针对英国精神卫生服务机构中处于危机状态的成年人，“开放式对话”与常规治疗的比较（ODDESSI试验）

针对英国精神卫生服务机构中处于危机状态的成年人，“开放式对话”与常规治疗的比较（ODDESSI试验）：一项多中心、整群随机对照试验

Open Dialogue versus treatment as usual for adults presenting in crisis to mental health services in England (the ODDESSI Trial): a multisite cluster-randomised trial

——《柳叶刀-精神病学》第13卷第10期，2026年10月——

<The Lancet / Psychiatry>, Volume 13, Issue 10. October 2026

【摘要】背景：“开放式对话”（Open Dialogue）是一种以人为本、跨诊断的心理健康护理模式，强调连续性、治疗性关系以及与服务对象社会网络之间的协作。这是一种覆盖整个服务体系的护理方法，涉及由服务对象、其社会网络成员以及通常两名在整个护理期间提供支持的专业人员共同参与的网络会议。在这项整群随机试验中，我们旨在评估“开放式对话”与“常规治疗”相比，针对在英国社区精神卫生服务机构寻求危机干预的成年人的临床疗效。方法：这是一项多中心、平行双臂、整群随机对照优效性试验，在伦敦和英格兰南部的五个国家医疗服务体系（NHS）信托机构下属的精神卫生服务部门进行。试验以服务覆盖区域内的初级保健诊所为单位划分群组（cluster）。参与者为年龄在18岁及以上、因心理健康危机寻求服务并注册在试验群组内诊所的成年人。随机分组在群组层面进行（比例为1:1），并按服务覆盖区域进行分层，同时平衡了全科医生（GP）诊所的平均注册患者人数及“多重剥夺指数”（2015年版）。本研究对首席研究员、高级统计学家及主要结局评估人员实施了盲法。参与者接受“开放式对话”或“常规治疗”（即目前在英国精神卫生服务体系中普遍实施的功能性团队模式）。主要结局指标是从本次危机初次康复到首次复发所需的时间（天数），随访期为2年，截止点为随访期结束。由参与者报告的次要结局指标包括：EuroQol视觉模拟量表（EQ-VAS）、社会支持量表（Social Provisions Scale）、Lubben社会网络量表、康复过程问卷（QPR）以及客户满意度问卷（CSQ），这些指标在2年内分5个时间点进行测量；临床指标则从电子健康记录中提取。具有相关亲身经历的人士参与了本研究的设计与实施工作。研究人员在各站点开始招募参与者之前，以及此后每6个月（直至该站点最后一名参与者完成随访），均对“开放式对话”及“常规治疗”模式的实施忠实度以及“开放式对话”的具体执行情况进行了评估。该试验已进行回顾性注册（ISRCTN52653325）并已完成。研究结果：研究确定了英国各地隶属于六个精神卫生信托机构（mental health Trusts）的185家全科诊所进行筛选。其中105家诊所被排除，80家被纳入聚类分组，形成了32个聚类；这些聚类被随机分配至两组（16个聚类接受常规治疗，16个聚类接受“开放式对话”干预）。一个精神卫生信托机构（涉及两个聚类）退出研究，最终共有五个精神卫生信托机构（30个聚类）参与了试验。在2019年6月25日至2021年12月9日期间，共有494名参与者（266名[54%]女性，221名[45%]男性，341名[69%]白人英国人；平均年龄38.1岁，标准差13.4）同意参与研究（常规治疗组223人，“开放式对话”组271人）。在这些参与者中，常规治疗组有174人（78%）和“开放式对话”组有225人（83%）实现了康复，且其数据足以用于判定复发情况；关于主要结局指标（即初次康复后至复发的时间），两组间无显著差异（边际风险比为0.95，95%置信区间为0.67–1.32）。在次要结局指标方面，“开放式对话”与较低的精神科住院率及较低的危机护理或二级心理健康服务转诊率相关，同时在自我评估康复情况、健康相关生活质量以及服务满意度方面均有所改善；但在社会网络质量或规模方面，两组间未见显著差异。研究期间共发生386起严重不良事件（常规治疗组281起，“开放式对话”组105起）；其中376起（97%）被判定与干预措施无关。解读：与常规治疗相比，“开放对话”（Open Dialogue）并未缩短至首次复发的时间（即主要结局指标），但它减少了急性住院床位的使用，改善了服务使用者报告的结局与体验，且未发现重大的安全性问题。未来尚需进一步研究，以确定“开放对话”能否提升社区精神卫生服务中危机干预与持续护理的有效性及可接受性。

