Cited by 504Anxiety, Depression, Psychometrics, Treatment, Cognitive ProcessesPsychometric Methodologies and TestingMental Health Treatment and Access

Patient Health Questionnaire Anxiety and Depression Scale: Initial Validation in Three Clinical Trials

Open access
Kroenke, Kurt, Wu, Jingwei, Yu, Zhangsheng, Bair, Matthew J., Kean, Jacob, Stump, Timothy, Monahan, Patrick O.·2016·Psychosomatic Medicine

Abstract

Objective: We examine the reliability and validity of the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS)—which combines the nine-item Patient Health Questionnaire depression scale and seven-item Generalized Anxiety Disorder scale—as a composite measure of depression and anxiety. Methods: Baseline data from 896 patients enrolled in two primary-care based trials of chronic pain and one oncology-practice–based trial of depression and pain were analyzed. The internal reliability, standard error of measurement, and convergent, construct, and factor structure validity, as well as sensitivity to change of the PHQ-ADS were examined. Results: The PHQ-ADS demonstrated high internal reliability (Cronbach α values of .8 to .9) in all three trials. PHQ-ADS scores can range from 0 to 48 (with higher scores indicating more severe depression/anxiety), and the estimated standard error of measurement was approximately 3 to 4 points. The PHQ-ADS showed strong convergent (most correlations, 0.7–0.8 range) and construct (most correlations, 0.4–0.6 range) validity when examining its association with other mental health, quality of life, and disability measures. PHQ-ADS cutpoints of 10, 20, and 30 indicated mild, moderate, and severe levels of depression/anxiety, respectively. Bifactor analysis showed sufficient unidimensionality of the PHQ-ADS score. PHQ-ADS change scores at 3 months differentiated ( p < .0001) between individuals classified as worse, stable, or improved by a reference measure, providing preliminary evidence for sensitivity to change. Conclusions: The PHQ-ADS may be a reliable and valid composite measure of depression and anxiety which, if validated in other populations, could be useful as a single measure for jointly assessing two of the most common psychological conditions in clinical practice and research. Trial Registration : Clinicaltrials.gov Identifier: NCT00926588 (SCOPE); NCT00386243 (ESCAPE); NCT00313573 (INCPAD).

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Registry

Crossref · 10.1097/psy.0000000000000322

Cites

74 of 74 references verified0 citation errors · 0 not checkable

Statistics

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Claims the paper makes

0 of 25 cited sources checked · 0 supported · 0 flagged

  • Findingown data

    The PHQ-ADS showed high internal reliability, with Cronbach's alpha between 0.8 and 0.9, in all three trials.

    “The PHQ-ADS demonstrated high internal reliability (Cronbach's alpha of 0.8 to 0.9) in all 3 trials.”
    • Also stated in: § Psychometric Characteristics of PHQ-9, GAD-7 and PHQ-ADS in the 3 Trials · plain
      “All 3 scale scores demonstrated good internal reliability, with Cronbach's alphas in the 0.8 to 0.9 range.”
    Quote in the paperSubstantial claim
  • Findingown data

    The PHQ-ADS had construct validity with quality-of-life and disability measures, with most correlations in the 0.4 to 0.6 range.

    “The PHQ-ADS showed strong convergent (most correlations 0.7-0.8 range) and construct (most correlations 0.4-0.6 range) validity when examining its association with other mental health, quality of life and disability measures.”
    Quote in the paperSubstantial claim
  • Findingown data

    The PHQ-ADS had strong convergent validity with other mental health measures, with most correlations in the 0.7 to 0.8 range.

    “The PHQ-ADS showed strong convergent (most correlations 0.7-0.8 range) and construct (most correlations 0.4-0.6 range) validity when examining its association with other mental health, quality of life and disability measures.”
    Quote in the paperSubstantial claim
  • Findingown data

    The estimated standard error of measurement for the PHQ-ADS was about 3 to 4 points.

    “the estimated SEM was approximately 3 to 4 points”
    Quote in the paperNot a substantial claim
  • Findingown data

    Bi-factor analysis showed that the PHQ-ADS score had sufficient unidimensionality.

