key: cord-0956476-c7ypnx2o
authors: Okajima, Isa; Chung, Seockhoon; Suh, Sooyeon
title: Validation of the Japanese-version Stress and Anxiety to Viral Epidemics-9 (SAVE-9) and relationship among stress, insomnia, anxiety, and depression in healthcare workers exposed to coronavirus disease 2019(1)
date: 2021-06-29
journal: Sleep Med
DOI: 10.1016/j.sleep.2021.06.035
sha: 0f1eb949fcf3c87b2e3c5ac560caabf48bf498e7
doc_id: 956476
cord_uid: c7ypnx2o

OBJECTIVE: This study aimed to validate the Japanese version of the 9-item Stress and Anxiety to Viral Epidemics scale (SAVE-9) and the relationships among the stress related to viral epidemics, insomnia, anxiety, and depression. PATIENTS/METHODS: A cross-sectional questionnaire-based study was conducted online. In total, 1000 healthcare workers (579 men, 421 women; mean age: 43.11 ± 11.69 years) were asked to complete the SAVE-9, Athens Insomnia Scale, Generalized Anxiety Disorder-7 Scale, and Center for Epidemiological Studies Depression Scale. For the analysis, participants were divided into two groups: healthcare workers at a medical institution designated for COVID-19 (COVID institution) and those working at an institution not designated for COVID-19 (non-COVID institution). RESULTS: Item response theory analysis showed that the SAVE-9 and SAVE-6 (6-item version) had good structural validity and internal consistency (ω = 0.91 and 0.93). Correlation analysis for convergent validity showed a significant positive correlation between both the SAVE-9 and SAVE-6 and the other scales for insomnia, anxiety, and depression. In addition, both SAVE-9 and SAVE-6 scores were higher for workers in COVID institutions than for those in non-COVID institutions. Furthermore, stress related to viral epidemics was found to directly affect anxiety (β = 0.48) and depression (β = 0.25) and indirectly affect anxiety (β = 0.37) and depression (β = 0.54) via insomnia (β = 0.33). CONCLUSIONS: This study confirmed that the reliability and validity of both the SAVE-9 and SAVE-6 and that insomnia mediated the effects of stress to viral epidemics on anxiety and depression symptoms.

during the COVID-19 pandemic reported the prevalence rates to be 22.8%, 23.2%, and 38.9%, 24 respectively [8] . Thus, many people exposed to unknown viral infections such as COVID-19 25 have experienced fear, insomnia, anxiety, depression, and other psychological difficulties. In 26 particular, it showed that insomnia is a significant predictor for the onset of depression (OR = 27 2.83) and anxiety (OR = 3. 23) in the meta-analytic study [9] . However, there has been a lack of 28 comprehensive measures in assessing fear of viral infection. 29

Recently, a scale was developed that measures anxiety related to viral epidemics [10] . 30

The Stress and Anxiety to Viral Epidemics (SAVE-9) scale is a 9-item self-reporting 31 questionnaire used to measure anxiety symptoms and work-related stress in response to a viral 32 epidemic among frontline healthcare workers [10] . The SAVE-9 assesses two factors: "anxiety 33 about the viral epidemic" (Items 1, 2, 3, 4, 5, and 8) and "work-related stress associated with the 34 viral epidemic" (Items 6, 7, and 9). The scale has previously demonstrated high internal 35 consistency (Cronbach's α = 0.80) and convergent validity for anxiety compared to the 36 Generalized Anxiety Disorder-7 scale (GAD-7; r = 0.51) and depression compared to the Patient 37 Health Questionnaire-9 (r = 0.41). Further, the "anxiety about the viral epidemic" factor, as a six-38 item version of the scale (SAVE-6), has been independently verified for reliability and validity in 39 a community sample [11] . 40

