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临床试验/NCT07062406
NCT07062406招募中不适用

Enhancing Diabetes Care: Implementing Cognitive Behavioral Therapy for Insomnia to Improve Sleep and Cardiometabolic Outcomes

Tulane University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
2
主要终点
Between-group difference in change in HbA1c from baseline to 3 months

研究概览

简要总结

Insomnia is highly prevalent in individuals with type 2 diabetes (T2D) and is associated with poor glycemic control. Louisiana has one of the highest diabetes prevalence rates in the U.S., with significant disparities by race, income, and rural residence. Despite growing recognition of sleep's role in diabetes management, sleep disturbances remain largely unaddressed in diabetes care. Cognitive behavioral therapy for insomnia (CBT-I) is the first-line treatment for chronic insomnia, yet it is underutilized in primary care clinics such as federally qualified health centers (FQHCs) that serve high-risk populations.

The long-term goal of this research is to improve cardiometabolic health and reduce diabetes disparities by integrating sleep interventions into diabetes care. This pilot study aims to: (1) evaluate the impact of CBT-I on sleep and diabetes-related outcomes, and (2) assess the acceptability, feasibility, and fidelity of implementing a 6-week CBT-I program in an FQHC setting.

The investigators will conduct a randomized controlled trial (RCT) with 30 FQHC patients (aged 40+) with uncontrolled T2D (HbA1c >7%) and comorbid insomnia (Insomnia Severity Index (ISI) score ≥15). Participants will be randomly assigned to either the CBT-I intervention or usual care. Sleep (ISI scores, actigraphy) and cardiometabolic (HbA1c, fasting glucose, insulin) outcomes will be assessed at baseline and three months post-randomization. Implementation success will be evaluated using fidelity, feasibility, and acceptability measures. Findings will provide preliminary evidence for integrating CBT-I into primary care, informing larger trials to improve diabetes outcomes and reduce disparities in Louisiana.

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
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • aged 40 or older
  • receive primary care from participating clinic
  • diagnosis of type 2 diabetes
  • most recent hemoglobin A1c (HbA1c) >7% within the past year
  • Insomnia Severity Index (ISI) score ≥15
  • able to speak English

排除标准

  • diagnosed or self-reported sleep apnea
  • pregnant or planning to become pregnant during the study period
  • having a psychiatric or medical condition that would interfere with the ability to complete study procedures
  • participating in another diabetes clinical trial
  • living in same household as another participant
  • required to work night shifts

研究组 & 干预措施

Cognitive Behavioral Therapy for Insomnia

Experimental

干预措施: Cognitive Behavioral Therapy for Insomnia (Behavioral)

Usual Care

Active Comparator

干预措施: Usual care for diabetes management (Other)

Usual Care

Active Comparator

干预措施: Usual care for treatment of insomnia (Other)

Cognitive Behavioral Therapy for Insomnia

Experimental

干预措施: Usual care for treatment of insomnia (Other)

Cognitive Behavioral Therapy for Insomnia

Experimental

干预措施: Usual care for diabetes management (Other)

结局指标

主要结局

Between-group difference in change in HbA1c from baseline to 3 months

时间窗: 3 months

Difference between intervention and usual care groups in change in hemoglobin A1c (HbA1c) from baseline to 3 months

次要结局

  • Between-group difference in change in insomnia symptoms from baseline to 3 months(3 months)
  • Between-group difference in change in concentration of insulin from baseline to 3 months(3 months)
  • Between-group difference in change in fasting glucose from baseline to 3 months(3 months)
  • Between-group difference in change in sleep efficiency from baseline to 3 months(3 months)
  • Between-group difference in change in wake after sleep onset (WASO) from baseline to 3 months(3 months)
  • Between-group difference in proportion without clinical insomnia symptoms at 3 months(3 months)
  • Between-group difference in change in insomnia symptoms from baseline to 6 weeks(6 weeks)
  • Between-group difference in change in sleep efficiency from baseline to 6 weeks(6 weeks)
  • Between-group difference in change in wake after sleep onset (WASO) from baseline to 6 weeks(6 weeks)
  • Between-group difference in proportion without clinical insomnia symptoms at 6 weeks(6 weeks)
  • Between-group difference in change in glucose time-in-range from baseline to 3 months(3 months)
  • Between-group difference in change in glucose time-in-range from baseline to 6 weeks(6 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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