Post Traumatic Stress DisorderNCT04442243
PTSD Symptoms Among Health Workers and Public Service Providers After the COVID-19 Outbreak: A 3 Month Follow up
An observational study of Post Traumatic Stress Disorder and Anxiety, run by University of Oslo.
Trial summary
The aim of this study is to investigate the levels of trauma and mental symptoms (i.e., depression and anxiety) among health workers and public service providers 3 months after (T2) the strict social distancing government initiated non-pharmacological interventions (NPIs) related to the COVID-19 pandemic (T1), in a… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post Traumatic Stress Disorder, Anxiety, Depression
- How many people
- 889 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Vulnerable health-care or public service providers was in this sample defined as doctors, nurses, psychologists, and any other health-care workers, as well as politicians and social workers. The participants reported if they worked directly or indirectly with COVID-19 patients.
Who may be able to join
- Health care or public service providers above 18
Who cannot join
- None
Trial locations and contacts
No sites are listed yet.
Omid Ebrahimi contact
About this study
The aim of this study is to investigate the levels of trauma and mental symptoms (i.e., depression and anxiety) among health workers and public service providers 3 months after (T2) the strict social distancing government initiated non-pharmacological interventions (NPIs) related to the COVID-19 pandemic (T1), in a period of lifted distancing protocols. The study also aims to investigate predictors of trauma-symptoms, by analyzing how predictors measured during the COVID-19 pandemic are associated with change in PTSD symptoms from T1 to T2.
Read the detailed description
Hypotheses/Research questions:
H1: There will be a significant decrease in PTSD-symptoms, anxiety and depression from T1 to T2.
Exploratory: Examine the differences in levels of trauma, anxiety, depression and quality of life among different health workers, public service providers, demographic subgroups, and between those working directly vs indirectly with COVID-19 patients at T2. Examine the differences in change of trauma, anxiety and depression among different health workers, public service providers, demographic subgroups, and between those working directly vs indirectly with COVID-19 patients.
H2: Higher level at T1 and less reduction from T1 to T2 in metacognition, strategies, burnout, worry about job and economy, interpersonal problems at baseline will be associated with less reduction in PTSD-symptom from T1 to T2, above and beyond direct vs. indirect exposure to trauma, demographic variables (age and gender, living with a partner, living with children).
This study is part of 'The Norwegian COVID-19, Mental Health and Adherence Project', involving multiple studies.
Sample size The sample size at T1 was 1778 participants. The sample size at T2 is not yet clarified, but we expect 50% drop out.
Sample size rationale The mentioned 'Norwegian COVID-19 and Mental Health and Adherence Project' involves multiple studies, where some involve a Complex Systems (Network analysis approach). These multivariate analyses require large samples and power analysis was conducted accordingly. Following power analysis guidelines by Fried \& Cramer (2017), it is recommended that the number of participants be at the very least 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.
Stopping rule:
The data collection will start at June 22th and continue until as many as possible of 1778 respondents at T1 have submitted the questionnaire. The data-collection at T2 will be stopped after three weeks.
Indices:
Given Acceptable Cronbach's alpha (above 0.7) two items was combined to represent worry about work and economy. 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). Interpersonal problems consisted of 17 items selected from the IIP-64. Burnout was measured with a single item. Worry about job and economy were measured with two time-points.
Statistical models:
Descriptive statistics with frequency tables including N, mean and SDs or median and interquartile range depending on the data will be presented. A cut-off of 31 on the PCL-5 will be used together with the DSM-5 diagnostic guidelines applied to the PCL-5 to categorize participants as fulfilling the PTSD symptom criteria or not. Participants indicating scores of 2 or above on at least one of five re-experiencing symptoms, one of two avoidance symptoms, two of seven symptoms of negative alterations in cognition and mood and two of six arousal symptoms were classified as fulfilling the PTSD symptom criteria. Subclinical PTSD will be assessed by specifying how large part of the sample which fulfill parts of the PTSD-criterias, more specifically have at least one symptom above threshold (2 or above) in each symptom-group. The results will be benchmarked against national and international studies.
For PHQ-9, scores above 10 are considered as cut-off indicating that the patient is within the depressive area.