    “Bi-factor analysis showed sufficient unidimensionality of the PHQ-ADS score.”
    • Also stated in: § Structural Validity of the PHQ-ADS · hedged
      “further suggesting sufficient unidimensionality and supporting the structural validity of a single PHQ-ADS composite score”
    Quote in the paperSubstantial claim
  • May combine two claims. 28
  • Classified as probably not a substantial claim. 5
  • May combine two claims.

    Findingown data

    PHQ-ADS change scores at 3 months differentiated between groups classified as worse, stable, or improved by a reference measure, giving preliminary evidence of sensitivity to change.

    “PHQ-ADS change scores at 3 months differentiated (P < .0001) between individuals classified as worse, stable, or improved by a reference measure, providing preliminary evidence for sensitivity to change.”
    • Also stated in: § Sensitivity to Change of the PHQ-ADS · plain
      “the PHQ-ADS change scores significantly differentiated between the worse, unchanged, and improved groups in both trials”
    Quote in the paperSubstantial claim
    • Rests on an assumption: The MHI-5 change classification of worse, unchanged, or improved is a valid reference standard for clinically meaningful change in depression and anxiety symptoms.
  • May combine two claims.

    Findingown data

    The WRMR threshold of at most 1.0 was met for the bi-factor model in all three trials, the two-factor model in one trial, and the one-factor model in none.

    “Finally, the WRMR threshold of ≤ 1.0 was achieved for the bi-factor model in all 3 trials, the 2-factor model in only 1 trial, and the 1-factor model in none of the trials.”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Findingown data

    The PHQ-ADS correlated most strongly with its component PHQ-9 and GAD-7 scales, and the PHQ-9 and GAD-7 correlated moderately strongly with each other.

    “As shown in Table 3, the PHQ-ADS had the strongest correlations with the PHQ-9 and GAD-7 (its two component scales), and the PHQ-9 and GAD-7 had moderately strong correlations with one another.”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Findingreasoning

    The INCPAD trial had the highest mean depression scores, while the SCOPE trial had the lowest depression and anxiety scores.

    “The INCPAD trial enrolled patients with depression as well as pain and therefore, not surprisingly, had the highest mean depression scores, whereas the SCOPE trial had the lowest depression and anxiety scores.”
    Quote in the paperNot a substantial claim
  • May combine two claims.

    Findingnone given

    All three trials focused on patients with pain rather than on individuals with depression or anxiety, except that INCPAD enrolled patients with depression.

    “First, all 3 trials focused on patients with pain, rather than individuals with depression (except INCPAD) or anxiety.”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Findingown data

    PHQ-ADS change scores differed significantly among the worse, unchanged, and improved categories by analysis of variance, and pairwise comparisons also differed in both trials.

    “The PHQ-ADS change scores among categories were significantly different (P < .0001) by analysis of variance, and pairwise comparisons between the worse, unchanged, and improved categories also differed (p < .001) in both trials.”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Findingown data

    The three trials included a substantial number of patients meeting clinical cutpoints for depression and combined depression/anxiety, but only a small proportion with anxiety only.

    “Also, there was a substantial number of patients who met clinical cutpoints for depression and combined depression/anxiety in the 3 trials, but only a small proportion with anxiety only.”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Findingown data

    In SCOPE, mean PHQ-ADS scores increased by 3.63 points in the worse group, decreased by 3.12 points in the stable group, and decreased by 7.96 points in the improved group, with standardized response means of -0.45, -0.51, and -0.98.

    “The mean PHQ-ADS score increased 3.63 points in the worse group, declined 3.12 points in the stable group, and declined 7.96 points in the improved group, resulting in SRMs of -0.45, --0.51, and --0.98, respectively.”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Findingown data

    Using a 1-SEM change, the estimated minimal clinically important difference was about 2 to 3 points for the PHQ-9 and GAD-7 and about 3 to 4 points for the PHQ-ADS.

    “Using a 1-SEM change to estimate a minimal clinically important difference (MCID), the MCID estimated from these 3 trials would be approximately 2 to 3 points for the PHQ-9 and GAD-7 and 3 to 4 points for the PHQ-ADS.”
    Quote in the paperNot a substantial claim
  • May combine two claims.

