Ignite Creation Date:
2024-05-06 @ 2:50 PM
Last Modification Date:
2024-10-26 @ 1:38 PM
Study NCT ID:
NCT04442204
Status:
UNKNOWN
Last Update Posted:
2020-06-23
First Post:
2020-06-19
Brief Title:
Predictors and Mechanisms of Depression and Anxiety During the COVID-19 Pandemic
Sponsor:
University of Oslo
Organization:
University of Oslo
Study Overview
Official Title:
Predictors and Mechanisms of Depression and Anxiety During the COVID-19 Pandemic
Status:
UNKNOWN
Status Verified Date:
2020-06
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Study description
The present study seeks to investigate the predictors and maintaining mechanisms of depression and anxiety symptoms during the COVID-19 pandemic exactly 3 months following the strictest viral mitigation strategies initiated in Norway in response to the pandemic This is the time period where the major pandemic protocols are lifted in Norway following three months of strict pandemic mitigation protocols The study further aims to identify subgroups with highest levels of depressive and anxiety symptoms during the measurement period to identify vulnerable subgroups with maintained symptoms three months following the pandemic
Hypotheses and research questions
Research Question 1 What is the level of depressive and anxiety symptoms three months following the employment of the strict viral mitigation protocols ie physical distancing protocols in the general adult population What are the proportion above the validated cut-offs for depression and general anxiety Hypothesis 1 There will be a significant decrease in the levels of depression and anxiety symptoms from the baseline T1 with the strictest mitigation protocols to measurement the measurement period three months into pandemic T2 where major pandemic mitigation protocols are lifted Additionally there will be a significant decrease in the proportion of the sample meeting validated cut-offs for depression and anxiety from T1 to T2
Hypothesis 2 Higher level at T1 and less reduction from T1 to T2 in positive metacognitions negative metacognitions and unhelpful coping strategies all measured with CAS-1 will be related to less reduction in depression and anxiety above and beyond age gender and education Higher level at T1 and increases from T1 to T2 in physical activity and perceived competence will be related to greater reduction in depression and anxiety above and beyond age gender and education
Exploratory The investigators will further explore the proportion showing reliable change in depression and anxiety and investigate the differences in changes in depression and anxiety across different demographic subgroups in the sample
The present study seeks to investigate the predictors and maintaining mechanisms of depression and anxiety symptoms during the COVID-19 pandemic exactly 3 months following the strictest viral mitigation strategies initiated in Norway in response to the pandemic This is the time period where the major pandemic protocols are lifted in Norway following three months of strict pandemic mitigation protocols The study further aims to identify subgroups with highest levels of depressive and anxiety symptoms during the measurement period to identify vulnerable subgroups with maintained symptoms three months following the pandemic
Hypotheses and research questions
Research Question 1 What is the level of depressive and anxiety symptoms three months following the employment of the strict viral mitigation protocols ie physical distancing protocols in the general adult population What are the proportion above the validated cut-offs for depression and general anxiety Hypothesis 1 There will be a significant decrease in the levels of depression and anxiety symptoms from the baseline T1 with the strictest mitigation protocols to measurement the measurement period three months into pandemic T2 where major pandemic mitigation protocols are lifted Additionally there will be a significant decrease in the proportion of the sample meeting validated cut-offs for depression and anxiety from T1 to T2
Hypothesis 2 Higher level at T1 and less reduction from T1 to T2 in positive metacognitions negative metacognitions and unhelpful coping strategies all measured with CAS-1 will be related to less reduction in depression and anxiety above and beyond age gender and education Higher level at T1 and increases from T1 to T2 in physical activity and perceived competence will be related to greater reduction in depression and anxiety above and beyond age gender and education
Exploratory The investigators will further explore the proportion showing reliable change in depression and anxiety and investigate the differences in changes in depression and anxiety across different demographic subgroups in the sample
Detailed Description:
Hypotheses and research questions
Research Question 1 What is the level of depressive and anxiety symptoms three months following the employment of the strict viral mitigation protocols ie physical distancing protocols in the general adult population What are the proportion above the validated cut-offs for depression and general anxiety Hypothesis 1 There will be a significant decrease in the levels of depression and anxiety symptoms from the baseline T1 with the strictest mitigation protocols to measurement the measurement period three months into pandemic T2 where major pandemic mitigation protocols are lifted Additionally there will be a significant decrease in the proportion of the sample meeting validated cut-offs for depression and anxiety from T1 to T2