For GAD-7 a cut-off of 8 and above will be used.
Paired sample t-test or paired samples Wilcoxon Test will be used to compare the PTSD-symptoms at T2, depending on the nature of the data.
A One-way ANOVA or Kruskal-Wallis test, depending on level of skewness, will be conducted to exploratory investigate differences between the different types of health-workers (e.g. medical doctor and clinical psychologists) and public service providers (e.g., politicians, social security), working directly vs indirectly. If there is significant differences between the groups the investigators will either use a post hoc test, Tukey (HSD) or Dunn-Bonferroni, depending on wether a parametric or non-parametric test has been used.
Repeated surveys like the present one typically have a lot of drop out and missing data. Therefore, we will use mixed models instead of paired t-tests, repeated measures ANOVAs, and ordinary linear regression to analyze the majority of the data. Mixed models use maximum likelihood estimation, which is the state of the art approach to handle missing data (Schafer \& Graham, 2002). Especially if data are missing at random, which is likely in our survey, mixed models give more unbiased results than the other analytic methods (O'Connel et al., 2017).
In preliminary analyses, and for each of the dependent variables (PCL-5, GAD-7 and PHQ-9), 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. Akaike's 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). The program SPSS 25.0 will be used (IBM Corp, 2018).
First, H1 about decrease in PCL-5, GAD-7 and PHQ-9 will be tested by using anxiety or depression as dependent variable in a model using time (T1 period = 0, T2 period = 1) as a predictor. Second, demographic group variables will be added as predictors. Third, the initial (T1) levels of metacognition, strategies, burnout, worry about job and economy, interpersonal problems will be added, together with the interactions of these constant covariates with time. These interactions represent tests of H2 about the covariates predicting change in PTSD-symptoms. Finally, the T2 levels of metacognition, strategies, burnout, worry about job and economy, interpersonal problems as constant covariates will be added, 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 PTSD-symptoms from T1 to T2s.
Transformations Depending on degree of skewness compared to theoretical possibilities and interpretations, variables will be assessed in their original and validated format as is recommended practice, as long as this is possible. As this study examines psychopathology levels amongst a general population (and not a clinical population), we do expect a skewed data PTSD-symptoms on depressive and anxiety levels with most individuals reporting low levels of PTSD -symptoms.
We will attempt to assess these variables in their original and validated format as is recommended practice, as long as this is possible. However, if this is not possible to the statistical assumptions behind the analyses, transformation may be needed to apply interval-based methods. Alternatively a non-parametric test will be used.
Inference criteria
Given the large sample size in this study, we pre-define our significance level:
p < 0.01 to determine significance
Data exclusion:
All health care or public service provides above 18 are included in this study. Vulnerable health-care or public service providers - in this sample defined as doctors, nurses, psychologists, and any other health-care workers, as well as politicians and social workers. The participants reported if they worked directly or indirectly with COVID-19 patients.
Exploratory:
Questions addressed in the future paper which is not pre-specified will be defined as exploratory.
- Conditions
- Post Traumatic Stress Disorder, Anxiety, Depression
- Medical subject headings
- Stress Disorders, Post-Traumatic, Anxiety Disorders, Depression
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD Checklist for DSM-5 (PCL-5)
PCL-5 is a 20-item self-administered questionnaire which assesses the full domain of the DSM-5 PTSD diagnosis. The self-report rating scale is 0-4 for each symptom. Rating scale descriptors are: "Not at all," "A little bit," Moderately," "Quite a bit," and "Extremely."The PCL-5 has four subscales, corresponding to each of the symptom clusters in the DSM-5.
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
Secondary outcomes (3)
Patient Health Questionnaire 9 (PHQ-9)
The Patient Health Questionnaire 9 (PHQ-9; Kroenke, Spitzer \& Williams, 2001) is used to measure symptoms of depression in accordance with the diagnostic criteria for major depressive disorder. The questionnaire consists of nine items where each is scored on a four-point Likert scale (0-3), with the range of scores from 0 to 27.
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
Generalized Anxiety Disorder 7 (GAD-7)
The Generalized Anxiety Disorder 7 (GAD-7; Spitzer, Kroenke, Williams \& Löwe, 2006) is a questionnaire consisting of seven items measuring symptoms of anxiety and worry. The items are scored on a four-point Likert scale (0-3), with the scores ranging from 0 to 21.