[Summary] Background: Open Dialogue is a person-centred, transdiagnostic model of mental health care that emphasises continuity, therapeutic relationships, and collaboration with the service user's social network. Open Dialogue is a service-wide approach to care involving network meetings with the service user, members of their social network, and usually two practitioners who support the network throughout the duration of care. In this cluster-randomised trial, we aimed to evaluate the clinical effectiveness of Open Dialogue versus treatment as usual for adults presenting in crisis to community mental health services in England. Methods: This multicentre, parallel two-arm, cluster-randomised, controlled superiority trial was conducted in mental health services in five National Health Service trusts in London and the South of England. Clusters were defined at the level of primary care practices within service catchment areas. Participants were adults aged 18 years or older presenting in crisis to mental health services and registered with a practice within trial clusters. Randomisation was done at the cluster level (1:1), stratified by catchment area, and balanced on average general practice (GP) list size and Index of Multiple Deprivation (2015). The chief investigator, senior statistician, and assessors of the primary outcome were masked in the study. Participants either received Open Dialogue or treatment as usual, which refers to the functional team model currently implemented throughout English mental health services. The primary outcome was time (days) to first relapse following initial recovery from the index crisis censored at the end of the 2-year follow-up period. Participant-reported secondary outcomes were EuroQol Visual Analogue Scale, Social Provisions Scale, Lubben Social Network Scale, Questionnaire about the Process of Recovery, and the Client Satisfaction Questionnaire, measured at five timepoints over 2 years, and clinical measures were extracted from electronic health records. People with relevant lived experience were involved in the design and execution of the study. Fidelity to the model of care in Open Dialogue and treatment as usual, and adherence to the delivery of Open Dialogue, were measured prior to each site starting participant recruitment, then every 6 months thereafter until the final participant follow-up in that site. The trial was retrospectively registered (ISRCTN52653325) and is complete. Findings: 185 general practices associated with six mental health Trusts across England were identified for screening. 105 practices were excluded, and 80 were included in cluster formation, forming 32 clusters that were randomly assigned (16 to treatment as usual and 16 to the Open Dialogue intervention). One mental health trust (two clusters) withdrew, resulting in five mental health trusts (30 clusters) participating in the trial. Between June 25, 2019, and Dec 9, 2021, 494 participants (266 [54%] female gender, 221 [45%] male gender, 341 [69%] White British) with a mean age of 38·1 years (SD 13·4) provided consent for study inclusion (223 in the treatment as usual group and 271 in the Open Dialogue group). Of these, 174 (78%) in the treatment as usual group and 225 (83%) in the Open Dialogue group recovered and had data enabling relapse determination; there was no significant difference between groups on the primary outcome of time to relapse following initial recovery (marginal hazard ratio 0·95 [95% CI 0·67–1·32]). For secondary outcomes, Open Dialogue was associated with significantly lower probabilities of psychiatric inpatient admission and re-referral to crisis care or secondary mental health services, and with improvements in self-rated recovery, health-related quality of life, and satisfaction with services. There were no significant differences in social network quality or size. There were 386 serious adverse events (281 in the treatment as usual group and 105 in the Open Dialogue group); 376 (97%) were deemed to be unrelated to the intervention. Interpretation: Open Dialogue did not reduce time to first relapse compared with treatment as usual, the primary outcome, but it reduced acute inpatient bed use, improved service user reported outcomes and experience, and there were no significant safety concerns. Further investigation is required to determine whether Open Dialogue can enhance the effectiveness and acceptability of crisis care and continuing care in community mental health services.

论文原文：Stephen Pilling, Thomas Craig, Katherine Clarke, et al. (2026). Open Dialogue versus treatment as usual for adults presenting in crisis to mental health services in England (the ODDESSI Trial): a multisite cluster-randomised trial. The Lancet / Psychiatry, Volume 13, Issue 10, Pages 841-851. October 2026.

https://doi.org/10.1016/S2215-0366(26)00229-4

（翻译兼责任编辑：MARY）

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