respectively, between 759 to 2530 participants are required. Data will be collected for three weeks, and participants are based on a representative sample of Norwegian adults with equal opportunity to partake in the study following 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 any 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 analysis and investigate whether data is missing at random.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All adults above 18 years residing in Norway and thus experiencing identical mitigation protocols are invited to participate the study, reached through a random digital sample, providing consent digitally.
Key inclusion criteria (3 listed)
- Eligible participants are all adults including those of 18 years and above,
- Who are currently living in Norway and thus experiencing identical NPIs, and
- Who will provide digital consent to partake in the study.
Key exclusion criteria (2 listed)
- Children and adolescents (individuals below 18)
- Adults not residing in Norway during the measurement period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cross-sectional study examining the impact of information sources to obtain information about COVID-19 on depression and anxiety symptomsCross-sectional study examining the impact of information sources to obtain information about COVID-19 on depression and anxiety symptoms | Behavioural | – |
Primary outcome
The Patient Health Questionnaire 9
Time frame: Data is set to be collected starting from 22nd of June until enough data has been collected. The data collection period will last no longer than three weeks.
The Patient Health Questionnaire 9 (PHQ-9; Kroenke, Spitzer \& Williams, 2001) is used to measure symptoms of depression in accordance with the diagnostic criteria for major depressive disorder. The questionnaire consists of nine items where each is scored on a four-point Likert scale (0-3), with the range of scores from 0 to 27. Higher scores indicate greater depression severity, and scores above 10 are considered as the cut-off that indicating that the patient is within the depressive area.
Generalized Anxiety Disorder 7
Time frame: Data is set to be collected starting from 22nd of June until enough data has been collected. The data collection period will last no longer than three weeks.
The Generalized Anxiety Disorder 7 (GAD-7; Spitzer, Kroenke, Williams \& Löwe, 2006) is a questionnaire consisting of seven items measuring symptoms of anxiety and worry. The items are scored on a four-point Likert scale (0-3), with the scores ranging from 0 to 21. Specific cut-off for Norwegian samples have been found yielding a cut-off of 8 and above for high sensitivity and specificity (Johnson, Ulvenes, Øktedalen \& Hoffart, 2019).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2020.
- Background: PubMed 28873325Fried EI, Cramer AOJ. Moving Forward: Challenges and Directions for Psychopathological Network Theory and Methodology. Perspect Psychol Sci. 2017 Nov;12(6):999-1020. doi: 10.1177/1745691617705892. Epub 2017 Sep 5.
- Background: PubMed 11556941Kroenke 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.
- Background: PubMed 16717171Spitzer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Omid Ebrahimi, Double PhD Candidate principal investigator
University of Oslo
Asle Hoffart, PhD principal investigator
Modum Bad
Sverre Urnes Johnson, PhD principal investigator
University of Oslo
Questions about this trial
What is this clinical trial studying?
An observational study of Depression and Anxiety, run by University of Oslo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Omid V. Ebrahimi, Double PhD Candidate (+47-22845295, omideb@uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Patient Health Questionnaire 9 (time frame: Data is set to be collected starting from 22nd of June until enough data has been collected. The data collection period will last no longer than three weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04444336, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2020.