■失眠是一种普遍且令人痛苦的睡眠障碍。多成分认知行为疗法是推荐的一线治疗方法,但是访问仍然非常有限,尤其是在治疗失眠的初级保健中。认知行为疗法的一个主要组成部分是一种称为睡眠限制疗法的行为疗法,这可能是由初级保健的通才作为简短的单成分干预措施提供的。
■健康专业管理的短暂失眠治疗试验的主要目的是确定初级保健中护士提供的睡眠限制治疗是否相对于睡眠卫生改善了失眠。次要目标是确定护士提供的睡眠限制治疗是否具有成本效益,并进行过程评估以了解干预措施的交付,保真度和可接受性。
■务实,多中心,单独随机,平行组,具有嵌入式过程评估的优越性试验。
■英格兰三个地区的国家卫生服务一般实践。
■使用经过验证的基于网络的随机化程序对年龄≥18岁的失眠症患者进行随机化。
为干预组的参与者提供了简短的四期护士提供的行为治疗,包括两次面对面和两次电话治疗。支持参与者遵循规定的睡眠时间表,以限制和标准化床上的时间。还向参与者提供了睡眠卫生传单。对照组通过电子邮件或邮寄方式收到相同的睡眠卫生传单。对常规护理没有限制。
■在3、6和12个月时评估结果。如果参与者贡献了至少一个随机化后结果,则将其纳入主要分析。主要终点是6个月时根据失眠严重程度指数自我报告的失眠严重程度。次要结果是健康相关和睡眠相关的生活质量,抑郁症状,工作效率和活动障碍,自我报告和活动记录定义的睡眠,和催眠药物的使用。使用每质量调整寿命年的增量成本评估成本效益。对于过程评估,对参与者进行了半结构化访谈,护士和执业经理或全科医生。由于干预的性质,参与者和护士都知道分组分配.
■我们在2018年8月29日至2020年3月23日期间招募了642名参与者(n=321用于睡眠限制治疗;n=321用于睡眠卫生)。五百八十名参与者(90.3%)在至少一个随访时间点提供了数据;257名(80.1%)参与者在睡眠限制治疗臂和291名(90.7%)参与者在6个月时提供了主要结果数据。失眠严重程度指数的估计调整平均差为-3.05(95%置信区间-3.83至-2.28;p<0.001,Cohen'sd=-0.74),这表明睡眠限制治疗组的参与者[平均(标准差)失眠严重程度指数=10.9(5.5)]报告的失眠严重程度低于睡眠卫生[平均(标准差)失眠严重程度指数=13.9(5.2)].在3个月(d=-0.95)和12个月(d=-0.72)时也发现了较大的治疗效果。对于自我报告的睡眠,在3、6和12个月时,睡眠限制治疗优于睡眠卫生。心理健康相关的生活质量,抑郁症状,工作生产力受损和睡眠相关生活质量。每组8名参与者经历了严重的不良事件,但没有人被认为与干预有关。获得的每质量调整生命年的增量成本为2075.71英镑,在20,000英镑的成本效益阈值下,干预措施具有成本效益的可能性为95.3%。过程评估发现,护士和患者都可以接受睡眠限制治疗,并以高保真度交付。
■当我们招募临床样本时,97%是白人背景,50%有大学学历,这可能会限制英格兰失眠人群的普遍性。
■初级护理中护士提供的简短的睡眠限制治疗在临床上对失眠障碍有效,安全,并且可能具有成本效益。
■未来的工作应该研究睡眠限制治疗在失眠治疗途径中的位置,评估不同初级保健失眠患者的普遍性,并考虑其他方法来增强患者对治疗的参与度。
■本试验注册为ISRCTN42499563。
■该奖项由美国国立卫生与护理研究所(NIHR)卫生技术评估计划(NIHR奖参考:16/84/01)资助,并在《卫生技术评估》中全文发表;卷。28号36.有关更多奖项信息,请参阅NIHR资助和奖励网站。
失眠是指入睡或保持睡眠的问题,这影响了10%的成年人口。失眠的推荐治疗方法是一种称为认知行为疗法的心理治疗。研究表明这是一种非常有效和持久的治疗方法,但是没有足够的训练有素的治疗师来支持英国大量的睡眠不良者。我们开发了一种简短的认知行为疗法,叫做睡眠限制疗法,这包括支持患者遵循新的睡眠-觉醒模式。我们进行了这项研究,看看睡眠限制疗法,由全科护士提供,可以改善失眠和生活质量。我们搜索了一般实践记录,并邀请失眠症患者参加。分配了六百四十二名参与者,偶然,限制睡眠治疗或比较治疗,叫做睡眠卫生。睡眠限制治疗包括四次与护士会面,并遵循规定的睡眠时间表。睡眠卫生涉及接收“做和不做”的睡眠传单。接受睡眠限制治疗的患者也获得了相同的睡眠卫生传单,因此两组之间的差异在于他们是否接受了护士治疗。我们测量睡眠,生活质量,通过问卷调查的白天功能和睡眠药物的使用,治疗前后。我们计算了提供治疗的费用,以及参与者在研究期间获得的其他国家卫生服务治疗的费用。我们还采访了参与者和护士,以了解他们对治疗的看法。我们发现,与睡眠卫生相比,睡眠限制治疗组的参与者的失眠症状减轻更大。他们也经历了改善睡眠,心理健康,生活质量和工作效率。两组在使用处方睡眠药物方面没有差异。我们的结果表明,这种治疗对于国家卫生局来说可能是物有所值的。护士和参与者都认为这种治疗是可以接受的和有益的。他们提出了一些潜在的改进措施。研究表明,护士实施的睡眠限制治疗可能是治疗失眠的临床有效方法,国家卫生服务物有所值。
