University of Michigan School of Nursing, 400 N. Ingalls, Room 4320, Ann Arbor, MI, 48109-5482, USA.
Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN, USA.
Support Care Cancer. 2020 Dec;28(12):6085-6094. doi: 10.1007/s00520-020-05461-6. Epub 2020 Apr 19.
Sleep disturbance is a prevalent problem for cancer survivors and effective behavioral treatments are not widely used for this population. This study evaluated home-based sleep interventions based on cognitive behavioral therapy for insomnia (CBT-I).
This phase II randomized controlled trial evaluated two manualized interventions over 7 weeks. The intervention group received sleep hygiene information, stimulus control, sleep restriction, and a bedtime imagery audio recording. The control group was similar, but without sleep restriction and used audio recordings of bedtime short stories instead of imagery. Eligibility included adult cancer survivors who had trouble falling asleep or falling back to sleep on 3 of 7 days. Patients with diagnoses of sleep or mental health disorders were excluded. The primary endpoint was change in time to fall asleep or falling back to sleep after awakening, from baseline to week 7. Two-sample T tests evaluated differences between arms for this endpoint.
Ninety-three of 168 planned participants were enrolled from 20 institutions. The study closed early for poor accrual. Baseline time to sleep was 45 min and 52 min for the intervention and control group, respectively. At 7 weeks, both groups improved, the intervention group to 26 min and control group to 30 min, a non-significant difference between groups (p = 0.85). Secondary outcomes improved in both groups with no significant differences between arms.
Improvement in sleep outcomes in both arms was consistent with other CBT-I interventions delivered through alternative approaches to provider-delivered therapy. More research on optimal scalable delivery of CBT-I is needed.
This study supports the effectiveness of CBT-I based behavioral interventions for sleep but also the need for better delivery methods to improve uptake and effect size.
ClinicalTrials.gov identifier: NCT00993928.
睡眠障碍是癌症幸存者中普遍存在的问题，但针对这一人群的有效行为治疗方法并未广泛应用。本研究评估了基于失眠认知行为疗法（CBT-I）的家庭睡眠干预措施。
这是一项为期 7 周的 II 期随机对照试验，评估了两种基于手册的干预措施。干预组接受了睡眠卫生信息、刺激控制、睡眠限制和睡前意象音频记录。对照组类似，但没有睡眠限制，使用睡前短故事的音频记录代替意象。纳入标准包括入睡或醒来后 3 天中有 3 天入睡或再次入睡困难的成年癌症幸存者。患有睡眠或精神健康障碍诊断的患者被排除在外。主要终点是从基线到第 7 周，入睡或醒来后再次入睡的时间变化。两样本 T 检验评估了该终点在两个手臂之间的差异。
从 20 个机构中计划纳入的 168 名患者中，有 93 名符合条件。由于入组人数少，该研究提前关闭。基线时入睡时间分别为干预组 45 分钟和对照组 52 分钟。在第 7 周，两组均有改善，干预组为 26 分钟，对照组为 30 分钟，两组之间无显著差异（p=0.85）。两组的次要结局均有改善，两组之间无显著差异。
两组的睡眠结果改善与通过其他方法提供的提供者提供的其他 CBT-I 干预措施一致。需要更多关于 CBT-I 最佳可扩展交付的研究。
本研究支持基于行为的 CBT-I 干预措施对睡眠的有效性，但也需要更好的交付方法来提高接受度和效果大小。
ClinicalTrials.gov 标识符：NCT00993928。
