NCT04443699

Brief Summary

Study description: The present study seeks to investigate factors associated with well-being in the general population during the COVID-19 pandemic, three months following the introduction of the strict social distancing interventions in Norway. Hypotheses and research questions: Research Question 1: What is the level of mental well-being following three months of strict mitigation strategies (i.e., physical distancing) in the general adult population during the COVID-19 pandemic? The mean level of mental well-being will be benchmarked against the mean level of mental well-being in similar pre-pandemic samples. Hypothesis 1: Physical activity, being employed, positive metacognitions, negative metacognitions, and unhelpful coping strategies at T1 will significantly predict well-being (T2). Being employed and increased reports of physical activity at T2 will predict higher levels of mental well-being at the measurement period (T2) and serve as protective factors. Increased positive metacognitions, negative metacognitions and unhelpful coping strategies measured with CAS-1 at T2 will predict lower levels of well-being (T2). Additionally, we will examine whether the obtained predictive relationships hold when depressive symptoms (PHQ-9) and anxiety symptoms (GAD-7) at T2 will be controlled for. Exploratory: Do the predictors physical activity, positive metacognitions, negative metacognitions, unhelpful coping strategies, all at baseline (T1), predict mental well-being at T2, beyond and above these same aforementioned predictors at T2 and age, gender, and education? In all predictive analyses, age, gender, and education will be controlled for. Exploratory: We will exploratory investigate the differences in levels of mental well-being across different demographic subgroups in the sample.

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
4,000

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 19, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • The Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS)

    • The Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS) (Tennant et al., 2007) is a measure consisting of items related entirely to positive aspects of mental health and is covering subjective well-being and psychological functioning. The scale consists of 7 items scored on a five-point Likert scale ranging from 'none of the time' to 'all of the time'.

    Data is set to be collected starting from 22nd of June until enough data has been collected. The data collection period will last no longer than three weeks

Interventions

Prospective study with two measurement points investigating the impact of viral mitigation protocols on mental health

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsBoth Biological Sex and self-representation of gender are measured
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All adults above 18 years residing in Norway and thus experiencing identical mitigation protocols are invited to participate the study, reaching randomly online with an equal opportunity of participating.

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 provide 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

Related Publications (1)

  • Ng Fat L, Scholes S, Boniface S, Mindell J, Stewart-Brown S. Evaluating and establishing national norms for mental wellbeing using the short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS): findings from the Health Survey for England. Qual Life Res. 2017 May;26(5):1129-1144. doi: 10.1007/s11136-016-1454-8. Epub 2016 Nov 16.

    PMID: 27853963BACKGROUND

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Prospective Studies

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Intervention Hierarchy (Ancestors)

Cohort StudiesEpidemiologic StudiesEpidemiologic Study CharacteristicsEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Omid Ebrahimi, Double PhD Candidate

    University of Oslo

    PRINCIPAL INVESTIGATOR
  • Sverre Urnes Sverre Urnes, PhD

    University of Oslo

    PRINCIPAL INVESTIGATOR
  • Hoffart Hoffart, PhD

    Modum Bad

    PRINCIPAL INVESTIGATOR
  • Sara Ebling, Cand.psychol. stud.

    University of Bergen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Omid Ebrahimi, Double PhD Candidate

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mr.

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