/clinical/,/clinical/cckm-tools/,/clinical/cckm-tools/content/,/clinical/cckm-tools/content/questionnaires/,/clinical/cckm-tools/content/questionnaires/related/,

/clinical/cckm-tools/content/questionnaires/related/name-97196-en.cckm

201606168

page

100

UWHC,UWMF,

Clinical Hub,UW Health Clinical Tool Search,UW Health Clinical Tool Search,Questionnaires,Related

A Brief Measure for Assessing Generalized Anxiety Disorder

A Brief Measure for Assessing Generalized Anxiety Disorder - Clinical Hub, UW Health Clinical Tool Search, UW Health Clinical Tool Search, Questionnaires, Related


ORIGINAL INVESTIGATION
A Brief Measure for Assessing Generalized
Anxiety Disorder
The GAD-7
Robert L. Spitzer, MD; Kurt Kroenke, MD; Janet B. W. Williams, DSW; Bernd Lo¨we, MD, PhD
Background:Generalized anxiety disorder (GAD) is one
of the most common mental disorders; however, there
is no brief clinical measure for assessing GAD. The ob-
jective of this study was to develop a brief self-report scale
to identify probable cases of GAD and evaluate its reli-
ability and validity.
Methods: A criterion-standard study was performed in
15 primary care clinics in the United States from No-
vember 2004 through June 2005. Of a total of 2740 adult
patients completing a study questionnaire, 965 patients
had a telephone interview with a mental health profes-
sional within 1 week. For criterion and construct valid-
ity, GAD self-report scale diagnoses were compared with
independent diagnoses made by mental health profes-
sionals; functional status measures; disability days; and
health care use.
Results: A 7-item anxiety scale (GAD-7) had good re-
liability, as well as criterion, construct, factorial, and pro-
cedural validity. A cut point was identified that opti-
mized sensitivity (89%) and specificity (82%). Increasing
scores on the scale were strongly associated with mul-
tiple domains of functional impairment (all 6Medical Out-
comes Study Short-Form General Health Survey scales
and disability days). AlthoughGAD and depression symp-
toms frequently co-occurred, factor analysis confirmed
them as distinct dimensions. Moreover, GAD and de-
pression symptoms had differing but independent ef-
fects on functional impairment and disability. There was
good agreement between self-report and interviewer-
administered versions of the scale.
Conclusion: The GAD-7 is a valid and efficient tool for
screening for GAD and assessing its severity in clinical
practice and research.
Arch Intern Med. 2006;166:1092-1097
O
NE OF THE MOST COM-
mon anxiety disorders
seen in general medical
practice and in the gen-
eral population is gener-
alized anxiety disorder (GAD). The disor-
der has an estimated current prevalence in
general medical practice of 2.8% to 8.5%
1-3
and in the general population of 1.6% to
5.0%.
4-6
Whereas depression in clinical set-
tings has generated substantial research,
there have been far fewer studies of anxi-
ety. In part, this may be because of the pau-
city of brief validated measures for anxiety
compared with the numerousmeasures for
depression,
7,8
such as the Primary Care
Evaluation of Mental Disorders 9-item Pa-
tient Health Questionnaire (PHQ).
9-11
This
situation is unfortunate, given the high
prevalence of anxiety disorders, as well as
their associated disability and the availabil-
ity of effective treatments, both pharmaco-
logical and nonpharmacological.
12,13
Measures of anxiety are seldom used in
clinical practice because of their length,
proprietary nature, lack of usefulness as
a diagnostic and severity measure,
14-17
and
requirement of clinician administration
rather than patient self-report.
18,19
The goal
of this study was to develop a brief scale
to identify probable cases of GAD and to
assess symptom severity. We conducted
a study in multiple primary care sites to
select the items for the final scale and to
evaluate its reliability and validity.
METHODS
GAD SCALE DEVELOPMENT
We first selected potential items for a brief GAD
scale. The initial item pool consisted of 9 items
that reflected all of the Diagnostic and Statisti-
cal Manual of Mental Disorders, Fourth Edition
(DSM-IV) symptom criteria for GAD and 4
items on the basis of review of existing anxi-
ety scales. A 13-item questionnaire was devel-
oped that asked patients how often, during the
last 2 weeks, they were bothered by each symp-
tom. Response options were “not at all,” “sev-
Author Affiliations: Biometrics
Research Department, New
York State Psychiatric Institute
and Department of Psychiatry,
Columbia University, New York
(Drs Spitzer and Williams);
Regenstrief Institute for Health
Care and Department of
Medicine, Indiana University,
Indianapolis (Dr Kroenke); and
Department of Psychosomatic
and General Internal Medicine,
University of Heidelberg,
Heidelberg, Germany
(Dr Lo¨we).
(REPRINTED) ARCH INTERN MED/VOL 166, MAY 22, 2006 WWW.ARCHINTERNMED.COM
1092
2006 American Medical Association. All rights reserved.
Downloaded From: http://archinte.jamanetwork.com/ by a University of Wisconsin -Madison User on 05/06/2015

