背景:癌症幸存者的睡眠障碍发生率是普通人群的3倍以上。幸存者睡眠障碍的原因是多方面的,包括与癌症诊断和治疗有关的焦虑和恐惧。失眠症的认知行为疗法(CBT-I)被认为是失眠的一线治疗方法;然而,缺乏受过培训的专业人员以及CBT-I服务的保险范围有限,限制了患者获得这些有效治疗的机会.证据支持CBT-I(dCBT-I)的数字交付,但是只有有限的证据支持它在癌症幸存者中的使用。智能手机技术的广泛采用为提供dCBT-I提供了新的渠道,但之前没有研究对幸存者的移动dCBT-I干预进行评估.为了满足癌症幸存者对可获得和有效的CBT-I的需求,MiSleepCoach计划的开发是为了适应CBT-I,将其作为自我指导的移动健康应用程序交付给癌症幸存者。
目的:这项单臂可行性研究评估了依从性,自然减员,有用性,和MiSleepCoach应用程序对失眠的满意度。
方法:7周,进行了单臂研究,招募成年乳房幸存者,前列腺,或结肠癌报告睡眠障碍。
结果:总计,30名参与者报名参加,100%完成研究,并在第7周提供数据。Further,在30名参与者中,有80%(n=24)至93%(n=28)的10个应用程序功能中的9个被发现有用。此外,27(90%)的参与者对MiSleepCoach应用程序感到满意,28(93%)的参与者建议对失眠者使用MiSleepCoach应用程序。失眠严重程度指数显示从基线(18.5,SD4.6)到第7周(10.4,SD4.2)下降8.1(P<.001;Cohend=1.5)。在基线,25名(83%)参与者在中度(n=19;15-21)或重度(n=6;22-28)失眠范围内得分。在第7周,共有4名(13%)患者在中度(n=4)或重度(n=0)范围内得分。服用处方睡眠药物的患者数量从基线时的7例(23%)减少到第7周的1例(3%;P<.001)。服用非处方睡眠药物的患者人数从基线时的14人(47%)减少到第7周的9人(30%;P=0.03)。
结论:MiSleepCoach应用程序显示出高水平的程序依从性和用户满意度,并对癌症幸存者失眠的严重程度产生重大影响。MiSleepCoach应用程序是对癌症相关失眠的有希望的干预措施,和进一步的临床试验是必要的。如果在未来的随机对照临床试验中证明可以显着减少癌症幸存者的失眠,这种干预措施将使更多的癌症幸存者更容易获得循证CBT-I治疗.
背景:ClinicalTrials.govNCT04827459;https://clinicaltrials.gov/study/NCT04827459。
BACKGROUND: Rates of sleep disturbance among survivors of cancer are more than 3 times higher than the general population. Causes of sleep disturbance among survivors are many and multifaceted, including anxiety and fear related to cancer diagnosis and treatments. Cognitive behavioral therapy for insomnia (CBT-I) is considered a first-line treatment for insomnia; However, a lack of access to trained professionals and limited insurance coverage for CBT-I services has limited patient access to these effective treatments. Evidence supports digital delivery of CBT-I (dCBT-I), but there is only limited evidence to support its use among survivors of cancer. Broad adoption of smartphone technology provides a new channel to deliver dCBT-I, but no prior studies have evaluated mobile dCBT-I interventions for survivors. To address the need for accessible and efficacious CBT-I for survivors of cancer, the Mi Sleep Coach program was developed to adapt CBT-I for delivery to survivors of cancer as a self-directed mobile health app.
OBJECTIVE: This single-arm feasibility
study assessed the adherence, attrition, usefulness, and satisfaction of the Mi Sleep Coach app for insomnia.
METHODS: A 7-week, single-arm
study was conducted, enrolling adult survivors of breast, prostate, or colon cancer reporting sleep disturbances.
RESULTS: In total, 30 participants were enrolled, with 100% completing the
study and providing data through week 7. Further, 9 out of 10 app features were found to be useful by 80% (n=24) to 93% (n=28) of the 30 participants. Furthermore, 27 (90%) participants were satisfied with the Mi Sleep Coach app and 28 (93%) would recommend the use of the Mi Sleep Coach app for those with insomnia. The Insomnia Severity Index showed a decrease from baseline (18.5, SD 4.6) to week 7 (10.4, SD 4.2) of 8.1 (P<.001; Cohen d=1.5). At baseline, 25 (83%) participants scored in the moderate (n=19; 15-21) or severe (n=6; 22-28) insomnia range. At week 7, a total of 4 (13%) patients scored in the moderate (n=4) or severe (n=0) range. The number of patients taking prescription sleep medications decreased from 7 (23%) at baseline to 1 (3%; P<.001) at week 7. The number of patients taking over-the-counter sleep medications decreased from 14 (47%) at baseline to 9 (30%; P=.03) at week 7.
CONCLUSIONS: The Mi Sleep Coach app demonstrated high levels of program adherence and user satisfaction and had large effects on the severity of insomnia among survivors of cancer. The Mi Sleep Coach app is a promising intervention for cancer-related insomnia, and further clinical trials are warranted. If proven to significantly decrease insomnia in survivors of cancer in future randomized controlled clinical trials, this intervention would provide more survivors of cancer with easy access to evidence-based CBT-I treatment.
BACKGROUND: ClinicalTrials.gov NCT04827459; https://clinicaltrials.gov/
study/NCT04827459.