Sousa et al.

Health and Quality of Life Outcomes (2015) 13:50

DOI 10.1186/s12955-015-0244-2

RESEARCH Open Access

Reliability and validity of the Portuguese version

of the Generalized Anxiety Disorder (GAD-7) scale
Tiago V Sousa1, Vânia Viveiros1, Maria V Chai1, Filipe L Vicente1, Gustavo Jesus1, Maria J Carnot1, Ana C Gordo2
and Pedro L Ferreira3,4*

Abstract
Background: Generalized anxiety disorder has a strong impact on health-related quality of life. For this reason, it
seems relevant to develop strategies allowing early diagnoses in order to promote appropriate treatments. The
objective of this study was to culturally adapt and validate the GAD-7 for the Portuguese patients with generalized
anxiety disorder.
Methods: For the cultural adaptation of the Portuguese version of the GAD-7 scale we started with a previous
translation made by Mapi Institute and decided to perform a clinical review followed by a cognitive debriefing
with patients. Once piloted, this version was then tested in a larger sample for feasibility and reliability (1-week
test-retest). Construct validity was assessed by the relationship between GAD-7 and socio-demographic and
clinical variables. Its unidimensionality was tested by principal component factor analysis. Criterion validity was
assessed by comparing GAD-7 scores with those obtained by HADS, and EQ-5D. STAI was mainly used as a
screening indicator for patient inclusion.
Results: GAD-7 was considered feasible with a mean completion time of 2.3 minutes and no major floor or
ceiling effects. We found an excellent Cronbach’s alpha internal consistency score (0.880) and the test-retest and
interclass correlation coefficients were also very good. Regarding the construct validity, younger patients, those
with higher education, employed and without anxiety symptoms revealed lower GAD-7 scores, meaning better
health. The unidimensionality of GAD-7 index was also confirmed by principal component factor analysis. At last,
GAD-7 was significantly correlated with other health outcome indices and the classification levels created by it
and by HADS showed to be dependent.
Conclusion: The excellent metric properties confirmed the cultural adaptation and validity of GAD-7 into Portuguese
population, allowing the clinicians an early detection and treatment of these patients.
Keywords: Generalized anxiety disorder (GAD), Portuguese version, Validation

Introduction Generalized anxiety disorder (GAD) was included for

Anxiety is the manifestation of an emotion, characterized the first time in the third edition of the DSM in 1980
by a physical and psychological discomfort described by [4]. Since then, its definition has been modified on
individuals as a feeling of restlessness, nervousness and subsequent DSM-III-R, DSM-IV and DSM-IV TR [5-8].
excessive concern [1-3]. Anxiety disorders are the most GAD is clearly distinguished from other anxiety and
common psychiatric disorders in Europe, with an annual depression disorders in both DSM-IV-TR and ICD-10.
prevalence of 12% in the European adult population and a GAD is defined, by the text revision of the fourth
lifetime prevalence of 5%. edition of Diagnostic and Statistical Manual of Mental
Disorders (DSM-IV-TR), as excessive anxiety and worry
about several events or activities for most days during at
* Correspondence: [email protected] least at 6-month period. The worry is difficult to control
3
Centre for Health Studies and Research, University of Coimbra, Coimbra,
Portugal
and is associated with somatic symptoms such as muscle
4
Faculty of Economics, University of Coimbra, Coimbra, Portugal tension, irritability, difficulty sleeping and restleness. The
Full list of author information is available at the end of the article

© 2015 Sousa et al.; licensee BioMed Central. This is an Open Access article distributed under the terms of the Creative
Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and
reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain
Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article,
unless otherwise stated.
Sousa et al. Health and Quality of Life Outcomes (2015) 13:50 Page 2 of 8

