Mental Well-beingNCT04443699
Predictors of Mental Well-being During the COVID-19 Pandemic
An observational study of Mental Well-being, run by University of Oslo.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Well-being
- What is being tested?
- Prospective study with two measurement points investigating the impact of viral mitigation protocols on mental health
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 4,000 participants
- Where
- No sites listed yet
- Study dates
- 22 Jun 2020to 13 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Children and adolescents (individuals below 18)
- Adults not residing in Norway during the measurement period
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read more
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.
Read the detailed description
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: The investigators will exploratory investigate the differences in levels of mental well-being across different demographic subgroups in the sample.
Statistical analysis:
A hierarchical regression analysis will be conducted with SWEMWBS as the dependent variable. In the first step stable characteristics (control variables) will be included: age, gender and education. In the second step physical activity, being employed, positive metacognitions, negative metacognitions, and unhelpful coping strategies at T2 will be included. Part correlations will be examined for each step, presenting the effect size of the hypothesized predictors on mental well-being. In the third step, anxiety and depression at T2 will be included as control variables. In the final step, physical activity, being employed, positive metacognitions, negative metacognitions, and unhelpful coping strategies at T1 will be included.
Multicollinearity and other statistical assumptions will be checked. Multicollinearity will be assessed with common guidelines (VIF < 5 and Tolerance > 0.2; Hocking, 2003; O'Brian, 2007).
Descriptive statistics with frequency tables including N, means, SDs and other standard descriptive statistics will examine the research question concerning general levels of mental well-being. Subgroup differences will be examined.
All analyses and questions addressed in the forthcoming paper that are not pre-specified in this pre-registered protocol will be defined as exploratory.
Sensitivity analyses and random subsample replications of the main findings will be conducted following selection of a random sample of participants that ensure a proportionate ratio between the collected sample and the adult population of Norway.
Possible transformations:
All variables will be assessed in their original and validated format as is recommended practice, as long as this is possible with regards to statistical assumptions underlying the pre-defined analyses (i.e., hierarchical regression). However, if this is not possible with regards to the statistical assumptions behind the analyses, transformation (e.g., square root or log-transformations) may be needed to apply interval-based methods. The investigators will examine the degree of skewness and evaluate this against the assumptions and analyses before choosing the appropriate analysis. The pre-registered and planned analysis include hierarchical regression as long as assumptions underlying this analysis is met. Alternatively, a non-parametric test will be used.
Inference criteria Given the large sample size in this study, the investigators pre-define their significance level: p < 0.01 to determine significance.
Sample size and power calculation:
The present study is part of a larger project with the first part aiming to investigate predictors of mental well-being through regression analyses, and the second part aiming to examine directional relations amongst specific symptoms and their centrality through complex systems approaches (i.e., network analysis). Consequently, power calculations are based on power required for network analyses. Following power analysis guidelines by Fried \& Cramer (2017), it is recommended that the number of participants are three times larger than the number of estimated parameters. However, more conservative recommendations by Roscoe (1975) for multivariate research, recommends sample size that is ten times larger than the number of estimated parameters. Thus, following these two approaches respectively, between 1584 to 5280 participants are required. Data will be collected for three weeks, and participants are based on a representative and random sample of Norwegian adults, randomly selected and provided equal opportunity to partake in the study, providing digital consent.
Missing data:
The TSD system (Services for Sensitive Data), a platform used in Norway to store person-sensitive data verifies participants officially through a kind of national ID number to give them full right to withdraw their data at any time, following the European GDPR (General Data Protection Regulation) laws. Accordingly, participants are allowed to withdraw their own data at any time. The survey includes mandatory fields of response. Participation is voluntarily, and withdrawal of provided data is possible at any moment. The investigators do not expect participants to withdraw their data and thus expect no missing data. However, if participants do withdraw their data, the investigators will conduct state-of-art missing data analyses and investigate whether data is missing at random.
- Conditions
- Mental Well-being
- Being tested
- Prospective study with two measurement points investigating the impact of viral mitigation protocols on mental health
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prospective study with two measurement points investigating the impact of viral mitigation protocols on mental healthBehavioural
Prospective study with two measurement points investigating the impact of viral mitigation protocols on mental health
What is being measured
The primary outcome is the main question the study is designed to answer.
