Objective To evaluate whether an integrated mental health video consultation approach (PROVIDE model) can improve symptoms compared with usual care in adults with depression and anxiety disorders attending primary care. Design Assessor masked, multicentre, randomised controlled trial (PROVIDE-C). Setting In 29 primary care practices in Germany, working remotely online from one trial hub. Participants 376 adults (18-81 years) who presented to their general practitioner (GP) with depression or anxiety, or both. Intervention Participants were randomised (1:1) to receive the PROVIDE model (n=187) or usual care (n=189). Usual care was provided by GPs through interventions such as brief counselling and psychotropic medication prescriptions and may or may not have included referrals to mental health specialists. The PROVIDE model comprised transdiagnostic treatment provided through five real-time video sessions between the patient at the primary care practice and a mental health specialist at an offsite location. Main outcome measures The primary outcome was the absolute change in the mean severity of depressive and anxiety symptoms measured using the patient health questionnaire anxiety and depression scale (PHQ-ADS) at six months, in the intention-to-treat population. Secondary outcomes, measured at six and 12 months, included PHQ-ADS subscores, psychological distress related to somatic symptoms, recovery, health related quality of life, quality and patient centredness of chronic illness care, and adverse events. Results Between 24 March 2020 and 23 November 2021, 376 patients were randomised into treatment groups. Mean age was 45 years (standard deviation (SD) 14), 63% of the participants were female, and mean PHQ-ADS-score was 26 points (SD 7.6). Compared with usual care, the PROVIDE intervention led to improvements in severity of depressive and anxiety symptom (adjusted mean change difference in the PHQ-ADS score −2.4 points (95% confidence interval −4.5 to −0.4), P=0.02) at six months. The effects were sustained at 12 months (−2.9 (−5.0 to −0.7), P<0.01). No serious adverse events were reported in either group. Conclusions Through relatively low intensity treatment, the PROVIDE model led to a decrease in depressive and anxiety symptoms with small effects in the short and long term. Depression and anxiety disorders are prevalent and therefore the small effect might cumulatively impact on population health in this population. Trial registration ClinicalTrials.gov [NCT04316572][1]. The trial investigators own and have complete control of the research data, which can be accessed at any time. For statistical analysis, the data will be downloaded and safely stored on a computing system maintained by Heidelberg University. For individual participant data meta-analysis, beginning nine months following article publication, deidentified participant data that underlie the results reported in this article (text, tables, figures, and appendices) and a data dictionary will be available to investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. Consent for data sharing was not obtained but the presented data are anonymised, and risk of identification is low. The study protocol has been published and the statistical analysis plan is provided in the supplementary material S1 (pages 1-17). [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT04316572&atom=%2Fbmj%2F386%2Fbmj-2024-079921.atom

中文翻译：

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初级保健中针对抑郁或焦虑患者的综合心理健康视频咨询模型 (PROVIDE-C)：评估者蒙面、多中心、随机对照试验


目的 评估综合心理健康视频咨询方法（PROVIDE 模式）与常规护理相比是否能够改善接受初级保健的抑郁症和焦虑症成人患者的症状。设计评估者隐蔽、多中心、随机对照试验 (PROVIDE-C)。设置德国 29 个初级保健机构，从一个试验中心远程在线工作。参与者包括 376 名成年人（18-81 岁），他们向全科医生 (GP) 报告患有抑郁症或焦虑症，或两者兼而有之。干预 参与者被随机 (1:1) 接受 PROVIDE 模式 (n=187) 或常规护理 (n=189)。全科医生通过简短咨询和精神药物处方等干预措施提供常规护理，可能包括也可能不包括转介给心理健康专家。 PROVIDE 模型包括通过初级保健诊所的患者和异地心理健康专家之间的五个实时视频会话提供的跨诊断治疗。主要结果指标主要结果是在意向治疗人群中使用患者健康问卷焦虑和抑郁量表（PHQ-ADS）在六个月时测量的抑郁和焦虑症状平均严重程度的绝对变化。次要结局在 6 个月和 12 个月时测量，包括 PHQ-ADS 分项评分、与躯体症状相关的心理困扰、康复、健康相关的生活质量、慢性病护理的质量和以患者为中心以及不良事件。结果 2020年3月24日至2021年11月23日期间，376名患者被随机分为治疗组。平均年龄为 45 岁（标准差 (SD) 14），63% 的参与者为女性，平均 PHQ-ADS 评分为 26 分（SD 7.6）。 与常规护理相比，PROVIDE 干预在六岁时改善了抑郁和焦虑症状的严重程度（PHQ-ADS 评分的调整后平均变化差 -2.4 分（95% 置信区间 -4.5 至 -0.4），P=0.02）几个月。效果持续 12 个月（-2.9（-5.0 至 -0.7），P<0.01）。两组均未报告严重不良事件。结论 通过相对较低强度的治疗，PROVIDE 模型导致抑郁和焦虑症状减少，短期和长期影响较小。抑郁症和焦虑症很普遍，因此微小的影响可能会累积影响该人群的健康。试验注册 ClinicalTrials.gov [NCT04316572][1]。试验研究者拥有并完全控制研究数据，可以随时访问。为了进行统计分析，数据将被下载并安全存储在海德堡大学维护的计算系统上。对于个体参与者数据荟萃分析，从文章发表后九个月开始，本文报告结果的去识别化参与者数据（文本、表格、图形和附录）和数据字典将提供给建议使用数据已得到为此目的设立的独立审查委员会的批准。未获得数据共享的同意，但提供的数据是匿名的，识别风险较低。研究方案已发表，统计分析计划在补充材料 S1（第 1-17 页）中提供。 [1]：/lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT04316572&atom=%2Fbmj%2F386%2Fbmj-2024-079921。原子