anxiety is distressing and produces impairment in Methods

important areas of the person’s life [9]. Description of GAD-7
GAD lifetime prevalence was estimated on 2.8% in The GAD-7 is a self-administered patient questionnaire
Europe [3,10,11]. The ratio of women to men with the normally used as a screening tool and as a severity
disorder is about 2 to 1. This disorder has probably the measure for patients with generalized anxiety disorder
highest comorbility with another mental disorder, such [21,22]. It has a unidimensional structure matching the
as depressive disorders, specific and social phobia, panic original structure of DSM-IV-TR diagnostic criteria with
disorder and substance-related disorder [9]. all items measuring the same concept and in the same
Portugal has an annual mental illness prevalence of direction. It is composed by seven items corresponding
22.9%, higher than other European countries. The ques- to symptoms based on the criteria for GAD in the Diag-
tion of how to explain such a high prevalence, different nostic and Statistical Manual of Mental Disorders [5-8]
from what was found in other Southern European coun- including (1) feeling nervous, anxious or on edge, (2)
tries still remains to be answered. Could it be the expos- not being able to stop or control worrying, (3) worrying
ure to more vulnerable and/or less protective factors in too much about different things, (4) trouble relaxing, (5)
relation to mental illness, leading to a higher frequency being so restless that it is hard to sit still, (6) becoming
of psychiatric disorder among the Portuguese popula- easily annoyed or irritable, and (7) feeling afraid as if
tion? If so, what is the nature and the role of the factors something awful might happen. The time period for the
involved? Is it possible that these results can be measurement is the two previous weeks and, through a
explained by the existence in the Portuguese culture of 4-point Likert scale from ‘not at all’ to ‘nearly every day’,
specific patterns of perception and manifestation of it is asked how often the patient has been bothered by
emotional complaints leading to increased expression of any of the presented problems.
symptoms that are the basis of the diagnosis of mental The GAD-7 index is obtained by adding the scores
illness? At present, there are no definitive answers to from the questionnaire, after having assigned 0 to the
these questions [12]. In addition, between 2008 and least severe situation, 3 to the most severe one, and 1
2009, anxiety disorders were one of the most common and 2 to the intermediate ones. The cut off points 5, 10
disorders within the Portuguese population, with an and 15 allow us to classify the anxiety as none/normal
annual prevalence of 16.5%. It was also found that 33.6% (0–4), mild (5–9), moderate (10–14), and severe (15–21).
patients with a severe psychiatric disorder in Portugal In general, anyone who scores 8 or above can be consid-
did not receive any kind of treatment [12]. ered as having significant anxiety symptoms [23].
Although the exact cause of GAD cannot be specified,
there are population groups at greater risk with high Linguistic and semantic equivalence
comorbidity [10]. The highest prevalence occurs in the We based our study on the official Portuguese version
45–59 age group, and it was more common in women copyrighted by Pfizer and already translated by Mapi
(7%) than in men (4%). Other important predictors Research Institute, a leading patient-centered research
include being separated, widowed or divorced, un- company. The linguistic validation of the GAD-7 into
employed or housewife [13,14]. Portuguese aimed to obtain a conceptually equivalent
Several studies have suggested that GAD negatively version easily understood by patients. With the collabor-
impacts on activities of daily life and patients’ health- ation of the instrument’s developer, this rigorous meth-
related quality of life (HRQoL), and results in the possi- odology involved a process which comprised several
bility of decreased lifetime work productivity, thereby steps: forward translations by two qualified translators, a
having a significant economic burden [15-18]. The reconciliated version, a translation by another qualified
literature showed that the strong impact of GAD on translator, and a cognitive debriefing on 5 healthy sub-
HRQoL is greater than the one observed in major de- jects [24,25].
pression [19], seeming relevant the development of strat- However, to complete the linguistic and cultural adap-
egies allowing early diagnoses, in order to promote tation we decided to perform a clinical review and a cog-
appropriate treatment. nitive debriefing with patients. Both were considered a
Taking into account the evaluation of anxiety and the in- means to test the instrument’s content validity, i.e., to
struments internationally developed, surprisingly there evidence its suitability to the specific purpose. So, for a
were no instrument culturally adapted and appropriately clinical review, we first asked a committee composed by
validated for the Portuguese population [20]. Therefore the both forward translators, six psychiatrists (authors), a
objective of this study was to culturally adapt and validate medical advisor from Pfizer (author) and two other psy-
the GAD-7 scale to the European Portuguese population chiatrists to clinically comment the Portuguese transla-
and to assess the psychometric properties of the adapted tion, taking into account the original one in English.
version in terms of feasibility, reliability and validity. Based on their remarks, we then made changes in the
Sousa et al. Health and Quality of Life Outcomes (2015) 13:50 Page 3 of 8

