Managing Diabetes Mindfully Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- HbA1C Blood Test
研究概览
简要总结
To evaluate the feasibility of conducting a trial of a mindfulness-based stress reduction (MBSR) program for patients with diabetes (DM) on measures of HbA1c, blood pressure, perceived stress, depression, patient self-efficacy and quality of life; and to estimate the effect of a MBSR program for patients with DM. It is expected that MBSR program participants will evidence a trend toward better clinical outcome measures of HbA1c, blood pressure, and standardized measures of diabetes self-management, perceived stress, depression, self-efficacy, and quality-of-life.
详细描述
Primary Objective: Evaluate the feasibility of conducting a trial of a MBSR program for patients with diabetes on measures of HbA1c, blood pressure, perceived stress, depression, patient self-efficacy and quality of life. Feasibility will be assessed via: a) the interest of patients in taking part in an MBSR program; c) the effectiveness of strategies for recruiting patients with diabetes into the study; d) rates of participant compliance with the MBSR; and, e) patient compliance with the program evaluation plan.
Estimate the effect of a MBSR program for patients with diabetes. It is expected that MBSR program participants will evidence a trend toward better clinical outcome measures of HbA1c, blood pressure, and standardized measures of diabetes self-management, perceived stress, depression, self-efficacy, and quality-of-life.
Secondary Objective: To explore the experience of people with diabetes who participate in an MBSR course through the use of semi-structured interviews.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-80 years of age
- •English speaking
- •have type 2 diabetes, with 2 HbA1C values >8 in prior 16 months
- •HbA1C value of >8 within 3 months of intervention start
- •able to read course materials
- •mentally intact with no history of mental illness or major depression
- •reachable by phone (for phone support component)
- •able to attend weekly classes
- •willing to provide written informed consent
排除标准
- •completed formal training in other mind body practices such as meditation, yoga, or tai chi within the prior year or currently have a regular ongoing practice in this area.
研究组 & 干预措施
Mindfulness-Based Stress Reduction
Subjects attend a community based Mindfulness-Based Stress Reduction course.
干预措施: Mindfulness-Based Stress Reduction (MBSR) (Behavioral)
结局指标
主要结局
HbA1C Blood Test
时间窗: Baseline and 12-15 weeks from start of intervention period
This HbA1C blood test will be compared to a qualifying HbA1C blood test.
次要结局
- Blood Pressure(8 weeks during intervention)