CBT for Secondary Insomnia in Chronic Pain Patients

描述(申请人提供)：据保守估计，有4,000万至7,000万人受到慢性疼痛的影响，其中近90%的患者抱怨睡眠不佳。尽管患病率很高，但在慢性疼痛继发失眠患者中进行的临床试验工作很少。 我们建议进行一项初步研究，以评估CBT治疗失眠是否可以成功地应用于慢性疼痛继发的失眠，并进一步评估睡眠领域的临床收益是否与更强的疼痛耐受性、改善的情绪和提高的生活质量有关。 因疼痛而继发失眠的受试者将被招募参加平行分组、随机、单盲、“安慰剂”对照试验。受试者将被分配到两组中的一组：一组接受CBT治疗失眠，包括睡眠限制、刺激控制、认知治疗和睡眠卫生；另一组接受非主动对照测量和治疗师接触时间。治疗将由接受过CBT失眠研究级培训的护士进行个体化治疗。睡眠、疼痛、情绪和生活质量症状将在两周的基线期间进行监测，在治疗阶段每周监测一次，并在治疗后的3个月和6个月每隔两周监测一次。 从R21中获得的数据将被用于1)CBT-I对慢性疼痛继发失眠患者的疗效评估，以及2)睡眠连续性改善对疼痛、情绪和生活质量的影响。在经验和理论基础上，预计CBT-I将对主要和次要结果衡量产生中等到很大的影响。如果项目成功，这些数据将被用作R01申请的基础。预计这类研究将提供所需的证据，使CBT-I成为慢性疼痛治疗的实践标准。

DESCRIPTION (provided by applicant): It is conservatively estimated that between 40 and 70 million people are affected by chronic pain and that nearly 90% of these patients complain of poor sleep. Despite high prevalence rates, very little clinical trial work has been undertaken in patients with insomnia secondary to chronic pain. We propose a preliminary study to evaluate whether CBT for insomnia can be successfully applied to insomnia secondary to chronic pain and to further assess whether clinical gains within the sleep domain are related to greater pain tolerance, improved mood and enhanced quality of life. Subjects with insomnia secondary to pain will be recruited to participate in a parallel-groups, randomized, single blind, "placebo" controlled trial. Subjects will be assigned to one of two groups: one receiving treatment (CBT for insomnia including sleep restriction, stimulus control, cognitive therapy and sleep hygiene), the other group receiving a non-active control for measurement and therapist contact time. Treatment will occur on an individual basis by a Nurse Practitioner trained in research grade CBT for Insomnia. Sleep, pain, mood and quality of life symptoms will be monitored for a 2-week baseline period, weekly during the treatment phase and for 2-week intervals at 3 and 6 months post treatment. The data obtained from this R21 will be used to create effect size estimates for 1) the efficacy of CBT-I in patients with insomnia secondary to chronic pain and 2) the effects of improved sleep continuity on pain, mood, and quality of life. It is anticipated, both on empirical and theoretical grounds, that CBT-I will produce moderate to large effects for both the primary and secondary outcome measures. If the project is successful, these data will be used as the basis for an R01 application. It is anticipated that studies of this kind will provide the kind of evidence required to make CBT-I a standard of practice for the management of chronic pain.