Portuguese version and performed a cognitive debriefing instrument EuroQoL EQ-5D [28-30], the Hospital Anxiety
interviewing ten patients with the purpose of finding the and Depression Scale (HADS) [31,32] and the State-
presence of any problems of clarity, understandability Trait Anxiety Inventory (STAI) [33], in their validated
and redundancy of the items. To assess the feasibility of Portuguese versions. For the characterization of target
GAD-7 we recorded the time taken by patients to fill the population we also collected socio-demographic data
questionnaire, as well as the difficulties patients had in (gender, age, educational level, family status and em-
answering it. Missing values, floor and ceiling effects ployment status) and some clinical data (clinical back-
were also analysed. ground, psychiatric and physical symptoms). The data
were collected by psychiatrists.
Study population The generic EQ-5D instrument was originally devel-
Once piloted, the Portuguese version was then tested for oped in the University of York, UK, and allows us to
reliability and validity. For this second phase we re- measure the global value that each individual assigns to
cruited 100 patients and asked five psychiatrists from his/her health status. It also yields to the construction of
the Psychiatric Hospital Centre, in Lisbon, to give the the utility indicator QALY (Quality-Adjusted Life Years)
questionnaires to patients. The sample size is considered used on clinical and policy decision-making [28]. The
an acceptable number for validation studies and for dimensions measured by this instrument’s descriptive
factor analysis [26]. Data were collected during a period system are (i) mobility, (ii) self-care, (iii) usual activities,
of 5 months, starting in December 2012. (iv) pain/discomfort, and (v) anxiety/depression. Each
The study population consisted of all individuals who dimension is scored in a 3-item severity scale and an
went for a consultation, in a consecutive way, having a econometric algorithm produces an index ranging from
diagnosis of GAD according to DSM-IV-TR criteria [8], −0.59 to 1.00 (negative scores meaning health states
and fulfilled the selection criteria outlined in the re- perceived as worse than death) and respecting the value
search protocol. The diagnosis was made by psychia- set that society assign to each measured health status.
trists, based on clinical interview. The sample size was EQ-5D also includes a visual analogue scale (VAS) de-
estimated taking into account the sensitivity of the GAD signed to look like a vertical thermometer, ranging from
questionnaire. One hundred patients with GAD assure 0, meaning the worst imaginable health state, to 100,
that a 95% confidence interval around a sensitivity of meaning the best imaginable health state.
0.90 is not greater than 0.05. HADS aims to determine the levels of anxiety and
As an inclusion criteria we accepted patients of both depression that a patient is experiencing. It is composed
genders, over 18 years old, able to understand and speak by seven items relate to anxiety and seven other items
Portuguese, with known diagnosis of generalized anxiety related to depression. An important point that distin-
disorder based on DSM-IV-TR [8], having anxiety symp- guishes HADS from other scales is that, to prevent the
toms with or without treatment. (score ≥ 20 points on interference of somatic disorders on the scale score, all
STAI anxiety scale). Patients with health conditions that the symptoms of anxiety or depression related to phys-
made them impossible to fill the scale without any help, ical diseases were deleted. Each item is scored from 0 to
with limited knowledge of the Portuguese language, 3 and the maximum total score is 21 for each subscale.
illiterate, or under pharmacological treatment that inter- Also, again for each subscale, the authors proposed a
fere with their ability to understand and answer the cut-off point such that a score smaller than 9 corre-
questions, were excluded. sponds to the absence of symptom and a score equal to
9 or higher corresponds to the presence of the symptom.
Reliability STAI is a self-reported measure that distinguishes be-
The reliability was tested by a 1-week test-retest. A sam- tween temporary condition of state anxiety and the long-
ple of 30 patients were given the GAD-7 in those two standing quality of trait anxiety. It takes about 10 minutes
different points in time and the Pearson, the item-total to be filled and consists of two subscales, each of them
and the intraclasse correlation coefficients were com- containing 20 items: (i) the S-Anxiety to evaluate the
puted. No clinical intervention occurred during this current state of anxiety, and (ii) the T-Anxiety to evaluate
week. With the whole sample we also determined the in- the relatively stable aspects of “anxiety proneness” (trait).
ternal consistency through the Cronbach’s alpha coeffi- For each of these subscales the scores are added, although
cient [27]. some of them need to be reversed, the total scores range
from 20 and 80, where a high score indicates greater
Validity anxiety.
In what concerns the validity tests, other official Portuguese To test the construct validity, we assessed the relation-
validated versions of measurement instruments were imple- ship between the GAD-7 and the scores of socio-
mented, namely, the self-administered generic quality of life demographic and clinical variable. Moreover, to test the
Sousa et al. Health and Quality of Life Outcomes (2015) 13:50 Page 4 of 8

