Stress Management Among Latinos With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 1
- 主要终点
- Hemoglobin A1c
研究概览
简要总结
The primary aims of this study are to:
- Tailor a diabetes stress management intervention for delivery by community health workers (CHWs) serving an urban Latino population.
- Investigate the efficacy of the stress management intervention on glycemic control.
Secondary aims of this study are to: 3. Investigate the efficacy of the stress management intervention on stress hormones, psychosocial functioning, and stress-glucose reactivity.
Study hypothesis:
A CHW-led group-based diabetes education model enhanced with stress management education will improve glycemic control more than CHW-led group-based diabetes education alone.
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
- 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
- •Latinos age 18 or older that are ambulatory
- •Spanish speaking
- •Diagnosed with type 2 diabetes for at least 1 year
- •Hemoglobin A1c levels greater than 7.0
排除标准
- •Medical instability or medical treatment requiring inpatient care
- •Diagnoses of bipolar disorder or thought disorder (or taking medications prescribed for either); current substance abuse or dependence disorder
- •Current suicidality or history of suicide attempt
- •History of psychiatric hospitalization
- •Taking antidepressant medications prescribed for the treatment of depression accompanied by either a) changes to the antidepressant regimen within previous 6 weeks, or b) anticipated changes to the regimen during period of study. Such patients will be deferred and re-evaluated for eligibility after 6 months
研究组 & 干预措施
Diabetes education
Group-based diabetes education delivered to participants through community health workers
Diabetes education plus stress management
Group-based diabetes education plus stress management delivered to participants through community health workers
干预措施: stress management (Behavioral)
结局指标
主要结局
Hemoglobin A1c
时间窗: 6 months
Blood will be drawn from participants and hemoglobin A1c levels will be measured
Hemoglobin A1c
时间窗: Baseline
Blood will be drawn from participants and hemoglobin A1c levels will be measured
Hemoglobin A1c
时间窗: 9 weeks
Blood will be drawn from participants and hemoglobin A1c levels will be measured
次要结局
- Diabetes specific distress(6 months)
- Diabetes specific distress(Baseline)
- Diabetes specific distress(9 weeks)