eral days,” “more than half the days,” and “nearly every day,”
scored as 0, 1, 2, and 3, respectively. In addition, an item to
assess duration of anxiety symptoms was included. Our goal
was to determine the number of items necessary to achieve good
reliability and procedural, construct, and diagnostic criterion
validity.
PATIENT SAMPLE
Patients were enrolled fromNovember 2004 through June 2005
from a research network of 15 primary care sites located in 12
states (13 family practice, 2 internal medicine) administered
centrally by Clinvest, Inc (Springfield, Mo). The purpose of the
project’s first phase (n=2149) was to select the scale items and
cutoff scores to be used for making a GAD diagnosis. The pur-
pose of the second phase (n=591) was to determine the scale’s
test-retest reliability. In all, 2982 subjects were approached and
2739 (91.9%) completed the study questionnaire with no or
minimal missing data. To minimize sampling bias, we ap-
proached consecutive patients at each site in clinic sessions un-
til the target quota for that week was achieved.
In the first phase, 1654 subjects also agreed to a telephone
interview, and of these, a random sample of 965 were inter-
viewed within 1 week of their clinic visit by 1 of 2 mental
health professionals (MHPs)—a PhD clinical psychologist and
a senior psychiatric social worker. In the study’s second
phase, 591 subjects who had completed the research ques-
tionnaire were sent a 1-page questionnaire that consisted of
the 13 potential GAD scale items. Of these, 236 subjects
returned the completed 1-page questionnaire with no or mini-
mal missing data within a week of completing the research
questionnaire at the clinic. The mean GAD scale score of sub-
jects returning the questionnaire did not differ from that of
subjects who did not return the questionnaire. The study was
approved by the Sterling Institutional Review Board, Spring-
field, Mo.
SELF-REPORT RESEARCH QUESTIONNAIRE
Before seeing their physicians, patients completed a 4-page ques-
tionnaire that included the 13 items being tested for use in the
GAD scale, as well as questions about age, sex, education, eth-
nicity, and marital status; the Medical Outcomes Study Short-
FormGeneral Health Survey (SF-20),
20,21
whichmeasures func-
tional status in 6 dimensions; and either the 12-item anxiety
subscale from the Symptom Checklist-90
16
(first study phase
only) or the Beck Anxiety Inventory
14
(second study phase only).
Depression was assessed with the PHQ-8, which includes all
items from the PHQ-9 except for the item about suicidal ide-
ation; PHQ-8 and PHQ-9 scores are highly correlated and have
nearly identical operating characteristics.
22
Finally, patients com-
pleted items regarding physician visits and disability days dur-
ing the previous 3 months.
MHP INTERVIEW
The 2 MHPs conducted structured psychiatric interviews by
telephone, blinded to the results of the self-report research ques-
tionnaire. The interview consisted of the GAD section of the
Structured Clinical Interview forDSM-IV,
23
modified with sev-
eral additional questions to assess in greater detail some of the
GAD diagnostic criteria ofDSM-IV. The resultingDSM-IVGAD
diagnosis, with the DSM-IV 6-month duration criterion, was
used as the criterion standard for assessing the validity of the
new scale. The interview also included the 13 potential GAD
scale items to test agreement between self-report and clinician
administration (ie, procedural validity).
24
DATA ANALYSIS
The best items for the GAD scale were selected by rank order-
ing the correlation of each itemwith the total 13-item scale score
in the sample of 1184 patients who did not undergo the MHP
interview. Item-total score correlations were reexamined in 2
independent subsamples of the study population: the 965 pa-
tients who underwent the MHP interview and the 591 pa-
tients in the second phase of the study. In addition, we con-
ducted receiver operating characteristic analyses with varying
numbers of items in these 965 patients by using an MHP di-
agnosis of GAD as the criterion standard. Divergent validity of
each item was assessed by calculating the difference between
the item correlations with the 13-item anxiety score and the
PHQ-8 depression score. Convergent validity was assessed by
examining correlations of the final version of the GAD scale
with the Beck Anxiety Inventory and the anxiety subscale of
the Symptom Checklist-90, even though neither scale is spe-
cific for GAD.
To assess construct validity, we used analysis of covari-
ance to examine associations between anxiety severity on the
final GAD scale and SF-20 functional status scales, self-
reported disability days, and physician visits, controlling for
demographic variables. For criterion validity, we investi-
gated sensitivity, specificity, predictive values, and likeli-
hood ratios for a range of cutoff scores of the final scale with
respect to the MHP diagnosis. To investigate whether anxi-
ety as measured by the GAD-7 and depression as measured
by the PHQ-8 reflect distinct dimensions, we assessed facto-
rial validity by using confirmatory factor analyses. Finally,
procedural validity and test-retest reliability were assessed
by means of intraclass correlation.
25
RESULTS
DESCRIPTION OF PATIENTS
The mean (SD) age of the patients was 47.4 (15.5) years
(range, 18-95 years). Most (65%) were female; 80%were
white non-Hispanic, 8%were African American, and 9%
were Hispanic; 64% were married, 13% were divorced,
and 15%were never married; and 31% had a high school
degree or equivalent, whereas 62% had attended some
college.
ITEM SELECTION FOR THE GAD SCALES
The GAD-7 (Figure 1) consists of the 7 items with
the highest correlation with the total 13-item scale
score (r=0.75-0.85). Receiver operating characteristic
analysis with this set of items showed an area under
the curve (0.906) as good as scales with as much as
the full 13-item set. These 7 items also had the highest
rank correlations in the developmental sample
(n=1184) and the 2 replication samples (n=965 and
n=591). The 2 core criteria (A and B) of the DSM-IV
definition of GAD are captured by the first 3 items of
the scale.
26
Of note, 6 of the 7 items had the greatest
divergent validity (ie, the highest difference between
the item-total scale score correlation and item-PHQ-8
depression score correlation [� r=0.16-0.21]). Because
each of the 7 items is scored from 0 to 3, the GAD-7
scale score ranges from 0 to 21.
(REPRINTED) ARCH INTERN MED/VOL 166, MAY 22, 2006 WWW.ARCHINTERNMED.COM
1093
2006 American Medical Association. All rights reserved.
Downloaded From: http://archinte.jamanetwork.com/ by a University of Wisconsin -Madison User on 05/06/2015