unidimensionality of GAD-7 an exploratory principal This study followed the basic ethical principles set by
component factor analysis [34] was performed. Kaiser- the Declaration of Helsinki and has been approved by
Meyer-Olkin (KMO) measure of sampling adequacy and the Ethics Board of the Lisbon Psychiatric Hospital. All
Bartlett’s test of sphericity were computed before the participants signed an informal consent, without any
factor analysis. benefits. Data collection was anonymous, without any
To test the criterion validity GAD-7 scores were com- reference to patients personal identity, which was
pared with the scores obtained by the other health status encoded in all study documents.
and quality of life measures. Concordances between cri-
teria were computed by correlation coefficients and
chi-square independence tests. Results
Besides these tests previously referred, we also per- The sample
formed descriptive analyses including measures of cen- Table 1 shows the distributions of the main socio-
tral tendency and dispersion. demographic and clinical variables.
Table 2 Quality of life variables
Table 1 Socio-demographic and clinical variables Variable Dimension N %
Variable Value N % GAD-7 Index Normal 4 4.0
Sample 100 100.0 Mild anxiety 7 7.1
Gender Female 78 78.8 Moderate anxiety 18 18.2
Male 21 21.2 Severe anxiety 70 70.7
Age Mean ± sd 52.2 ± 13.5 Mean ± sd 15.7 ± 4.6
Min – Max 21 - 78 Min - Max 2 - 21
Education ≤4 years 44 44.9 EQ-5D Index [−0.50; −0.25] 2 2.0
5 to 9 years 22 22.4 [−0.25; 0.00] 1 1.0
10-12 years 21 21.4 [ 0.00; +0.25] 17 17.2
>12 years 11 11.2 [+0.25; +0.50] 33 33.3
Family status Single 11 11.0 [+0.50; +0.75] 27 27.3
Married/Living together 38 68.0 [+0.75; +1.00] 19 19.2
Divorced 17 17.0 Mean ± sd 0.46 ± 0.29
Widowed 4 4.0 Min - Max −0.37 - 1.00
Employment status Employed 32 32.3 VAS [ 0; 25] 17 17.9
Unemployed/Student 21 21.2 [25; 50] 29 30.5
Retired 40 40.4 [50; 75] 40 42.1
Sick leave 6 6.1 [75; 100] 9 9.5
Clinical background Yes 59 59.0 Mean ± sd 44.33 ± 22.27
No 41 41.0 Min - Max 0 - 95
Psychiatric background Yes 80 80.8 HADS Anxiety Without symptoms 12 12.0
No 19 19.2 With symptoms 88 88.0
Physical symptoms 1 Pain 45 45.0 Mean ± sd 13.6 ± 4.2
Headache 43 43.0 Min - Max 1 - 21
Tremors 32 32.0 Depression Without symptoms 31 31.0
Palpitations 46 46.0 With symptoms Mean 69 69.0
Sudoresis 40 40.0 Mean ± sd 10.8 ± 4.4
Difficulty breathing 22 22.0 Min - Max 0 - 21
Nausea 14 14.0 STAI State Anxiety Mean ± sd 48.5 ± 4.3
Diarrhoea 13 13.0 Min - Max 39 - 61
Other 2 2.0 Trait Anxiety Mean ± sd 50.5 ± 4.9
sd: standard deviation.
Min - Max 38 - 60
Min-Max: Minimum-Maximum.
1
A patient may have more than one symptom. sd: standard deviation Min/Max: Minimum/Maximum.
Sousa et al. Health and Quality of Life Outcomes (2015) 13:50 Page 5 of 8

