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    Jose A Rodas

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    ee cone rcs A Brief Measure for Assessing Generalized Anxiety Disorder The GAD-7 Robert L. Spitzer, MD; Kurt Kroenke, MD; Janet B. W. Williams, DSW; Bernd Lowe, MD, PhD Background: Generalized anxiety disorder (GAD) is one fof the most common mental disorders; however, there is no brief clinical measure for assessing GAD, The ob- jective ofthis study was to develop ariel sell-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 total of 2740 adult paticnts completing a study questionnaire, 965 patients had a telephone interview with a mental health profes- sional within 1 week. For criterion and consttuct valid lty, 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-ivem ans y scale (GAD-7) had good re- liability, as well as criterion, construct, factorial, and pro- ccedural validity. A cut point was identified that opti- mized sensitivity (89%) and specificity (829%). Increasing scores on the scale were strongly associated with mul- tiple domains f functional impairment (all 6 Medical Out- ‘comes Study Short-Form General Health Survey scales and disability days). Although GAD and depression symp- toms frequently co-occurred, factor analysis confirmed them as distinct dimensions. Moreover, GAD and d pression symptoms had differing but independent el fects on functional impairment and disability. There was ‘good agreement between self-report and interviewer ‘administered versions of the scale Conelusion: The GAD-7 isa valid and efficient tool for screening for GAD and assessing its severity in clinical practice and research, “Arch Intern Med. 2006;166:1092-1097 Author Afliations: Biometrics Research Department, New York State Psychiatric Institute and Department of Psychiatry ‘Columbia University, New York (Drs Spitzer and Williams); Regenstrief Insitute for Health (Care and Department of ‘Medicine, Indiana University Indianapolis (De Kroenke); and Department of Psychosomatic and General Internal Medicine, University of Heidelberg, Heidelberg, Germany (Dr Lowe) (aepnurED) ARCHINTERN WEDIVOL Tes WAT NE OF THE Most COM- mon anxiety disorders seen in general medical practice and in the gen- «ral population is gener- alized anxiety disorder (GAD). The disor- dr has an estimated curzent prevalence in seneral medical practice of 2.8% to 8.5% and in the general population of 1.6% to 5.0%6."* Whereasdepresston in clinical set- tings has generated substantial research, there have been far fewer studies of anxi- Inpar, this may be because ofthe pau- ‘ity of brici validated measures for anxiety ‘compared with the numerous measures for depression,’® such as the Primary Care Evaluation of Mental Disorders item Pa- tient Health Questionnaire (PHQ).*" This situation is unfortunate, given the high prevalence of anxiety disorders, as well as thir associated disability andthe available ity of elfecuve weatments, both pharmaco- logical and nonpharmacological.'= Measures of anxiety are seldom used in clinical pracice because oftheir length, proprietary nature, lack of usefulness as diagnostic and severity measure," and requirement of clinician administration rather than patient sell-report. The goal of this study was to develop a brief scale to identify probable cases of GAD and to assess symptom severity. We conducted ‘study in multiple primary care sites to select the items for the final scale and to evaluate its reliability and validity LESS GAD SCALE DEVELOPMENT ‘We fist selected potenti items fora brief GAD scale. The intial tem pool consisted of9 stems that reflected all ofthe Diagnostic and Statist- ‘al Manual of Mental Disorders, Fourth Edition (DSM-IV) symptom criteria for GAD and 4 items on the basis of review of existing ansi- ly scales, 13-item questionnaire was devel- ‘oped that asked patients how often, daring the last 2 wees, they were bothered by cach symp- tom, Response options were "aot at all,” "se¥- (©2000 American Medical Association, All rights reserved. eral days,” “more than half he days,” and “nearly everyday. Scored 3:0, 1.2 and 3. respectively. In addition, an tem 10 desces duration of anxiety symptoms was included. Our goal twas odetermine the