RELIABILITY AND PROCEDURAL VALIDITY
The internal consistency of the GAD-7 was excellent
(Cronbach �=.92). Test-retest reliability was also good
(intraclass correlation=0.83). Comparison of scores de-
rived from the self-report scales with those derived from
theMHP-administered versions of the same scales yielded
similar results (intraclass correlation=0.83), indicating
good procedural validity.
DIAGNOSTIC CRITERION VALIDITY AND SCALE
OPERATING CHARACTERISTICS
Table 1 summarizes the operating characteristics of the
GAD-7 at various cut points. As expected, as the cut point
increases, sensitivity decreases and specificity increases in
a continuous fashion. At a cut point of 10 or greater, sen-
sitivity and specificity exceed 0.80, and sensitivity is nearly
maximized. Results were similar for men and women and
for those aged less and those agedmore than themean age
of 47 years. The proportion of primary care patients who
score at this level is high (23%). A cut point of 15 or greater
maximizes specificity and approximates a prevalence (9%)
more in line with current epidemiologic estimates of GAD
prevalence in primary care. However, sensitivity at this high
cut point is low (48%).Most patients (89%)with GAD had
GAD-7 scores of 10 or greater, whereasmost patients (82%)
without GAD had scores less than 10.
The mean (SD) GAD-7 score was 14.4 (4.7) in the 73
patients with GAD diagnosed according to theMHP and
4.9 (4.8) in the 892 patients without GAD. The preva-
lence of GAD according to the MHP interview was 9%
in women and 4% in men. In the entire sample of 2739
patients, the mean GAD-7 score was 6.1 in women and
4.6 in men.
Although the GAD-7 scale inquires about symptoms
in the past 2 weeks, the criterion-standard MHP inter-
view required at least a 6-month duration of symptoms
consistent withDSM-IV diagnostic criteria for GAD.None-
theless, the operating characteristics of the scale were good
because most patients with high symptom scores had
chronic symptoms. Of the 433 patients with GAD-7 scores
of 10 or greater, 96% had symptoms for 1month ormore,
and 67% had symptoms for 6 months or more.
CONSTRUCT VALIDITY
There was a strong association between increasing GAD-7
severity scores and worsening function on all 6 SF-20
scales (Table 2). As GAD-7 scores went from mild to
moderate to severe, there was a substantial stepwise de-
cline in functioning in all 6 SF-20 domains. Most pair-
wise comparisons within each SF-20 scale between suc-
cessive GAD-7 severity levels were significant. The
relationship between GAD severity and functional im-
pairment was similar in men and women.
Figure 2 illustrates graphically the relationship be-
tween increasing GAD-7 scale scores and worsening func-
tional status. Decrements in SF-20 scores are shown in terms
of effect size (ie, the difference in mean SF-20 scores, ex-
pressed as the number of SDs, between each GAD-7 inter-
val subgroup and the reference group). The reference group
is the group with the lowest GAD-7 scores (ie, 0-4), and
the SD used is that of the entire sample. Effect sizes of 0.5
and 0.8 are typically considered moderate and large be-
tween-group differences, respectively.
27
When the GAD-7 was examined as a continuous vari-
able, its strength of association with the SF-20 scales was
concordant with the pattern seen in Figure 2. The GAD-7
correlated most strongly with mental health (0.75), fol-
lowed by social functioning (0.46), general health per-
ceptions (0.44), bodily pain (0.36), role functioning
(0.33), and physical functioning (0.30).
Table 3 shows the association between GAD-7 se-
verity levels and 3 other measures of construct validity:
self-reported disability days, clinic visits, and the gen-
eral amount of difficulty patients attribute to their symp-
toms. Greater levels of anxiety severity were associated
with a monotonic increase in disability days, health care
use, and symptom-related difficulty in activities and re-
lationships. When the GAD-7 was examined as a con-
tinuous variable, its correlation was 0.27 with disability
days, 0.22 with physician visits, and 0.63 with symptom-
related difficulty.
Convergent validity of the GAD-7 was good, as dem-
onstrated by its correlations with 2 anxiety scales: the Beck
Anxiety Inventory (r=0.72) and the anxiety subscale of
the SymptomChecklist-90 (r=0.74). Consistent with re-
sults of previous studies of anxiety and depression,
4,28
the
GAD-7 and Symptom Checklist-90 anxiety scales also
strongly correlated with our depression measure, the
PHQ-8 (r=0.75 and r=0.74, respectively). Nonetheless,
measuring anxiety and depression was complementary
rather than duplicative. We determined the prevalence
of high anxiety and high depression symptom severity
in our sample, defined as severe scores (�15) on the
GAD-7 and PHQ-8 depression scales, respectively. In the
2114 patients who completed the GAD-7 and the PHQ-8,
there were 1877 (88.8%) patients with neither high anxi-
ety nor high depression, 99 (4.68%) with high anxiety
only, 68 (3.2%)with high depression only, and 70 (3.31%)
with high anxiety and high depression. Thus, more than
half (99/169) of patients with high anxiety scores did not
GAD-7
7. Feeling afraid as if something awful might happen 0 1 2 3
Not
at all
Several
days
More
than half
the days
Nearly
every
day
Over the last 2 weeks, how often have you been
bothered by the following problems?
01 2 31. Feeling nervous, anxious or on edge
01 2 32. Not being able to stop or control worrying
01 2 33. Worrying too much about different things
01 2 34. Trouble relaxing
01 2 35. Being so restless that it is hard to sit still
01 2 36. Becoming easily annoyed or irritable
Tota l
Score
=
Add
Columns
++
If you checked off any problems, how difficult have these problems made it for you
to do your work, take care of things at home, or get along with other people?
Not difficult
at all
Somewhat
difficult
Very
difficult
Extremely
difficult
Figure 1. The generalized anxiety disorder 7-item (GAD-7) scale.
(REPRINTED) ARCH INTERN MED/VOL 166, MAY 22, 2006 WWW.ARCHINTERNMED.COM
1094
2006 American Medical Association. All rights reserved.
Downloaded From: http://archinte.jamanetwork.com/ by a University of Wisconsin -Madison User on 05/06/2015

