Potential Harms of Feedback After Web-Based Depression Screening: Secondary Analysis of Negative Effects in the Randomized Controlled DISCOVER Trial.

backgroundWeb-based depression screening followed by automated feedback of results is frequently used and promoted by mental health care providers. However, criticism points to potential associated harms. Systematic empirical evidence on postulated negative effects is missing.

objectiveWe aimed to examine whether automated feedback after web-based depression screening is associated with misdiagnosis, mistreatment, deterioration in depression severity, deterioration in emotional response to symptoms, and deterioration in suicidal ideation at 1 and 6 months after screening.

methodsThis is a secondary analysis of the German-wide, web-based, randomized controlled DISCOVER trial. Affected but undiagnosed individuals screening positive for depression (9-item Patient Health Questionnaire [PHQ-9] ≥10 points) were randomized 1:1:1 to receive nontailored feedback, tailored feedback, or no feedback on their screening result. Misdiagnosis and mistreatment were operationalized as having received a depression diagnosis by a health professional and as having started guideline-based depression treatment since screening (self-report), respectively, while not having met the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) (DSM-V) criteria of a major depressive disorder at baseline (Structured Clinical Interview for DSM-V Disorders). Deterioration in depression severity was defined as a pre-post change of ≥4.4 points in the PHQ-9, deterioration in emotional response to symptoms as a pre-post change of ≥3.1 points in a composite scale of the Brief Illness Perception Questionnaire, and deterioration in suicidal ideation as a pre-post change of ≥1 point in the PHQ-9 suicide item. Outcome rates were compared between each feedback arm and the no feedback arm in terms of relative risks (RRs).

resultsIn the per protocol sample of 948 participants (n=685, 72% female; mean age of 37.3, SD 14.1 years), there was no difference in rates of misdiagnosis (ranging from 3.5% to 4.9% across all study arms), mistreatment (7.2%-8.3%), deterioration in depression severity (2%-6.8%), deterioration in emotional response (0.7%-2.9%), and deterioration in suicidal ideation at 6 months (6.8%-13.1%) between the feedback arms and the no feedback arm (RRs ranging from 0.46 to 1.96; P values ≥.13). The rate for deterioration in suicidal ideation at 1 month was increased in the nontailored feedback arm (RR 1.92; P=.01) but not in the tailored feedback arm (RR 1.26; P=.43), with rates of 12.3%, 8.1%, and 6.4% in the nontailored, tailored, and no feedback arms, respectively. All but 1 sensitivity analyses as well as subgroup analyses for false-positive screens supported the findings.

conclusionsThe results indicate that feedback after web-based depression screening is not associated with negative effects such as misdiagnosis, mistreatment, and deterioration in depression severity or in emotional response to symptoms. However, it cannot be ruled out that nontailored feedback may increase the risk of deterioration in suicidal ideation. Robust prospective research on negative effects and particularly suicidal ideation is needed and should inform current practice.

trial registrationClinicalTrials.gov NCT04633096; https://clinicaltrials.gov/study/NCT04633096; Open Science Framework 10.17605/OSF.IO/TZYRD; https://osf.io/tzyrd.