numberof ims necesay to achieve good reliably and procedural, consinct, and diagnostic eteion validity PATIENT SAMPLE, Patients were enrolled from November 2004 through June 2005 fronna research network of 1 primary crests cated in slates (13 famly practice, 2 internal medicine) administered Centrally by claves, Ine (pringheld, Mo). The purpose ofthe Project's first phase (n= 2149) was tosclect the sele tems and Eto cores fo be used for making a GAD diagnosis. The pur- pose ofthe second phase (n=591) was to determine hescale's Ascretest reli. val 2082 subjects were approached and 3739 (01.9%) completed the study questionnaire with no or ‘minimal missing data. To minimize sampling bias, we ap proached consective patent cach ste incline sessionsu- Ul the target quota for that week was achieved. tn the frst phase, 1654 subject alo agreed to atlephone Amterview, and ofthese, a random sample of 95 were iner- viewed within 1 week of their clini visi by 1 of 2 mental health professionals (MPS)—a PAD clinical psychologist and 2 senior paychiatric socal worker. In the study’ second Phase, 391 subjects who had completed the research ques- tlonnaie were sent a -page questionnaire that consisted of the 13 potential GAD scale Htems. Of these, 236 subjects returned the completed Ispage questionnaire with no or ini inal missing data within a week of completing the research Guestonnaifeat the clini. The mean GAD scale score of sub- fete returning the questionnatre did not differ frm that of abject who did not return the questionnaire. The study was Spproved by the String Institutional Review Board, Spring- ek Mo SELF-REPORT RESEARCH QUESTIONNAIRE Before seeing thet physicians, patients completed a 4-pageques- tionnaire that included the 13 tems being tested for use in the GAD scale, as well as questions about age, sex, education, cth- nicity, and marital status; the Medical Outcomes Study Short- Form General Health Survey (SF-20),** which measures func- tional status in 6 dimensions; and either the 12-tem anxiety subscale from the Symptom Checklist-90" (ist study phase only) or the Beck Anxiety Inventory (second study phase onl). Depression was assessed with the PHQ-8, which includes all items from the PHQ-9 except forthe item about suicidal ide- ation; PHQ-8 and PHQ-0 scores are highly correlated and have ‘arly identical operating characteristics” Finally patients com- pleted items regarding physician visits and disability days dur- {ng the previous 3 months, MUP INTERVIEW ‘The 2 MHPs conducted structured psychiatric interviews by telephone, blinded tothe results of the self-report research ques- tionnaire. The interview consisted of the GAD section of the Structured Clinical Interview for DSM-IV,” modified with sev- «ral additional questions to assess in greater detail some ofthe GAD diagnostic criteria of DSM-IV. The resulting DSM-IV GAD diagnosis, with the DSM-IV o-month duration criterion, was tused as the criterion standard for assessing the validity of the now scale. The interview also included the 13 potential GAD scale tems o test agreement between sell-eport and clinician administration (ic, procedural validity)" (REPRINTED) RRCHINTERN WEDIVOL Ts, WAT DATA ANALYSIS “Thebes items for the GAD scale were seleced by rank order- ing he correlation of achitem with he ol 1-tem scale sore inthe sample of 1184 patients who didnot undergo the MAP interview. lem-tolal score corlations were reexamined in 2 independent subsamples ofthe study population: the 965 pa- tients who underwent the MHP interview and the 591 pa- tents tn the second phase ofthe study In aditon, we con- Alcted receiver operating characteristic analyses with varying tiumbers of tne in these 965 patents by using an MHP gnosis of GAD asthe enterion standard. Divergent ally of tach tem was asesed by calulating the diference between the tem correlations withthe Litem anally score and the PHQ'S depression score. Convergent validly was assessed by ‘examining correlations ofthe final version ofthe GAD scale ‘vith the Heck Ansiety Inventory and the nxiely subscale of the Symptom Checklis-00, eventhough neither scale fs pe- llc for GAD. “To assess construct validity, we used analysis of cova ance o examine asocatons between anxiety severity on