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'.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study start22 Jun 2020 (estimated)
- Primary completion13 Jul 2020 (estimated)
- Study completion13 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental Well-beingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Collaborators
- Modum Bad
- Responsible party
- Principal investigator, Omid V. Ebrahimi, University of Oslo
- Investigators
- Omid Ebrahimi, Double PhD Candidate, Principal investigator, University of OsloSverre Urnes Sverre Urnes, PhD, Principal investigator, University of OsloHoffart Hoffart, PhD, Principal investigator, Modum BadSara Ebling, Cand.psychol. stud., Principal investigator, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04443699
- Sponsor's protocol ID
- REK125510-12
- Status last verified
- Jun 2020
- First submitted
- 19 Jun 2020
- Last updated
- 23 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 27853963
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Mental Well-being During the COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT04443699
- Acronym / sponsor ID
- REK125510-12
- Conditions
- Mental Well-being
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Collaborators
- Modum Bad
- Study start
- 22 Jun 2020 (estimated)
- Primary completion
- 13 Jul 2020 (estimated)
- Study completion
- 13 Jul 2020 (estimated)
- First posted
- 23 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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: The investigators will exploratory investigate the differences in levels of mental well-being across different demographic subgroups in the sample.
Statistical analysis:
A hierarchical regression analysis will be conducted with SWEMWBS as the dependent variable. In the first step stable characteristics (control variables) will be included: age, gender and education. In the second step physical activity, being employed, positive metacognitions, negative metacognitions, and unhelpful coping strategies at T2 will be included. Part correlations will be examined for each step, presenting the effect size of the hypothesized predictors on mental well-being. In the third step, anxiety and depression at T2 will be included as control variables. In the final step, physical activity, being employed, positive metacognitions, negative metacognitions, and unhelpful coping strategies at T1 will be included.
Multicollinearity and other statistical assumptions will be checked. Multicollinearity will be assessed with common guidelines (VIF < 5 and Tolerance > 0.2; Hocking, 2003; O'Brian, 2007).
Descriptive statistics with frequency tables including N, means, SDs and other standard descriptive statistics will examine the research question concerning general levels of mental well-being. Subgroup differences will be examined.
All analyses and questions addressed in the forthcoming paper that are not pre-specified in this pre-registered protocol will be defined as exploratory.
Sensitivity analyses and random subsample replications of the main findings will be conducted following selection of a random sample of participants that ensure a proportionate ratio between the collected sample and the adult population of Norway.
Possible transformations:
All variables will be assessed in their original and validated format as is recommended practice, as long as this is possible with regards to statistical assumptions underlying the pre-defined analyses (i.e., hierarchical regression). However, if this is not possible with regards to the statistical assumptions behind the analyses, transformation (e.g., square root or log-transformations) may be needed to apply interval-based methods. The investigators will examine the degree of skewness and evaluate this against the assumptions and analyses before choosing the appropriate analysis. The pre-registered and planned analysis include hierarchical regression as long as assumptions underlying this analysis is met. Alternatively, a non-parametric test will be used.
Inference criteria Given the large sample size in this study, the investigators pre-define their significance level: p < 0.01 to determine significance.
Sample size and power calculation:
The present study is part of a larger project with the first part aiming to investigate predictors of mental well-being through regression analyses, and the second part aiming to examine directional relations amongst specific symptoms and their centrality through complex systems approaches (i.e., network analysis). Consequently, power calculations are based on power required for network analyses. Following power analysis guidelines by Fried \& Cramer (2017), it is recommended that the number of participants are three times larger than the number of estimated parameters. However, more conservative recommendations by Roscoe (1975) for multivariate research, recommends sample size that is ten times larger than the number of estimated parameters. Thus, following these two approaches respectively, between 1584 to 5280 participants are required. Data will be collected for three weeks, and participants are based on a representative and random sample of Norwegian adults, randomly selected and provided equal opportunity to partake in the study, providing digital consent.
Missing data:
The TSD system (Services for Sensitive Data), a platform used in Norway to store person-sensitive data verifies participants officially through a kind of national ID number to give them full right to withdraw their data at any time, following the European GDPR (General Data Protection Regulation) laws. Accordingly, participants are allowed to withdraw their own data at any time. The survey includes mandatory fields of response. Participation is voluntarily, and withdrawal of provided data is possible at any moment. The investigators do not expect participants to withdraw their data and thus expect no missing data. However, if participants do withdraw their data, the investigators will conduct state-of-art missing data analyses and investigate whether data is missing at random.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Children and adolescents (individuals below 18)
- Adults not residing in Norway during the measurement period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prospective study with two measurement points investigating the impact of viral mitigation protocols on mental healthProspective study with two measurement points investigating the impact of viral mitigation protocols on mental health | Behavioural | – |
Primary outcome
The Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS)
Time frame: 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
• 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'.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2020.
- Background: PubMed 27853963Ng 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Omid Ebrahimi, Double PhD Candidate principal investigator
University of Oslo
Sverre Urnes Sverre Urnes, PhD principal investigator
University of Oslo
Hoffart Hoffart, PhD principal investigator
Modum Bad
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Well-being, run by University of Oslo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Omid Ebrahimi, Double PhD Candidate (+47-22845295, omideb@uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS) (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04443699, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2020.