Shaffer Kelly M, Ritterband Lee M, You Wen, Buysse Daniel J, Mattos Meghan K, Camacho Fabian, Glazer Jillian V, Klinger Julie, Donovan Heidi
Center for Behavioral Health and Technology, University of Virginia, Charlottesville, VA, United States.
Department of Public Health Sciences, University of Virginia, Charlottesville, VA, United States.
JMIR Res Protoc. 2022 Jan 12;11(1):e34792. doi: 10.2196/34792.
Family caregivers are more likely to experience insomnia relative to noncaregivers but have significant barriers to accessing gold standard cognitive behavioral therapy for insomnia treatment. Delivering interventions to caregivers through the internet may help increase access to care, particularly among higher-intensity caregivers who provide assistance with multiple care tasks over many hours per week. Although there are existing internet interventions that have been thoroughly studied and demonstrated as effective in the general population, the extent to which these interventions may be effective for caregivers without tailoring to address this population's unique psychosocial needs has not been studied.
The goal of this trial is to determine what tailoring may be necessary for which caregivers to ensure they receive optimal benefit from an existing evidence-based, internet-delivered cognitive behavioral therapy for insomnia program named Sleep Healthy Using the Internet (SHUTi). Specifically, we will test the association between caregivers' engagement with SHUTi and their caregiving context characteristics (ie, caregiving strain, self-efficacy, and guilt) and environment (ie, proximity to care recipient; functional status, cognitive status, and problem behavior of care recipient; and type of care provided). Among caregivers using the program, we will also test the associations between change in known treatment mechanisms (sleep beliefs and sleep locus of control) and caregiving context factors.
A total of 100 higher-intensity caregivers with significant insomnia symptoms will be recruited from across the United States to receive access to SHUTi in an open-label trial with mixed methods preassessments and postassessments. At postassessment (9 weeks following preassessment completion), participants will be categorized according to their engagement with the program (nonusers, incomplete users, or complete users). Study analyses will address 3 specific aims: to examine the association between caregivers' engagement with SHUTi and their caregiving context (aim 1a); to describe caregivers' barriers to and motivations for SHUTi engagement from open-ended survey responses (aim 1b); and among caregivers using SHUTi, to determine whether cognitive mechanisms of change targeted by SHUTi are associated with differences in caregiving context (aim 2).
Institutional review board approvals have been received. Data collection is anticipated to begin in December 2021 and is expected to be completed in 2023.
Findings will inform the next research steps for tailoring and testing SHUTi for optimal impact and reach among caregivers. Beyond implication to the SHUTi program, the findings will be translatable across intervention programs and will hold significant promise to reduce inefficiencies in developing digital health interventions for caregivers while also increasing their impact and reach for this underserved population.
ClinicalTrials.gov; NCT04986904; https://clinicaltrials.gov/ct2/show/NCT04986904?term=NCT04986904.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/34792.
与非照料者相比，家庭照料者更易出现失眠症状，但在寻求失眠治疗的金标准——认知行为疗法时面临重大障碍。通过互联网为照料者提供干预措施可能有助于增加获得护理的机会，尤其是对于那些高强度照料者，他们每周要花费多个小时协助完成多项照料任务。虽然现有的互联网干预措施已在普通人群中得到充分研究并证明有效，但这些干预措施在未针对该人群独特的心理社会需求进行调整的情况下，对照料者的有效性程度尚未得到研究。
本试验的目的是确定针对哪些照料者进行何种调整，以确保他们能从现有的基于证据、通过互联网提供的失眠认知行为疗法项目“使用互联网保持健康睡眠”（SHUTi）中获得最大益处。具体而言，我们将测试照料者参与SHUTi与他们的照料背景特征（即照料压力、自我效能感和内疚感）以及环境（即与受照料者的距离；受照料者的功能状态、认知状态和问题行为；以及提供的照料类型）之间的关联。在使用该项目的照料者中，我们还将测试已知治疗机制（睡眠信念和睡眠控制点）的变化与照料背景因素之间的关联。
将从美国各地招募100名有严重失眠症状的高强度照料者，在一项采用混合方法进行预评估和后评估的开放标签试验中让他们使用SHUTi。在后评估（预评估完成后9周）时，参与者将根据他们对该项目的参与程度（非使用者、未完成使用者或完成使用者）进行分类。研究分析将涉及3个具体目标：研究照料者参与SHUTi与他们的照料背景之间的关联（目标1a）；从开放式调查回复中描述照料者参与SHUTi的障碍和动机（目标1b）；在使用SHUTi的照料者中，确定SHUTi所针对的认知变化机制是否与照料背景差异相关（目标2）。
已获得机构审查委员会的批准。预计数据收集将于2021年12月开始，预计2023年完成。
研究结果将为下一步针对照料者调整和测试SHUTi以实现最佳效果和覆盖面提供参考。除了对SHUTi项目有意义外，这些结果将可推广到其他干预项目，并有望显著减少为照料者开发数字健康干预措施时的低效情况，同时增加对这一服务不足人群的影响和覆盖面。
ClinicalTrials.gov；NCT04986904；https://clinicaltrials.gov/ct2/show/NCT04986904?term=NCT04986904。
国际注册报告识别码（IRRID）：PRR1-10.2196/34792。