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
The Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)
WEMWBS short version consist of 7 items
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 posted22 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 Post Traumatic Stress DisorderStudies 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
- 889 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
- Omid Ebrahimi, Mr, Principal investigator, University of Oslo & Modum BadAsle Hoffart, PhD, Principal investigator, University of Oslo & Modum Bad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04442243
- Sponsor's protocol ID
- REK125510 (4)
- Status last verified
- Jun 2020
- First submitted
- 19 Jun 2020
- Last updated
- 24 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 24 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PTSD Symptoms Among Health Workers and Public Service Providers After the COVID-19 Outbreak: A 3 Month Follow up
- ClinicalTrials.gov ID
- NCT04442243
- Acronym / sponsor ID
- REK125510 (4)
- Conditions
- Post Traumatic Stress Disorder, Anxiety, Depression
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 889 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
- 22 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 trauma and mental symptoms (i.e., depression and anxiety) among health workers and public service providers 3 months after (T2) the strict social distancing government initiated non-pharmacological interventions (NPIs) related to the COVID-19 pandemic (T1), in a period of lifted distancing protocols. The study also aims to investigate predictors of trauma-symptoms, by analyzing how predictors measured during the COVID-19 pandemic are associated with change in PTSD symptoms from T1 to T2.
Detailed description
Hypotheses/Research questions:
H1: There will be a significant decrease in PTSD-symptoms, anxiety and depression from T1 to T2.
Exploratory: Examine the differences in levels of trauma, anxiety, depression and quality of life among different health workers, public service providers, demographic subgroups, and between those working directly vs indirectly with COVID-19 patients at T2. Examine the differences in change of trauma, anxiety and depression among different health workers, public service providers, demographic subgroups, and between those working directly vs indirectly with COVID-19 patients.
H2: Higher level at T1 and less reduction from T1 to T2 in metacognition, strategies, burnout, worry about job and economy, interpersonal problems at baseline will be associated with less reduction in PTSD-symptom from T1 to T2, above and beyond direct vs. indirect exposure to trauma, demographic variables (age and gender, living with a partner, living with children).
This study is part of 'The Norwegian COVID-19, Mental Health and Adherence Project', involving multiple studies.
Sample size The sample size at T1 was 1778 participants. The sample size at T2 is not yet clarified, but we expect 50% drop out.
Sample size rationale The mentioned 'Norwegian COVID-19 and Mental Health and Adherence Project' involves multiple studies, where some involve a Complex Systems (Network analysis approach). These multivariate analyses require large samples and power analysis was conducted accordingly. Following power analysis guidelines by Fried \& Cramer (2017), it is recommended that the number of participants be at the very least 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.
Stopping rule:
The data collection will start at June 22th and continue until as many as possible of 1778 respondents at T1 have submitted the questionnaire. The data-collection at T2 will be stopped after three weeks.
Indices:
Given Acceptable Cronbach's alpha (above 0.7) two items was combined to represent worry about work and economy. 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). Interpersonal problems consisted of 17 items selected from the IIP-64. Burnout was measured with a single item. Worry about job and economy were measured with two time-points.
Statistical models:
Descriptive statistics with frequency tables including N, mean and SDs or median and interquartile range depending on the data will be presented. A cut-off of 31 on the PCL-5 will be used together with the DSM-5 diagnostic guidelines applied to the PCL-5 to categorize participants as fulfilling the PTSD symptom criteria or not. Participants indicating scores of 2 or above on at least one of five re-experiencing symptoms, one of two avoidance symptoms, two of seven symptoms of negative alterations in cognition and mood and two of six arousal symptoms were classified as fulfilling the PTSD symptom criteria. Subclinical PTSD will be assessed by specifying how large part of the sample which fulfill parts of the PTSD-criterias, more specifically have at least one symptom above threshold (2 or above) in each symptom-group. The results will be benchmarked against national and international studies.
For PHQ-9, scores above 10 are considered as cut-off indicating that the patient is within the depressive area.
For GAD-7 a cut-off of 8 and above will be used.