In Japan, there is currently no scale available to measure stress and anxiety related to 41 viral epidemics and few studies exist on the mental health effects of COVID-19 [12] . In addition, 42 there has been a lack of studies considering psychological responses among healthcare workers, 43 especially, studies distinguishing between those who work directly with COVID-19 patients 44 compared to those who do not. Therefore, this study aimed to develop a Japanese version of the 45 SAVE-9 and to examine a relationship among stress related to viral epidemics, insomnia, anxiety, 46 and depression in healthcare workers with and without direct contact with COVID-19 patients. 47 48 2 Material and methods 49

The study was approved by the Ethics Committee of Tokyo Kasei University (ID: Ita-50 2020-17, date: October 28, 2020). All study participants provided informed consent. 51

The data analyzed in this study were collected in December 2020. The study participants 53 were recruited by Rakuten Research, Inc., an online marketing research company that holds the 54 contact details of approximately 2.3 million Japanese survey respondents. An e-mail containing a 55 link to an online questionnaire was sent to individuals selected at random and stratified by 56 gender and age throughout Japan. The participants were 1000 healthcare workers (579 men, 421 57 women; mean age, 43.11 ± 11.69 years). Of them, 232 (124 men, 108 women, mean age: 47.19 ± 58 11.55 years) worked in medical institutions designated for COVID-19 (COVID institutions) and 59 768 (455 men, 313 women, mean age: 46.25 ± 11.71 years) worked in institutions not designated 60 for COVID-19 (non-COVID institutions). 61

The participants were asked to provide their age, gender, occupation, and duration of 64 employment at their current job. In addition, they were asked if they worked at a COVID 65 institution or a non-COVID institution. 66

The SAVE-9 is a validated 9-item self-report questionnaire that assesses anxiety 68 symptoms and work-related stress in response to viral epidemics [10, 11] . In addition to the 69 original version of SAVE-9, there is the 6-item (SAVE-6) previously used in community 70

samples [11] . The scores for both the SAVE-9 and SAVE-6 are summed independent of each 71 other, with higher scores indicating more anxiety and stress. 72

The Athens Insomnia Scale (AIS) is a validated 8-item self-report questionnaire that 74 assesses insomnia severity [13] [14] [15] . The score for the AIS is summed, with higher scores 75 indicating more severe insomnia. A cut-off score of 5.5 points for the AIS was previously 76 determined; therefore, in the present study, respondents with AIS scores of 6 or higher were 77 considered to have clinical insomnia [14] . 78

The GAD-7 is a validated 7-item self-report questionnaire that assesses the severity of 80 anxiety disorders [16, 17] . The scale has been recommended to assess anxiety symptoms as listed 81 in the DSM-5 [18]. The score for the GAD-7 is summed, with higher scores indicating more 82 anxiety. A cut-off score of 5 has previously been determined for the GAD-7 [16]; therefore, in 83 the present study, respondents with GAD-7 scores of 5 or higher were considered to have 84 psychopathological anxiety. 85

The Center for Epidemiological Studies Depression Scale (CES-D) is a validated 20-item 87 self-report questionnaire that assesses depressive symptoms [19, 20] . Scores for the CES-D are 88 summed, with higher scores reflecting higher levels of depression. A cut-off score of 16 points 89 J o u r n a l P r e -p r o o f has previously been determined for the CES-D [19] ; therefore, in the present study, respondents 90 with CES-D scores of 16 or higher were considered to have clinical depression. 91

The sample size was based on a power analysis conducted for the correlation coefficients (r) 93 between SAVE-9, GAD-7, and PHQ-9 in Chung's study [10] . Correlation coefficient between 94 SAVE-9 and GAD-7 was 0.51 (p < 0.001) and that between SAVE-9 and PHQ-9 was 0.41 (p < 95 0.001) in 1,019 participants. It was calculated that power (1-β) were both 1.00. Therefore, we 96 recruited a thousand participants. 97

We developed the SAVE-9-J after obtaining permission from the first and corresponding Second, the scale was back-translated from Japanese into English independently by two native 104 speakers of both Japanese and English. The two back-translations were reviewed and confirmed 105 to be acceptable by the original author. 106