UNASSIGNED: Insomnia is a prevalent and distressing sleep disorder. Multicomponent cognitive-behavioural therapy is the recommended first-line treatment, but access remains extremely limited, particularly in primary care where insomnia is managed. One principal component of cognitive-behavioural therapy is a behavioural treatment called sleep restriction therapy, which could potentially be delivered as a brief single-component intervention by generalists in primary care.
UNASSIGNED: The primary objective of the Health-professional Administered Brief Insomnia Therapy trial was to establish whether nurse-delivered sleep restriction therapy in primary care improves insomnia relative to sleep hygiene. Secondary objectives were to establish whether nurse-delivered sleep restriction therapy was cost-effective, and to undertake a process evaluation to understand intervention delivery, fidelity and acceptability.
UNASSIGNED: Pragmatic, multicentre, individually randomised, parallel-group, superiority trial with embedded process evaluation.
UNASSIGNED: National Health Service general practice in three regions of England.
UNASSIGNED: Adults aged ≥ 18 years with insomnia disorder were randomised using a validated web-based randomisation programme.
UNASSIGNED: Participants in the intervention group were offered a brief four-session nurse-delivered behavioural treatment involving two in-person sessions and two by phone. Participants were supported to follow a prescribed sleep schedule with the aim of restricting and standardising time in bed. Participants were also provided with a sleep hygiene leaflet. The control group received the same sleep hygiene leaflet by e-mail or post. There was no restriction on usual care.
UNASSIGNED: Outcomes were assessed at 3, 6 and 12 months. Participants were included in the primary analysis if they contributed at least one post-randomisation outcome. The primary end point was self-reported insomnia severity with the Insomnia Severity Index at 6 months. Secondary outcomes were health-related and sleep-related quality of life, depressive symptoms, work productivity and activity impairment, self-reported and
actigraphy-defined sleep, and hypnotic medication use. Cost-effectiveness was evaluated using the incremental cost per quality-adjusted life-year. For the process evaluation, semistructured interviews were carried out with participants, nurses and practice managers or general practitioners. Due to the nature of the intervention, both participants and nurses were aware of group allocation.