Table 3 Distribution of GAD-7 items

GAD-7 item Not at all Several days More than half the days Nearly every day
Feeling nervous, anxious or on edge 3.0% 10.1% 33.3% 53.5%
Not being able to stop or control worrying 1.0% 17.2% 24.2% 57.6%
Worrying too much about different things 2.0% 12.1% 33.3% 52.5%
Trouble relaxing 5.1% 12.1% 38.4% 44.4%
Being so restless that it is hard to sit still 8.1% 19.2% 34.3% 38.3%
Becoming easily annoyed or irritable 3.0% 17.2% 30.3% 49.5%
Feeling afraid as if something awful might happen 9.1% 13.1% 37.4% 40.4%

The sample included 78.8% of female with a mean age Reliability

of 52.2 ± 13.5. Regarding the education, 44.9% had, at The Cronbach’s α obtained for the GAD’s seven items
most, four years of schooling, 32.3% were employed and was an excellent value (0.880) and it maintains excellent
68.0% were married or lived together. Among these pa- even if we delete an item, as shown in the second col-
tients, 59.0% had a previous clinical diagnosis and 80.8% umn of Table 4.
a previous psychiatric diagnosis. In what concerns phys- Moreover, all items showed high item-total correlation
ical symptoms, the highest prevalent were palpitations, scores (column 3) and high test-retest correlation coeffi-
pain, headaches, and sudoresis. cients (column 4) and intraclass correlation coefficients
Table 2 presents the distributions of the health status, (column 5).
symptoms and health-related quality of live variables.
Regarding the health status and quality of life, the ma- Construct validity
jority of the patients (70.7%) may be classified as severely Table 5 shows the sensitivity of GAD-7 index over the differ-
anxious, which is evidenced by the self-perception given ent values of the socio-demographic and clinical variables.
by the EQ-5D: mean index = 0.46 and mean VAS = As we can draw from this table there is no significant
44.33. More than four fifth of the patients (88.0%) had difference of GAD-7 index regarding gender, family sta-
symptoms of anxiety and 69.0% showed symptoms of tus, and clinical or psychiatric background. We also evi-
depression. Accordingly, both the state and trait anxiety denced significant lower GAD-7 index, i.e., better health,
scores were median, indicating a moderate form of for younger (less than 40 years old) patients, those with
anxiety. higher education, employed and without symptoms.
To test the construct validity we also performed a
Feasibility principal component factor analysis and we evidenced
The mean GAD-7 completion time was 2.3 ± 1.3 minutes, the desirable unidimensional structure, corresponding to
ranging from 30 seconds to 4.7 minutes. All items were 58.8% of explained variance.
filled. To assess the floor and ceiling effects of GAD-7 GAD-7 index was correlated to the other health out-
we analysed the distribution of each item (see Table 3). come indices. Starting with EQ-5D, both indices had a
No major floor effect was found. In fact, only items 5 significant correlation (EQ-5D index: −0.538; VAS: −0.378).
and 7 had a percentage higher than 8%. On the other However, the correlations with STAI indices were also
hand, our sample showed a group of patients with very smaller, although significant (S-Anxiety: r = 0.378; T-
severe levels of anxiety. Anxiety: r = 0.353). In what concerns the HADS, GAD-

Table 4 Reliability indicators

GAD-7 item α If item deleted Item-total correlation Test-retest correlation Intraclass
coefficient correlation
Feeling nervous, anxious or on edge 0.854 0.817** 0.857** 0.819
Not being able to stop or control worrying 0.879 0.650** 0.576** 0.570
Worrying too much about different things 0.863 0.760** 0.677** 0.671
Trouble relaxing 0.852 0.828** 0.596** 0.555
Being so restless that it is hard to sit still 0.860 0.790** 0.629** 0.620
Becoming easily annoyed or irritable 0.867 0.739** 0.654** 0.644
Feeling afraid as if something awful might happen 0.865 0.764** 0.931** 0.930
**p < 0.01.
Sousa et al. Health and Quality of Life Outcomes (2015) 13:50 Page 6 of 8

