CBTi for the Treatment of Insomnia in Type 1 Diabetes
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Acceptability
研究概览
简要总结
The goal of this study is to learn if treating insomnia with a therapy intervention in people with type 1 diabetes will help to better control sugar levels, sleep, and quality of life. The questions this study aims to answer include:
Will this intervention help the insomnia symptoms? Will obtaining better sleep aid in the control of diabetes through measures like sugar levels? Will the intervention help with quality of life factors like mood and fatigue?
Researchers will compare participants receiving the therapy intervention for sleep with those in the "healthy living" intervention to see if the outcomes are different based on the treatment.
Participants in the therapy intervention group will:
- meet virtually with a therapist for 8 sessions via Zoom. Once a week for the first 4 weeks and then every other week for the last 4 sessions.
Participants in the healthy living group will:
- receive weekly health education emails
- receive brief weekly calls from a coach to answer any questions
Participants, regardless of intervention, over the 12 week study period will:
- monitor their sleep for 2 weeks through a sleep-monitoring watch
- share their continuous glucose monitoring data throughout the study
- answer questionnaires prior to the intervention, halfway through the intervention and then after the intervention
- attend 3 in person office visits
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 18 to 65 years old
- •Have been diagnosed with Type 1 Diabetes for at least a year
- •Use a continuous glucose monitor
- •Have poor sleep quality
- •Able to attend 3 office visits
排除标准
- •Currently or planning pregnancy or breast feeding
- •Employed with a rotating or night shift
- •Are at a high risk for obstructive sleep apnea
- •Non-English speaking (unable to participate in therapy or questionnaire).
- •Take medications for sleep
- •moderately severe to severe depression
- •Have a significant medical history that includes conditions like heart failure, cirrhosis, COPD, diseases requiring oxygen, active treatment for cancer or psychiatric problems, history of stroke with neurological deficits, cognitive impairment, kidney failure that requires dialysis, illicit drug use, use of ADHD stimulant medications.
结局指标
主要结局
Acceptability
时间窗: From enrollment to the end of the intervention (12 weeks)
Will be measured via the Acceptability of Intervention Measure (AIM) at the end of the interventions. AIM is measured through 4 questions on a scale of 1-5 resulting in scores from 4 to 20 points. The higher the score the higher the acceptability.
次要结局
- Pittsburgh Sleep Quality Index (PSQI)(Week 0 (baseline), Week 6 (midpoint) and Week 12 (end of treatment))
- Glycemic Control(Week 0 (baseline) and Week 12 (end of treatment))
- Sleep duration(Week 0 (baseline) and Week 12 (end of treatment))
- Patient-Reported Outcomes Measurement Information System (PROMIS) for Sleep Disturbance(Week 0 (baseline), Week 6 (midpoint) and Week 12 (end of treatment))
- Glycemic Variability(Week 0 (Baseline), 6 weeks (midpoint0 and 12 weeks (end of treatment))
- Pittsburgh Sleep Quality Index (PSQI)(Week 0 (baseline), Week 6 (midpoint) and Week 12 (end of treatment))
- Glycemic Control(Week 0 (baseline) and Week 12 (end of treatment))
- Sleep duration(Week 0 (baseline) and Week 12 (end of treatment))
- Patient-Reported Outcomes Measurement Information System (PROMIS) for Sleep Disturbance(Week 0 (baseline), Week 6 (midpoint) and Week 12 (end of treatment))