    Findingown data

    Among the trial patients, 286 (31.9%) scored at or above 10 on both the PHQ-9 and GAD-7, 266 (29.7%) on the PHQ-9 only, 21 (2.3%) on the GAD-7 only, and 323 (36.1%) on neither.

    “The number of patients in the 3 trials that achieved this cutpoint on both the PHQ-9 and GAD-7 was 286 (31.9%); on the PHQ-9 only, 266 (29.7%); on the GAD-7 only, 21 (2.3%); and on neither measure, 323 (36.1%).”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Findingown data

    Patient samples in two of the trials were exclusively Veterans and predominantly men.

    “Second, patient samples in two of the trials were exclusively Veterans and predominantly men; thus, data on the PHQ-ADS in non-Veteran samples including more women is warranted.”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Findingown data

    Most factor loadings were substantially above 0.40 and were only slightly higher in the two-factor model than in the one-factor model.

    “most of the factor loadings were substantially higher than the acceptable threshold of 0.40, and were only slightly higher for the 2-factor compared to the 1-factor model”
    Quote in the paperNot a substantial claim
  • May combine two claims.

    Findingown data

    The three scales showed moderately strong convergent validity with composite psychological measures, with the PHQ-ADS having slightly higher correlations than the PHQ-9 and GAD-7.

    “The 3 scales also showed moderately strong convergent validity with the 3 composite psychological measures (PROMIS-ADS, MHI-5, and MCS) with the PHQ-ADS having slightly higher correlations than the PHQ-9 and GAD-7.”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Findingown data

    Fit generally improved slightly when comparing the two-factor model with the one-factor model, and improved more when comparing the bi-factor model with either.

    “There was generally a small improvement in fit when comparing the 2-factor to 1-factor model, and a greater improvement when comparing the bi-factor to either the 1-factor or 2-factor models.”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Findingown data

    In the three trials, mean PHQ-9 scores reflected moderate depression and mean GAD-7 scores reflected mild anxiety.

    “As shown in Table 2, the mean PHQ-9 and GAD-7 scores in the 3 trials represent moderate levels of depression and mild levels of anxiety, respectively.”
    Quote in the paperNot a substantial claim
  • May combine two claims.

    Findingown data

    In INCPAD, mean PHQ-ADS scores decreased in all three groups: by 5.10 points in the worse group, 9.72 points in the unchanged group, and 16.40 points in the improved group, with standardized response means of -0.57, -1.28, and -1.89.

    “The mean PHQ-ADS score decreased in all 3 groups (--5.10 points in the worse group, --9.72 points in the unchanged group, and --16.40 in the improved group, resulting in SRMs of --0.57, --1.28, and -1.89, respectively.”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Findingown data

    The CFI threshold of at least .95 was met for all three models in SCOPE and ESCAPE but only for the bi-factor model in INCPAD.

    “The CFI threshold of ≥ .95 was achieved for all 3 models in the SCOPE and ESCAPE trials but only for the bifactor model in the INCPAD trial.”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Findingown data

    Using a 2-SEM change, the estimated minimal clinically important difference was about 4 to 6 points for the PHQ-9 and GAD-7 and about 6 to 8 points for the PHQ-ADS.

    “Using a more conservative estimate of a 2-SEM change, the MCID would be approximately 4 to 6 points for the PHQ-9 and GAD-7 and 6 to 8 points for the PHQ-ADS.”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Findingown data

    The RMSEA threshold of at most .06 was met for the bi-factor model in two trials but for none of the one-factor or two-factor models.

    “The RMSEA threshold of ≤ .06 was achieved for the bifactor model in two of the trials but in none of the trials for the 1-factor and 2-factor models.”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Interpretationown data

    The PHQ-ADS may be a reliable and valid composite measure of depression and anxiety.

    “The PHQ-ADS may be a reliable and valid composite measure of depression and anxiety”
    • Also stated in: § Conclusions · hedged
      “The PHQ-ADS may be a reliable and valid composite measure of depression and anxiety which, if validated in other populations, could be useful as a single measure for jointly assessing two of the most common psychological conditions in clinical practice and research.”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Interpretationown data

    PHQ-ADS scores of 10, 20, and 30 mark mild, moderate, and severe depression/anxiety, respectively.