Hypothesis 2 Higher level at T1 and less reduction from T1 to T2 in positive metacognitions negative metacognitions and unhelpful coping strategies all measured with CAS-1 will be related to less reduction in depression and anxiety above and beyond age gender and education Higher level at T1 and increases from T1 to T2 in physical activity and perceived competence will be related to greater reduction in depression and anxiety above and beyond age gender and education
Explorative The investigators will further explore the proportion showing reliable change in depression and anxiety and investigate the differences in changes in depression and anxiety across different demographic subgroups in the sample
Statistical analyses
Repeated surveys like the present one typically have missing data Therefore The investigators will use mixed models instead of paired t-tests repeated measures ANOVAs and ordinary linear regression to analyze the data Mixed models use maximum likelihood estimation the state of the art approach in handling missing data Schafer Graham 2002 Particularly if data are missing at random which is likely in our survey mixed models present more unbiased results than the other analytic methods OConnel et al 2017 Depression and anxiety will be used as dependent variables in two separate mixed models
In preliminary analyses and for each of the dependent variable PHQ-9 GAD-7 the combination of random effects and covariance structure of residuals that gives the best fit for the empty model the model without fixed predictors except the intercept will be chosen Akaikes Information Criterion AIC will used to compare the fit of different models Models that give a reduction in AIC greater than 2 will be considered better Burnham Anderson 2004
First H1 about decrease in GAD-7 and PHQ-9 will be investigated by using PHQ-9 in one analysis and GAD-7 in the other as dependent variable in a model using time T1 0 T2 1 as a predictor Second demographic control variables will be added as predictors Third the initial T1 levels of negative metacognitions positive metacognitions unhelpful coping strategies physical activity and perceived competence to deal with the crisis will be added as constant covariates together with the interactions of these constant covariates with time These interactions represent tests of H2 about the covariates predicting change in anxiety and depression respectively Finally the present T2 levels of negative metacognitions positive metacognitions unhelpful coping strategies physical activity and perceived competence to deal with the crisis will be added as constant covariates together with the interactions of these constant covariates with time These interactions represent tests of H2 about the change in the covariates from T1 to T2 predicting change in depression and anxiety from T1 to T2 respectively
Descriptive statistics with frequency tables including N means and SDs and other standard descriptive statistics will examine the research question concerning general levels of depressive- and anxiety symptoms Subgroup differences will be examined with chi-squared statistics To investigate the percentage of individuals with depressive and anxiety symptoms common cut-offs are used including 10 on PHQ-9 Kroenke et al 2001 and 8 on GAD-7 Johnson Ulvenes Øktedalen Hoffart 2019
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 ie multiple regression However if this is not possible with regards to the statistical assumptions behind the analyses transformation eg 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 analyses include multiple regression as long as assumptions are 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 001 to determine significance
Sample size
The sample size at T1 included a representative and random selection 10 084 adult participants For the present study at T2 all participants will be invited to participate in accordance with the study plan The data collection period will continue for up to three weeks until as many of the participants at baseline have responded
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 provide digital consent to partake in the study
Exclusion Criteria
Children and adolescents individuals below 18
Adults not residing in Norway during the measurement period
Measures
Outcome variables include the following validated measures PHQ-9 and GAD-7 Predictor variables include the following validated measures positive metacognitions measured with CAS-1 subscale negative metacognitions measured with CAS-1 subscale unhelpful coping strategies also called strategies measured with CAS-1 subscale physical activity measure of number of times participant has been physically active for at least 30 minutes in an activity increasing pulse and leading to sweat for the past two weeks perceived competence to deal with the pandemic measured with Basic Psychological Needs and Frustration Scale a single item adapted for the ability to deal pandemic consequences rather than ability to deal with difficult situations in general
Age gender and education will be controlled for
Research Question 1 What is the level of depressive and anxiety symptoms three months following the employment of the strict viral mitigation protocols ie physical distancing protocols in the general adult population What are the proportion above the validated cut-offs for depression and general anxiety Hypothesis 1 There will be a significant decrease in the levels of depression and anxiety symptoms from the baseline T1 with the strictest mitigation protocols to measurement the measurement period three months into pandemic T2 where major pandemic mitigation protocols are lifted Additionally there will be a significant decrease in the proportion of the sample meeting validated cut-offs for depression and anxiety from T1 to T2
