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Published on: April 26, 2024
Instructional Emphasis and PHQ-9 and GAD-7 Scores Among Participants With Anxiety or Depression: A Randomized
Sean D Young1, William G Cumberland2, Desirée A Fehmie1
1Department of Emergency Medicine, School of Medicine, University of California, Irvine.
Importance:
The Patient Health Questionnaire-9 (PHQ-9) is widely used to assess depression, and the General Anxiety Disorder-7 (GAD-7) is widely used to assess anxiety, yet the extent to which subtle differences in instruction delivery influence symptom scores is poorly understood.
Objective:
To determine whether emphasizing instructional wording alters PHQ-9 and GAD-7 responses among US adults with depression or anxiety.
Design, Setting, And Participants:
This randomized clinical trial was conducted from April 17 to May 30, 2025. Participants included US adults with self-reported clinician-diagnosed or treated major depressive disorder or generalized anxiety disorder, recruited via online advertisements and assessed by telephone.
Interventions:
Participants completed the PHQ-9 and the GAD-7 twice within the same session. Control participants received standard instructions for both administrations. Intervention participants received standard instructions initially and, for the second administration, were reminded to attend to the wording of the questionnaire instructions, with emphasis placed on the word bothered.
Main Outcomes And Measures:
The primary outcome was changes in PHQ-9 and GAD-7 total scores. Secondary outcomes were a score reduction greater than 20% and categorical change in score severity (eg, moderate to mild).
Results:
Among 200 total participants (n = 100 in the intervention group and n = 100 in the control group; mean [SD] age, 41.5 [15.4] years; 146 female [73%]), those in the intervention group demonstrated greater score reductions than those in the control group on the PHQ-9 (difference in changes: -2.60 [95% CI, -3.30 to -1.91]; P < .001) and the GAD-7 (difference in changes: -2.63 [95% CI, -3.35 to -1.99]; P < .001). Intervention participants had higher odds of achieving a score reduction greater than 20% (PHQ-9: adjusted odds ratio [AOR], 14.29 [95% CI, 5.95-34.48], P < .001; GAD-7: AOR, 10.20 [95% CI, 5.08-20.41], P < .001) and categorical improvement (PHQ-9: AOR, 9.17 [95% CI, 4.35-19.61], P < .001; GAD-7: AOR, 7.14 [95% CI, 3.57-14.29], P < .001) compared with control participants.
Conclusions And Relevance:
In this randomized clinical trial of instructional emphasis on PHQ-9 and GAD-7 scores among participants with anxiety or depression, findings suggest that variation in how questionnaire instructions are emphasized can influence PHQ-9 and GAD-7 scores, underscoring the need for standardized administration in clinical, research, and digital settings.
Trial Registration:
ClinicalTrials.gov Identifier: NCT06956378.
