Prof Sebastian Kohlmann PhD , Franziska Sikorski MSc , Prof Hans-Helmut König MD , Marion Schütt MSc , Prof Antonia Zapf PhD , Prof Bernd Löwe MD
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We recruited individuals (aged ≥18 years) who were undiagnosed with depression and screened positive for depression on an internet-based self-report depression rating scale (Patient Health Questionnaire-9 [PHQ-9] ≥10 points). Participants were randomly assigned 1:1:1 to automatically receive no feedback, non-tailored feedback, or tailored feedback on the depression screening result. Randomisation was stratified by depression severity (moderate: PHQ-9 score 10–14 points; severe: PHQ-9 score ≥15 points). Participants could not be masked but were kept unaware of trial hypotheses to minimise expectancy bias. The non-tailored feedback included the depression screening result, a recommendation to seek professional diagnostic advice, and brief general information about depression and its treatment. The tailored feedback included the same basic information but individually framed according to the participants’ symptom profiles, treatment preferences, causal symptom attributions, health insurance, and local residence. Research staff were masked to group allocation and outcome assessment as these were done using online questionnaires. The primary outcome was change in depression severity, defined as change in PHQ-9 score 6 months after random assignment. Analyses were conducted following the intention-to-treat principle for participants with at least one follow-up visit. This trial was registered at <span>ClinicalTrials.gov</span><svg><path></path></svg>, <span>NCT04633096</span><svg><path></path></svg>.</p></div><div><h3>Findings</h3><p>Between Jan 12, 2021, and Jan 31, 2022, 4878 individuals completed the internet-based screening. Of these, 1178 (24%) screened positive for depression (mean age 37·1 [SD 14·2] years; 824 [70%] woman, 344 [29%] men, and 10 [1%] other gender identity). 6 months after random assignment, depression severity decreased by 3·4 PHQ-9 points in the no feedback group (95% CI 2·9–4·0; within-group d 0·67; 325 participants), by 3·5 points in the non-tailored feedback group (3·0–4·0; within-group d 0·74; 319 participants), and by 3·7 points in the tailored feedback group (3·2–4·3; within-group d 0·71; 321 participants), with no significant differences among the three groups (p=0·72). The number of participants seeking help for depression or initiating psychotherapy or antidepressant treatment did not differ among study groups. The results remained consistent when adjusted for fulfilling the DSM-5-based criteria for major depressive disorder or subjective belief of having a depressive disorder. Negative effects were reported by less than 1% of the total sample 6 months after random assignment.</p></div><div><h3>Interpretation</h3><p>Automated feedback following internet-based depression screening did not reduce depression severity or prompt sufficient depression care in individuals previously undiagnosed with but affected by depression.</p></div><div><h3>Funding</h3><p>German Research Foundation.</p></div>","PeriodicalId":48534,"journal":{"name":"Lancet Digital Health","volume":"6 7","pages":"Pages e446-e457"},"PeriodicalIF":23.8000,"publicationDate":"2024-06-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2589750024000700/pdfft?md5=339cfa330e95efe94536fa8c159d0a77&pid=1-s2.0-S2589750024000700-main.pdf","citationCount":"0","resultStr":"{\"title\":\"The efficacy of automated feedback after internet-based depression screening (DISCOVER): an observer-masked, three-armed, randomised controlled trial in Germany\",\"authors\":\"Prof Sebastian Kohlmann PhD , Franziska Sikorski MSc , Prof Hans-Helmut König MD , Marion Schütt MSc , Prof Antonia Zapf PhD , Prof Bernd Löwe MD\",\"doi\":\"10.1016/S2589-7500(24)00070-0\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><p>Despite the availability of effective treatments, most depressive disorders remain undetected and untreated. 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Participants could not be masked but were kept unaware of trial hypotheses to minimise expectancy bias. The non-tailored feedback included the depression screening result, a recommendation to seek professional diagnostic advice, and brief general information about depression and its treatment. The tailored feedback included the same basic information but individually framed according to the participants’ symptom profiles, treatment preferences, causal symptom attributions, health insurance, and local residence. Research staff were masked to group allocation and outcome assessment as these were done using online questionnaires. The primary outcome was change in depression severity, defined as change in PHQ-9 score 6 months after random assignment. Analyses were conducted following the intention-to-treat principle for participants with at least one follow-up visit. This trial was registered at <span>ClinicalTrials.gov</span><svg><path></path></svg>, <span>NCT04633096</span><svg><path></path></svg>.