Mindfulness: a Novel Approach for the Management of Diabetes-related Distress
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Diabetes Distress
研究概览
简要总结
The purpose of this study is to evaluate the impact of stress reduction on physiological and psychological variables in adults with Type 2 diabetes (T2DM) who have moderate to severe levels of diabetes-related emotional distress. Subjects will be randomized to one of two interventions. We will evaluate the impact of the interventions on glucose metabolism, blood pressure, diabetes-related distress and quality of life. Additionally, we will investigate the role of neuroendocrine dysfunction, systemic inflammation and diabetes self-care practices as mediators in the relationship between increased stress, adverse glucose metabolism and elevated blood pressure in those subjects with T2DM.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 30 years
- •Male or female
- •Duration of diabetes 1-15 years from time of initial diagnosis
- •Diagnosis of T2DM made/confirmed by physician
- •Completed diabetes education in the past
- •Most recent HgA1c >7%; measurement must be within the past 6 months either in physicians office or at the Thriving with Diabetes Boot Camp Class
- •Treatment for diabetes must include any or all of the following modalities:
- •diet, exercise, oral medications, insulin or other injectable diabetic medication
- •Score > 30 on the Problem Area in Diabetes (PAID) Questionnaire
- •Able to use a glucometer for self-monitoring of blood glucose values
- •Most recent clinic blood pressure less than 180/95
排除标准
- •History of ketoacidosis
- •Age at diagnosis of T2DM < 30 years
- •Score >15 on the PHQ-9
- •Previous training in relaxation or meditation techniques
- •Current practice of yoga, tai chi or any other mind-body movement for > 60 minutes per week
- •Current use of a psychoactive drug for less than 3 months or not yet on a stable dose
- •Inability to participate fully or behave appropriately in the group treatment setting, as observed by baseline acknowledgement of substance abuse, psychotic episode(s), psychiatric hospitalization or history of self- harm within the past 2 years, or current suicidal or homicidal ideation
- •Inability to complete standardized instruments because of a cognitive deficit or language barrier
- •Current use or use within the past 3 months of oral glucocorticoids, excluding intraocular, topical or inhaled preparations
- •History of inflammatory diseases including rheumatoid arthritis and inflammatory bowel disease
- •Use of immune modulating agents
- •Night shift work or other type of schedule in which sleep wake cycle is disrupted
- •Women who consume > 7 alcoholic drinks per week and men who consume > 14 drinks per week
- •Current use or history of daily tobacco use within the past 1 year
- •End stage renal failure on dialysis
- •Pregnancy or post partum <3 months
- •Subjects with known secondary causes of hypertension including renal artery stenosis, pheochromocytoma, coarctation of aorta, hyperaldosteronemia
- •Non-dominant arm circumference > 46cm
- •Unwilling to accept randomization
结局指标
主要结局
Diabetes Distress
时间窗: 0,8,24 weeks
The Problem Areas in Diabetes will be used to assess the change in diabetes emotional distress at baseline, immediately following the 8 week intervention and at 24 weeks from baseline
HgA1c
时间窗: 0,8,24 weeks
We will assess change in glycemic control using the A1c. It will be measured at baseline, immediately following the 8 week intervention and at 24 weeks from baseline.
次要结局
- SF36 Mental Health Score(0,8,24 weeks)
- Trait Anxiety(0,8,24 weeks)
- SF36 Physical Health Score(0, 8,24 weeks)
- Depression(0,8,24 weeks)
- Coping Style(0,8,24 weeks)
- IL-6(0,8, 24 weeks)
- Average 24 hour glucose by continuous glucose monitor (cgm)(0,8,24 weeks)
- Mean Day Diastolic Ambulatory Blood Pressure(0,8,24 weeks)
- Cortisol Awakening Response(0,8,24 weeks)
- Mean Night Systolic Ambulatory Blood Pressure(0,8,24 weeks)
- General Stress(0,8,24 weeks)
- Block Food Frequency Questionnaire(Week 0)
- Mean 24 hour ambulatory systolic blood pressure(0,8,24 weeks)
- Mean 24 hour diastolic ambulatory blood pressure(0,8,24 weeks)
- HOMA-IR(0,8,24 weeks)
- State Anxiety(0,8,24 weeks)
- Cortisol 24 hour area under the curve(0,8,24 weeks)
- Summary of Diabetes Self-Care Activities(0,8,24 weeks)
- Average day time glucose(0,8,24 weeks)
- Social Support(0,8,24 weeks)
- Average night time glucose(0,8,24 weeks)
- Mean Day Systolic Ambulatory Blood Pressure(0,8,24 weeks)
- Mean Night Diastolic Ambulatory Blood Pressure(0,8,24 weeks)