Acta Neurol Scand 2016: 134: 458–466 DOI: 10.1111/ane.12564 © 2016 John Wiley & Sons A/S.

s A/S. Published by John Wiley & Sons Ltd

ACTA NEUROLOGICA
SCANDINAVICA

Anxiety in Multiple Sclerosis:

psychometric properties of the State-Trait
Anxiety Inventory
Santangelo G, Sacco R, Siciliano M, Bisecco A, Muzzo G, Docimo R, G. Santangelo1,2, R. Sacco3,
De Stefano M, Bonavita S, Lavorgna L, Tedeschi G, Trojano L, M. Siciliano1, A. Bisecco3,
Gallo A. Anxiety in Multiple Sclerosis: psychometric properties of the G. Muzzo3, R. Docimo3,
State-Trait Anxiety Inventory. M. De Stefano3, S. Bonavita3,
Acta Neurol Scand 2016: 134: 458–466. L. Lavorgna3, G. Tedeschi2,3,
© 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.
L. Trojano1,4, A. Gallo3
1
Objective – The aims of the present study were to examine Department of Psychology, Second University of
psychometric properties of the Spielberger State-Trait Anxiety Naples, Caserta, Italy; 2IDC-Hermitage-Capodimonte,
Inventory (STAI-Y-1 and STAI-Y-2, respectively) in a Multiple Naples, Italy; 3MS Center, I Division of Neurology,
Dept of Medical, Surgical, Neurological, Metabolic and
Sclerosis (MS) population and to identify a cut-off score to detect
Aging Sciences, Second University of Naples, Naples,
those MS patients with high level of state and/or trait anxiety who
Italy; 4Salvatore Maugeri Foundation, Scientific
could be more vulnerable to development of depression and/or Institute of Telese, Telese Terme, Italy
cognitive defects. Material and methods – The STAI-Y-1 and STAI-Y-
2 was completed by a group of patients (n = 175) affected by MS and
a group of healthy subjects (n = 150) matched for age, educational Key words: multiple sclerosis; anxiety; depression;
level, and gender. In MS patients internal consistency, divergent and STAI-Y; cognitive deficits; validation
discriminant validities were evaluated. Construct validity was L. Trojano, Department of Psychology, Second
examined by exploratory factor analysis for each scale. Results – University of Naples, Caserta, Italy
There was no missing data, no floor or ceiling effects for both scales. Tel.: +39 0823274784
The two scales showed high internal consistency, good divergent, and Fax: +39 0823274774
Known-groups validities. To identify high levels of state and trait e-mail: luigi.trojano@unina2.it
and
anxiety in a patient with MS, we proposed three gender specific G. Santangelo, Department of Psychology, Second
screening cut-off values (1, 1.5, 2 SD) for the STAI-Y-1 and the University of Naples, Caserta, Italy
STAI-Y-2. Conclusions – The findings showed that the STAI-Y-1 and Tel.: +39 0823275328
the STAI-Y-2 are a valid tool for clinical use in MS patients and can Fax: +39 0823274774
be useful to measure the severity of anxiety and to identify those e-mail: gabriella.santangelo@unina2.it
patients with high anxiety to introduce them in specific non-
pharmacological intervention. Accepted for publication January 11, 2016

Recently, this condition has been found to be

Introduction
Multiple Sclerosis (MS) is characterized by physi-
cal symptoms, cognitive deficits, and behavioral
disturbances. Although prevalence rate of anxiety
symptoms in MS was estimated as high as 21.9%
(1), less attention has been paid to anxiety disor-
ders including generalized anxiety disorder and
social anxiety in MS patients. In particular, few
studies on MS took into account the basic dis-
tinction between state and trait anxiety (2–5).
State anxiety is defined as a transitory emotional
condition characterized by subjective, consciously
perceived feelings of tension and apprehension,
and by strong autonomic nervous system activity.
related to poorer performance on tasks for atten-
tion and information processing speed in MS
patients (2–5). Trait anxiety is defined, instead, as
a general tendency to respond with anxiety to
perceived threats in the environment, and as a
relatively stable characteristic of an individual.
Trait anxiety is thought to be related to a distinc-
tive cognitive style: highly anxious individuals
tend to perceive even moderate events as stressful
and to have strong neurophysiological responses
to threat or negative stimuli with consequent
activation of the hypothalamic-pituitary-adrenal
axis, increase of glucocorticoid levels and also
development of neurocognitive deficits (6, 7).