Hypothesis 2 Higher level at T1 and less reduction from T1 to T2 in positive metacognitions negative metacognitions and unhelpful coping strategies all measured with CAS-1 will be related to less reduction in depression and anxiety above and beyond age gender and education Higher level at T1 and increases from T1 to T2 in physical activity and perceived competence will be related to greater reduction in depression and anxiety above and beyond age gender and education
Explorative The investigators will further explore the proportion showing reliable change in depression and anxiety and investigate the differences in changes in depression and anxiety across different demographic subgroups in the sample
Statistical analyses
Repeated surveys like the present one typically have missing data Therefore The investigators will use mixed models instead of paired t-tests repeated measures ANOVAs and ordinary linear regression to analyze the data Mixed models use maximum likelihood estimation the state of the art approach in handling missing data Schafer Graham 2002 Particularly if data are missing at random which is likely in our survey mixed models present more unbiased results than the other analytic methods OConnel et al 2017 Depression and anxiety will be used as dependent variables in two separate mixed models
In preliminary analyses and for each of the dependent variable PHQ-9 GAD-7 the combination of random effects and covariance structure of residuals that gives the best fit for the empty model the model without fixed predictors except the intercept will be chosen Akaikes Information Criterion AIC will used to compare the fit of different models Models that give a reduction in AIC greater than 2 will be considered better Burnham Anderson 2004
First H1 about decrease in GAD-7 and PHQ-9 will be investigated by using PHQ-9 in one analysis and GAD-7 in the other as dependent variable in a model using time T1 0 T2 1 as a predictor Second demographic control variables will be added as predictors Third the initial T1 levels of negative metacognitions positive metacognitions unhelpful coping strategies physical activity and perceived competence to deal with the crisis will be added as constant covariates together with the interactions of these constant covariates with time These interactions represent tests of H2 about the covariates predicting change in anxiety and depression respectively Finally the present T2 levels of negative metacognitions positive metacognitions unhelpful coping strategies physical activity and perceived competence to deal with the crisis will be added as constant covariates together with the interactions of these constant covariates with time These interactions represent tests of H2 about the change in the covariates from T1 to T2 predicting change in depression and anxiety from T1 to T2 respectively
Descriptive statistics with frequency tables including N means and SDs and other standard descriptive statistics will examine the research question concerning general levels of depressive- and anxiety symptoms Subgroup differences will be examined with chi-squared statistics To investigate the percentage of individuals with depressive and anxiety symptoms common cut-offs are used including 10 on PHQ-9 Kroenke et al 2001 and 8 on GAD-7 Johnson Ulvenes Øktedalen Hoffart 2019
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 ie multiple regression However if this is not possible with regards to the statistical assumptions behind the analyses transformation eg 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 analyses include multiple regression as long as assumptions are 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 001 to determine significance
Sample size
The sample size at T1 included a representative and random selection 10 084 adult participants For the present study at T2 all participants will be invited to participate in accordance with the study plan The data collection period will continue for up to three weeks until as many of the participants at baseline have responded
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 provide digital consent to partake in the study
Exclusion Criteria
Children and adolescents individuals below 18
Adults not residing in Norway during the measurement period
Measures
Outcome variables include the following validated measures PHQ-9 and GAD-7 Predictor variables include the following validated measures positive metacognitions measured with CAS-1 subscale negative metacognitions measured with CAS-1 subscale unhelpful coping strategies also called strategies measured with CAS-1 subscale physical activity measure of number of times participant has been physically active for at least 30 minutes in an activity increasing pulse and leading to sweat for the past two weeks perceived competence to deal with the pandemic measured with Basic Psychological Needs and Frustration Scale a single item adapted for the ability to deal pandemic consequences rather than ability to deal with difficult situations in general
Age gender and education will be controlled for
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None