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Insomnia After the COVID-19 Pandemic

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ClinicalTrials.gov Identifier: NCT04443361
Recruitment Status : Not yet recruiting
First Posted : June 23, 2020
Last Update Posted : June 23, 2020
Sponsor:
Collaborator:
Modum Bad Psychiatric Center
Information provided by (Responsible Party):
Sverre Urnes Johnson, University of Oslo

Brief Summary:
The aim of this study is to investigate the levels of insomnia 3 months after (T2) the strict physical distancing government initiated physical distancing protocols related to the COVID-19 pandemic (T1). The study also aims to investigate how predictors measured after and before the COVID-19 pandemic are associated with sleep problems at T2.

Condition or disease
Insomnia Metacognitive Beliefs Anxiety Depression Sleep

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Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Insomnia After the COVID-19 Pandemic
Estimated Study Start Date : June 22, 2020
Estimated Primary Completion Date : July 13, 2020
Estimated Study Completion Date : July 13, 2020



Primary Outcome Measures :
  1. Bergen insomnia scale (BIS) [ Time Frame: Data is set to be collected starting from 22th of June. The data collection period will last no longer than three weeks depending on the response to the questionnaire ]
    Bergen Insomnia scale is developed as a short measure of insomnia consisting of six items measured on a 8-point Likert-scale (Pallesen et al., 2008)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
The general population in Norway.
Criteria

Inclusion Criteria:

  • 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 had provided digital consent to partake in the study.

Exclusion Criteria:

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


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): NCT04443361


Contacts
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Contact: Sverre Urnes Johnson, PhD 41633313 s.u.johnson@psykologi.uio.no
Contact: Omid Ebrahimi, Mr omideb@uio.no

Sponsors and Collaborators
University of Oslo
Modum Bad Psychiatric Center
Investigators
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Principal Investigator: Asle Hoffart, PhD University of Oslo & Modum Bad
Principal Investigator: Omid Ebrahimi, Mr University of Oslo & Modum Bad
Principal Investigator: Sverre Urnes Johnson, PhD University of Oslo & Modum Bad
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Responsible Party: Sverre Urnes Johnson, Associate Professer Sverre Urnes Johnson, University of Oslo
ClinicalTrials.gov Identifier: NCT04443361    
Other Study ID Numbers: REK125510 (7)
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
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders