Brief Behavioral Intervention for Insomnia During Chemotherapy

描述（由申请人提供）：睡眠障碍，尤其是失眠，在接受化疗的癌症患者中很普遍。我们的初步数据显示，我们的新干预，短暂失眠行为疗法（BBT-I），可以显著减少接受化疗的乳腺癌患者的失眠。BBT-I以标准失眠认知行为疗法（CBT-I）为模型，包括刺激控制和睡眠调度，并已成功修改，使其更适合于接受辅助或新辅助化疗且近期出现失眠症状的乳腺癌患者。我们的初步研究表明，BBT-I是一种可接受和可行的干预乳腺癌患者失眠的方法，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与注意匹配行为控制在减少乳腺癌患者失眠、疲劳和认知困难方面的疗效。此外，本研究将研究调节因子（年龄、抑郁、焦虑和潮热）、特定行为机制（睡眠行为不良、功能失调的信念和态度）和生理机制（昼夜节律失调、觉醒-睡眠周期中断和自主神经张力）作为干预相关失眠变化的潜在介质的潜在参与，以及疲劳和认知困难的次要结局。为了实现这些目标，将招募180名在化疗期间患有急性失眠的乳腺癌患者，并随机接受BBT-I或健康饮食教育的行为控制。每个干预条件将包括2个面对面会议+ 4个电话，为期六周。评估将包括睡眠日记、问卷调查、神经心理测试、活动记录仪、心率变异性测量、基线、干预后、6个月和12个月随访时唾液皮质醇收集。通过在患者刚刚开始失眠的化疗期间提供这种干预，我们希望在生存期减轻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.