Table 5 Relationship between GAD-7 index and (HADS-A: χ2 = 43.59; HADS-D: χ2 = 27.73) ware associ-
socio-demographic and clinical variables ated to p-values lower than 0.005.
Variable Value GAD-7 t/F Sig On the other hand patients with symptoms detected
index by HADS have always a higher GAD-7 index, as shown
Gender Female 15.96 1.14 0.256 in Table 6.
Male 14.65
Age Less than 40 years 13.41 3.861 0.024
Between 40 and 59 years 16.45
Discussion
The authors intended to test the culturally adapted into
60 or more years 16.30
Portuguese version of the GAD-7 scale concerning feasi-
Education ≤4 years 17.45 7.631 0.001 bility, reliability and validity.
5 to 9 years 15.05 Excellent reliability values were found when compar-
≥10 years 13.62 ing each item of the measure with the total scores and
Family status Married/Living together 15.84 0.340 0.734 also in the test-retest, showing an excellent homogeneity
in concept measurement and stability between evalua-
Not married 15.50
tions over time.
Employment status Employed 13.56 −0.3660 0.000
We correlated the scores from GAD-7 with those from
Non-employed 16.91 HADS. As a result, we evidenced a very high significant
Clinical background Yes 16.20 1.262 0.210 correlations with both HADS anxiety and depression
No 15.02 subscales, which supports the use of the GAD-7 as a
Psychiatric Yes 15.90 0.542 0.589 screening tool. However, regarding the STAI a signifi-
background cant but weaker correlation was found probably due its
No 15.26
complexity.
Pain Yes 17.33 3.514 0.001
When comparing the GAD-7 results with other health
No 14.39 outcome measures yielded from the EQ-5D scale, a rela-
Headache Yes 17.02 2.664 0.009 tion was found between GAD assessments using the
No 14.73 scale and the disability level assessed by several domains
Tremors Yes 17.84 4.054 0.000 of daily life, which is in accordance with previous data
reported in GAD studies [35-37]. This shows that this
No 14.72
instrument is a solid tool for easily exploring patients
Palpitations Yes 16.78 2.181 0.032
with GAD, establishing the level of severity, and linking
No 14.81 it to the degree of disability in the main areas of daily
Sudoresis Yes 17.15 2.625 0.010 living. Thus, GAD emerges as a strong predictor of func-
No 14.76 tional impairment [19].
Difficulty breathing Yes 18.09 2.848 0.005 The results obtained for the Portuguese version of the
GAD-7 and the impact of the socio-demographic char-
No 15.05
acteristics and clinical variables in the measurements were
Nausea Yes 18.21 2.242 0.027
in line with data available in the reviewed literature, with
No 15.32 exception of family status and clinical/psychiatric back-
Diarrhea Yes 18.46 3.577 0.001 ground. In our sample, anxiety levels were independent
No 15.31 from family status, with no significant difference between
t: Student’s t. single, married/living together, divorced and widowed.
F: Fisher’s F. Another unexpected result was that clinical and psychi-
Sig: significance (p-value).
atric background did not influence the results. This might

Table 6 Comparison between GAD-7 index with HADS

7 showed to be better correlated with anxiety subscale
Variable Value GAD-7 index t Sig
(r = 0.699) than with depression subscale (r = 0.450).
Comparing the anxiety classification obtained by HADS – Anxiety Without symptoms 8.42 −7.329 0.000
GAD-7, HADS-Anxiety and HAD-Depression measures With symptoms 16.74
we noticed that they are not independent, meaning that HADS – Depression Without symptoms 12.17 −5.937 0.000
patients without symptoms revealed by both HADS With symptoms 17.27
indices are also classified by GAD-7 as normal or with a t: Student’s t.
mild anxiety. The corresponding chi-squared values Sig: significance (p-value).
Sousa et al. Health and Quality of Life Outcomes (2015) 13:50 Page 7 of 8

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