Adapting Sleep and Yoga Interventions for Maximal Effectiveness in Low Income Populations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Sleep Duration
研究概览
简要总结
The purpose of this study is to evaluate the feasibility of conducting a future randomized control trial that will compare the efficacy of sleep behavioral interventions in a high-risk community including adapted sleep hygiene and yoga. The investigators will conduct a 40 person 12-week randomized control trial (RCT) in low-income housing population where half the participants will receive a community adapted sleep hygiene intervention (SH) and half will receive a community adapted sleep hygiene intervention and a yoga intervention. The investigators will evaluate the feasibility of recruiting from our target community, randomizing individuals to interventions delivered in community rooms with home-based practices, and delivering the targeted interventions with high adherence and fidelity.
详细描述
Inadequate sleep is highly prevalent in low-socioeconomic status (SES) and minority groups and associated with multiple health problems. The root causes of inadequate sleep are often related to behavioral practices and stress, both of which may be favorably impacted using socio-contextually appropriate sleep hygiene recommendations and mind-body practices such as yoga. A preliminary RCT that will address the role of sleep behavioral interventions in a high-risk community will be conducted. This evidence is needed to guide mind-body therapies in low-SES communities in which such strategies are under-utilized to improve health.
The investigators have assembled a multidisciplinary team of experts in sleep medicine, complementary and integrative health, behavioral medicine, community engagement, social epidemiology, and clinical trials to conduct a planning study to adapt behavioral sleep interventions for residents in urban low-income housing and to evaluate their uptake and fidelity. The investigators have conducted qualitative formative evaluation work and conducted modified SH and Yoga pilot studies. In this phase, the investigators will deliver a 12-week trial testing the feasibility of (1) an adapted sleep hygiene intervention (SH) and (2) yoga + adapted sleep hygiene intervention SH+Y):
A. A Sleep Hygiene (SH) Intervention, addressing: beliefs and attitudes towards sleep; challenges for adhering to sleep hygiene recommendations given chaotic family routines, work schedules and bedroom conditions; strategies for overcoming barriers, and prioritization of recommendations most likely to be efficacious.
B. A Yoga (Y) Intervention: intervention intensity/duration and class format; tailored home-based recommendations for bedtime practice combining meditation, breathing and postures; tools to assess and enhance adherence; race/ethnicity concordance of the instructor and student; and use of peer yoga assistants.
The investigators aim to conduct a 40 person 12-week RCT of SH vs SH+Y to inform the design of a future large-scale RCT. The investigators will evaluate the feasibility of recruiting from our target community, randomizing individuals to interventions delivered in community rooms with home-based practices, and delivering the targeted interventions with high adherence and fidelity. The following will be evaluated:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Verbally proficient in English
- •Self-reported average (over the prior month) weekday sleep duration of < 6 hours
- •Reside in a public housing
排除标准
- •Severe physical conditions preventing participation in yoga, including major surgery or head injury in the prior 3 months, or unstable vertebral injury with inability to sit or lie down for 5 or more minutes; or glaucoma
- •Major psychiatric disease (e.g. schizophrenia, depression, PTSD) resulting in hospitalization in the last year; or disease severity that, in the opinion of the investigator, would make it difficult for the participant to partake in the study activities.
- •Severe sleep disorders: self-report of physician diagnosed insomnia requiring hypnotics more than 3 times/ week or an untreated known sleep disorder (sleep apnea, RLS), that in the opinion of the investigator, would make it difficult for the participant to achieve sleep hygiene goals.
- •Needing an assistive device such as a walker or cane, frequent falls, history of stroke resulting in weakness or numbness interfering with moving easily, or other problems causing ongoing balance issues and difficulty walking
- •Yoga class participation in last 6 weeks
- •Known pregnancy.
- •Participation in prior sleep and yoga study pilots
结局指标
主要结局
Sleep Duration
时间窗: 12 weeks
Change in sleep duration from baseline to follow-up measure by actigraphs. We will conduct a repeated measures ANCOVA, modeling time, intervention group and a time\*intervention interaction. We will explore change in stress, anxiety, depressive symptoms, mindfulness, and sleep hygiene score as potential explanatory variables.
次要结局
未报告次要终点
研究者
Susan Redline
Professor
Brigham and Women's Hospital