458

High anxiety trait has been identified as a vulner-
ability factor for depression in the general popu-
lation (8). In MS the relationships between
anxiety and depression are not well-established,
but a recent study revealed a relationship between
anxiety, self-reported stressful life events and
relapses in MS (9). Moreover, evidence of a sig-
nificant association between baseline personality
characteristics (i.e. a person’s tendency to experi-
ence negative affect, anxiety, and psychological
distress) and mood/anxiety disorders in MS sug-
gested that specific personality trait (i.e., anxiety
trait) could increase the likelihood of subsequent
mood changes (10). Taking into account such evi-
dence, early and accurate identification of high
levels of state and/or trait anxiety in MS patients
can thus contribute to optimal clinical manage-
ment of these patients.
Several rating scale can be used to screen and
assess severity of anxiety, but until now, their
psychometric properties in MS have been
explored only by two studies. O  Donnchadha
et al. (11) demonstrated that the Beck Anxiety
Inventory cannot be considered valid for screen-
ing anxiety in patients with MS, because of its
high reliance on presence of physical symptoms,
that could lead to overestimate anxiety prevalence
in MS patients. Honarmand and Feinstein (12)
assessed the Hospital Anxiety and Depression
Scale (HADS) in MS against the Diagnostic and
Statistical Manual of Mental Disorders (DSM)-
IV criteria, and provided a cut-off score for
identification of generalized anxiety disorder.
However, the authors underlined that the HADS
can be useful as a marker of generalized anxiety
disorder but not of other anxiety disorders. Thus
far, no scale assessing both state and trait anxiety
separately has been validated in MS patients.
The Spielberger State-Trait Anxiety Inventory
(STAI-Y) (13) has been specifically developed to
evaluate state and trait anxiety by means of two
parallel versions, the STAI-Y-1 and the STAI-Y-2,
respectively. The two versions can be used inde-
pendently from each other, have solid psychomet-
ric properties in the general population (14, 15),
and have been extensively used in research studies.
On this background, the present study aimed
to explore the psychometric properties of the
STAI-Y-1 and the STAI-Y-2 in MS sample, in
order to provide clinicians with a reliable instru-
ment to assess presence and severity anxiety, and
to develop prevention and intervention
approaches in MS patients.
Until now, normative data of STAI-Y scales
have been provided mainly in older adults (14,
15) and in general Australian adult population
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Anxiety in patients with Multiple Sclerosis
divided in two age groups (16). Since MS mainly
affects young adults, with mean age at onset of
30–40 years (17), we also aimed at identifying
cut-off scores applicable specifically to young
patients in order to evaluate anxiety early in the
disease course. To achieve this aim, we recruited
a group of healthy subjects matched for age, gen-
der, and education.
Materials and methods
Consecutive patients with diagnosis of MS
according to the revised McDonald criteria (18),
referred to our MS Center at the Second Univer-
sity of Naples were screened from 2011 to 2013.
Inclusion and exclusion criteria were: diagnosis
of MS according to revised McDonald criteria
(18); age ≥18; lack of concurrent severe medical
conditions; lack of current or past psychiatric
and neurological disorder other than MS (e.g.,
dementia according to DSM-V); no relapse and/
or corticosteroid therapy within 4 weeks of asse-
ssment.
Healthy controls (HCs) matched for age, gen-
der, and educational level were recruited among
patients’ friends, through employment facilities
and churches to obtain reference cut-off values
suggestive for relevant anxiety levels.
Demographic (age, gender, schooling) and clin-
ical (age at disease onset, disease duration, phar-
macological regimen) data were recorded.
All procedures performed in study involving
human participants were in accordance with the
ethical standards of the institutional and/or
national research committee and with the Decla-
ration of Helsinki 1964 and was approved by the
local ethics committee. Written informed consent
was obtained from all individual participants
included in the study.
Procedure
At enrollment all MS patients and HCs under-
went a clinical interview for collecting demo-
graphic data (as age, gender, schooling) and a
clinical interview based on DSM-V criteria for
diagnosis of depression; moreover, we recorded
patients’ age at disease onset, forms of MS, dis-
ease duration and pharmacological regimen. All
patients also underwent clinical evaluation,
including Expanded Disability Status Scale
(EDSS) to quantify MS disability.
All MS patients and HCs completed the Italian
version of the STAI-Y-1 and the STAI-Y-2. The
STAI-Y-1 consists of 20 statements that evaluate
how the respondent feels ‘right now, at this
459

