Department of Public Health and Nursing, Norwegian University of Science and Technology, Trondheim, Norway.
Unit for Physiotherapy Services, Trondheim Municipality, Trondheim, Norway.
BMC Prim Care. 2023 Mar 2;24(1):61. doi: 10.1186/s12875-023-02018-4.
Insomnia is common in the general population and is a risk factor for ill-health, which highlights the importance of treating insomnia effectively and cost-efficiently. Cognitive-behavioural therapy for insomnia (CBT-I) is recommended as first-line treatment due to its long-term effectiveness and few side-effects, but its availability is limited. The aim of this pragmatic, multicentre randomized controlled trial is to investigate the effectiveness of group-delivered CBT-I in primary care compared to a waiting-list control group.
A pragmatic multicentre randomized controlled trial will be conducted with about 300 participants recruited across 26 Healthy Life Centres in Norway. Participants will complete online screening and provide consent before enrolment. Those who meet the eligibility criteria will be randomized to a group-delivered CBT-I or to a waiting list according to a 2:1 ratio. The intervention consists of four two-hour sessions. Assessments will be performed at baseline, 4 weeks, 3- and 6 months post-intervention, respectively. The primary outcome is self-reported insomnia severity at 3 months post-intervention. Secondary outcomes include health-related quality of life, fatigue, mental distress, dysfunctional beliefs and attitudes about sleep, sleep reactivity, 7-day sleep diaries, and data obtained from national health registries (sick leave, use of relevant prescribed medications, healthcare utilization). Exploratory analyses will identify factors influencing treatment effectiveness, and we will conduct a mixed-method process evaluation to identify facilitators and barriers of participants' treatment adherence. The study protocol was approved by the Regional Committee for Medical and Health Research ethics in Mid-Norway (ID 465241).
This large-scale pragmatic trial will investigate the effectiveness of group-delivered cognitive behavioural therapy versus waiting list in the treatment of insomnia, generating findings that are generalizable to day-to-day treatment of insomnia in interdisciplinary primary care services. The trial will identify those who would benefit from the group-delivered therapy, and will investigate the rates of sick leave, medication use, and healthcare utilization among adults who undergo the group-delivered therapy.
The trial was retrospectively registered in the ISRCTN registry (ISRCTN16185698).
失眠在普通人群中很常见，是健康状况不佳的一个风险因素，这凸显了有效且具有成本效益地治疗失眠的重要性。认知行为疗法（CBT-I）因其长期有效性和较少的副作用而被推荐为一线治疗方法，但它的可用性有限。本研究采用实用、多中心随机对照试验，旨在调查初级保健中小组式 CBT-I 与等待名单对照组相比的有效性。
本实用、多中心随机对照试验将在挪威的 26 个健康生活中心招募约 300 名参与者。参与者将在注册前完成在线筛查并提供同意书。符合入选标准的参与者将按照 2:1 的比例随机分配到小组式 CBT-I 组或等待名单组。干预措施包括 4 个两小时的疗程。评估将分别在基线、4 周、3 个月和 6 个月时进行。主要结局是干预后 3 个月时的自我报告失眠严重程度。次要结局包括健康相关生活质量、疲劳、精神困扰、睡眠相关信念和态度障碍、睡眠反应性、7 天睡眠日记，以及从国家健康登记处获得的数据（病假、使用相关规定药物、医疗保健利用）。探索性分析将确定影响治疗效果的因素，我们将进行混合方法的过程评估，以确定参与者治疗依从性的促进因素和障碍。该研究方案已获得 Mid-Norway 地区医学和健康研究伦理委员会的批准（ID 465241）。
这项大规模实用试验将研究小组式认知行为疗法与等待名单治疗失眠的有效性，为跨学科初级保健服务中日常失眠治疗提供可推广的发现。该试验将确定哪些人会从小组式治疗中受益，并将调查接受小组式治疗的成年人的病假、药物使用和医疗保健利用率。
该试验在 ISRCTN 注册处（ISRCTN87754004）进行了回顾性注册。
