ImportanceDirect-to-patient interventions enabling transitions from long-term benzodiazepine receptor agonist (BZRA) use to cognitive behavioral therapy for insomnia (CBTI) by older adults has the potential to reduce BZRA use and related harms while improving sleep outcomes without requiring prearranged clinician involvement.ObjectiveTo compare 2 direct-to-patient behavior change interventions with treatment as usual (TAU) on BZRA use, sleep, and other health outcomes, and uptake of CBTI techniques.Design, Setting, and ParticipantsThe Your Answers When Needing Sleep in New Brunswick (YAWNS NB) study was a 3-arm, pragmatic, open-label, minimum-contact, randomized clinical trial. The study began November 2020 and ended June 2022. Participants were randomly allocated to 1 of 3 groups, including 2 different mailed behavior change interventions or no intervention (TAU). Participants were from communities across the province of New Brunswick, Canada, and included adults 65 years and older living independently with long-term use of BZRAs and current or past insomnia.InterventionsThe Sleepwell package (YAWNS-1) consisted of a cover letter and 2 booklets (“How to Stop Sleeping Pills” and “How to Get Your Sleep Back”). The other package (YAWNS-2) included updated versions of the 2 booklets (“You May Be at Risk” and “How to Get a Good Night’s Sleep Without Medication”) used in the Eliminating Medications Through Patient Ownership of End Results (EMPOWER) study.Main Outcomes and MeasuresBZRA use at 6 months was the primary measure. Secondary measures included CBTI use, sleep, insomnia, daytime sleepiness, safety, anxiety, frailty, and quality of life.ResultsA total of 1295 individuals expressed interest in the study, and 565 (43.6%) completed a baseline assessment. Participants had a mean (SD) age of 72.1 (5.7) years, a mean (SD) BZRA use duration of 11.4 (9.1) years, and 362 (64.1%) were female. Discontinuations and dose reductions of 25% or greater were highest with YAWNS-1 (50 of 191 [26.2%]; 39 of 191 [20.4%]; total, 46.6%) compared with YAWNS-2 (38 of 187 [20.3%]; 27 of 187 [14.4%]; total, 34.8%, P = .02) and TAU (14 of 187 [7.5%]; 24 of 187 [12.8%]; total, 20.3%, P < .001). YAWNS-1 also demonstrated better uptake of CBTI techniques and sleep outcomes compared with YAWNS-2 (new CBTI techniques: 3.1 vs 2.4; P =.03; sleep efficiency change: 4.1% vs −1.7%; P =.001) and reduced insomnia severity and daytime sleepiness compared with TAU (insomnia severity index change: −2.0 vs 0.3; P <.001; Epworth Sleepiness Scale change: −0.8 vs 0.3; P =.001).Conclusions and RelevanceResults of the YAWNS NB randomized clinical trial show that, as a simple, scalable, direct-to-patient intervention, YAWNS-1 substantially reduced BZRA use and improved sleep outcomes. It could be implemented to transform insomnia care for older adults at the population level.Trial RegistrationClinicalTrials.gov Identifier: NCT04406103

中文翻译：

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患者自我指导干预以减少镇静剂的使用并改善睡眠


重要性直接面向患者的干预措施使老年人从长期使用苯二氮卓类受体激动剂 （BZRA） 过渡到失眠认知行为疗法 （CBTI），有可能减少 BZRA 的使用和相关危害，同时改善睡眠结果，而无需预先安排的临床医生参与。目的比较 2 种直接面向患者的行为改变干预措施与常规治疗 （TAU） 对 BZRA 使用、睡眠和其他健康结局以及 CBTI 技术的采用。设计、设置和参与者新不伦瑞克省需要睡眠时的答案 （YAWNS NB） 研究是一项 3 臂、务实、开放标签、最少接触、随机临床试验。该研究于 2020 年 11 月开始，并于 2022 年 6 月结束。参与者被随机分配到 3 组中的 1 组，包括 2 种不同的邮寄行为改变干预或无干预 （TAU）。参与者来自加拿大新不伦瑞克省的社区，包括 65 岁及以上独立生活、长期使用 BZRA 和当前或过去失眠的成年人。干预措施Sleepwell 套餐 （YAWNS-1） 包括一封求职信和 2 本小册子（“如何停止安眠药”和“如何恢复睡眠”）。另一个套餐 （YAWNS-2） 包括通过患者拥有最终结果消除药物 （EMPOWER） 研究中使用的 2 本小册子（“You May at Risk”和“How to Get a Good Sleep Without Drugs”）的更新版本。主要结局和措施 6 个月时使用 BZRA 是主要指标。次要指标包括 CBTI 使用、睡眠、失眠、白天嗜睡、安全性、焦虑、虚弱和生活质量。结果共有 1295 人表示对该研究感兴趣，565 人 （43.6%） 完成了基线评估。 参与者的平均 （SD） 年龄为 72.1 （5.7） 岁，平均 （SD） BZRA 使用时间为 11.4 （9.1） 年，其中 362 名 （64.1%） 为女性。与 YAWNS-2 （187 例中的 38 例 [20.3%];187 例中的 27 例 [14.4%];总计 34.8%，P = .02）相比，YAWNS-1 的停药和剂量减少 25% 或以上 （191 例中的 50 例 [26.2%];191 例中的 24 例 [12.8%];总计 20.3%，P < .001）相比最高。与 YAWNS-2 相比，YAWNS-1 还显示出更好的 CBTI 技术和睡眠结局（新的 CBTI 技术：3.1 vs 2.4;P =.03;睡眠效率变化：4.1% 对 -1.7%;P =.001） 和与 TAU 相比，失眠严重程度和白天嗜睡降低（失眠严重程度指数变化：-2.0 vs 0.3;P <。001;Epworth 嗜睡量表变化：-0.8 vs 0.3;P =.001）。结论和相关性YAWNS NB 随机临床试验的结果显示，作为一种简单、可扩展、直接面向患者的干预措施，YAWNS-1 大大减少了 BZRA 的使用并改善了睡眠结果。它可以在人口层面改变老年人的失眠护理。试验注册临床试验。gov 标识符： NCT04406103