</p></div><div><h3>Findings</h3><p>Between Jan 12, 2021, and Jan 31, 2022, 4878 individuals completed the internet-based screening. Of these, 1178 (24%) screened positive for depression (mean age 37·1 [SD 14·2] years; 824 [70%] woman, 344 [29%] men, and 10 [1%] other gender identity). 6 months after random assignment, depression severity decreased by 3·4 PHQ-9 points in the no feedback group (95% CI 2·9–4·0; within-group d 0·67; 325 participants), by 3·5 points in the non-tailored feedback group (3·0–4·0; within-group d 0·74; 319 participants), and by 3·7 points in the tailored feedback group (3·2–4·3; within-group d 0·71; 321 participants), with no significant differences among the three groups (p=0·72). The number of participants seeking help for depression or initiating psychotherapy or antidepressant treatment did not differ among study groups. 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The efficacy of automated feedback after internet-based depression screening (DISCOVER): an observer-masked, three-armed, randomised controlled trial in Germany
Background
Despite the availability of effective treatments, most depressive disorders remain undetected and untreated. Internet-based depression screening combined with automated feedback of screening results could reach people with depression and lead to evidence-based care. We aimed to test the efficacy of two versions of automated feedback after internet-based screening on depression severity compared with no feedback.
Methods
DISCOVER was an observer-masked, three-armed, randomised controlled trial in Germany. We recruited individuals (aged ≥18 years) who were undiagnosed with depression and screened positive for depression on an internet-based self-report depression rating scale (Patient Health Questionnaire-9 [PHQ-9] ≥10 points). Participants were randomly assigned 1:1:1 to automatically receive no feedback, non-tailored feedback, or tailored feedback on the depression screening result. Randomisation was stratified by depression severity (moderate: PHQ-9 score 10–14 points; severe: PHQ-9 score ≥15 points). Participants could not be masked but were kept unaware of trial hypotheses to minimise expectancy bias. The non-tailored feedback included the depression screening result, a recommendation to seek professional diagnostic advice, and brief general information about depression and its treatment. The tailored feedback included the same basic information but individually framed according to the participants’ symptom profiles, treatment preferences, causal symptom attributions, health insurance, and local residence. Research staff were masked to group allocation and outcome assessment as these were done using online questionnaires. The primary outcome was change in depression severity, defined as change in PHQ-9 score 6 months after random assignment. Analyses were conducted following the intention-to-treat principle for participants with at least one follow-up visit. This trial was registered at ClinicalTrials.gov, NCT04633096.
Findings
Between Jan 12, 2021, and Jan 31, 2022, 4878 individuals completed the internet-based screening. Of these, 1178 (24%) screened positive for depression (mean age 37·1 [SD 14·2] years; 824 [70%] woman, 344 [29%] men, and 10 [1%] other gender identity). 6 months after random assignment, depression severity decreased by 3·4 PHQ-9 points in the no feedback group (95% CI 2·9–4·0; within-group d 0·67; 325 participants), by 3·5 points in the non-tailored feedback group (3·0–4·0; within-group d 0·74; 319 participants), and by 3·7 points in the tailored feedback group (3·2–4·3; within-group d 0·71; 321 participants), with no significant differences among the three groups (p=0·72). The number of participants seeking help for depression or initiating psychotherapy or antidepressant treatment did not differ among study groups. The results remained consistent when adjusted for fulfilling the DSM-5-based criteria for major depressive disorder or subjective belief of having a depressive disorder. Negative effects were reported by less than 1% of the total sample 6 months after random assignment.
Interpretation
Automated feedback following internet-based depression screening did not reduce depression severity or prompt sufficient depression care in individuals previously undiagnosed with but affected by depression.
期刊介绍:
The Lancet Digital Health publishes important, innovative, and practice-changing research on any topic connected with digital technology in clinical medicine, public health, and global health.
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