Testing mHealth Delivery of Cognitive Behavioral Therapy for Insomnia to Breast Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Insomnia Symptoms
研究概览
简要总结
The aim of this study is to determine the impact of the voice-activated smart speaker CBT-I components on insomnia symptoms among breast cancer survivors using a randomized clinical trial.
详细描述
This study is a Phase II SBIR to further test efficacy of a voice-activated technology to deliver components of cognitive behavioral therapy for insomnia (CBT-I) to breast cancer survivors (BCS) compared to a web-based control. Participants will be randomly assigned to the voice-activated or web-based treatment arms and will complete a 6-week intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Willingness to maintain a consistent dosing pattern if currently taking sleep medications or using cannabis for sleep
- •Females; Age 18+
- •Self-reported or documented diagnosis of breast cancer stage I-III or stage IV ECOG 0-1
- •Completed curative treatment (surgery, radiation, chemotherapy) > 3 months prior to enrollment [ongoing adjuvant therapy permitted]
- •Has not undergone other behavioral sleep treatment within the prior 12 months
- •Score greater than or equal to 8 on the Insomnia Severity Index
- •Able to understand and speak English
排除标准
- •Diagnosed, untreated obstructive sleep apnea syndrome, narcolepsy, restless leg syndrome, periodic limb movement disorder, delayed sleep phase syndrome, central apnea
- •Bi-polar disorder, schizophrenia, initiation of psychological treatment within three months, alcohol or drug abuse in the prior year (Alcohol >2 drinks/day or consuming 5+ drinks in a single day in the prior month). (Moderate ADHD, depression and anxiety will not be exclusion criteria.)
- •Shift-work in the prior three months or anticipated during the study time
- •Planned regular travel out of time zone (>1 hour) during the study period.
- •Currently or planning to become pregnant during the study period
研究组 & 干预措施
Voice-Activated Smart Speaker Program
Faster Asleep
干预措施: Faster Asleep Smart Speaker Program (Behavioral)
Website
Faster Asleep Website
干预措施: Faster Asleep Website (Behavioral)
结局指标
主要结局
Insomnia Symptoms
时间窗: 6 weeks
Data will be collected on the Insomnia Severity Index (ISI) total score pre- and post-intervention as our primary outcome. The ISI is a seven-item questionnaire with response categories from 0-4 (total score 0-28) asking about sleep patterns and specifically characterizing insomnia over the two weeks prior. The ISI defines 'no clinically significant' insomnia as a score of 0-7, 'sub-threshold' insomnia as a score of 8-14, 'moderate severity clinical' insomnia' a scores of 15-21, and 'severe clinical' insomnia as a score of 22-28. Clinically relevant target for success is to achieve sub-threshold or better scores (≤14) among \>80% of the intervention participants
次要结局
- Six Week Change in Total Sleep Time(6 weeks)
- Six Week Change in Sleep Efficiency(6 weeks)
- Six Week Change in Wake After Sleep Onset(6 weeks)
- Six Week Change in Sleep Onset Latency(6 weeks)
研究者
Hannah Arem
Scientific Director, Implementation Science
Medstar Health Research Institute