Santa Ponsa Health Center, Majorca Department of Primary Care, Baleares Health Service [IbSalut], Riu Síl, 25, 07180, Santa Ponça, Majorca, Spain.
Balearic Islands Health Research Institute (IdISBa), Edificio S, University Hospital Son Espases, Carretera de Valldemossa, 79, 07120, Palma, Majorca, Spain.
BMC Fam Pract. 2021 Apr 16;22(1):77. doi: 10.1186/s12875-021-01429-5.
Cognitive behavioral therapy for chronic insomnia (CBT-i) is the treatment of choice for this condition but is underutilized in patients who attend primary care. The purpose of the present feasibility-pilot study was to assess the feasibility and acceptability of a cluster-randomized study of CBT-i in a primary care setting.
This study, performed at two primary health care centers in Majorca, Spain, was a mixed methods feasibility-pilot study of a parallel cluster-randomized design comparing CBT-i and usual care (UC). Patients were included if they were 18 to 65 years-old; had diagnoses of chronic insomnia according to the Insomnia Severity Index (ISI ≥ 8); had insomnia for more than 3 months. Twenty-five GPs and nurses and 32 patients were randomly allocated to two groups. The main outcome of the intervention was improvement of dimensions of sleep quality, measured using the Spanish version of the Pittsburgh Sleep Quality Index, at baseline and at 3 months after the intervention. Other primary outcomes of the study were the feasibility and applicability of the intervention, collected through nominal groups. A thematic analysis was performed to classify primary care provider (PCP) proposals. Additionally, we assessed the recruitment process, compliance with the intervention sessions, and patient retention.
We adapted the CBT-i approach of Morin to a primary care context. After intervention training, PCPs expressed the need for more extensive training in the different aspects of the therapy and the discussion of more cases. PCPs considered the intervention as adequate but wanted fewer but longer sessions as well as to discard the cognitive restructuring component. PCPs considered it crucial to prepare each session in advance and to establish a specific agenda for the CBT-i. Regular reminders given to PCPs and patients were suggested to improve study participation. Compared to the UC group, higher proportions of patients in the intervention group had short sleep latency, slept for longer than 5 h, and had fewer sleep disruptions.
This feasibility-pilot study identified several key issues that must be addressed before performing a CBT-i intervention in future clinical trial in a primary care setting.
NCT04565223 . (Clinical trials.gov) Registered 1 September 2020-Retrospectively registered.
认知行为疗法（CBT-i）是治疗慢性失眠的首选方法，但在接受初级保健的患者中并未得到充分利用。本研究旨在评估在初级保健环境中进行 CBT-i 的集群随机研究的可行性和可接受性。
本研究在西班牙马略卡岛的两个初级保健中心进行，是一项混合方法可行性试点研究，采用平行集群随机设计比较 CBT-i 和常规护理（UC）。纳入标准为：年龄 18-65 岁；根据失眠严重程度指数（ISI≥8）诊断为慢性失眠；失眠时间超过 3 个月。25 名全科医生和护士以及 32 名患者被随机分配到两组。干预的主要结局是使用西班牙语匹兹堡睡眠质量指数（PSQI）评估睡眠质量维度的改善，在干预前和干预后 3 个月进行评估。该研究的其他主要结局是通过名义小组收集干预的可行性和适用性。对初级保健提供者（PCP）的建议进行了主题分析。此外，我们评估了招募过程、对干预会议的遵守情况以及患者保留率。
我们将 Morin 的 CBT-i 方法改编为初级保健环境。在干预培训后，PCP 表示需要更广泛地培训治疗的不同方面，并讨论更多的病例。PCP 认为干预措施是适当的，但希望减少但延长疗程，并放弃认知重构部分。PCP 认为提前准备每次会议并为 CBT-i 制定特定议程至关重要。建议定期向 PCP 和患者发送提醒，以提高研究参与度。与 UC 组相比，干预组中有更多的患者入睡潜伏期较短、睡眠时间超过 5 小时且睡眠中断较少。
这项可行性试点研究确定了在未来初级保健环境中进行 CBT-i 干预之前必须解决的几个关键问题。
NCT04565223 。（ClinicalTrials.gov）于 2020 年 9 月 1 日注册-回顾性注册。