Santangelo et al.
moment’. The STAI-Y-2 scale consists of twenty
statements that evaluate how the respondent feels
‘generally’. All items are scored on 4-point Likert
scale (to mean ‘not at all’, ‘somewhat’, ‘moder-
ately’, or ‘very much so’ for the STAI-Y-1; to
mean ‘almost never’, ‘sometimes’, ‘often’, ‘almost
always’ for STAI-Y-2); scoring is reversed for 10
STAI-Y-1 items and 9 STAI-Y-2 items. The total
score for both scales ranges from 20 to 80 (higher
scores indicate more severe anxiety).
To evaluate global cognitive status, MS
patients underwent the Rao’s Brief Repeatable
Battery (BRB) and the Stroop Color–Word Inter-
ference Test (SCWIT). The BRB includes the fol-
lowing five tasks: Selective Reminding test (SRT)
assessing verbal learning and recall; 10/36 Spatial
Recall Test (SPART), assessing visual learning
and recall (SPART-D); Symbol Digit Modalities
Test (SDMT) and Paced Auditory Serial Addi-
tion Test (PASAT) evaluating sustained attention
and information processing speed, respectively;
Word List Generation Test (WLG) assessing ver-
bal fluency on semantic stimulus. Executive func-
tions were assessed by means of the SCWIT,
added to the Italian version of the BRB.
All patients also completed the Fatigue Severity
Scale (FSS) to assess subjective fatigue; the Beck
Depression Inventory-II (BDI-II) and the Chicago
Multiscale Depression Inventory (CMDI) to assess
depressive symptoms. Moreover, functional auton-
omy was evaluated by a clinical interview including
questions about instrumental activities of daily liv-
ing. The references of questionnaires and cognitive
tests are reported in Supplemental Material.
Cognitive battery and behavioral scales (i.e.
FSS; BDI-II, CMDI) were administrated to
investigate the divergent validity of the STAI-Y
scales.
Statistical analysis
Percentage of missing or invalid items (<5% is an
index of acceptable data quality), mean, median,
skewness (criterion: 1 to +1) (19) and extent of
ceiling and floor effects (<15% were defined as
optimal) were computed to assess data quality
(20) of the STAI-Y-1 and the STAI-Y-2 scales.
Internal consistency of STAI-Y-1 and STAI-Y-
2 as evaluated by Cronbach’s alpha (21); a value
≥0.70 was considered as acceptable (22). Scaling
assumptions referring to the correct grouping of
items and the appropriateness of their summed
score were checked using corrected item-total cor-
relation (standard, ≥0.40; (23)).
Since the STAI-Y consists of two question-
naires, which assess current (state) anxiety and
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the general propensity to experience anxiety
(trait), we performed two separate Principal
Components Analysis (PCA) with varimax nor-
malized rotation to extract the components of
each scale (state and trait anxiety). Pearson corre-
lation coefficient was calculated to investigate the
association of total score of the STAI-Y-1 and of
the STAI-Y-2 with Component Scores.
To explore divergent validity of both scales,
correlation analysis (Pearson correlation coeffi-
cient) between the STAI-Y scales and cognitive
tests, FSS, BDI-II, CMDI were performed. Effect
size for the correlation coefficient was defined by
the following criteria: r < 0.3 weak; r = 0.3–0.5
moderate; r > 0.05 strong (24).
Precision was evaluated by computing the stan-
dard error of measurement (SEM); a SEM value
≤1⁄2 standard deviation was taken as the criterion
of acceptable precision (22).
To explore the known-group validity, we com-
pared anxiety scores in patients with mild
(EDSS ≤ 3) vs moderate or severe disability
(EDSS > 3).
Association between disease duration and anxi-
ety was evaluated by Pearson correlation coeffi-
cient.
Moreover, we computed the Discrimination
Index ‘D’ for each item of the STAI-Y-1 and the
STAI-Y-2 scales (25). Such an index reflects the
proportion of patients with high anxiety (i.e., a
score above the median) and with a high score (item
score 3 or 4) on a specific item, compared with the
proportion of patients with low anxiety and with a
high score on the same item. The index ‘D’ ranges
from +1 to 1; a Discrimination Index ≥0.40 is con-
sidered as an evidence of excellent item discrimina-
tive power, a ‘D’ ranging 0.30–0.39 is considered
good, values 0.29–0.20 are considered acceptable,
those below 0.20 are considered poor (25).
All analyses were performed using SPSS version
20, (SPSS Inc., Chicago, IL) with P value<0.05
considered statistically significant.
To identify high levels of trait and state anxiety
in MS patients, we used scores obtained in the
HC group matched for age, gender and educa-
tional level and computed several cut-off scores
based on 1, 1.5 and 2 standard deviations (SD)
above the mean for the two scales.
Results
The sample included 175 MS patients (122 female
and 53 male) and 150 HCs (105 females and 45
males) were enrolled (Table 1).
In MS sample, all data collected on the STAI-
Y-1 and the STAI-Y-2 were computable and
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Anxiety in patients with Multiple Sclerosis

Table 1 Characteristics of patients with Multiple Sclerosis (MS) and Healthy Table 2 Mean, standard deviation, and Item-total score correlation of STAI-Y-1
Subjects and STAI-Y-2

