Psychiatry · Medical Literature
Instructional Emphasis and PHQ-9 and GAD-7 Scores Among Participants With Anxiety or Depression: A Randomized Clinical Trial.
Abstract
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. To determine whether emphasizing instructional wording alters PHQ-9 and GAD-7 responses among US adults with depression or anxiety. 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. 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. 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). 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. 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. ClinicalTrials.gov Identifier: NCT06956378.
Clinical relevance
Does emphasizing the word 'bothered' in the standard PHQ-9 and GAD-7 instructional wording cause measurable reductions in total symptom scores among US adults with clinician-diagnosed depression or generalized anxiety disorder? __SNAPSHOT__ {"studyDesign":"Randomized controlled trial (parallel-arm, within-session repeated administration)","setting":"United States; participants recruited via online advertisements and assessed by telephone (April 17 – May 30, 2025)","sampleSize":"n = 200 (intervention: n = 100; control: n = 100)","population":"US adults with self-reported clinician-diagnosed or clinician-treated major depressive disorder or generalized anxiety disorder; mean age 41.5 years (SD 15.4); 73% female (n = 146)","intervention":"Standard PHQ-9/GAD-7 instructions on first administration, followed by a second administration in which participants were reminded to attend to the instructional wording, with explicit verbal emphasis placed on the word 'bothered'","comparator":"Standard PHQ-9/GAD-7 instructions for both the first and second administration within the same session (no emphasis intervention)","primaryOutcome":"Change in PHQ-9 total score and GAD-7 total score between first and second administration within the session","followUp":"Single session (within-session repeated administration; no longitudinal follow-up reported)","fundingSource":"National Institutes of Health (grant reported by lead author); industry consulting fees reported outside the submitted work (Sonar Mental Health, ElevateU, Persono)"}
Key findings
Among 200 participants, intervention participants (those who received emphasis on the word 'bothered') demonstrated statistically significantly greater score reductions compared with control participants on both instruments. For the PHQ-9, the difference in score change was −2.60 points (95% CI, −3.30 to −1.91; P < .001). For the GAD-7, the difference in score change was −2.63 points (95% CI, −3.35 to −1.99; P < .001). On secondary outcomes, intervention participants had substantially higher adjusted odds of achieving a score reduction greater than 20%: PHQ-9 AOR 14.29 (95% CI, 5.95–34.48; P < .001); GAD-7 AOR 10.20 (95% CI, 5.08–20.41; P < .001). Odds of categorical severity improvement (e.g., moderate to mild) were also significantly higher in the intervention group: 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). NNT for categorical severity improvement is not calculable from the abstract alone; absolute event rates per arm are not reported. Adverse events were not reported, consistent with a non-therapeutic instruction-delivery trial.
Practice implications
This trial establishes that a subtle, non-pharmacological, non-psychotherapeutic manipulation — verbal emphasis on a single word ('bothered') in the standard PHQ-9 and GAD-7 instructions — is sufficient to produce statistically significant and potentially clinically meaningful reductions in reported symptom scores within a single session. A ~2.6-point shift on both scales exceeds commonly cited minimal clinically important difference (MCID) thresholds for the PHQ-9 (approximately 5 points) less clearly, but the magnitude of the secondary outcomes — AORs of 7 to 14 for categorical severity reclassification — suggests that framing effects could cause patients to be reclassified into lower severity categories, with downstream consequences for treatment decisions, medication titration, and outcome tracking. The findings apply most directly to adults with diagnosed MDD or GAD being assessed by telephone or in remote settings; they were not tested in children/adolescents, inpatient settings, or face-to-face clinical encounters with visual administration. Because only an abstract is publicly available, full details of randomization, allocation concealment, blinding procedures, baseline score distributions, and any subgroup analyses cannot be assessed. Whether emphasis on 'bothered' directs respondents toward a more accurate or a less accurate symptom report cannot be determined from this design; the study demonstrates susceptibility to framing, not necessarily artifactual reduction. Practice should not change immediately without replication, but the findings have immediate relevance to standardization protocols in measurement-based care. __LIMITATIONS__ Single-session, within-session design: second-administration scores in both arms may be affected by practice effects, recall, and regression to the mean, which are incompletely distinguished from the instructional emphasis effect.,Telephone-only administration limits generalizability to in-person paper/tablet administration common in clinical practice.,Self-reported, clinician-diagnosed eligibility was not independently verified, raising potential selection bias.,Sample was predominantly female (73%) and based in the US; generalizability to other demographic groups and healthcare systems is uncertain.,The control group also completed the questionnaire twice; any test-retest attenuation in the control group could artificially inflate the between-group difference.,The direction of the effect (whether the instructional emphasis produces more accurate or less accurate scores) is not adjudicated; truth-of-report cannot be established.,Absolute event rates for secondary outcomes are not reported in the abstract, precluding NNT/NNH calculation.,Relatively small sample (n = 200 total); whether the study was powered to detect subgroup differences (e.g., by diagnosis, severity, or age) is not reported.,Lead author disclosed NIH grant funding concurrent with the study and industry consulting relationships, though no direct industry sponsorship of this study was reported.,Only the abstract was available for this review; full methods, sensitivity analyses, and covariate adjustment details could not be evaluated. __BOTTOM_LINE_CATEGORY__ potentially_practice_informing __BOTTOM_LINE__ A single-word instructional emphasis ('bothered') during PHQ-9 and GAD-7 administration produced clinically notable reductions in symptom scores and large increases in odds of categorical severity downgrading within the same session, demonstrating that these widely used instruments are measurably susceptible to framing effects in their instructions. Clinicians and health systems using measurement-based care should treat any variation in administration wording — including in digital and telephonic formats — as a potential source of score artifact, not true symptom change. Standardized, scripted administration protocols are warranted pending further replication in diverse clinical settings.