The efficacy of automated feedback after internet-based depression screening (DISCOVER): an observer-masked, three-armed, randomised controlled trial in Germany

IF 23.8 1区 医学 Q1 MEDICAL INFORMATICS
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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引用次数: 0

Abstract

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.

Funding

German Research Foundation.

基于互联网的抑郁筛查(DISCOVER)后自动反馈的疗效:在德国进行的观察者掩蔽、三臂随机对照试验
背景尽管已经有了有效的治疗方法,但大多数抑郁症仍未被发现和治疗。基于互联网的抑郁症筛查与筛查结果的自动反馈相结合,可以帮助抑郁症患者并提供循证治疗。我们的目的是测试两种版本的自动反馈在基于互联网的筛查后对抑郁症严重程度的影响,并与无反馈进行比较。方法DISCOVER 是一项在德国进行的观察者掩蔽、三臂随机对照试验。我们招募了未确诊为抑郁症的个人(年龄≥18 岁),他们在基于互联网的自我报告抑郁评分量表(患者健康问卷-9 [PHQ-9] ≥10分)中被筛查出患有抑郁症。参与者按 1:1:1 的比例被随机分配到自动接受无反馈、非定制反馈或针对抑郁筛查结果的定制反馈。随机分配按抑郁严重程度分层(中度:PHQ-9 评分 10-14 分;重度:PHQ-9 评分≥15 分)。参与者不能被蒙蔽,但不知道试验假设,以尽量减少预期偏差。非定制反馈包括抑郁症筛查结果、寻求专业诊断建议以及有关抑郁症及其治疗的简要一般信息。定制反馈包括相同的基本信息,但根据参与者的症状特征、治疗偏好、症状成因归因、医疗保险和当地居住地进行了个性化设置。研究人员对组别分配和结果评估进行了保密,因为这些都是通过在线问卷进行的。主要结果是抑郁严重程度的变化,即随机分配 6 个月后 PHQ-9 评分的变化。对至少进行过一次随访的参与者按照意向治疗原则进行分析。该试验已在 ClinicalTrials.gov 注册,编号为 NCT04633096。研究结果在 2021 年 1 月 12 日至 2022 年 1 月 31 日期间,共有 4878 人完成了基于互联网的筛查。其中,1178 人(24%)筛查出抑郁症阳性(平均年龄 37-1 [SD 14-2] 岁;824 [70%] 名女性,344 [29%] 名男性,10 [1%] 名其他性别认同者)。随机分配 6 个月后,无反馈组的抑郁严重程度下降了 PHQ-9 3-4 分(95% CI 2-9-4-0;组内 d 0-67;325 名参与者),非定制反馈组下降了 3-5 分(3-0-4-0;组内 d 0-74;319 名参与者),定制反馈组下降了 3-7 分(3-2-4-3;组内 d 0-71;321 名参与者),三组之间无显著差异(P=0-72)。各研究组中,因抑郁而寻求帮助或开始心理治疗或抗抑郁治疗的人数没有差异。根据符合基于 DSM-5 的重度抑郁障碍标准或主观认为患有抑郁障碍的情况进行调整后,结果仍然一致。在随机分配后的 6 个月中,只有不到 1%的样本报告了负面影响。解释基于互联网的抑郁症筛查后的自动反馈并没有降低抑郁症的严重程度,也没有促使之前未被诊断出患有抑郁症但受到抑郁症影响的人接受足够的抑郁症治疗。
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来源期刊
CiteScore
41.20
自引率
1.60%
发文量
232
审稿时长
13 weeks
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. The journal’s open access content crosses subject boundaries, building bridges between health professionals and researchers.By bringing together the most important advances in this multidisciplinary field,The Lancet Digital Health is the most prominent publishing venue in digital health. We publish a range of content types including Articles,Review, Comment, and Correspondence, contributing to promoting digital technologies in health practice worldwide.
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