Monash University, Clayton, Victoria, Australia.
Monash-Epworth Rehabilitation Centre, Richmond, Victoria, Australia.
PeerJ. 2023 Dec 14;11:e16543. doi: 10.7717/peerj.16543. eCollection 2023.
Disturbed sleep is common among people living with dementia and their informal caregivers, and is associated with negative health outcomes. Dyadic, multi-modal interventions targeting caregiver and care-recipient sleep have been recommended yet remain limited. This protocol details the development of a single-arm feasibility trial of a multi-modal, therapist-led, six-week intervention targeting sleep disturbance in dyads of people living with dementia and their primary caregiver.
We aim to recruit 24 co-residing, community-dwelling dyads of people living with dementia and their primary informal caregiver ( = 48) with sleep concerns (Pittsburgh Sleep Quality Index ≥5 for caregivers, and caregiver-endorsed sleep concerns for the person living with dementia). People who live in residential care settings, are employed in night shift work, or are diagnosed with current, severe mental health conditions or narcolepsy, will be excluded. Participants will wear an actigraph and complete sleep diaries for two weeks prior, and during the last two weeks, of active intervention. The intervention is therapist-led and includes a mix of weekly small group video sessions and personalised, dyadic sessions (up to 90 min each) over six weeks. Sessions are supported by a 37-page workbook offering strategies and spaces for reflections/notes. Primary feasibility outcomes are caregiver: session attendance, attrition, and self-reported project satisfaction. Secondary outcomes include dyadic self-reported and objectively-assessed sleep, depression and anxiety symptoms, quality of life, and social support. Self-report outcomes will be assessed at pre- and post-intervention.
If feasible, this intervention could be tested in a larger randomised controlled trial to investigate its efficacy, and, upon further testing, may potentially represent a non-pharmacological approach to reduce sleep disturbance among people living with dementia and their caregivers.
ACTRN12622000144718: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=382960&showOriginal=true&isReview=true.
患有痴呆症的患者及其非专业照护者普遍存在睡眠障碍，且与负面健康结果相关。针对照护者和被照护者睡眠的双模态干预措施已被推荐，但仍很有限。本方案详细介绍了一项针对痴呆症患者及其主要照护者的睡眠障碍的单臂可行性试验的开发，该试验为多模态、治疗师主导的为期六周的干预措施。
我们旨在招募 24 对有睡眠问题的共同居住的社区居住的痴呆症患者及其主要非专业照护者（=48）（照护者匹兹堡睡眠质量指数≥5，痴呆症患者的照护者认可的睡眠问题）。居住在住宿护理环境中、从事夜班工作或患有当前严重精神健康状况或发作性睡病的人将被排除在外。参与者将在干预前两周和干预的最后两周佩戴活动记录仪并填写睡眠日记。该干预措施由治疗师主导，包括每周进行小团体视频会议和个性化的、双模式的小组会议（每次 90 分钟），共六周。小组会议由 37 页的工作手册提供支持，其中提供了策略和反思/笔记空间。主要可行性结果是照护者：小组会议出席率、流失率和自我报告的项目满意度。次要结果包括双模式自我报告和客观评估的睡眠、抑郁和焦虑症状、生活质量和社会支持。自我报告的结果将在干预前后进行评估。
如果可行，该干预措施可以在更大的随机对照试验中进行测试，以研究其疗效，并且在进一步测试后，可能代表一种非药物方法来减少痴呆症患者及其照护者的睡眠障碍。
ANZCTR 试验注册：ACTRN12622000144718：https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=382960&showOriginal=true&isReview=true。