have high depression scores. Also, when patients had high
anxiety and high depression scores, there was an addi-
tive effect on the SF-20 mental health and social func-
tioning scales, as well as self-reported disability days and
health care use.
FACTORIAL VALIDITY
Principal component analysis of a set of 15 items that in-
cludes the 8 depression items of the PHQ-8 and the 7 anxi-
ety items of the GAD-7 indicated that the first 2 emer-
gent factors had an eigenvalue greater than 1. Sixty-
three percent of the total variance was explained by the
first 2 factors. The varimax-rotated component-matrix
clearly confirmed the original allocation of the items to
the PHQ scales, with all depression items having the high-
est factor loadings on 1 factor (0.58-0.75) and all anxi-
ety items having the highest factor loadings on the sec-
ond factor (0.69-0.81).
COMMENT
This study has several major findings. First, a 7-item anxi-
ety scale—the GAD-7—is a useful tool with strong cri-
terion validity for identifying probable cases of GAD. Sec-
ond, the scale is also an excellent severity measure as
demonstrated by the fact that increasing scores on the
GAD-7 are strongly associated with multiple domains of
functional impairment and disability days. Third, al-
thoughmany patients had anxiety and depressive symp-
toms, factor analysis confirms GAD and depression as dis-
tinct dimensions.
This study reports the development and validation of
ameasure for evaluating the presence and severity of GAD
in clinical practice, the GAD-7, one of the fewGADmea-
sures that is also specifically linked to the DSM-IV (Text
Revision) criteria.
19,26
A score of 10 or greater on the GAD-7
represents a reasonable cut point for identifying cases of
GAD. Cut points of 5, 10, and 15 might be interpreted
as representingmild, moderate, and severe levels of anxi-
ety on the GAD-7, similar to levels of depression on the
PHQ-9.
10
The GAD-7 may be particularly useful in as-
sessing symptom severity andmonitoring change across
time, although its responsiveness to change remains to
be tested in treatment studies.
Construct validity was demonstrated by the fact that
increasing scores on the GAD-7 scale were strongly as-
sociated with multiple domains of functional impair-
Table 1. Operating Characteristics of GAD-7 at Different Cutoffs*
GAD-7 Scale Score† Sensitivity, % Specificity, % PPV, % NPV, % LR� Prevalence, %
8 92 76 24 99 3.8 29
9 90 79 26 99 4.3 26
10 89 82 29 99 5.1 23
11 82 85 31 98 5.5 20
12 73 89 35 98 6.5 16
13 66 91 38 97 7.7 13
14 56 92 37 96 7.2 12
15 48 95 42 96 8.7 9
Abbreviations: GAD-7, generalized anxiety disorder 7-item scale; LR�, likelihood ratio for a positive test; NPV, negative predictive value; PPV, positive predictive
value.
*In 965 patients who underwent structured psychiatric interview by a mental health professional to determine the presence of generalized anxiety disorder by
using Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition diagnostic criteria.
†The actual score is greater than or equal to the score shown.
Table 2. Relationship Between GAD-7 Severity Score and SF-20 Health-Related Quality of Life Scales*
Level of Anxiety Severity
GAD-7 Scale Score
Mean (95% Confidence Interval) SF-20 Scale Score
Mental Social Role General Pain Physical
Minimal
0-4 (n = 1182) 82 (81-83) 91 (89-92) 84 (82-86) 68 (67-69) 71 (70-72) 84 (82-85)
Mild
5-9 (n = 511) 65 (64-66) 79 (77-81) 69 (66-73) 52 (50-54) 56 (54-58) 74 (72-76)
Moderate
10-14 (n = 264) 54 (52-55) 69 (66-71) 59 (54-63) 43† (40-45) 51† (48-54) 66† (63-69)
Severe
5-21 (n = 171) 41 (39-43) 55 (52-59) 46 (40-52) 39† (36-43) 47† (43-50) 61† (58-65)
Abbreviations: GAD-7, generalized anxiety disorder 7-item scale; SF-20, Medical Outcomes Study Short-Form General Health Survey.
*SF-20 scores are adjusted for age, sex, race, education, and study site. Point estimates for the mean and 95% confidence intervals (±1.96 � standard error of
the mean) are displayed. Number of patients adds to 2128 because of missing data. Missing data for any subscale of SF-20 was less than 5%.
†Pairwise comparisons within each scale that are not significant from one another. However, most pairwise comparisons of mean SF-20 scores with each
GAD-7 scale level within each scale are significant at P�.05 by using a Bonferroni correction for multiple comparisons.
(REPRINTED) ARCH INTERN MED/VOL 166, MAY 22, 2006 WWW.ARCHINTERNMED.COM
1095
2006 American Medical Association. All rights reserved.
Downloaded From: http://archinte.jamanetwork.com/ by a University of Wisconsin -Madison User on 05/06/2015