MS patients Healthy subjects Item-total

(n = 175) (n = 150) F P Standard score
Mean deviation correlation
Age (years) 38.6  10.8 39.6  13.6 0.543 0.462
Education (years) 12.6  3.9 13.1  4.1 1.106 0.294 STAI-Y-1
Gender (F/M) 122/53 105/45 0.003 0.955 Item 1. I fellcalm 2.58 0.860 0.532
STAI-Y-1 44.6  13.4 39.7  11.7 12.518 <0.001 Item 2. I fellsecure 2.38 0.907 0.603
STAI-Y-2 42  12 39.9  10.1 10.893 0.001 Item 3. I fell tense 2.26 1.005 0.596
Type of MS Item 4. I fellstrained 1.91 1.057 0.614
CIS 6 Item 5. I fell at ease 2.59 1.001 0.662
RR 147 Item 6. I fell upset 1.71 0.916 0.685
SP 16 Item 7. I am presently worrying 1.94 1.128 0.660
PP 6 over possible misfortunes
EDSS Median: 2 Item 8. I fell statisfied 2.57 0.938 0.665
Disease duration (years) 10.9  9.1 Item 9. I fell frightened 1.57 0.841 0.591
Treatment Item 10. I fell comfortable 2.42 0.906 0.571
First-line injectable 143 Item 11. I fell self-confident 2.39 0.927 0.639
DMDs* Item 12. I fell nervous 2.18 1.076 0.757
Second-line DMDs: 6 Item 13. Iam jittery 2.04 1.063 0.740
Natalizumab Item 14. I fell indecisive 1.85 0.989 0.640
Second-line DMDs: 6 Item 15. I am relaxed 2.63 0.949 0.714
Fingolimod Item 16. I fell content 2.58 0.905 0.617
No DMD 36 Item 17. I am worried 2.04 1.008 0.715
Item 18. I fell confused 1.80 1.017 0.713
F, Females; M, males; STAI-Y, Spielberger State-Trait Anxiety Inventory; CIS, Clini- Item 19. I fell steady 2.80 0.935 0.593
cally Isolated Syndrome; RR, Relapsing Remitting; SP, Secondary Progressive; PP, Item 20. I fell pleasant 2.42 0.918 0.657
Primary Progressive; DMD, disease modifying drug; *first-line injectable DMDs STAI-Y-2
(i.e. interferon-beta-1a/1b or glatiramer acetate) Item 21. I fell pleasant 2.18 0.941 0.596
Item 22. I fell nervous and restless 2.11 0.887 0.618
Item 23. I fell satisfied with myself 2.26 1.028 0.660
Item 24. I wish I could be as happy 2.21 1.138 0.568
there was no missing value. The mean STAI-Y-1 as others seem to be
was 44.65 and the median was 43 (difference Item 25. I fell like a failure 1.43 0.784 0.662
Item 26. I fell rested 2.82 0.914 0.553
between mean score and the median was 1.65). Item 27. I am ‘calm, cool, and collected’ 2.38 1.064 0.667
There was no floor or ceiling effect; skewness was Item 28. I fell that difficulties are piling 1.94 0.927 0.669
0.467. up so that I cannot overcome them
As for the STAI-Y-2, the mean was 43.51 and Item 29. I worry too much over something 2.30 1.048 0.490
that really doesn’t matter
the median was 42 (difference between mean Item 30. I am happy 2.15 0.973 0.650
score and the median was 1.51). There was no Item 31. I have disturbing thoughts 2.08 0.912 0.658
floor or ceiling effect; skewness was 0.005. Item 32. I lack self-confidence 1.94 1.018 0.661
Cronbach’s alpha was 0.942 and 0.931 for the Item 33. I feel secure 2.40 1.023 0.765
Item 34. I make decisions easily 2.49 1.028 0.503
STAI-Y-1 total score and for the STAI-Y-2 total Item 35. I fell inadequate 1.66 0.869 0.637
score, respectively. Item-total score correlation Item 36. I am content 2.28 0.963 0.696
analysis showed high correlation of all items with Item 37. Some unimportant thought runs 2.07 0.998 0.510
the total score for both the STAI-Y-1 and the through my mind and bothers me
Item 38. I take disappointments so keenly 2.17 1.029 0.585
STAI-Y-2 (Table 2). that I can’t put them out of my mind
As for the STAI-Y-1, PCA revealed that the Item 39. I am a steady person 2.23 0.961 0.475
three components with the highest eigenvalues Item 40. I get in a state of tension or 2.41 0.983 0.646
accounted for 64.2% of the total variance turmoil as I think over my recent concerns
and interests
(Table 3). Component 1 explained 47.7% of the
variance and included items 4, 6, 7, 9, 14, 17, 18
(Cronbach’s alpha = 0.896). Component 2
explained 10.8% of the variance and included Y-1 total score (Component 1: r = 0.650,
items 1, 2, 5, 8, 10, 11, 16, 20 (Cronbach’s P < 0.001; Component 2: r = 0.612, P < 0.001;
alpha = 0.897). Component 3, explaining 5.6% of Component 3: r = 0.449, P < 0.001).
the variance, included items representing physical As for the STAI-Y-2, PCA revealed the presence
aspects of state anxiety (items 3, 12, 13, 15, 19; of three components explaining 58.1% of the total
Cronbach’s alpha = 0.879). The above three com- variance (Table 3). These three components
ponents were correlated among them. All compo- explained 44%, 7.9%, and 6.1% of variance. Com-
nents were significantly correlated with the STAI- ponent 1 included items 21, 23–25, 28, 30, 35, 36