Descriptive statistics were computed using R statistical software version 3.6.3 (R Project 108 for Statistical Computing, Vienna, Austria). To confirm the prevalence of clinical anxiety, 109 depression, and insomnia in participants working in either COVID or non-COVID institutions, 110

we conducted an χ 2 test, residual analysis, and phi coefficient (φ) analysis. In general, an 111 absolute g value of ≥ 0.1 indicates a small effect size, a value around 0.3 indicates a moderate 112 effect size, and a value ≥ 0.5 indicates a large effect size [21] . 113

We conducted item response theory (IRT) analysis using the "ltm" package [22] . An IRT 114 analysis allows for more precise examinations of the characteristics of each question than that 115 based on classical test theory (CTT). To clarify the availability of the IRT for the SAVE-9, the 116 discrimination parameters (a), boundary characteristic values (b i ), and difficulty parameters (b' i ) 117 of each item were evaluated using a graded response model [23] in the present analysis. 118

One of the most important assumptions of the application of IRT analysis is that it is 119 unidimensional. To confirm the unidimensionality of the SAVE-9, which is an ordinal scale, we 120 described the shape of the scree plot and conducted a polychoric correlation analysis for SAVE-9 121 items and a categorical factor analysis utilizing a maximum likelihood solution method. The item 122 response category characteristic curve (IRCCC), which relates the probability of an item 123 response to the underlying attribute (θ) and the test information function (TIF) were described to 124 confirm a response characteristic of each item. The internal consistency of the SAVE-9 was 125 evaluated using the McDonald's ω coefficient, which is the best measure of internal consistency 126

[24]. 127 Convergent validity was evaluated by correlation analysis of the SAVE-9-J with the 128 GAD-7, CES-D, and AIS. To evaluate concurrent validity, we compared differences in the 129 SAVE-9-J scores between COVID and non-COVID institutions using an unpaired two-tailed 130

Welch's t-test. We estimated the effect sizes of scales between the institutions using Hedges' g. 131

In general, an absolute g value of ≥ 0.2 indicates a small effect size, a value around 0.5 indicates 132 a moderate effect size, and a value ≥ 0.8 indicates a large effect size [21] . 

Demographic characteristics are presented in Table 1 . The most common occupation 144 among respondents were nurses (38%), followed by doctors (35%), and others (27%), including 145 a physical therapist, medical technologist, social worker, occupational therapist, speech-146 language-hearing therapist, and clinical therapist. The mean duration of employment at one's 147 current job was 12 years. The prevalence of psychopathological insomnia in the present sample 148 was 42.2% (COVID institutions vs. non-COVID institutions: 52% vs. 39%), anxiety was 47.1% 149 (59% vs. 43%), and depression was 33.1% (40% vs. 31%; Table 1 ). The results of the χ 2 test and 150 residual analysis showed that the proportions of participants with symptoms of 151 psychopathological insomnia, anxiety, and depression working in COVID institutions were 152 significantly larger than for those working in non-COVID institutions (all p < 0.05; Table 1) . 153

From the shape of a scree plot, the first eigenvalue (5.2) was found to be much greater 155 than the others (< 1.3), suggesting that a unidimensional model was reasonable for this example. 156

The results of a polychoric correlation analysis showed high correlation coefficients among 157 Items 1, 2, 3, 4, 5, and 8 (r = 0.54 to 0.87) and among Items 6, 7, and 9 (r = 0.50 to 0.66; 158 Supplement 1). In addition, the results of the categorical factor analysis showed that the 159 contribution ratio was 62.3% and factor loadings ranged from 0.53 to 0.95. The communality of 160 Items 1, 2, 3, 4, 5, and 8 was high (range: 0.57 to 0.91); however, it was relatively low for Items 161 6,7, and 9 (range: 0.28 to 0.38; Supplement 2). 162 