ment. Furthermore, there was a strong association with
self-reported disability days and amodest association with
increased health care use.
To facilitate assessment of change in severity of anxi-
ety symptoms, the GAD-7 asks about recent symptoms
(ie, in the past 2 weeks). However, most patients with
high scores had chronic symptoms, which is why the op-
erating characteristics proved good with use of our cri-
terion-standard MHP interviews based on the conven-
tional GAD duration criterion of 6months. However, the
National Comorbidity Survey showed that patients with
episodes of 1 to 5months do not differ greatly from those
with episodes of 6 months or more in onset, persis-
tence, impairment, comorbidity, parental GAD, or so-
ciodemographic correlates.
5
Kessler et al
5
conclude that
there is little basis for excluding these people from a di-
agnosis. Notably, 96% of patients with GAD-7scores of
10 or greater in our primary care sample had symptoms
of a month or more, whereas 67% had symptoms of 6
months or longer. It may be that in treatment trials in
which response to therapy is evaluated, assessing GAD
symptom change during a shorter time (eg, the past week)
may be desirable.
The high comorbidity of anxiety and depressive dis-
orders and the high correlation between depressive
and anxiety measures is well known.
17,29
Not surpris-
ingly, our depression measure, the PHQ-8, strongly
correlated with the GAD-7 and the Symptom
Checklist-90 anxiety scales. Nonetheless, factor analy-
sis confirmed the value of assessing anxiety and
depression as 2 separate dimensions. In addition, a
number of patients with high anxiety symptoms
according to the GAD-7 did not have high depression
symptom severity, and patients with increasing sever-
ity of anxiety symptoms had corresponding greater
impairment in multiple domains of functional status.
Together, these findings indicate that using only a
depression measure to identify depressed patients who
may benefit from treatment will miss a clinically
important part of the patient population with dis-
abling anxiety who also would benefit from treatment.
Several limitations of our study should be noted. First,
the GAD-7 scale focuses on only 1 anxiety disorder, al-
though there are many patients with other anxiety dis-
orders, such as social phobia and posttraumatic stress dis-
order, who need clinical attention. However, GAD is one
of the most common mental disorders seen in outpa-
tient practice. Second, the GAD-7 provides only prob-
able diagnoses that should be confirmed by further evalu-
ation. Third, because our study was cross-sectional,
prospective observational and treatment studies are
needed to determine the responsiveness of the GAD-7
in assessing change across time. Because there is already
evidence for the responsiveness of the PHQ-9 and PHQ-2
depression scales,
30,31
future research also likely will dem-
onstrate that the GAD-7 scale is useful in assessing changes
in the severity of anxiety over time.
This study has a number of strengths, including its
large sample size, diverse clinical settings, and its gen-
eralizability to primary care, where most patients with
anxiety and depression are treated.
2
Also, the GAD-7 is
efficient in that it is brief and can be completed entirely
by the patient. This latter feature is particularly impor-
tant, given the time constraints and competing de-
mands for busy clinicians.
32
Although the GAD-7 was de-
veloped and validated in primary care, we expect that,
like the PHQ-9 depressionmeasure, the GAD-7 will have
considerable utility in busy mental health settings and
clinical research, which is especially important given the
high prevalence and substantial disability associated with
GAD.
0
–0.5
–1.0
–1.5
–2.0
–2.5
Mental Social General Role Pain Physical
SF-20 Scale
E
f
f
e
c
t