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Santangelo et al.

Table 3 Factor analysis of STAI-Y-1 and STAI-Y-2

Components

1 2 3

STAI-Y-1
Item 7. I am presently worrying over possible misfortunes 0.762 0.211 0.176
Item 6. I fell upset 0.754 0.210 0.231
Item 14. I fell indecisive 0.738 0.244 0.119
Item 4. I fell strained 0.717 0.130 0.251
Item 18. I fell confused 0.706 0.361 0.154
Item 9. I fell frightened 0.684 0.214 0.124
Item 17. I am worried 0.645 0.303 0.326
Item 11. I fell self-confident 0.267 0.787 0.052
Item 8. I fell statisfied 0.315 0.765 0.070
Item 20. I fell pleasant 0.239 0.753 0.177
Item 16. I fell content 0.198 0.737 0.173
Item 10. I fell comfortable 0.069 0.722 0.283
Item 2. I fell secure 0.354 0.675 0.001
Item 1. I fell calm 0.116 0.603 0.292
Item 5. I fell at ease 0.311 0.527 0.392
Item 3. I fell tense 0.473 0.038 0.687
Item 13. I am jittery 0.552 0.193 0.667
Item 12. I fell nervous 0.592 0.184 0.655
Item 19. I fell steady 0.065 0.492 0.655
Item 15. I am relaxed 0.233 0.534 0.606
Cronbach’s alpha 0.896 0.897 0.879
Correlation with STAI-Y-1 total score r = 0.650, P < 0.001 r = 0.621, P < 0.001 r = 0.449, P < 0.001
STAI-Y-2
Item 36. I am content 0.742 0.118 0.373
Item 30. I am happy 0.740 0.083 0.337
Item 35. I fell inadequate 0.661 0.365 0.087
Item 24. I wish I could be as happy as others seem to be 0.640 0.278 0.074
Item 21. I fell pleasant 0.619 0.145 0.316
Item 25. I fell like a failure 0.549 0.385 0.259
Item 23. I fell satisfied with myself 0.526 0.222 0.480
Item 28. I fell that difficulties are piling up so that 0.522 0.505 0.170
I cannot overcome them
Item 37. Some unimportant thought runs through 0.035 0.776 0.173
my mind and bothers me
Item 29. I worry too much over something that really -0.136 0.680 0.487
doesn’t matter
Item 38. I take disappointments so keenly that I can’t 0.239 0.673 0.180
put them out of my mind
Item 40. I get in a state of tension or turmoil as I think 0.408 0.670 0.078
over my recent concerns and interests
Item 22. I fell nervous and restless 0.421 0.596 0.082
Item 32. I lack self-confidence 0.438 0.572 0.191
Item 31. I have disturbing thoughts 0.478 0.567 0.131
Item 39. I am a steady person 0.168 0.076 0.757
Item 34. I make decisions easily 0.160 0.205 0.669
Item 27. I am ‘calm, cool, and collected’ 0.391 0.288 0.594
Item 33. I feelsecure 0.496 0.336 0.581
Item 26. I fellrested 0.466 0.091 0.488
Cronbach’salpha 0.878 0.856 0.787
Correlation with STAI-Y-2 total score r = 0.642, P < 0.001 r = 0.580, P < 0.001 r = 0.500, P < 0.001

Major loadings > 0.40 for each item are printed in bold.

and corresponded to possible indicators of depres-
sion (Cronbach’s alpha = 0.878); Component 2
included 22, 29, 31, 32, 37, 38, 40 and corre-
sponded to indicators of anxiety such as worry,
tension, and disturbing thoughts (Cronbach’s
alpha = 0.856); Component 3 including item 27,
33, 34, 39 and corresponded to indicators of anxi-
ety absent such as to fell calm and secure, to make
decisions easily (Cronbach’s alpha = 0.787).
Finally, item 26 (I feel rested) from the trait sub-
scale load both on the factor 1 and 3. The above
three components were correlated among them.
All three components were significantly correlated
with the STAI-Y-2 total score (Component 1:
r = 0.642, P < 0.001; Component 2: r = 0.580,
P < 0.001; Component 3: r = 0.500, P < 0.001).

