NCT04444115

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.

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
10,084

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 20, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

June 22, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 23, 2020

Completed
20 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 20, 2020

Last Update Submit

June 20, 2020

Conditions

Keywords

COVID-19, social distancing, loneliness, worry, rumination, depression, anxiety

Outcome Measures

Primary Outcomes (3)

  • UCLA Loneliness Scale-8 (ULS-8)

    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).

    From 22nd of June to 13th of July

  • Patient Health Questionnaire-9 (PHQ-9)

    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).

    From 22nd of June to 13th of July

  • Generalized Anxiety Disorder-7 (GAD-7)

    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).

    From 22nd of June to 13th of July

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • all adults residing in Norway

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Hoffart A, Johnson SU, Ebrahimi OV. Loneliness during the COVID-19 pandemic: change and predictors of change from strict to discontinued social distancing protocols. Anxiety Stress Coping. 2022 Jan;35(1):44-57. doi: 10.1080/10615806.2021.1958790. Epub 2021 Jul 27.

MeSH Terms

Conditions

COVID-19Rumination SyndromeDepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesGastrointestinal DiseasesDigestive System DiseasesFeeding and Eating DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Asle Hoffart, PhD

CONTACT

Sverre Urnes Johnson, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

June 20, 2020

First Posted

June 23, 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

Data Sharing

IPD Sharing
Will not share