針對英國精神衛生服務機構中處於危機狀態的成年人，“開放式對話”與常規治療的比較（ODDESSI試驗）：一項多中心、整群隨機對照試驗

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

——《柳葉刀-精神病學》第13卷第10期，2026年10月——

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

【摘要】背景：“開放式對話”（Open Dialogue）是一種以人為本、跨診斷的心理健康護理模式，強調連續性、治療性關係以及與服務對象社會網絡之間的協作。這是一種覆蓋整個服務體系的護理方法，涉及由服務對象、其社會網絡成員以及通常兩名在整個護理期間提供支持的專業人員共同參與的網絡會議。在這項整群隨機試驗中，我們旨在評估“開放式對話”與“常規治療”相比，針對在英國社區精神衛生服務機構尋求危機干預的成年人的臨床療效。方法：這是一項多中心、平行雙臂、整群隨機對照優效性試驗，在倫敦和英格蘭南部的五個國家醫療服務體系（NHS）信託機構下屬的精神衛生服務部門進行。試驗以服務覆蓋區域內的初級保健診所為單位劃分群組（cluster）。參與者為年齡在18歲及以上、因心理健康危機尋求服務並註冊在試驗群組內診所的成年人。隨機分組在群組層面進行（比例為1:1），並按服務覆蓋區域進行分層，同時平衡了全科醫生（GP）診所的平均註冊患者人數及“多重剝奪指數”（2015年版）。本研究對首席研究員、高級統計學家及主要結局評估人員實施了盲法。參與者接受“開放式對話”或“常規治療”（即目前在英國精神衛生服務體系中普遍實施的功能性團隊模式）。主要結局指標是從本次危機初次康復到首次復發所需的時間（天數），隨訪期為2年，截止點為隨訪期結束。由參與者報告的次要結局指標包括：EuroQol視覺模擬量表（EQ-VAS）、社會支持量表（Social Provisions Scale）、Lubben社會網絡量表、康復過程問卷（QPR）以及客戶滿意度問卷（CSQ），這些指標在2年內分5個時間點進行測量；臨床指標則從電子健康記錄中提取。具有相關親身經歷的人士參與了本研究的設計與實施工作。研究人員在各站點開始招募參與者之前，以及此後每6個月（直至該站點最後一名參與者完成隨訪），均對“開放式對話”及“常規治療”模式的實施忠實度以及“開放式對話”的具體執行情況進行了評估。該試驗已進行回顧性註冊（ISRCTN52653325）並已完成。研究結果：研究確定了英國各地隸屬於六個精神衛生信託機構（mental health Trusts）的185家全科診所進行篩選。其中105家診所被排除，80家被納入聚類分組，形成了32個聚類；這些聚類被隨機分配至兩組（16個聚類接受常規治療，16個聚類接受“開放式對話”干預）。一個精神衛生信託機構（涉及兩個聚類）退出研究，最終共有五個精神衛生信託機構（30個聚類）參與了試驗。在2019年6月25日至2021年12月9日期間，共有494名參與者（266名[54%]女性，221名[45%]男性，341名[69%]白人英國人；平均年齡38.1歲，標準差13.4）同意參與研究（常規治療組223人，“開放式對話”組271人）。在這些參與者中，常規治療組有174人（78%）和“開放式對話”組有225人（83%）實現了康復，且其數據足以用於判定復發情況；關於主要結局指標（即初次康復後至復發的時間），兩組間無顯著差異（邊際風險比為0.95，95%置信區間為0.67–1.32）。在次要結局指標方面，“開放式對話”與較低的精神科住院率及較低的危機護理或二級心理健康服務轉診率相關，同時在自我評估康復情況、健康相關生活質量以及服務滿意度方面均有所改善；但在社會網絡質量或規模方面，兩組間未見顯著差異。研究期間共發生386起嚴重不良事件（常規治療組281起，“開放式對話”組105起）；其中376起（97%）被判定與干預措施無關。解讀：與常規治療相比，“開放對話”（Open Dialogue）並未縮短至首次復發的時間（即主要結局指標），但它減少了急性住院床位的使用，改善了服務使用者報告的結局與體驗，且未發現重大的安全性問題。未來尚需進一步研究，以確定“開放對話”能否提升社區精神衛生服務中危機干預與持續護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.

論文原文：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

（翻譯兼責任編輯：MARY）

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