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Anxiety in patients with Multiple Sclerosis

Total and components scores of both anxiety
scales correlated poorly with cognitive variables,
moderately with EDSS, strongly with depression
scores (Table 4), indicating good divergent valid-
ity.
According to EDSS score, 112 patients with
mild disability and 63 patients with moderate/sev-
ere disability differed only on the STAI-Y-2
(41.7  1.4 vs 46.7  14.6, F = 6.016, P < 0.001;
STAI-Y-1: mild disability, 43.2  12.5 vs moder-
ate/severe disability 47.3  14.4, F = 3.819,
P = 0.052), indicating good known-groups valid-
ity.
SEM value was 3.20 for the STAI-Y-1 and
3.33 for the STAI-Y-2.
As for discriminatory power of individual items
of the STAI-Y-1, we found that 15/20 items
showed a discrimination index of ≥0.40 (‘excellent
items’), 4/20 had a discrimination index between
0.30–0.39 (‘good’ items), only item 9 had a dis-
crimination index of 0.25 (‘acceptable’ items). As
regards the STAI-Y-2, 8/20 items had a discrimi-
nation index of ≥0.40 (‘excellent items’), 7/20
items had a discrimination index between 0.30–
0.39 (‘good’ items), 3/20 items had a discrimina-
tion index of 0.25 (‘acceptable’ items), whereas
items 25 and 35 showed discrimination indices
below 0.20 (‘poor’ items).
The correlation between the STAI-Y scales
scores and disease duration was not significant
(STAI-Y-1: r = 0.006, P = 0.941; STAI-Y-2:
r = 0.144, P = 0.071).
To identify high levels of state and trait anxiety
in a patient with MS, we proposed three gender
specific screening cut-off values (1, 1.5, 2 SD) for
the STAI-Y-1 and the STAI-Y-2 in Table 5. This
will allow using different anxiety thresholds
depending on the aim of future studies.
Prevalence of anxiety in MS
The high level of state anxiety in patients
occurred in 29.7%, 16%, and 9.1% using 1, 1.5,
2 SD, respectively. The high level of trait anxiety
in our MS sample was found in 30.3%, 17.7%,
10.3% of the patients using 1, 1.5, 2 SD, respec-

Table 4 Divergent validity of the STAI-Y-1, STAI-Y-2 and their components

Components –STAY-1 Components –STAY-2

STAI-Y-1 1 2 3 STAI-Y-2 1 2 3

EDSS r 0.134 0.146 0.138 0.103 0.225 0.194 0.140 0.019

p 0.080 0.055 0.071 0.176 0.003 0.010 0.065 0.802
SRT-LTS r 0.176 0.109 0.149 0.030 0.199 0.195 0.159 0.038
p 0.020 0.152 0.050 0.694 0.009 0.010 0.036 0.623
SRT-CLTR r 0.146 0.077 0.154 0.005 0.178 0.132 0.119 0.046
P 0.054 0.315 0.043 0.950 0.019 0.083 0.117 0.550
SRT-D r 0.120 0.034 0.161 0.003 0.144 0.102 0.162 0.037
P 0.115 0.656 0.024 0.966 0.058 0.181 0.033 0.630
SPART r 0.148 0.138 0.135 0.052 0.302 0.194 0.240 0.070
p 0.051 0.069 0.076 0.496 0.001 0.010 0.001 0.358
SPART-D r 0.191 0.134 0.203 0.047 0.287 0.201 0.223 0.053
p 0.012 0.079 0.007 0.540 0.001 0.008 0.003 0.485
SDMT r 0.200 0.115 0.269 0.089 0.310 0.268 0.233 0.001
p 0.008 0.132 0.001 0.244 0.001 0.001 0.002 0.999
PASAT 3” r 0.156 0.120 0.202 0.104 0.215 0.181 0.179 0.011
p 0.041 0.116 0.008 0.172 0.005 0.017 0.018 0.885
PASAT 2” r 0.112 0.090 0.152 0.089 0.153 0.120 0.146 0.015
p 0.143 0.242 0.046 0.247 0.046 0.118 0.055 0.849
WLG r 0.077 0.082 0.046 0.013 0.127 0.120 0.087 0.000
p 0.316 0.283 0.551 0.868 0.097 0.117 0.255 0.995
SCWIT r 0.046 0.074 0.152 0.214 0.104 0.109 0.022 0.032
p 0.550 0.341 0.048 0.005 0.180 0.159 0.780 0.679
FSS r 0.458 0.355 0.317 0.067 0.519 0.415 0.286 0.160
p 0.001 0.001 0.001 0.380 0.001 0.001 0.001 0.035
BDI r 0.680 0.413 0.481 0.219 0.760 0.555 0.402 0.271
p 0.001 0.001 0.001 0.027 0.001 0.001 0.001 0.006
CMDI r 0.687 0.519 0.399 0.220 0.713 0.579 0.442 0.169
p 0.001 0.001 0.001 0.001 0.001 0.001 0.001 0.027

