Screening for depression in primary care alone is not sufficient to improve clinical outcomes. However, targeted feedback of the screening results to patients might result in beneficial effects. The GET.FEEDBACK.GP trial investigated whether targeted feedback of the depression screening result to patients, in addition to feedback to general practitioners (GPs), leads to greater reductions in depression severity than GP feedback alone or no feedback. The GET.FEEDBACK.GP trial was an investigator-initiated, multicentre, three-arm, observer-blinded, randomised controlled trial. Depression screening was conducted electronically using the Patient Health Questionnaire-9 (PHQ-9) in 64 GP practices across five regions in Germany while patients were waiting to see their GP. Currently undiagnosed patients (aged ≥18 years) who screened positive for depression (PHQ-9 score ≥10), were proficient in the German language, and had a personal consultation with a GP were randomly assigned (1:1:1) into a group that received no feedback on their depression screening result, a group in which only the GP received feedback, or a group in which both GP and patient received feedback. Randomisation was stratified by treating GP and PHQ-9 depression severity. Trial staff were masked to patient enrolment and study group allocation and GPs were masked to the feedback recieved by the patient. Written feedback, including the screening result and information on depression, was provided to the relevant groups before the consultation. The primary outcome was PHQ-9-measured depression severity at 6 months after randomisation. An intention-to-treat analysis was conducted for patients who had at least one follow-up visit. This study is registered at () and is complete. Between July 17, 2019, and Jan 31, 2022, 25 279 patients were approached for eligibility screening, 17 150 were excluded, and 8129 patients completed screening, of whom 1030 (12·7%) screened positive for depression. 344 patients were randomly assigned to receive no feedback, 344 were assigned to receive GP-targeted feedback, and 339 were assigned to receive GP-targeted plus patient-targeted feedback. 252 (73%) patients in the no feedback group, 252 (73%) in the GP-targeted feedback group, and 256 (76%) in the GP-targeted and patient-targeted feedback group were included in the analysis of the primary outcome at 6 months, which reflected a follow-up rate of 74%. Gender was reported as female by 637 (62·1%) of 1025 participants, male by 384 (37·5%), and diverse by four (0·4%). 169 (16%) of 1026 patients with available migration data had a migration background. Mean age was 39·5 years (SD 15·2). PHQ-9 scores improved for each group between baseline and 6 months by –4·15 (95% CI –4·99 to –3·30) in the no feedback group, –4·19 (–5·04 to –3·33) in the GP feedback group, and –4·91 (–5·76 to –4·07) in the GP plus patient feedback group, with no significant difference between the three groups (global p=0·13). The difference in PHQ-9 scores when comparing the GP plus patient feedback group with the no feedback group was –0·77 (–1·60 to 0·07, =–0·16) and when comparing with the GP-only feedback group was –0·73 (–1·56 to 0·11, =–0·15). No increase in suicidality was observed as an adverse event in either group. Providing targeted feedback to patients and GPs after depression screening does not significantly reduce depression severity compared with GP feedback alone or no feedback. Further research is required to investigate the potential specific effectiveness of depression screening with systematic feedback for selected subgroups. German Innovation Fund. For the German translation of the abstract see Supplementary Materials section.

中文翻译：

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一般实践中抑郁症筛查后以患者为目标的反馈的临床有效性 (GET.FEEDBACK.GP)：德国一项由研究者发起、前瞻性、多中心、三臂、观察者盲法、随机对照试验

仅在初级保健中筛查抑郁症不足以改善临床结果。然而，将筛查结果有针对性地反馈给患者可能会产生有益的效果。GET.FEEDBACK.GP 试验调查了除了向全科医生 (GP) 反馈之外，向患者提供抑郁症筛查结果的有针对性的反馈是否比仅向全科医生反馈或不反馈更能降低抑郁严重程度。GET.FEEDBACK.GP 试验是一项由研究者发起、多中心、三臂、观察者盲法、随机对照试验。当患者等待看全科医生时，使用患者健康问卷 9 (PHQ-9) 在德国五个地区的 64 家全科医生诊所进行了电子抑郁症筛查。目前未确诊的抑郁症筛查呈阳性（PHQ-9 评分≥10）、精通德语并与全科医生进行过个人会诊的患者（年龄≥18岁）被随机分配（1:1:1）到一组没有收到抑郁症筛查结果反馈的组、只有全科医生收到反馈的组或全科医生和患者都收到反馈的组。根据治疗 GP 和 PHQ-9 抑郁症的严重程度对随机分组进行分层。试验工作人员对患者入组和研究组分配不知情，全科医生对患者收到的反馈不知情。咨询前已向相关团体提供书面反馈，包括筛查结果和抑郁症信息。主要结局是随机分组后 6 个月时 PHQ-9 测量的抑郁严重程度。对至少进行过一次随访的患者进行了意向治疗分析。这项研究已在 () 注册并已完成。2019年7月17日至2022年1月31日期间，共有25 279名患者接受了资格筛查，17 150名患者被排除，8129名患者完成了筛查，其中1030名患者（12·7%）筛查出抑郁症呈阳性。344 名患者被随机分配为不接受反馈，344 名患者被分配为接受 GP 目标反馈，339 名患者被分配为接受 GP 目标加患者目标反馈。主要分析中包括无反馈组中的 252 名患者 (73%)、GP 目标反馈组中的 252 名患者 (73%) 以及 GP 目标和患者目标反馈组中的 256 名患者 (76%) 6 个月时的结果，随访率为 74%。1025 名参与者中，有 637 名 (62·1%) 报告性别为女性，384 名参与者 (37·5%) 报告性别为男性，另有 4 名参与者 (0·4%) 报告性别不同。在拥有可用迁移数据的 1026 名患者中，169 名 (16%) 有迁移背景。平均年龄为 39·5 岁 (SD 15·2)。在基线和 6 个月之间，每组的 PHQ-9 分数提高了 –4·15 (95% CI –4·99 至 –3·30)，无反馈组提高了 –4·19 (–5·04 至 –3) ·33) 在 GP 反馈组中，–4·91 (–5·76 至 –4·07) 在 GP 加患者反馈组中，三组之间没有显着差异（总体 p=0·13）。将 GP 加患者反馈组与无反馈组进行比较时，PHQ-9 评分的差异为 –0·77（–1·60 至 0·07，=–0·16）；与仅 GP 反馈组相比，PHQ-9 评分差异为 –0·77（–1·60 至 0·07，=–0·16）组为 –0·73（–1·56 至 0·11，=–0·15）。两组中均未观察到自杀倾向增加作为不良事件。与仅向全科医生提供反馈或不提供反馈相比，在抑郁症筛查后向患者和全科医生提供有针对性的反馈并不能显着降低抑郁症的严重程度。需要进一步的研究来调查抑郁症筛查的潜在具体有效性，并为选定的亚组提供系统反馈。德国创新基金。有关摘要的德语翻译，请参阅补充材料部分。