Perini Family Survivors' Center, Dana-Farber Cancer Institute, Boston, MA, United States.
Department of Psychology, Suffolk University, Boston, MA, United States.
JMIR Res Protoc. 2024 Nov 28;13:e60762. doi: 10.2196/60762.
BACKGROUND: Cancer survivors are at increased risk for chronic insomnia, even years after treatment completion. As insomnia is associated with a variety of long-term health consequences, access to insomnia treatment is critically important for the survivor population. Cognitive behavioral therapy for insomnia (CBTI) is the recommended first-line treatment for insomnia but remains largely unavailable to survivors. Treatment barriers include geographic limitations, a shortage of trained providers, and demanding treatment regimens. Designed with these limitations in mind, the Sleep Treatment Education Program (STEP-1) delivers components of CBTI in a low-intensity educational intervention delivered online. OBJECTIVE: This is a phase II pilot randomized controlled trial. The primary aims are to test the efficacy of STEP-1 to improve (1) insomnia symptoms and (2) mood in cancer survivors compared to a control condition. The secondary aims will (1) explore participant factors associated with clinically significant response, (2) evaluate acceptability of the control intervention, (3) explore feasibility of delivering individualized coaching sessions for participants who do not have a significant response to STEP-1, and (4) describe participants' satisfaction with STEP-1 and suggestions for improvement. METHODS: This 2-arm randomized controlled trial enrolled 70 off-treatment cancer survivors aged 40-89 years with clinically significant insomnia. Participants are randomized to receive either the STEP-1 intervention or control condition (relaxation education); interventions are delivered in one-on-one, synchronous, virtual videoconference sessions by trained interventionists. The STEP-1 intervention presents educational information on the development of insomnia after cancer and offers suggestions for improving insomnia symptoms based on the CBTI elements of sleep hygiene, stimulus control, and cognitive restructuring. With the interventionist, participants review the suggestions and develop a personalized sleep action plan for implementation. The relaxation education session provides information on the potential benefits of relaxation and how to independently access online relaxation exercises. The Insomnia Severity Index is used to measure insomnia symptoms, and the Profile of Mood States Short Form is used to measure mood at baseline and 4 and 8 weeks after intervention. The primary end point is change in the Insomnia Severity Index score at 8 weeks, and the secondary end point is change in mood symptoms (Profile of Mood States Short Form) at 8 weeks. RESULTS: This trial was funded in July 2022. Enrollment and data collection began in February 2023 and concluded in October 2024, with 70 participants enrolled. The analysis will begin in fall 2024, and the results are expected in winter 2025. CONCLUSIONS: Trial results will determine if STEP-1 effects go beyond those that could be attributed to placebo and other nonspecific treatment factors. Should results support the efficacy of STEP-1 to improve mood and insomnia symptoms, we anticipate developing efficacy and implementation trials of STEP-1 in larger and more diverse samples. TRIAL REGISTRATION: ClinicalTrials.gov NCT05519982; https://clinicaltrials.gov/study/NCT05519982. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/60762.
背景:癌症幸存者即使在治疗完成多年后,也存在慢性失眠的高风险。由于失眠与各种长期健康后果有关,因此获得失眠治疗对幸存者群体至关重要。认知行为疗法(CBTI)是失眠的推荐一线治疗方法,但对于幸存者来说,这种方法仍然在很大程度上无法获得。治疗障碍包括地理限制、训练有素的提供者短缺和要求苛刻的治疗方案。为了应对这些限制,睡眠治疗教育计划(STEP-1)将 CBTI 的部分内容以在线低强度教育干预的形式提供。
目的:这是一项 II 期试点随机对照试验。主要目的是测试 STEP-1 在改善(1)癌症幸存者的失眠症状和(2)情绪方面的疗效,与对照组相比。次要目的将包括:(1)探索与临床显著反应相关的参与者因素,(2)评估对照组干预的可接受性,(3)探索为对 STEP-1 没有显著反应的参与者提供个性化指导会议的可行性,以及(4)描述参与者对 STEP-1 的满意度和改进建议。
方法:这项 2 臂随机对照试验招募了 70 名年龄在 40-89 岁、有临床显著失眠的癌症治疗后幸存者。参与者被随机分配接受 STEP-1 干预或对照组(放松教育);干预以接受过培训的干预者提供的一对一、同步、虚拟视频会议的形式进行。STEP-1 干预提供了癌症后失眠发展的教育信息,并根据睡眠卫生、刺激控制和认知重构的 CBTI 要素提供了改善失眠症状的建议。参与者与干预者一起审查建议,并制定个性化的睡眠行动计划以实施。放松教育课程提供了关于放松的潜在益处以及如何独立访问在线放松练习的信息。使用失眠严重程度指数来衡量失眠症状,使用心境状态简表来衡量干预后 4 周和 8 周的情绪状态。主要终点是 8 周时失眠严重程度指数评分的变化,次要终点是 8 周时情绪症状(心境状态简表)的变化。
结果:该试验于 2022 年 7 月获得资助。招募和数据收集于 2023 年 2 月开始,于 2024 年 10 月结束,共招募了 70 名参与者。分析将于 2024 年秋季开始,预计在 2025 年冬季得出结果。
结论:试验结果将确定 STEP-1 的效果是否超出了安慰剂和其他非特异性治疗因素的作用。如果结果支持 STEP-1 对改善情绪和失眠症状的疗效,我们预计将在更大、更多样化的样本中开展 STEP-1 的疗效和实施试验。
试验注册:ClinicalTrials.gov NCT05519982;https://clinicaltrials.gov/study/NCT05519982。
国际注册报告标识符(IRRID):DERR1-10.2196/60762。
JMIR Res Protoc. 2024-11-28
JAMA Netw Open. 2024-9-3
Public Health Nurs. 2019-3-28