EDSS, Expanded Disability Status Scale; SRT-LTS, Selective Reminding Test -Long-Term Storage; SRT-CLTR, Selective Reminding Test-Consistent Long-Term Retrieval; SRT-D,
selective reminding test-delayed; SPART, Spatial Recall Test; SPART-D, spatial recall test-delayed, SDMT, Symbol Digit Modalities Test; PASAT-3”, Paced Auditory Serial
Addition Test-3 s; PASAT-2”, Paced Auditory Serial Addition Test-2 s; WLG, Word List Generation Test; SCWIT, Stroop word-color task; FSS, Fatigue Severity Scale; BDI,
Beck Depression Inventory; CMDI, Chicago Multiscale Depression Inventory.

463

Santangelo et al.
Table 5 Gender specific cut-off values (1, 1.5, 2 Standard Deviations) for both State-Trait Anxiety Inventory (STAI-Y) scales
Cut-off Percentage of patients
Mean  SD with 1 SD with score above 1 SD
STAI-Y-1
Whole group 39.6  11.7 51.4 29.7%
Females group 41.3  12.4 53.75 25.4%
Males group 35.8  8.9 44.7 43.4%%
STAI-Y-2
Whole group 39.9  10.1 50.01 30.3%
Females group 41.8  10 51.82 31.1%
Males group 35.5  9 44.5 41.5%
tively. As reported in Table 5, the percentage of
anxiety is higher in males than in females.
Discussion
The present study explored psychometric proper-
ties of the STAI-Y-1 and the STAI-Y-2 scales in
a large sample of non-demented MS patients.
Both scales showed good psychometric proper-
ties, and in particular, they showed good internal
consistency, with Cronbach’s alpha values >0.9.
Such values were very close to that reported in
previous validation studies 0.86 for high school
students, 0.95 for military recruits (13), 0.86 for
patients with urinary symptoms (26). No floor or
ceiling effects were found, and skewness was
within limits.
The PCA on the STAI-Y-1 identified three
components. The component 1 included items
dealing with worries about possible misfortunes
and with current feelings of being strained,
frightened, indecisive, confused, and upset; this
component may be named ‘State Anxiety Pre-
sent’. The component 2 included items such as
feeling calm, secure, at ease, satisfied, confort-
able, self-confident, content, and pleasant; this
component might be labeled ‘State Anxiety
Absent’. Finally, the component 3 included
items related to physical aspects of state anxiety
such as feeling tense, nervous or relaxed and
steady and therefore, and could be named ‘Phys-
ical aspects of state anxiety’. The present three-
factor structure of the STAI-Y-1 is partially in
line with previous studies. Indeed, the so-called
State-Anxiety Absent and State-Anxiety Present
factors have been identified in previous studies
too (27–30), whereas the third factor has not
been reported in previous studies. This diver-
gence might be ascribed to specific features of
MS patients, in whom physical symptoms
related to state anxiety warrant to be evaluated
separately from psychic symptoms (i.e., worry
and disturbing thoughts).
464
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Cut-off with Percentage of patients Percentage of
1.5 SD with score above 1.5 SD Cut-off with 2 SD patients with score above 2 SD
57.26 16% 63.13 9.1%
59.65 13.9% 66.15 7.4%
49.15 34% 53.6 24.5%
55.07 17.7% 60.13 10.3%
56.83 18% 61.84 11.5%
49 32.1% 53.5 15.1%
The PCA on the STAI-Y-2 revealed three com-
ponents. Component 1 included items exploring
possible indicators of ‘Emotional Well-being’, i.e.
items such as feeling pleasant, happy, satisfied
with oneself, or feeling like a failure, hopeless.
Component 2 included items dealing with feeling
nervous and restless, worried over something that
really doesn’t matter, and correspond to indica-
tors of ‘Trait Anxiety Present’. Component 3
including items assessing capacity of being calm,
cool and collected, secure, and of making deci-
sion easily; such items corresponded to indicators
of ‘Trait Anxiety Absent’. Finally, item 26 (I feel
rested) from the trait subscale loaded both on the
factors 1 and 3, thus suggesting that item should
be interpreted cautiously in MS patients since it
may related to both anxiety and depression. Our
findings about ‘Trait anxiety absent’ and ‘Trait
anxiety Present’ factors confirmed previous
reports on HCs in Western countries (27–30). We
also found a third component, named ‘Emotional
Well-being’ that is not usually identified in studies
on HCs. Such finding would suggest the idea that
STAI-Y-2 items assessing depression and self-
deprecation (31, 32) should be considered as
forming a possibly distinct subscale, when dealing
with MS patients.
The usefulness of the STAI-Y-1 and the STAI-
Y-2 for assessing several aspects of anxiety in MS
is supported by our analysis of single items’ dis-
criminative power. All 20 items included in the
STAI-Y-1 had a high discriminative power
between patients with high and low anxiety. Only
2 items of the STAI-Y-2 (both loading on factor
3: item 35, I feel inadequate; item 25, I feel like a
failure) had poor discriminative power between
the two groups, likely because they evaluate
depressive rather than anxious symptoms.
As for divergent validity of the STAI-Y-1 and
the STAI-Y-2, we found that total score of both
scales correlated weakly or moderately with
scores of the cognitive battery and the fatigue
scale, indicating at least fair discriminant validity.

