Intervention Mapping to Adapt a Mindfulness-based Intervention for Adults With Diabetes and Emotional Distress
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Diabetes Distress
研究概览
简要总结
We will conduct a single-arm pilot study of an integrated mindfulness-based stress reduction (MBSR)/diabetes self-management education (DSME) intervention in a small group of participants, low-income adults with type 2 diabetes and diabetes distress. We will evaluate the preliminary efficacy, acceptability, and feasibility of the intervention.
详细描述
The intervention will comprise components of MBSR and DSME and will be delivered in a group setting with 8 weekly sessions. We anticipate enrollment of 30 participants, who will be adults with poorly controlled type 2 diabetes and elevated diabetes distress recruited from Cooper Green Mercy Health Systems, a safety-net health system serving residents of Jefferson County, Alabama. A trained masters-level interventionist will deliver the integrated intervention. The aim of the intervention is to reduce diabetes distress and improve glycemic control.
Participants will be assessed at baseline and 2 months. We will assess the preliminary efficacy of the intervention through pre/post evaluation of diabetes distress, diabetes self-management behaviors, and glycemic control as measured by hemoglobin A1c. Additionally, we will assess acceptability of the intervention through follow-up qualitative, focus groups with intervention participants; the feasibility of intervention delivery will be assessed using process measures.
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
- 19 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes
- •Receipt of care at Cooper Green Mercy Healthcare System (CGMHS), one or more visits to primary care or diabetes clinic within the prior year
- •An elevated point-of-care hemoglobin A1c (A1C) ≥7.5
- •Presence of moderate diabetes distress (indicated by a score of ≥2 on the Diabetes Distress Scale)
排除标准
- •Non-English speaking
- •Currently pregnant
- •Personal history or prior diagnosis of bipolar disorder, schizophrenia, or psychosis
结局指标
主要结局
Diabetes Distress
时间窗: 2-months
Measured by the diabetes distress scale (DDS), a 17-item self-report measure, assessing domains of emotional burden, physician-related distress, regimen-related distress, and interpersonal distress. The questionnaire will be administered to participants in English by a trained interviewer. The mean item score yields a possible score from 1 to 6; a score of \<2 indicates little/no distress, 2 to 2.9 moderate distress, and ≥3 high distress.
Hemoglobin A1c (A1C)
时间窗: 2-months
Participants will have a point-of-care A1C measured; A1C will be obtained by trained study personnel using finger-stick testing with the A1C Now+20 Test Kit (PTS diagnostics). 1C reports a % glycated hemoglobin level; a higher score indicates higher average blood glucose levels over the preceding 3 months. An A1C greater than or equal to 7.5% indicates poorly controlled type 2 diabetes.
次要结局
- Feasibility: Percentage of Eligible Participants Who Enroll(Baseline)
- Feasibility: Percentage of Sessions Attended(2-months)
- Medication Adherence(2-months)
- Acceptability of the Intervention to Participants: Semi-structured Interviews(2-months)
- Feasibility: Distribution of Participants by Demographics(Baseline)
- Diabetes Self-management Behaviors(2-months)
- Feasibility: Percentage of Screened Participants Who Are Eligible(Baseline)
研究者
Caroline Presley
Principal Investigator
University of Alabama at Birmingham