the final GAD scale and SF-20 functional status scales, sll reported disbily days, and physican vist, controlling for demographic variables. For criterion validity, we investi- gated sensitivity, specificity, predictive values, and likeli- Hood ratios fora range of cutoff scores ofthe inal sale with reapect tothe MHP diagnosis, To investigate whether an ely as eased by the GAD-7 and depresion as measured by the PHQ- reflect distinct dimensions, we assessed laco- tal validity by using confirmatory factor analyses. Finally procedural validity a test-retest reliability were assessed by means of intraclass correlation.” ss} 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% we white non-Hispanic, 8% were African American, and 9% ‘were Hispanic; 64% were married, 13% were divorcet and 15% were never married; and 31% had a high schoo! 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 (7=0.75-0.85). Receiver operating characteristic analysis with this set of ilems showed an area under the curve (0.906) as good as scales with as much as the full 13-item set. These 7 stems also had the highest rank correlations in the developmental sample (n=1184) and the 2 replication samples (n=965 and n=501). The 2 core criteria (A and B) of the DSM-IV definition of GAD are captured by the first 3 items of the scale OF note, 6 of the 7 items had the greatest divergent validity (ie, the highest difference between the item-total seale score correlation and item-PHQ-8 depression score correlation [A 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 (©2000 American Medical Association, All rights reserved. ‘Downloaded From: https:/jamanetwork.com/ on 03/00/2023 02 yest ayn eee Seacaanirpaama Me et oe Felgen ra oS piatbiguiaspecmiwonig 9 1 tS Ptemepiomudancatentey = 9 12 a ig ota Steguntaaemel = 81k ig on orn ty on ntl gps Ott Me £3 —= lf, — 7 ghd opi od ani te dejearwn ethos ay wer Made Sana le Egan it Sarit SRP a a a 3 Figure 1. The gnerald arty ora 7-tem (GAD) sal RELIABILITY AND PROCEDURAL VALIDITY The internal consistency of the GAD-7 was excellent (Cronbach «=.92). Test-retest reliability was also good Gntraclass correlation=0.83). Comparison of scores de- rived from the self-report scales with those derived from the MHP-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, asthe cut point increases, sensitivity decreases and specilicity iscreases in continuous fashion. At a cut point of 10 or greater, sen- sitivity and specificity exceed 0.80, and sensitivity is nearly maximized. Results were sinilar for men and women and for those aged less and those aged more than the mean age ‘of 47 years, The proportion of primary eare patients who scoreat this level is high (23%). A cut point of 15 or greater maximizes specificity and approximates prevalence (0%) more inline with current epidemiologic estimates of GAD prevalencein 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, whereas most 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 the MHP and 49 (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 patienls, 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 with DSM-IV diagnostic criteria for GAD, None- theless, the operating characteristics of the scale were good because most patients with high symptom scores had (aepnurED) ARCHINTERN WEDIVOL Tes WAT chronic symptoms. Ofthe 433 patients with GAD-7 scores ‘of 10 or greater, 96% had symptoms for | month or more, and 67% had symptoms for 6 months or more CONSTRUCT VALIDITY There wasastrong association between increasing GAD-7 severity scores and worsening function on all 6 SF-20 scales (Table 2). As GAD-7 scores went from mld to moderate to severe, there was a substantial stepwise de cline in functioning in all SE-20 domains. Most pal ‘wise comparisons within each SP-20 scale between stc- cessive GAD-7 severity levels were significant. The relationship between GAD severity and functional im- paiement was similar in men and women. jure 2 illustrates graphically the relationship be twcem increasing GAD-7 scale scores and worsening Func- tonal stats, Decremenis in SF-20 scores are shown i ers of effect size (ie, the diference in mean SF-20 scores, ex- pressed asthe number of SDs, between each GAD-7 inter- val subgroup and the reference