Moreover, the three component scores of both
the STAI-Y-1 and the STAI-Y-2 poorly corre-
lated with cognitive and fatigue scores.
Although distinct from each other, depression
and anxiety share some affective, behavioral,
somatic, and cognitive symptoms (i.e., dysphoria,
negative affective, crying, irritability, decreased
activity, poor social skills, restless sleep, helpless-
ness, worry) (33). The strong correlation of total
STAI-Y-1 and STAI-Y-2 scores with BDI-II and
CMDI scores might reflect the symptomatic over-
lap between these affine behavioral disturbances.
This interpretation is also supported by the evi-
dence that factors including items related to anxi-
ety in the two STAI-Y scales were poorly to
moderately correlated with scores on depression
scales (BDI-II and CMDI). This finding seems to
suggest usefulness of the computing scores on the
specific subscales to evaluate different aspects of
state and trait of anxiety, independently from
depressive symptoms.
We found higher STAI-Y scores in patients
with moderate/severe disability when compared
with those with mild physical disability on the
trait anxiety scale but not on the state anxiety
scale. This finding may underline the need for the
clinician to consider that moderate/severe disabil-
ity is also associated with higher trait anxiety.
These patients may be unable to cope with stress-
ful life events, and therefore they may need to be
included in a non-pharmacological intervention
to get a psychological support and help them to
use active copying strategies (34). Moreover, the
lack of association between anxiety levels and
MS duration suggested that anxiety can occur
throughout the disease course and that anxiety
levels should be assessed even at early phases of
MS.
In the present study, we provided three screen-
ing cut-off values (1, 1.5, 2 SD) for the STAI-Y-1
and the STAI-Y-2 (Table 5) so that clinicians or
researchers can use different anxiety thresholds
depending on the aim of their studies. Moreover,
since gender differences in anxiety levels are
reported, we also provided gender specific cut-off
values (1, 1.5, 2 SD) for both STAI-Y scales. In
our MS sample, we found higher percentage of
anxiety in males than in females. This finding is
divergent from a recent study on MS patients
(35). This divergence might depend on method-
ological differences: we used STAI-Y and gender-
specific cut-off scores, whereas Theaudin et al.
(35) measured anxiety by anxiety subscale of
HADS using a same cut-off score (>8) for both
males and females. However, this issue deserves
to be further investigated.
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Anxiety in patients with Multiple Sclerosis
Our study has however some limitations. We
did not explore convergent validity and test–retest
reliability of the two STAI scales, but their psy-
chometric properties are well-established. More-
over, we did not employ the diagnostic criteria of
DSM-V, or clinical interviews such as MINI (36),
for identifying patients with anxiety disorder and
providing diagnostic cut-off scores for the two
scales. However, it is worth underlining that the
cut-off values provided in the present study are
not intended for diagnostic purposes, could only
serve to screen patients with possible high levels
of state and/or trait anxiety for further diagnostic
and therapeutic work-up.
The STAI-Y-1 and the STAI-Y-2 have good
clinicometric properties in MS patients and can
be useful to measure severity of anxiety and to
identify those patients with high anxiety to intro-
duce them in specific non-pharmacological inter-
vention. The identification of patients with high
anxiety levels could also suggest evaluating cogni-
tive status by user-friendly tests (37).
Acknowledgement
The authors have no acknowledgment to declare.
Conflict of interest and sources of funding statement
The authors have no conflict of interest and no
source of funding.
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