S
i
z
e
Mild
Moderate
Severe
Figure 2. Relationship between anxiety severity as measured with the
generalized anxiety disorder 7-item (GAD-7) scale and decline in functional
status as measured with the 6 subscales of the Medical Outcomes Study
Short-Form General Health Survey (SF-20). The decrement in SF-20 scores
is shown as the difference between each GAD-7 scale severity group and the
reference group (ie, those with GAD-7 scale scores of 0 to 4). Effect size is
the difference in group means divided by the SD.
Table 3. Relationship Between GAD-7 Anxiety Severity
Score and Disability Days, Symptom-Related Difficulty,
and Clinic Visits*
Level of Anxiety
Severity GAD-7
Scale Score
Mean No. of
Disability Days
(95% CI)†
Mean No. of
Physician
Visits
(95% CI)†
Percentage
of Symptom-
Related
Difficulty‡
Minimal
0-4 (n = 1182) 3.9 (3.0-4.7) 1.2 (1.1-1.3) 15.0
Mild
5-9 (n = 511) 7.5 (6.2-8.7) 1.7 (1.5-1.9) 5.5
Moderate
10-14 (n = 264) 10.7 (8.9-12.4) 2.2 (1.9-2.5) 13.7
Severe
15-21 (n = 171) 16.8 (14.6-19.1) 2.4 (2.0-2.8) 47.4
Abbreviations: GAD-7, generalized anxiety disorder 7-item scale;
CI, confidence interval.
*All pairwise comparisons between each GAD-7 scale severity level are
significant at P�.05 by using a Bonferroni correction for multiple
comparisons, with the exception of mean physician visits at moderate vs
severe GAD-7 score severity levels.
†Disability days refers to number of days in the past 3 months that the
patients’ symptoms interfered with their usual activities. Physician visits also
refers to the past 3 months. Both are self-reported, and means are adjusted
for age, sex, race, education, study site, and number of physical disorders.
Number of patients adds to 2128 because of missing data. Missing data
were less than 5%.
‡Response to single question: “How difficult have these problems made it
for you to do your work, take care of things at home, or get along with other
people?” The 4 response categories are “not difficult at all,” “somewhat
difficult,” “very difficult,” and “extremely difficult.” Symptom-related
difficulty in this table refers to patients reporting “very” or “extremely”
difficult.
(REPRINTED) ARCH INTERN MED/VOL 166, MAY 22, 2006 WWW.ARCHINTERNMED.COM
1096
2006 American Medical Association. All rights reserved.
Downloaded From: http://archinte.jamanetwork.com/ by a University of Wisconsin -Madison User on 05/06/2015

