NCT04443361

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.

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
5,000

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2020

Completed
3 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 19, 2020

Last Update Submit

June 22, 2020

Conditions

InsomniaMetacognitive BeliefsAnxietyDepressionSleep

Outcome Measures

Primary Outcomes (1)

  • Bergen insomnia scale (BIS)

    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)

    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

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The general population in Norway.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersAnxiety DisordersDepression

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersBehavioral SymptomsBehavior

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sverre Urnes Johnson, PhD

CONTACT

41633313s.u.johnson@psykologi.uio.no

Omid Ebrahimi, Mr

CONTACT

omideb@uio.no

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professer Sverre Urnes Johnson

Study Record Dates

First Submitted

June 19, 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