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

NCT04365881 | Completed DMC

• 1 other identifier: REK12345
• Study Type: observational
• Target: 10,084
• Locations: 1 country
• Sites: 1

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.

Conditions

Loneliness, Worry, Rumination, Health Anxiety, Depression, Anxiety

Keywords

COVID-19, Non-pharmacological interventions (NPIs), loneliness, worry, rumination, depression, anxiety

Outcome Measures

Primary Outcomes (3)

• UCLA Loneliness Scale-8 (ULS-8)

  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.

  From March31st 2020 to April 7th 2020

• Patient Health Questionnaire-9 (PHQ-9)

  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).

  From March31st 2020 to April 7th 2020

• Generalized Anxiety Disorder-7 (GAD-7)

  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).

  From March31st 2020 to April 7th 2020

Interventions

Cross-sectional observational study OTHER

Survey

Also known as: Survey

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All adults residing in Norway during the government-initiated non-pharmacological interventions for the COVID-19 pandemia

You may qualify if:

• all adults residing in Norway

You may not qualify if:

• none

Sponsors & Collaborators

• Modum Bad: lead
• University of Oslo: collaborator

Study Sites (1)

University of Oslo

Oslo, Norway

Location

MeSH Terms

Conditions

Rumination Syndrome; Depression; Anxiety Disorders; COVID-19

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Feeding and Eating Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2020
• First Posted: April 28, 2020
• Study Start: March 31, 2020
• Primary Completion: April 7, 2020
• Study Completion: April 7, 2020
• Last Updated: April 28, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)