Accepted for Publication: January 2, 2006.
Correspondence: Robert L. Spitzer, MD, Department of
Psychiatry, New York State Psychiatric Institute, Unit 60,
1051 Riverside Dr, New York, NY 10032 (RLS8
@Columbia.edu).
Funding/Support: The development of the GAD-7 scale
was underwritten by an unrestricted educational grant
from Pfizer Inc (New York, NY). Dr Spitzer had full ac-
cess to the data in the study and takes responsibility for
the integrity of the data and the accuracy of the data analy-
sis.
Acknowledgment:Mark Davies, MS, assisted in the sta-
tistical analysis. Jeffrey G. Johnson, PhD, assisted in data
collection and commented on early drafts. Diane Engel,
MSW, also assisted in data collection.
REFERENCES
1. Olfson M, Fireman B, Weissman MM, Leon AC, Sheehan DV, Kathol RG. Mental
disorders and disability among patients in a primary care group practice. Am J
Psychiatry. 1997;154:1734-1740.
2. Roy-Byrne PP,Wagner A. Primary care perspectives on generalized anxiety disorder.
J Clin Psychiatry. 2004;65(suppl 13):20-26.
3. Leon AC, Olfson M, Broadhead WE, et al. Prevalence of mental disorders in pri-
mary care: implications for screening. Arch Fam Med. 1995;4:857-861.
4. Wittchen HU, Zhao S, Kessler RC, EatonWW. DSM-III-R generalized anxiety dis-
order in the National Comorbidity Survey. Arch Gen Psychiatry. 1994;51:355-
364.
5. Kessler RC, Brandenburg N, Lane M, et al. Rethinking the duration requirement
for generalized anxiety disorder: evidence from the National Comorbidity Sur-
vey Replication. Psychol Med. 2005;35:1073-1082.
6. Kessler RC, Keller MB, Wittchen HU. The epidemiology of generalized anxiety
disorder. Psychiatr Clin North Am. 2001;24:19-39.
7. Williams JW, Pignone M, Ramirez G, Perez SC. Identifying depression in pri-
mary care: a literature synthesis of case-finding instruments.Gen Hosp Psychiatry.
2002;24:225-237.
8. Lo¨we B, Spitzer RL, Gra¨fe K, et al. Comparative validity of three screening ques-
tionnaires for DSM-IV depressive disorders and physicians’ diagnoses. J Affect
Disord. 2004;78:131-140.
9. Spitzer RL, Kroenke K, Williams JB; Patient Health Questionnaire Primary Care
Study Group. Validation and utility of a self-report version of PRIME-MD: the PHQ
primary care study. JAMA. 1999;282:1737-1744.
10. Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression
severity measure. J Gen Intern Med. 2001;16:606-613.
11. Lo¨weB,Gra¨fe K, Zipfel S, Witte S, Loerch B, Herzog W. Diagnosing ICD-10 de-
pressive episodes: superior criterion validity of the Patient Health Questionnaire.
Psychother Psychosom. 2004;73:386-390.
12. Fricchione G. Clinical practice: generalized anxiety disorder. N Engl J Med. 2004;
351:675-682.
13. Westen D, Morrison K. A multidimensional meta-analysis of treatments for de-
pression, panic, and generalized anxiety disorder: an empirical examination of
the status of empirically supported therapies. J Consult Clin Psychol. 2001;
69:875-899.
14. Beck AT, Epstein N, Brown G, Steer RA. An inventory for measuring clinical anxi-
ety: psychometric properties. J Consult Clin Psychol. 1988;56:893-897.
15. Zimmerman M, Mattia JI. A self-report scale to help make psychiatric diag-
