NCT04442360

Brief Summary

Study description: 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 22, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

June 22, 2020

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 13, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 13, 2020

Completed
Last Updated

June 23, 2020

Status Verified

June 1, 2020

Enrollment Period

21 days

First QC Date

June 19, 2020

Last Update Submit

June 19, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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).

    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.

Interventions

Prospective study with two measurement points investigating the impact of viral mitigation protocols on mental health

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsBoth Biological Sex and self-representation of gender are measured
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All adults above 18 years residing in Norway and thus experiencing identical mitigation protocols are invited to participate the study, reaching randomly online with an equal opportunity of participating.

You may qualify if:

  • 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.

You may not qualify if:

  • Children and adolescents (individuals below 18)
  • Adults not residing in Norway during the measurement period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 31447721BACKGROUND
  • 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.

    PMID: 11556941BACKGROUND
  • 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.

    PMID: 16717171BACKGROUND
  • 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.

    PMID: 12171378BACKGROUND
  • 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.

MeSH Terms

Conditions

DepressionGeneralized Anxiety Disorder

Interventions

Prospective Studies

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorAnxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Cohort StudiesEpidemiologic StudiesEpidemiologic Study CharacteristicsEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Omid V. Ebrahimi, PhD

    University of Oslo

    PRINCIPAL INVESTIGATOR
  • Asle Hoffart, PhD

    Modum Bad

    PRINCIPAL INVESTIGATOR
  • Sverre Urnes Johnson, PhD

    University of Oslo

    PRINCIPAL INVESTIGATOR
  • Ole Myklebust Amundsen, Cand.Psychol Student

    University of Bergen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Omid V. Ebrahimi, Double PhD Candidate

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mr.

Study Record Dates

First Submitted

June 19, 2020

First Posted

June 22, 2020

Study Start

June 22, 2020

Primary Completion

July 13, 2020

Study Completion

July 13, 2020

Last Updated

June 23, 2020

Record last verified: 2020-06