Enhancing Digital CBT-I to Improve Adherence and Reduce Disparities
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- Adherence to Sleep Restriction
研究概览
简要总结
The primary objective of this research study is to increase adherence of Digital Cognitive Behavioral Treatment for Insomnia (dCBT-I). Additionally, this study will examine behavioral, physical, and sociocultural factors associated with treatment engagement.
详细描述
Insomnia is a debilitating condition that impacts one third of adults, with a majority not having access to proper treatment. Digital Cognitive Behavioral Treatment for Insomnia (dCBT-I). is a method that is becoming more accessible and with strong success rate with treatment completion; however, non-completion rates are common, specifically in those with low socioeconomic status (SES).
This study will examine the addition of telehealth coaching to dCBT-I to increase adherence rates. Telehealth coaching will aim to provide support to mitigate the impact of lower health literacy, and will also enhance self-efficacy as a mechanism to promote treatment persistence.
Participants will be recruited from the Henry Ford Health System (HFHS) outpatient network as well as the Medicare/Medicaid data warehouse. Subjects will be screened to determine eligibility, and then will be randomized into one of two insomnia treatment groups (control dCBT-I and dCBT-I with telehealth coaching). Treatment involves 6 weekly dCBT-I sessions. In the dCBT-I with coaching component, those who are at risk for treatment non-completion will be offered two telehealth sessions of brief behavioral therapy for insomnia. Those in the control dCBT-I who are at risk for treatment non-completion will be provided digital sleep education.
At the end of the treatment period, some participants will complete a semi-structured interview to assess for facilitators and barriers to treatment engagement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
盲法说明
The principle investigator will be blind to the group assignment
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
- •Determination of insomnia (ISI >14)
排除标准
- •Age < 18
- •Unwillingness/inability to participate
- •Bipolar or Seizure Disorders
- •Untreated sleep disorders other than insomnia
- •Untreated and severe medical or psychiatric disorders
研究组 & 干预措施
Enhanced dCBT-I
This group will complete d-CBTI and be assigned a coach that will help with completion of the treatment and will be available to call personally to discuss questions and issues.
干预措施: Enhanced dCBT-I (Behavioral)
Control dCBT-I
Participants in this group will complete dCBT-I individually without assistance from a healthcare provider
结局指标
主要结局
Adherence to Sleep Restriction
时间窗: throughout the study until the final study visit, up to 6 weeks
Determined based on the variance of sleep diary variables
Treatment Completion
时间窗: throughout the study until the final study visit, up to 6 weeks
Completion of all 6 sessions of dCBT-I.
Risk of treatment non-completion
时间窗: throughout the study until the final study visit, up to 6 weeks
Determined based on missing two consecutive sessions of dCBT-I.Missing two consecutive sessions equals being behind on sessions by 14 days.
次要结局
- Insomnia(throughout the study until the final study visit, up to 6 weeks)
- Sociocultural environment(within 2 weeks of post-treatment)
- Physical Environment(within 2 weeks of post-treatment)
研究者
Philip Cheng
Principal Investigator
Henry Ford Health System