Effects of Cognitive Behavioral Therapy for Insomnia in Type 2 Diabetes Mellitus: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Subjective Sleep Quality
研究概览
简要总结
This study will explore the effects of cognitive behavioral therapy for insomnia (CBTI) compare to health educations in patients with type 2 diabetes (T2DM) with insomnia symptoms.
详细描述
This study will recruit participants with T2DM with insomnia symptoms and randomize them to weekly CBTI or health education for 8 weeks. Outcomes will be measured at baseline and 8 week, and 16 weeks (8 weeks post intervention).
Primary outcome will be subjective sleep quality as assessed by Pittsburgh Sleep Quality Index Secondary outcomes will be fasting glucose, hemoglobin A1C, insulin levels, high sensitivity c-reactive protein, objective sleep parameters from accelerometer, depressive symptoms, daytime sleepiness, quality of life, anxiety symptoms and stress symptoms.
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
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Type 2 diabetes mellitus age 30 to 65 years old
- •Hemoglobin A1C ≥ 6.5 but ≤ 10 %
- •Have poor sleep quality as assessed by Insomnia Severity Index ≥ 15
- •Receive the same hypoglycemic treatments 3 months before the intervention
- •If using sleep aid, the dose needs to be stable for 3 months prior to the enrollment
- •Ability to use the electronic devices (computer, tablet) and assess the internet
- •Willing to attend all of the 8 sessions activities
排除标准
- •Type 1 diabetes mellitus
- •Night shift work
- •Insulin therapy
- •Severe hypoglycemia who required hospitalization or emergency department visit in the past 6 months
- •History of diabetic ketoacidosis in the past 6 months
- •Medically unstable conditions eg. renal replacement therapy, liver failure, heart failure, active cancer, epilepsy, unstable cerebrovascular disease
- •Psychosis, uncontrolled depression
- •Untreated obstructive sleep apnea or STOP-BANG ≥ 5
- •Language/communication/hearing/sight disability
- •Pregnancy or lactation
- •Care giver of infant
- •Harmful alcohol/smoking (≥15 standard-drink in men and ≥8 standard-drink in women)
研究组 & 干预措施
Health education
Health education group will attend online meeting, 1 hour weekly for 8 weeks.
干预措施: Health education (Behavioral)
Cognitive behavioral therapy
Cognitive behavioral therapy for insomnia (CBTI) is non-medical treatment to improve insomnia. CBTI group will attend online meeting, 1 hour weekly for 8 weeks.
干预措施: cognitive behavioral therapy for insomnia (Behavioral)
结局指标
主要结局
Subjective Sleep Quality
时间窗: 16 weeks
Subjective Sleep Quality as assessed by Pittsburgh Sleep Quality Index
次要结局
- High sensitivity c-reactive protein(8 weeks)
- Metabolic parameters(8 weeks)
- Patient reported outcomes(16 weeks)
- Objective sleep parameters(8 weeks)