Brief Behavioral Intervention for Insomnia During Chemotherapy

描述(申请人提供)：睡眠障碍，特别是失眠，在接受化疗的癌症患者中很普遍。我们的初步数据显示，我们的新型干预措施--短暂行为疗法(BBT-I)显著减少了接受化疗的乳腺癌患者的失眠。BBT-I是以标准的失眠认知行为疗法(CBT-I)为模型，包括刺激控制和睡眠安排，并已成功地进行了修改，使其更适合于最近出现失眠症状的乳腺癌患者进行辅助或新辅助化疗。我们的初步研究表明，BBT-I是治疗乳腺癌患者失眠的一种可接受和可行的干预措施，也可能导致疲劳和认知困难的改善。方法：本研究旨在确定BBT-I与注意力匹配行为控制相比较在减少乳腺癌患者失眠、疲劳和认知困难方面的有效性。此外，本研究还将探讨调节因素(年龄、抑郁、焦虑和潮热)、特定的行为机制(不适应睡眠行为、功能失调的信念和态度)和生理机制(昼夜节律失调、觉醒-睡眠周期紊乱和自主音调)作为干预相关失眠改变以及疲劳和认知困难继发结果的潜在中介因素的潜在参与。为了实现这些目标，180名在化疗期间患有急性失眠的乳腺癌患者将被招募并随机接受BBT-I或以健康饮食教育为重点的行为控制。每个干预条件包括两次面对面的会议，四次电话通话，为期六周。评估将包括基线、干预后以及6个月和12个月的随访时的睡眠日记、问卷调查、神经心理测试、活动描记、心率变异性测量和唾液皮质醇收集。通过在患者刚开始出现失眠的化疗期间提供这种干预，我们希望在生存期缓解和避免慢性失眠的发展。

DESCRIPTION (provided by applicant): Sleep disturbance, particularly insomnia, is prevalent in cancer patients undergoing chemotherapy. Our preliminary data show that our novel intervention, Brief Behavioral Therapy for Insomnia (BBT-I), significantly reduces insomnia in breast cancer patients receiving chemotherapy. BBT-I is modeled on standard cognitive behavioral therapy for insomnia (CBT-I), including both stimulus control and sleep scheduling, and has been successfully modified to make it more suitable for breast cancer patients undergoing adjuvant or neoadjuvant chemotherapy with recently developed insomnia symptoms. Our preliminary research suggests that BBT-I is an acceptable and feasible intervention for insomnia in breast cancer patients that might also lead to improvement in fatigue and cognitive difficulties. Methods: This research is designed to determine the efficacy of the BBT-I in comparison with the attention-matched behavioral control in reducing insomnia, fatigue, and cognitive difficulties in breast cancer patients. In addition, this study will examine the potential involvement of moderators (age, depression, anxiety, and hot flashes), specific behavioral mechanisms (maladaptive sleep behaviors, dysfunctional beliefs and attitudes), and physiological mechanisms (dysregulated circadian rhythms, disrupted wake-sleep cycles, and autonomic tone) as potential mediators of intervention-related changes in insomnia and the secondary outcomes of fatigue and cognitive difficulties. To address these aims, 180 breast cancer patients with acute insomnia during chemotherapy treatment will be recruited and randomized to receive either BBT-I or a behavioral control focused on Healthy Eating Education. Each intervention condition will consist of 2 face-to-face sessions + 4 phone calls, delivered over a period of six weeks. Assessments will include sleep diary, questionnaires, neuropsychological testing, actigraphy, heart rate variability measurement, and salivary cortisol collection at baseline, post-intervention, and 6- and 12 months follow ups. By offering this intervention during chemotherapy when patients are just beginning to develop insomnia, we hope to alleviate and avoid the development of chronic insomnia in the survivorship phase.