Paired sample t-test or paired samples Wilcoxon Test will be used to compare the PTSD-symptoms at T2, depending on the nature of the data.
A One-way ANOVA or Kruskal-Wallis test, depending on level of skewness, will be conducted to exploratory investigate differences between the different types of health-workers (e.g. medical doctor and clinical psychologists) and public service providers (e.g., politicians, social security), working directly vs indirectly. If there is significant differences between the groups the investigators will either use a post hoc test, Tukey (HSD) or Dunn-Bonferroni, depending on wether a parametric or non-parametric test has been used.
Repeated surveys like the present one typically have a lot of drop out and missing data. Therefore, we will use mixed models instead of paired t-tests, repeated measures ANOVAs, and ordinary linear regression to analyze the majority of the data. Mixed models use maximum likelihood estimation, which is the state of the art approach to handle missing data (Schafer \& Graham, 2002). Especially if data are missing at random, which is likely in our survey, mixed models give more unbiased results than the other analytic methods (O'Connel et al., 2017).
In preliminary analyses, and for each of the dependent variables (PCL-5, GAD-7 and PHQ-9), 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. Akaike's 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). The program SPSS 25.0 will be used (IBM Corp, 2018).
First, H1 about decrease in PCL-5, GAD-7 and PHQ-9 will be tested by using anxiety or depression as dependent variable in a model using time (T1 period = 0, T2 period = 1) as a predictor. Second, demographic group variables will be added as predictors. Third, the initial (T1) levels of metacognition, strategies, burnout, worry about job and economy, interpersonal problems will be added, together with the interactions of these constant covariates with time. These interactions represent tests of H2 about the covariates predicting change in PTSD-symptoms. Finally, the T2 levels of metacognition, strategies, burnout, worry about job and economy, interpersonal problems as constant covariates will be added, 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 PTSD-symptoms from T1 to T2s.
Transformations Depending on degree of skewness compared to theoretical possibilities and interpretations, variables will be assessed in their original and validated format as is recommended practice, as long as this is possible. As this study examines psychopathology levels amongst a general population (and not a clinical population), we do expect a skewed data PTSD-symptoms on depressive and anxiety levels with most individuals reporting low levels of PTSD -symptoms.
We will attempt to assess these variables in their original and validated format as is recommended practice, as long as this is possible. However, if this is not possible to the statistical assumptions behind the analyses, transformation may be needed to apply interval-based methods. Alternatively a non-parametric test will be used.
Inference criteria
Given the large sample size in this study, we pre-define our significance level:
p < 0.01 to determine significance
Data exclusion:
All health care or public service provides above 18 are included in this study. Vulnerable health-care or public service providers - in this sample defined as doctors, nurses, psychologists, and any other health-care workers, as well as politicians and social workers. The participants reported if they worked directly or indirectly with COVID-19 patients.
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
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Vulnerable health-care or public service providers was in this sample defined as doctors, nurses, psychologists, and any other health-care workers, as well as politicians and social workers. The participants reported if they worked directly or indirectly with COVID-19 patients.
Key inclusion criteria (1 listed)
- Health care or public service providers above 18
Key exclusion criteria (1 listed)
- None
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
PTSD Checklist for DSM-5 (PCL-5)
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
PCL-5 is a 20-item self-administered questionnaire which assesses the full domain of the DSM-5 PTSD diagnosis. The self-report rating scale is 0-4 for each symptom. Rating scale descriptors are: "Not at all," "A little bit," Moderately," "Quite a bit," and "Extremely."The PCL-5 has four subscales, corresponding to each of the symptom clusters in the DSM-5.
3 secondary outcomes
Patient Health Questionnaire 9 (PHQ-9)
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
Generalized Anxiety Disorder 7 (GAD-7)
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
The Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 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 contact
Omid Ebrahimi, Mr principal investigator
University of Oslo & Modum Bad
Asle Hoffart, PhD principal investigator
University of Oslo & Modum Bad
Questions about this trial
What is this clinical trial studying?
An observational study of Post Traumatic Stress Disorder and Anxiety, 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 1 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 24 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 (+47 41633313, sverreuj@psykologi.uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD Checklist for DSM-5 (PCL-5) (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 24 Jun 2020.