group). The reference group isthe group with the lowest GAD-7 scores (ie, 0-4) and the SD used is that ofthe entire sample. Elect sizes of 0.5 and 0.8 are (ypcally considered moderate and large be- twiecn-group differences, respectively. \When the GAD-7 was examined asa continuous vari able, its strength of association with the SF-20 sales was ‘concordant withthe pattern seen in Figure 2. The GAD-7 correlated most strongly with mental health (0.75), fol- lowed by social fanctioning (0.46), general health pei ceptions (0.44), bodily pain (0.36), role functioning (033), and physical fanctioning (0.30) Table 3 shows the association between GAD-7 s verity levels and 3 other measures of construct validity self-reported disability days, clinic visits, and the ge ral amount of difficulty patients attnbute wo theiesyimp- toms. Greater levels of anxiety severity were associated ‘witha monotonic increase in disability days, health care use, and symptom-related difficulty in activities and laionships. 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 dificult Convergent validity of the GAD-7 was good, as dem- ‘onstrated by ts correlations with 2ansiety scales: the Beck ‘Anxiety Inventory (r=0.72) and the anxiety subscale of the Symptom Checklist-90 (r=0.74). Consistent with sults ofprevious studies of anxiety and depression," the GAD-7 and Symptom Checklist-00 anxiety scales also strongly correlated with our depression measure, the PHQ-8 (1=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 (215) on the GAD-7 and PHQ-8 depression sales, respectively In the 2114 patients who completed the GAD-7 and the PHQ-8, there were 1877 (88.8%) patients with neither high ans ety nor high depression, 99 (4.68%) with high ansiety ‘only, 68 (3.2%) with high depression only, and 70 (3.31%) ‘with high ansity and high depression. Thus, more than half (99/169) of patents with high anxiety scores did not (©2000 American Medical Association, All rights reserved. Table 4. Operating Characteristics of GAD-7 at DiferentCuot ‘0-7 Seale See senate pec, PPV. Nv, ry = @ 76 4 w 38 ® 0 79 26 0 43 0 0 2 Fy 0 51 1 2 5 a 8 55 2 a a 3 8 6 a a a a7 a u 56 @ a 6 2 6 a % 2 rs a7 ‘Abrevaons GADT, gneaiedansty pre-e sea LA, lod rato fora polive tet NV, negative predte val: PP, pst predctve value “in 965 pats who underwent structure psychi iar by a mental heath pro using isgnoct and Sasa Manual of Mtl isordes. Fourth Eaton agnostics “heal care get than or equal othe sor shown, onal to trie te presence of gnaaized arity ised by ‘Table 2. Relatlonship Between GAD-7 Severity Score and SF-20 Health-Related Qually of Life Scales Tusa (9%: Conanesinervat) SF-20 Seale Sere "wentai—‘Soolt——Role——=omeral Palm Physical" azjat-ss) or .02) eas) (6780) © T1072) 48S) 65,6466) 70,781) 6016673) SOSH) © S8GLSH 7472-76) 54/5255) 6D(G5-71) (SHS) ABH (AOS) STF ABSA) 6280) 521 (n= 171) 413043) 551625 a5 4082) 304 368) THAD) SBS) ‘Abretons: GAD, gneaied ant lode -tem sea; SF-20 Medal Outcomes Study Shor Gurl Heath Survey. S20 score are adjusted fo age, sx cs, education and study sis Pott estates ort ean an O's conidenee neal (1.96 x standard etror ol tho mean) ara splayed. Number of patntsads o 2128 because of mising data Nisin data foray subsal of 3-20 was ss han 5. “Pariee comparisons wn ach eel tate no gniant om one ate. Hower mot paris corpaean of mean SF-20 sors with each aa sn vl wth cath sens re signeant mt P= bby ang a Bonar orton for mle comparison have high depression scores. Also, when paienishad high terion validity for identifying probable eases of GAD. Sec- aniety and high depression scores, chere was an addi- ond, the scale te also an excellent severity measire as tive elect on the SE20 mental health and socal fanc- demonstrated by the fact that increasing scores on the tioning scales, as wellassell-reported disability daysand —GAD-7 are strongly associated with multple domains of healthcare use functional impairment and disability days, Third, al- though many patients had anuity and depressive symp- FACTORIAL VALIDITY toms, factor analysis confirms GAD and depression asd Principal component analysis ofa set of 15 items thatin- "This study reports the development and validation of cludes the depression tems ofthe PHQ-Sand the Tans _g measure fr evaluating the presence and severity of GAD ‘xy items of the GAD-7 indicated thai the fest 2emer_yelineal practice, the GAD-7_one ofthe few GAD mea. gent factors had an clgenvalue greater than 1. Sixty~ sures thats also specifically linked tothe DSM-IV (Text tne percent of the total variance was explained by the Revision) erterin "A score of 10 rgreaeron the GAD-7 first 2 factors. The varimax-rotated component-matrix represents a reasonable cut point for identifying cases of cleanly confirmed the original llocalion of the sem 10 Gai Cus polos of 3 10. 