NCT07062887招募中不适用
A Digital Mindfulness and Biometric Feedback Application for Young Adults With Type 1 Diabetes
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Mindfulness app usage
研究概览
简要总结
The purpose of this research study is to test a mindfulness app called Calm Health among young adults with type 1 diabetes or other absolute insulin deficiency diabetes. Mindfulness is the practice of being aware of your thoughts and feelings in the moment without judgment or negative reaction. All participants will receive mindfulness guidance and personalized feedback about the relationship among your mindfulness, blood sugar, stress, and sleep.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Receiving diabetes care at Yale New Haven Children's Hospital or Yale New Haven Hospital.
- •Sign and date informed consent form we will provide
- •Willingness to complete procedures and availability for duration of the study
- •Aged 18-30 years
- •Diagnosed with type 1 diabetes (T1D) or other absolute insulin deficiency diabetes (latent autoimmune diabetes of adulthood, diabetes secondary to pancreatitis) for at least 1 year.
- •User of a continuous glucose monitor (CGM) in your routine clinical care for at least the past 2 weeks.
- •Able to use a smartphone.
- •Able to read and write English.
排除标准
- •Current meditation or mindfulness practice meeting or exceeding the study's recommended schedule
- •Current severe untreated psychiatric illness (e.g., bipolar disorder, schizophrenia, major depression, panic disorder, borderline personality disorder, organic mood or mental disorders) or active suicidal ideation
- •New or unstable psychopharmaceutical treatment in past 2 months.
- •Current or planned pregnancy during study period.
研究组 & 干预措施
Mindfulness App
Experimental
Use the mindfulness app for 6 weeks, wear an actigraphy watch, share the data from your own continuous glucose monitor (CGM), answer surveys and interviews about the app.
干预措施: Mindfulness app (Behavioral)
结局指标
主要结局
Mindfulness app usage
时间窗: 6 weeks
Minutes of usage per week
次要结局
- Exit survey(6 weeks)
- T1D-related emotional distress(6 weeks)
- Type 1 Diabetes Distress(6 weeks)
- Type 1 diabetes-specific health related quality of life(6 weeks)
- Anxiety(6 weeks)
- Depression(6 weeks)
- Mindful attention awareness(6 weeks)
- Self-Compassion(6 weeks)
- Practice of mindfulness(6 weeks)
研究者
研究点 (2)
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