    “PHQ-ADS cutpoints of 10, 20, and 30 indicated mild, moderate, and severe levels of depression/anxiety, respectively.”
    • Also stated in: § Discussion · hedged
      “Second, cutpoints of 10, 20, and 30 on the PHQ-ADS indicate mild, moderate, and severe levels of depression/anxiety symptoms, respectively.”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Interpretationown data

    Taken together, the fit indices and factor loadings support the traditional scoring of the PHQ-9 and GAD-7 as depression and anxiety scales and support sufficient unidimensionality of the PHQ-ADS composite score.

    “Taken together, the fit indices and the factor loadings point to the validity of the traditional scoring of the PHQ-9 and GAD-7 as depression and anxiety scale scores as well as the sufficient unidimensionality of scoring the PHQ-ADS as a composite score.”
    Quote in the paperSubstantial claim
  • Probably not a substantial claim: may not pass S2 (checkable).

    Interpretationreasoning

    The PHQ-ADS score may be useful in studies as an outcome variable or as a covariate in multivariable analyses.

    “The PHQ-ADS score may be useful in studies for which a single depression/anxiety score is desirable as either an outcome variable or as a covariate to adjust for in multivariable analyses.”
    Quote in the paperNot a substantial claim
  • May combine two claims.

    Premisecitation

    Both the PHQ-9 and GAD-7 have been shown to be sensitive to change when treatment response is monitored.

    “Moreover, both measures have proven sensitive to change when monitoring treatment response.20;33-36”
    Quote in the paperNot a substantial claim0 of 5 sources checked
    • cites [20] source

      Not checked in the free run.

    • cites [33] source

      Not checked in the free run.

    • cites [34] source

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    • cites [35] source

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      Not checked in the free run.

  • Classified as probably not a substantial claim. May combine two claims.

    Premisecitation

    The PHQ-9 and GAD-7 have strong internal and test-retest reliability and construct and factor-structure validity.

    “The PHQ-9 and GAD-7 have strong internal and test-retest reliability as well as construct and factor-structure validity.20”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [20] source

      Not checked in the free run.

  • May combine two claims.

    Interpretationreasoning

    A PHQ-ADS screening cutpoint would be higher than the PHQ-9 or GAD-7 cutpoint of 10 because the PHQ-ADS has a greater score range; for example, 20 corresponded to moderate depression/anxiety on the PHQ-ADS in this sample.

    “Certainly, a PHQ-ADS screening cutpoint would be higher than that of the PHQ-9 or GAD-7 (which are ≥ 10) since its score range is greater; for example, 10 represents a cutpoint for moderate depressive symptoms on the PHQ-9 and moderate anxiety symptoms on the GAD-7, whereas 20 represented a cutpoint for moderate depressive/anxiety symptoms on the PHQ-ADS in our sample.”
    Quote in the paperNot a substantial claim
  • May combine two claims.

    Study design and conductown data

    The study did not use a structured criterion standard diagnostic interview, so it could not compare the sensitivity and specificity of the PHQ-ADS with the PHQ-9 and GAD-7.

    “Fifth, we did not use a structured criterion standard diagnostic interview in these 3 trials to determine which patients met criteria for depressive or anxiety disorders, and thus were unable to compare the sensitivity and specificity of the PHQ-ADS with the PHQ-9 and GAD-7.”
    Quote in the paperSubstantial claim
  • Classified as probably not a substantial claim.

    Interpretationreasoning

    Because depression and anxiety are moderately strongly intercorrelated, a composite score is attractive as a covariate in multivariable and adjusted analyses.

    “Fourth, the moderately strong intercorrelation between depression and anxiety makes a composite score attractive as a covariate in multivariate modeling and other types of adjusted analyses.”
    Quote in the paperSubstantial claim
  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Premisecitation

    The PHQ-9 and GAD-7 are among the best validated and most commonly used measures of depression and anxiety, respectively.

