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Loneliness During the NPIs for the COVID-19 Pandemic in Norway: Risk Factors and Associations With Psychopathology

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ClinicalTrials.gov Identifier: NCT04365881
Recruitment Status : Completed
First Posted : April 28, 2020
Last Update Posted : April 28, 2020
Sponsor:
Collaborator:
University of Oslo
Information provided by (Responsible Party):
Modum Bad

Brief Summary:

The present study of loneliness during the COVID-19-related NPIs is part of a larger project aiming to investigate psychological reactions and symptoms associated with the current and ongoing governmental initiatives in place in Norway.

The results will lead to a better understanding of the psychological effects on quarantine on the population and consequently will be relevant for the development of tailored prevention and intervention programs fit for pandemic crises.

Objectives Investigate the levels of loneliness in a general population during the strict social distancing government-initiated non-pharmacological interventions (NPIs) for the COVID-19 pandemic.

Investigate risk and resilience factors for loneliness and the associations between loneliness and psychopathology symptoms during the NPIs.

Aims Inform the general public, policy makers, scientists, and health practitioners about the associations of the NPIs with the mental health problem of loneliness and its potential effect on psychopathology.

Provide a foundation for policymakers and health-care professionals to employ interventions that protect the general public against increased psychological suffering and dysfunction during society's handling of pandemics.


Condition or disease Intervention/treatment
Loneliness, Worry, Rumination, Health Anxiety, Depression, Anxiety Other: Cross-sectional observational study

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Study Type : Observational
Actual Enrollment : 10084 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Loneliness During the Non-pharmacological Epidemiological Interventions for the COVID-19 Pandemic in Norway: Risk Factors and Associations With Psychopathology
Actual Study Start Date : March 31, 2020
Actual Primary Completion Date : April 7, 2020
Actual Study Completion Date : April 7, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety


Intervention Details:
  • Other: Cross-sectional observational study
    Survey
    Other Name: Survey


Primary Outcome Measures :
  1. UCLA Loneliness Scale-8 (ULS-8) [ Time Frame: From March31st 2020 to April 7th 2020 ]
    The UCLA Loneliness Scale-8 (ULS-8) measures the frequency and intensity of aspects of the lonely experience, using a 1 (never) to 4 (always) Likert-type scale. A composite score was computed by summing the items after reverse coding when appropriate, such that higher scores indicate greater loneliness. In terms of symptoms, validated measures routinely used in clinical practice to screen symptom-levels suggestive of psychiatric diagnosis were utilized.

  2. Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: From March31st 2020 to April 7th 2020 ]
    The Patient Health Questionnaire-9 (PHQ-9)16 consists of nine items covering the DSM-IV criteria for major depression scored on a four-point Likert-scale (0-3), with scores ranging from 0 to 27. High scores on the PHQ-9 reveal greater depression severity and scores above 10 are considered as the cut-off indicative of a depressive diagnosis with a sensitivity and specificity of 88%.16 The PHQ-9 has revealed good psychometric properties, as demonstrated by Kroenke et al. (2001).

  3. Generalized Anxiety Disorder-7 (GAD-7) [ Time Frame: From March31st 2020 to April 7th 2020 ]
    The Generalized Anxiety Disorder-7 (GAD-7)17 consists of seven items covering the DSM-IV criteria for GAD on a four-point Likert scale (0-3) with scores ranging from 0 to 21. Higher scores reveal greater GAD symptoms, and scores above 10 are considered as the cut-off indicative of a GAD-diagnosis with a specificity of 82% and sensitivity of 89%.17 The GAD-7 has revealed construct validity and reliability (Kroenke, Spitzer, Williams, Monahan & Löwe, 2007; Löwe et al., 2008).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
All adults residing in Norway during the government-initiated non-pharmacological interventions for the COVID-19 pandemia
Criteria

Inclusion Criteria:

  • all adults residing in Norway

Exclusion Criteria:

  • none

Information from the National Library of Medicine

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): NCT04365881


Locations
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Norway
University of Oslo
Oslo, Norway
Sponsors and Collaborators
Modum Bad
University of Oslo
Investigators
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Principal Investigator: Omid V. E. Ebrahimi, Cand Psychol University of Oslo and Modum Bad
Principal Investigator: Asle Hoffart, PhD Modum Bad and University of Oslo
Principal Investigator: Sverre Urnes Johnson, PhD University of Oslo and Modum Bad
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Responsible Party: Modum Bad
ClinicalTrials.gov Identifier: NCT04365881    
Other Study ID Numbers: REK12345
First Posted: April 28, 2020    Key Record Dates
Last Update Posted: April 28, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Modum Bad:
COVID-19, Non-pharmacological interventions (NPIs), loneliness, worry, rumination, depression, anxiety
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms