InsomniaNCT04443361
Insomnia After the COVID-19 Pandemic
An observational study of Insomnia and Metacognitive Beliefs, run by University of Oslo.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia, Metacognitive Beliefs, Anxiety
- How many people
- 5,000 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: The general population in Norway.
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 had provided 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.
Omid Ebrahimi, Mr contact
About this study
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.
Read the detailed description
Hypothesis/Research Questions H1: What is the level of mental insomnia 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 insomnia will be benchmarked against the mean level of insomnia in similar pre-pandemic samples.
Exploratory: What is the level of insomnia in different demographic subgroups.
H2: The level of metacognition, strategies, worry about job and economy, health-anxiety and physical activity at T2 will predict insomnia at T2, beyond and above, age, gender, and education.
Exploratory: Does metacognition, strategies, worry about job and economy, health-anxiety and physical activity at T1 predict Insomnia at T2, beyond and above psychiatric diagnosis, age, gender, and education and predictors at T2?
Statistical analysis:
A hierarchical regression analysis will be conducted using BIS as the dependent variable. In the first step stable characteristics (control variables) will be included: age, gender and education. In the second step metacognition, strategies, worry about job and economy, health-anxiety and physical activity at T2 will be included. Part-correlation will be reported for step 2, presenting the effect size of the predictors on insomnia. In the third step, anxiety and depression at T2 will be included as control for the variables at the next step. In the last step metacognition, strategies, worry about job and economy, health-anxiety and physical activity, 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 and SDs and other standard descriptive statistics will be used to examine the level of insomnia. Subgroup differences will be examined with chi-squared statistics or other statistic based on the characteristics of the data (e.g. skewness).
All analysis and questions addressed in the forthcoming paper that are not pre-specificd in this pre-registered protocol will be defined as exploratory.
Sensitivity analyses and random subsample replications of the main finding will be conducted following selection of a random sample of participants that ensure a proportional ratio between the collected sample and the adult population in Norway
Measures On the CAS1 four items were combined into the subscale "positive metacognition", four items were combined into the subscale "negative metacognition", and 8 items were combined into the subscale strategies (Nordahl \& Wells, 2019). Physical activity was measured with a single item. Worry about job and economy consisted of two items. Health anxiety consists of four items.
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., multiple 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, alternatively the use of non-parametric tests.
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:
The present study is part of a larger project with the part aiming to investigate predictors of sleep trough regression analysis, and the second part aiming to examine directional relations among specific symptoms and their centrality through network analysis. Thus, the power calculations are based on power required for network analysis.
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.
Eligibility 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
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. We do not expect participants to withdraw their data and thus expect no missing data. However, if participants do withdraw their data, we will conduct state-of-art missing data analyses and investigate whether data is missing at random.
Exploratory:
Questions addressed in the future paper which is not pre-specified will be defined as exploratory.
- Conditions
- Insomnia, Metacognitive Beliefs, Anxiety, Depression, Sleep
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Anxiety Disorders, Depression
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
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.
- Other trials for InsomniaStudies 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
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Collaborators
- Modum Bad
- Responsible party
- Principal investigator, Sverre Urnes Johnson, University of Oslo
- Investigators
- Asle Hoffart, PhD, Principal investigator, University of Oslo & Modum BadOmid Ebrahimi, Mr, Principal investigator, University of Oslo & Modum BadSverre Urnes Johnson, PhD, Principal investigator, University of Oslo & Modum Bad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04443361
- Sponsor's protocol ID
- REK125510 (7)
- 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
- Individual data sharing
- No
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
- Insomnia After the COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT04443361
- Acronym / sponsor ID
- REK125510 (7)
- Conditions
- Insomnia, Metacognitive Beliefs, Anxiety, Depression, Sleep
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 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.
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.
Detailed description
Hypothesis/Research Questions H1: What is the level of mental insomnia 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 insomnia will be benchmarked against the mean level of insomnia in similar pre-pandemic samples.
Exploratory: What is the level of insomnia in different demographic subgroups.
H2: The level of metacognition, strategies, worry about job and economy, health-anxiety and physical activity at T2 will predict insomnia at T2, beyond and above, age, gender, and education.
Exploratory: Does metacognition, strategies, worry about job and economy, health-anxiety and physical activity at T1 predict Insomnia at T2, beyond and above psychiatric diagnosis, age, gender, and education and predictors at T2?
Statistical analysis:
A hierarchical regression analysis will be conducted using BIS as the dependent variable. In the first step stable characteristics (control variables) will be included: age, gender and education. In the second step metacognition, strategies, worry about job and economy, health-anxiety and physical activity at T2 will be included. Part-correlation will be reported for step 2, presenting the effect size of the predictors on insomnia. In the third step, anxiety and depression at T2 will be included as control for the variables at the next step. In the last step metacognition, strategies, worry about job and economy, health-anxiety and physical activity, 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 and SDs and other standard descriptive statistics will be used to examine the level of insomnia. Subgroup differences will be examined with chi-squared statistics or other statistic based on the characteristics of the data (e.g. skewness).
All analysis and questions addressed in the forthcoming paper that are not pre-specificd in this pre-registered protocol will be defined as exploratory.
Sensitivity analyses and random subsample replications of the main finding will be conducted following selection of a random sample of participants that ensure a proportional ratio between the collected sample and the adult population in Norway
Measures On the CAS1 four items were combined into the subscale "positive metacognition", four items were combined into the subscale "negative metacognition", and 8 items were combined into the subscale strategies (Nordahl \& Wells, 2019). Physical activity was measured with a single item. Worry about job and economy consisted of two items. Health anxiety consists of four items.
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., multiple 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, alternatively the use of non-parametric tests.
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:
The present study is part of a larger project with the part aiming to investigate predictors of sleep trough regression analysis, and the second part aiming to examine directional relations among specific symptoms and their centrality through network analysis. Thus, the power calculations are based on power required for network analysis.
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.
Eligibility 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
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. We do not expect participants to withdraw their data and thus expect no missing data. However, if participants do withdraw their data, we will conduct state-of-art missing data analyses and investigate whether data is missing at random.
Exploratory:
Questions addressed in the future paper which is not pre-specified will be defined as exploratory.
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
- The general population in Norway.
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 had provided digital consent to partake in the study.
Key exclusion criteria (1 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.
Primary outcome
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)
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.
- Individual participant dataSharing planned: No
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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, Mr contact
Asle Hoffart, PhD principal investigator
University of Oslo & Modum Bad
Omid Ebrahimi, Mr principal investigator
University of Oslo & Modum Bad
Sverre Urnes Johnson, PhD principal investigator
University of Oslo & Modum Bad
Questions about this trial
What is this clinical trial studying?
An observational study of Insomnia and Metacognitive Beliefs, 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 1 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 Sverre Urnes Johnson, PhD (41633313, s.u.johnson@psykologi.uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.