Examining the Effect of a Novel Stress Reduction Intervention no the Control of Prediabetes: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- HbA1c
研究概览
简要总结
This feasibility study seeks to develop and pilot test Emotional Awareness and Expression Therapy as a possible treatment for people with prediabetes.
详细描述
Prediabetes is a clinical condition in which hemoglobin A1C is between 5.6 and 6.4, and is usually associated with being overweight, poor diet, limited exercise, and psychological stress. This condition develops in to Type II diabetes in many people, and interventions to prevent such progression are needed. Because stress can directly negative impact blood glucose metabolism and can indirectly affect it through unhealthy behaviors (e.g., diet, exercise), it may be possible to reduce stress and improve clinical outcomes. Although most stress management approaches help people to calm their physiology and reduce their negative emotions, another approach to stress treatment is to help people disclose emotionally difficult experiences, become aware of and express their emotions, and change interpersonal relationships by becoming more assertive as well as more open/connected.
Emotional Awareness and Expression Therapy (EAET) is an approach to stress reduction that uses these principles and it has been shown to be effective for somatic symptom disorders like chronic pain. In this study, we will adapt EAET to the prediabetes context and test its feasibility, acceptability and initial efficacy.
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 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Affiliated with Wayne State University (faculty, staff, student, or family member/friend thereof)
- •HbA1C value of 5.7% to 6.4%
- •overweight or obese (≥25 kg/m2) Also, if over ≥ 18 and < 45 years of age must have at least one of the following: a) physical inactivity, b) close family history of diabetes, c) history of hyperlipidemia, d) history of hypertension, e) history of gestational diabetes, and/or f) from high risk race groups (e.g., African American, Latino, Native American, and pacific Islander).
排除标准
- •Confirmed history of Type 2 Diabetes
- •have prediabetes being treated pharmacologically
- •taking medications that affect blood glucose (e.g., corticosteroids)
- •chronic depression or major psychotic disorder
- •any comorbidities that limit survival or ability to tolerate the intervention (Cushing's, cancer treatment, asthma with inhaled corticosteroids, unstable CAD or MI in last 6 months, CHF, COPD requiring oxygen, chronic kidney disease)
研究组 & 干预措施
Modified EAET for Prediabetes
Small groups of people with prediabetes will meet for 4, weekly, 2-hour sessions by telehealth, and will engage in modified EAET for prediabetes
干预措施: Modified EAET for prediabetes (Behavioral)
结局指标
主要结局
HbA1c
时间窗: Change from baseline to 3-month follow-up and 6-month follow-up
Hemoglobin A1c from venous blood
C-peptide
时间窗: Change from baseline to 3-month follow-up and 6-month follow-up
venous blood surrogate marker of insulin levels
次要结局
- Perceived Stress Scale(Change from baseline to 3-month follow-up and 6-month follow-up)
- Body mass index(Change from baseline to 3-month follow-up and 6-month follow-up)
- Health behavior(Change from baseline to 3-month follow-up and 6-month follow-up)
研究者
Mark A. Lumley
Professor
Wayne State University