UNASSIGNED: We recruited 642 participants (n = 321 for sleep restriction therapy; n = 321 for sleep hygiene) between 29 August 2018 and 23 March 2020. Five hundred and eighty participants (90.3%) provided data at a minimum of one follow-up time point; 257 (80.1%) participants in the sleep restriction therapy arm and 291 (90.7%) participants in the sleep hygiene arm provided primary outcome data at 6 months. The estimated adjusted mean difference on the Insomnia Severity Index was -3.05 (95% confidence interval -3.83 to -2.28; p < 0.001, Cohen\'s d = -0.74), indicating that participants in the sleep restriction therapy arm [mean (standard deviation) Insomnia Severity Index = 10.9 (5.5)] reported lower insomnia severity compared to sleep hygiene [mean (standard deviation) Insomnia Severity Index = 13.9 (5.2)]. Large treatment effects were also found at 3 (d = -0.95) and 12 months (d = -0.72). Superiority of sleep restriction therapy over sleep hygiene was evident at 3, 6 and 12 months for self-reported sleep, mental health-related quality of life, depressive symptoms, work productivity impairment and sleep-related quality of life. Eight participants in each group experienced serious adverse events but none were judged to be related to the intervention. The incremental cost per quality-adjusted life-year gained was £2075.71, giving a 95.3% probability that the intervention is cost-effective at a cost-effectiveness threshold of £20,000. The process evaluation found that sleep restriction therapy was acceptable to both nurses and patients, and delivered with high fidelity.
UNASSIGNED: While we recruited a clinical sample, 97% were of white ethnic background and 50% had a university degree, which may limit generalisability to the insomnia population in England.
UNASSIGNED: Brief nurse-delivered sleep restriction therapy in primary care is clinically effective for insomnia disorder, safe, and likely to be cost-effective.
UNASSIGNED: Future work should examine the place of sleep restriction therapy in the insomnia treatment pathway, assess generalisability across diverse primary care patients with insomnia, and consider additional methods to enhance patient engagement with treatment.
UNASSIGNED: This trial is registered as ISRCTN42499563.
UNASSIGNED: The award was funded by the National Institute of Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 16/84/01) and is published in full in Health Technology Assessment; Vol. 28, No. 36. See the NIHR Funding and Awards website for further award information.
Insomnia refers to problems with falling asleep or staying asleep, which affects 10% of the adult population. The recommended treatment for insomnia is a psychological treatment called cognitive–behavioural therapy. Research shows this to be a very effective and long-lasting treatment, but there are not enough trained therapists to support the large number of poor sleepers in the United Kingdom. We have developed a brief version of cognitive–behavioural therapy, called sleep restriction therapy, which involves supporting the patient to follow a new sleep–wake pattern. We carried out this study to see if sleep restriction therapy, given by nurses working in general practice, can improve insomnia and quality of life. We searched general practice records and invited people with insomnia to take part. Six hundred and forty-two participants were assigned, by chance, to either sleep restriction therapy or a comparison treatment, called sleep hygiene. Sleep restriction therapy involved meeting with a nurse on four occasions and following a prescribed sleep schedule. Sleep hygiene involved receiving a leaflet of sleep ‘do’s and dont’s’. Those receiving sleep restriction therapy were also provided with the same sleep hygiene leaflet so that the difference between the two groups was whether or not they received nurse treatment. We measured sleep, quality of life, daytime functioning and use of sleep medication through questionnaires, before and after treatment. We calculated the cost to deliver the treatment, as well as the cost of other National Health Service treatments that participants accessed during the study. We also interviewed participants and nurses to understand their views of the treatment. We found that participants in the sleep restriction therapy group experienced greater reduction in their insomnia symptoms compared to sleep hygiene. They also experienced improved sleep, mental health, quality of life and work productivity. The two groups did not differ in their use of prescribed sleep medication. Our results suggest that the treatment is likely to represent good value for money for the National Health Service. Both nurses and participants considered the treatment to be acceptable and beneficial, and they suggested some potential refinements. The study shows that nurse-delivered sleep restriction therapy is likely to be a clinically effective approach to the treatment of insomnia, and good value for money for the National Health Service.