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Loneliness During Strict and Lifted Social Distancing Protocols Against the COVID-19 Pandemic

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04444115
Recruitment Status : Not yet recruiting
First Posted : June 23, 2020
Last Update Posted : June 23, 2020
Sponsor:
Collaborator:
University of Oslo
Information provided by (Responsible Party):
Asle Hoffart, Modum Bad

Brief Summary:

Description The aim of the present study is to investigate (a) changes in the levels of loneliness in the general adult population from a period of strict distancing protocols designed to impede transmission of the corona virus (T1) to a later period of lifted distancing protocols period (T2), (b) the risk and resilience factors for persistence in loneliness across these periods and (c) the associations between loneliness at T1 and changes in loneliness from T1 to T2 and changes in psychopathology symptoms from T1 to T2.

An investigation of loneliness persistence in addition to its association with risk factors and the persistence of psychopathology provides a knowledge basis for employing interventions that protect the general public against increased distress and dysfunction during and after society's handling of pandemics.


Condition or disease
Loneliness During COVID-19

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Study Type : Observational
Estimated Enrollment : 10084 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Loneliness During the COVID-19 Pandemic: Change and Predictors of Change From Strict to Lifted Social Distancing Protocols
Estimated Study Start Date : June 22, 2020
Estimated Primary Completion Date : July 13, 2020
Estimated Study Completion Date : July 13, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety




Primary Outcome Measures :
  1. UCLA Loneliness Scale-8 (ULS-8) [ Time Frame: From 22nd of June to 13th of July ]
    The UCLA Loneliness Scale-8 (ULS-8; Hays & DiMatteo, 1987) measures the frequency and intensity of aspects of the lonely experience, using a 1 (never), 2 (rarely), 3 (sometimes) and 4 (often) scale. A composite score is computed by summing the items after reverse coding when appropriate, with composites ranging from 8 to 32. A score greater than half the maximum score (16) has been used to indicate caseness (Shevlin, Murphy, Mallett, Stringer, & Murphy, 2013). This implies that respondents at least sometimes experience at least one of the loneliness aspects described in the 8 items. The ULS-8 has demonstrated good psychometric properties (Hays & DiMatteo, 1987; Hartshorne, 1993).

  2. Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: From 22nd of June to 13th of July ]
    The Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer, & Williams, 2001) consists of nine items covering the DSM-IV criteria for major depression scored on a four-point 0 (not at all) to 3 (almost every day) scale, with total scores ranging from 0 to 27. The PHQ-9 has revealed good psychometric properties, as demonstrated by Kroenke, Spitzer, and Williams (2001).

  3. Generalized Anxiety Disorder-7 (GAD-7) [ Time Frame: From 22nd of June to 13th of July ]
    The Generalized Anxiety Disorder-7 (GAD-7; Kroenke, Spitzer, Williams, Monahan & Löwe, 2007) consists of seven items covering the DSM-IV criteria for GAD scored on a four-point 0 (not at all) to 3 (almost every day) scale, with total scores ranging from 0 to 21. The GAD-7 has revealed construct validity and reliability (Kroenke et al., 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:   Non-Probability Sample
Study Population
Eligible participants are all individuals of 18 years and above, who are living in Norway and thus experience identical distancing protocols, and who provide informed consent to participate in the study.
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): NCT04444115


Contacts
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Contact: Asle Hoffart, PhD +4790594733 asle.hoffart@modum-bad.no
Contact: Sverre Urnes Johnson, PhD +4741633313 Sverre.Johnson@modum-bad.no

Sponsors and Collaborators
Modum Bad
University of Oslo
Investigators
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Principal Investigator: Omid 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: Asle Hoffart, Prof, Modum Bad
ClinicalTrials.gov Identifier: NCT04444115    
Other Study ID Numbers: 802810-1
First Posted: June 23, 2020    Key Record Dates
Last Update Posted: June 23, 2020
Last Verified: June 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 Asle Hoffart, Modum Bad:
COVID-19, social distancing, loneliness, worry, rumination, depression, anxiety