Nurse-Supported Self-Directed Cognitive Behavioral Therapy for Insomnia: A Randomized Clinical Trial.

IF 22.5 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL JAMA Internal Medicine Pub Date : 2024-09-09 DOI:10.1001/jamainternmed.2024.4419
Christi S Ulmer, Corrine I Voils, Amy S Jeffreys, Maren Olsen, Jennifer Zervakis, Kaitlyn Goodwin, Pamela Gentry, Cynthia Rose, Hollis J Weidenbacher, Jean C Beckham, Hayden B Bosworth
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Abstract

Importance: Cognitive behavioral therapy for insomnia (CBTi) is the standard of care for treating insomnia disorder, but access is limited. Alternative approaches are needed to expand access to the standard of care.

Objective: To examine the effectiveness of a nurse-supported, self-directed behavioral insomnia intervention for decreasing insomnia severity and improving sleep outcomes among veterans, a population with considerable mental health comorbidity.

Design, setting, and participants: This randomized clinical trial included 178 patients with insomnia disorder who were recruited from a Veterans Affairs hospital (Durham VA Healthcare System) from September 2019 to April 2022 and randomized following baseline assessment; follow-ups were conducted at 8 weeks (primary end point) and 6 months. Data analysis was primarily conducted during the summer of 2023 and concluded in May 2024.

Intervention: Six weekly phone calls from a nurse interventionist plus assigned treatment manual readings covering CBTi treatment components. The health education manual focused on health topics but not sleep.

Main outcomes and measures: The primary outcome was the Insomnia Severity Index (score range, 0-28; remission <8; differential improvement of 3 points targeted) score assessed at 8 weeks postrandomization. Secondary outcomes were sleep outcomes, depression, fatigue, treatment response, and remission.

Results: Of 178 study participants, the mean (SD) age was 55.1 (13.2) years, and 128 (71.9%) identified as men. At 8 weeks, Insomnia Severity Index scores decreased by an estimated mean (SE) of 5.7 (0.51) points in the intervention group and 2.0 (0.47) points in the control group, a differential mean improvement of 3.7 points (95% CI, -5.0 to -2.4; P < .001). Differences were sustained at 6 months (mean, -2.8; 95% CI, -4.4 to -1.3; P < .001). The intervention also resulted in greater improvements at 8 weeks postrandomization in diary sleep onset latency, wake after sleep onset, and sleep efficiency and actigraphy sleep efficiency; these differences were sustained at 6 months. At 8 weeks, depression and fatigue were significantly reduced, and the odds of treatment response and remission were greater in the intervention group compared with controls.

Conclusions and relevance: This randomized clinical trial found that despite greater prevalence of mental health conditions and sleep difficulties among veterans, a nurse-supported self-directed CBTi was more effective than health education control for reducing insomnia severity and improving sleep outcomes. Although less effective than therapist-delivered CBTi, findings were comparable with other trials using modified CBTi protocols.

Trial registration: ClinicalTrials.gov Identifier: NCT03727438.

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护士支持的失眠症自我指导认知行为疗法:随机临床试验。
重要性:失眠认知行为疗法(CBTi)是治疗失眠症的标准疗法,但其普及程度有限。需要采用其他方法来扩大标准治疗的覆盖面:目的:研究由护士支持的、自我指导的失眠行为干预对降低失眠严重程度和改善退伍军人睡眠质量的有效性:这项随机临床试验包括178名失眠症患者,他们于2019年9月至2022年4月期间从一家退伍军人事务医院(达勒姆退伍军人医疗保健系统)招募,并在基线评估后进行随机分配;随访时间为8周(主要终点)和6个月。数据分析主要在 2023 年夏季进行,并于 2024 年 5 月结束:干预措施:干预护士每周六次电话指导,加上指定的治疗手册阅读,内容涵盖 CBTi 治疗内容。健康教育手册侧重于健康主题,但不包括睡眠:主要结果是失眠严重程度指数(评分范围为 0-28;缓解结果):在 178 名研究参与者中,平均(标清)年龄为 55.1(13.2)岁,128 人(71.9%)为男性。8 周后,干预组失眠严重程度指数评分估计平均(SE)下降了 5.7(0.51)分,对照组下降了 2.0(0.47)分,平均改善幅度相差 3.7 分(95% CI,-5.0 至 -2.4;P 结论及意义:这项随机临床试验发现,尽管退伍军人中精神健康状况和睡眠困难的患病率更高,但在降低失眠严重程度和改善睡眠结果方面,护士支持的自我指导式 CBTi 比健康教育对照组更有效。虽然效果不如治疗师提供的CBTi,但研究结果与其他使用改良CBTi方案的试验结果相当:试验注册:ClinicalTrials.gov Identifier:试验注册:ClinicalTrials.gov Identifier:NCT03727438。
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来源期刊
JAMA Internal Medicine
JAMA Internal Medicine MEDICINE, GENERAL & INTERNAL-
CiteScore
43.50
自引率
1.30%
发文量
371
期刊介绍: JAMA Internal Medicine is an international, peer-reviewed journal committed to advancing the field of internal medicine worldwide. With a focus on four core priorities—clinical relevance, clinical practice change, credibility, and effective communication—the journal aims to provide indispensable and trustworthy peer-reviewed evidence. Catering to academics, clinicians, educators, researchers, and trainees across the entire spectrum of internal medicine, including general internal medicine and subspecialties, JAMA Internal Medicine publishes innovative and clinically relevant research. The journal strives to deliver stimulating articles that educate and inform readers with the latest research findings, driving positive change in healthcare systems and patient care delivery. As a member of the JAMA Network, a consortium of peer-reviewed medical publications, JAMA Internal Medicine plays a pivotal role in shaping the discourse and advancing patient care in internal medicine.
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