13 migh be tnerpeceed the PHQ scales, withalldepressionitemshaving the high- _y epresenting mild, moderate and severe levels of anxi- 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). yon the GAB, sla to levels of depression on the PHQ!" The GAD-T may be partially tacful Ina Et Construct ald was demonstated by the atta thisstudy hassevera major ndings Psa 7stemansle —inereaing scores on the GAD" sale were strongly ae ety seale—the GAD-7—is a useful tool with strong eri- sociated with multiple domains of functional impair- (aepnny ED) ARGHINTERN (©2000 American Medical Association, All rights reserved. as 20 Bin acer 5° at Soctl Geek el Pa S620 See ada seer as measured ith the “Tear (GAD. 7) sale ad aca In funetona tau as measured wth th ubealefthe Medea Outcomes Sty ‘Short Form Gael Heath Say (S20, The deeamant in 20 eeras ie shown a the rene botean each GAD-T sl sees group ad the ‘erence group (those with GAD-7 eal scare of Ota) Etec sae thottrencen group means ded bye SD ment, Furthermore, there was a strong association with self-reported disability daysand a modest 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- crating characteristics proved good with use of our eri lerion-standard MHP interviews based on the conven- ional GAD duration criterion of 6 months. However, the National Comorbidity Survey showed that patients with episodes of 1 wo 5 months do not differ greatly [rom those ‘with episodes of 6 months or more in onset, persis- tence, impairment, comorbidity, parental GAD, or so- clodemographie correlates.> Kessler etal? conclude that there is litte basis for excluding these people from a di- agnosis. Notably, 96% of patients with GAD-7scores of 10 oF greater in our primary care sample had symptoms ‘of a month or more, whereas 67% had symptoms of © months or longer. It may be that in treatment trials in which response to therapy is evaluated, assessing GAD symptom change duringa 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.” Not surpris- ingly, our depression measure, the PHQ-8, strongly correlated with the GAD-7 and the Symptom Checklist-00 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- lty of anxiety symptoms had corresponding greater impairment in multiple domains of functional status, Together, these findings indicate that using only a depression measure to identily 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 {rom treatment. (aepnurED) ARCHINTERN WEDIVOL Tes WAT Table 3. Relationship Between GAD-7 Anxiety Severity Score and Disability Days, Symptom-Related Diticuly, and Clinic Visits® ot Pecenag Levelt antely Mano. ot Payton of symplom- ‘evenly GAD-7| lea sys iste ‘Seal Sore (ea%ont exe cht iia O4in=tt82) 39047) 12/1113) 180 ais S9in=5tt) 756287) 1711519) 85 orate 10-14(n=264) 107(80128 22/1025) 137 smite 1821 (2171) 168 (146191) 242028 a7 Abbreviations: GADT,gneazod anit ode 7-tem sea cl onfidenge ne “Al pase camgarzane between each GAD- sala sevety lea ar ‘Spica a P=03 by usin orton crectan for multe amparcon, wth he xeon of mean ye ist derate ‘rte GAD-? sere every les Diaby days eters o numba of ays in tha past 3 months tha the patents symptoms ineeaa wth ha ural aces. Prysesn vt lo fos to iu pat 3 onthe. Both ara salseportaa and meas ae austed forage sb race, edueato,study ste and numberof physical disorders. Namba patents add 09128 barauee of msing data Missing dats, vite sean 5 spon fo single question: “How cult have these problems made it {oryouto do your work tla creo things at hme gt long wh ater people” The despanse categories are otdfeult at al” “someuhat ‘tel, very ate and“evtemsly dieu,” Symptom rises

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