The correlation analysis for convergent validity showed a significant positive correlation 175 all ps < 0.001; Table 2) . 179

The means and standard deviations for scores in the COVID institutions (n = 232) and 180 non-COVID institutions (n = 768) are presented in Table 3 . The results of Welch's t-tests for 181 concurrent validity showed that total scores for the SAVE-9 (t 355 = 3.69, p < 0.001), SAVE-6 182 (t 368 = 3.65, p < 0.001), AIS (t 374 = 3.15, p = 0.002), GAD-7 (t 334 = 4.83, p < 0.001), and CES-D 183 (t 351 = 2.37, p = 0.002) were significantly higher in the COVID institutions than in the non-184 COVID institutions. Effect sizes were small for all scales (Headges' g: 0.19 to 0.40; Table 3 ). 185

The SEM results showed the hypothesized model ( The study aimed to develop a Japanese version of the SAVE-9 and assess its reliability 197 and validity. The findings indicated that both the 9-item (SAVE-9) and 6-item (SAVE-6) scales 198 were viable, as both were shown to have high reliability and validity. Based on the results of IRT analysis, the discrimination of all items of the SAVE-9 was 206 more than 1. However, according to the results of the IRCCCs, the SAVE-6 is more 207 discriminative than the SAVE-9. The original version of the SAVE-9 was constructed with two 208 factors, while the SAVE-6 comprises the items of Factor 1 [10]. In addition, the reliability and 209 validation of the SAVE-6 was previously confirmed in a community sample [11] . The fact that 210 the same structure was used in Japan and Korea might indicate that this is a measure that 211 transcends cultural differences. In the future, it is necessary to examine the factor structure in 212 various countries for cross-cultural validation. 213

The correlation analysis showed a significant positive moderate correlation between the 214 stress to viral epidemics (SAVE-9 and SAVE-6), insomnia (AIS), anxiety (GAD-7), and 215 depression (CES-D). The original version of the SAVE-9 was also positively moderately 216 associated with anxiety (r = 0.51) and depression (r = 0.41), except for insomnia [10] . Further, 217 scores for both SAVE-9 and SAVE-6 were higher among healthcare workers in medical 218 institutions designated for COVID-19 than in those not designated for COVID-19, which was 219 consistent with the findings of a previous study [7] . However, all effect sizes were low in the 220 present study. This could be because Lai et al. [7] conducted their study in the early stages of the 221 COVID-19 pandemic, whereas the present study was conducted as the pandemic was becoming 222 widespread. Therefore, it is highly likely that stress related to viral epidemics would have 223 increased, regardless of whether respondents worked in medical institutions designated for 224

The results of the SEM further revealed that stress related to viral epidemics could affect 226 anxiety and depression directly and indirectly via insomnia. In particular, this is the first study to 227 find that insomnia mediated the effects of stress to viral epidemics on anxiety and depression 228 symptoms. This result is consistent with previous studies which found that stress reactivity is a 229 vulnerability factor for insomnia and insomnia is a risk factor for anxiety and depression [9] [29] . However, this study has some limitations. First, as the study was conducted as an online 238 survey and participants were limited to healthcare workers, the findings might not be 239

representative of the general population in Japan. In particular, future studies to examine the 240 usefulness of the SAVE-6 should be conducted with community samples. 241

To our knowledge, this was the first study to develop the Japanese version of scales 243 measuring stress related to viral epidemics and use this measure to reveal the prevalence of 244 psychopathological insomnia, anxiety, and depression during the COVID-19 pandemic. As Items 245 6, 7, and 9 of the SAVE-9 are specific to work-related stress associated with viral epidemics, the 246 reliability and validity of the SAVE-6 were confirmed, thus indicating its usefulness for 247 examining the impact of COVID-19 on mental and physical health within the general population. Each of the five trace lines represents one of the five response options that were used to assess 260 for SAVE-9: 1 = "never", 2 = "rarely", 3 = "sometimes", 4 = "often", and 5 = "always". The first 

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