Optimizing an Integrated Mind and Body Treatment for Insomnia: The SLEEPS Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Intervention Feasibility
研究概览
简要总结
This single-arm feasibility trial will provide digital cognitive behavioral therapy for insomnia (CBT-I) and passive body heating (PBH) sessions using a sauna blanket over a 9-week treatment period to adults aged 18 years or older with insomnia disorder.
详细描述
Insomnia disorder is a common and consequential mental health problem, with prevalence estimates at approximately 10%. The American College of Physicians recommends cognitive behavioral therapy for insomnia (CBT-I), an efficacious "mind" (psychological and behavioral) treatment, as the first-line treatment for adults with insomnia. Yet, about half of individuals experience residual insomnia symptoms after CBT-I. Accordingly, researchers have sought to augment CBT-I, primarily with pharmacotherapy, but many people do not want to use pharmacologic agents due to concerns about side effects and dependence. Passive-body heating (PBH), a "body" treatment, involves heating the body via hot baths or showers, infrared sauna, or other heat sources. PBH has been found to reduce the time needed to fall asleep and to improve sleep quality. PBH may improve sleep by increasing skin temperature and decreasing core body temperature, a dynamic associated with sleep onset. CBT-I and PBH thus target distinct factors that may contribute to insomnia, and the investigators hypothesize that the combination of CBT-I and PBH holds promise as a multi-component treatment for insomnia disorder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •English-speaking
- •Willing to use birth control if assigned female sex at birth
- •Location to plug sauna blanket into regular wall outlet
- •Ability to lie in sauna blanket for 15 minutes
- •Ability to fit in the sauna blanket (no taller than 6' 3", no greater than 250 lbs)
- •Daily access to the internet via computer, smartphone, or tablet
- •Elevated insomnia symptoms as indexed by a score of 11 or greater on the Insomnia Severity Index (ISI)
- •Insomnia disorder (characterized by difficulty initiating sleep) as indexed by a positive diagnosis on the Structured Clinical Interview for DSM-5 Sleep Disorders (SCISD)
排除标准
- •Night shift worker
- •Current or planned routine body heating practices (e.g., saunas, hot tubs)
- •Pregnant or plans to become pregnant during the participation period
- •Other diagnosed sleep disorders or suspected sleep disorders
- •Medical conditions that might increase the risk of passive body heating using an infrared sauna blanket
- •Mental health disorder that may better explain insomnia, require priority treatment, or be exacerbated by time in bed restriction
结局指标
主要结局
Intervention Feasibility
时间窗: 9 weeks
Proportion of eligible prospective participants who consent to complete at least 6 weeks of at least 3 PBH sessions per week over the 9-week intervention period.
次要结局
未报告次要终点