    “The Patient Health Questionnaire 9-item depression scale (PHQ-9) and 7-item Generalized Anxiety Disorder scale (GAD-7) are among the best validated and most commonly used depression and anxiety measures, respectively.20-25”
    Quote in the paperNot a substantial claim0 of 6 sources checked
    • cites [20] source

      Not checked in the free run.

    • cites [21] source

      Not checked in the free run.

    • cites [22] source

      Not checked in the free run.

    • cites [23] source

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  • Classified as probably not a substantial claim.

    Interpretationreasoning

    The PHQ-ADS may be useful for monitoring treatment of depression and anxiety together.

    “The PHQ-ADS may also be useful in monitoring the concomitant treatment of depression and anxiety, especially since some treatments work across both conditions.”
    Quote in the paperSubstantial claim
    • Rests on an assumption: Some interventions, such as cognitive-behavioral therapy and certain classes of antidepressants, are effective for both depression and anxiety.
  • May combine two claims.

    Study design and conductown data

    The study did not test responsiveness of the PHQ-ADS to treatment because none of the three trials specifically treated anxiety and only one targeted depression.

    “Third, we did not test responsiveness to treatment of the PHQ-ADS since none of the 3 trials were specifically treating anxiety and only one was targeting depression.”
    Quote in the paperSubstantial claim
31 of 31
  • The paper relies on this without support.

    The MHI-5 change classification of worse, unchanged, or improved is a valid reference standard for clinically meaningful change in depression and anxiety symptoms.

    “three MHI-5 change groups (worse, same, improved) were computed for each patient by determining whether the MHI-5 declined or improved by more than 1.0 standard error of measurement (SEM) from baseline to follow-up at 3 months”
    “the comparison of PHQ-ADS change scores among worse, stable, and improved groups as defined by the MHI-5 suggest the PHQ-ADS is sensitive to change over time”
  • The paper relies on this without support.

    Some interventions, such as cognitive-behavioral therapy and certain classes of antidepressants, are effective for both depression and anxiety.

    “some interventions (e.g., cognitive-behavioral therapy; certain classes of antidepressants) are effective for both depression and anxiety”
2 of 2

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Authors
Kroenke, K., Wu, J., Yu, Z., Bair, M. J., Kean, J., Stump, T., & Monahan, P. O.
Affiliations
Regenstrief Institute (US)
Corresponding author
Kroenke, Kurt
Venue
Psychosomatic Medicine
Published
2016-07
Volume
78
Issue
6
Pages
716-727
ISSN
  • 0033-3174 (ISSN-L)
  • 1534-7796
OpenAlex
W2397812290
Cited by
504
References
76
Citations by year
2026: 70 · 2025: 80 · 2024: 76 · 2023: 50 · 2022: 69 · 2021: 77 · 2020: 43 · 2019: 18 · 2018: 9 · 2017: 9 · 2013: 1
FWCI
17.08
Type
journal article
Language
en
Open access
Locations
  • Psychosomatic Medicine (publishedVersion)
  • PubMed (publishedVersion)
  • PubMed Central (acceptedVersion)
  • IUScholarWorks (Indiana University) (submittedVersion)
  • PMC
Funders
  • U.S. Department of Veterans Affairs (IIR 07-119, IK2 RX000879)
  • National Institutes of Health (UL1TR001108)
  • National Cancer Institute (R01CA115369)
  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (R01AR064081)
  • National Center for Advancing Translational Sciences
Topics
  • Social Sciences › Psychology › Experimental and Cognitive Psychology › Anxiety, Depression, Psychometrics, Treatment, Cognitive Processes
  • Social Sciences › Decision Sciences › Management Science and Operations Research › Psychometric Methodologies and Testing
  • Social Sciences › Psychology › Social Psychology › Mental Health Treatment and Access
Keywords
depression, anxiety, psychometric validation, reliability statistics, sensitivity to change, chronic pain, cancer pain, primary care, bifactor analysis, unidimensionality, quality of life, disability
MeSH terms
Adult, Aged, Aged, 80 and over, Anxiety Disorders, Depressive Disorder, Female, Humans, Male, Middle Aged, Psychiatric Status Rating Scales, Psychometrics, Veterans, Reproducibility of Results, Young Adult

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