noses: the Psychiatric Diagnostic Screening Questionnaire. Arch Gen Psychiatry.
2001;58:787-794.
16. Derogatis LR, Lipman RS, Rickels K, Uhlenhuth EH, Covi L. The Hopkins Symp-
tom Checklist (HSCL): a measure of primary symptom dimensions. Mod Probl
Pharmacopsychiatry. 1974;7:79-110.
17. Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the Hospital Anxiety
and Depression Scale: an updated literature review. J Psychosom Res. 2002;
52:69-77.
18. Hamilton M. The assessment of anxiety states by rating. Br J Med Psychol. 1959;
32:50-55.
19. AntonyMM, Orsillo SM, Roemer L, eds. Practitioner’s Guide to Empirically Based
Measures of Anxiety. New York, NY: Kluwer Academic/Plenum Publishers; 2001.
20. Stewart AL, Hays RD, Ware JE Jr. The MOS short-form general health survey:
reliability and validity in a patient population. Med Care. 1988;26:724-735.
21. Ware JE, Sherbourne CD. The MOS 36-item short-form health survey (SF-36),
I: conceptual framework and item selection. Med Care. 1992;30:473-483.
22. Kroenke K, Spitzer RL. The PHQ-9: a new depression diagnostic and severity
measure. Psychiatr Ann. 2002;9:1-7.
23. First MB, Spitzer RL, Williams JBW, Gibbon M. Structured Clinical Interview for
DSM-IV (SCID).Washington, DC: American Psychiatric Association; 1995.
24. Pinto-Meza A, Serrano-Blanco A, Penarrubia MT, Blanco E, Haro JM. Assessing
depression in primary care with the PHQ-9: can it be carried out over the telephone?
J Gen Intern Med. 2005;20:738-742.
25. Deyo RA, Diehr P, Patrick DL. Reproducibility and responsiveness of health sta-
tus measures: statistics and strategies for evaluation. Control Clin Trials. 1991;
12:142S-158S.
26. American Psychiatric Association. Diagnostic and Statistical Manual of Mental
Disorders DSM-IV-TR (Text Revision). 4th ed. Washington, DC: American Psy-
chiatric Association; 2000.
27. Kazis LE, Anderson JJ, Meenan RF. Effect sizes for interpreting changes in health
status. Med Care. 1989;27:S178-S189.
28. Carter RM, Wittchen HU, Pfister H, Kessler RC. One-year prevalence of sub-
threshold and threshold DSM-IV generalized anxiety disorder in a nationally rep-
resentative sample. Depress Anxiety. 2001;13:78-88.
29. Clark DA, Steer RA, Beck AT. Common and specific dimensions of self-reported
anxiety and depression: implications for the cognitive and tripartite models.
J Abnorm Psychol. 1994;103:645-654.
30. Lo¨weB,Unu¨tzer J, Callahan CM, Perkins AJ, Kroenke K. Monitoring depression
treatment outcomes with the Patient Health Questionnaire-9. Med Care. 2004;
42:1194-1201.
31. Lo¨we B, Kroenke K, Gra¨fe K. Detecting and monitoring depression with a 2-item
questionnaire (PHQ-2). J Psychosom Res. 2005;58:163-171.
32. Klinkman MS. Competing demands in psychosocial care: a model for the iden-
tification and treatment of depressive disorders in primary care. Gen Hosp
Psychiatry. 1997;19:98-111.
(REPRINTED) ARCH INTERN MED/VOL 166, MAY 22, 2006 WWW.ARCHINTERNMED.COM
1097
2006 American Medical Association. All rights reserved.
Downloaded From: http://archinte.jamanetwork.com/ by a University of Wisconsin -Madison User on 05/06/2015