Community-Engaged Approach to Supporting South Asians With Type 2 Diabetes at Risk for Depression
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in HbA1c Levels
研究概览
简要总结
This study will adapt a community health worker (CHW)-led Type 2 diabetes (T2D) intervention to include mental health and digital components using a trauma informed care approach, and test the feasibility and acceptability of this intervention to support South Asians with T2D at risk for depression.
详细描述
Specific Aim 1: Examine factors associated with distress, poor mental health, and comorbid T2D and depression among South Asians to inform pilot study structure and content.
Specific Aim 2: Adapt CHW-led T2D intervention to include mental health and digital components using a trauma-informed care approach and the ecological validity model.
Specific Aim 3: Evaluate the feasibility and acceptability of a pilot CHW-led intervention to support participants with T2D who are at risk for depression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aim 1 (Qualitative Component):
- •South Asian ethnicity based on self-report information
- •18 years of age or older
- •Residing in NYC
- •Willingness and capacity to provide consent
- •Aim 3: Pilot Intervention:
- •South Asian ethnicity based on patient demographic information
- •18 to 75 years of age
- •Appointment for routine non-emergent primary care in the past 12 months
- •Diagnosis of Type 2 diabetes
- •Patient Health Questionnaire-9 (PHQ-9) score of ≥5 (mild to severe depression)
- •Residing in NYC
- •Willingness and capacity to provide consent
排除标准
- •Aim 1 (Qualitative Component):
- •Diagnosed cognitive deficits or limited decision-making capacity
- •Aim 3: Pilot Intervention:
- •Pregnant at the time of screening
- •Type 1 diabetes or diabetes secondary to other conditions (e.g., steroid-induced, pancreatic insufficiency)
- •Malignancy or life-threatening illness with a life expectancy of <5 years
- •Inability to perform unsupervised physical activity
- •Diagnosed cognitive deficits or limited decision-making capacity
- •Currently taking anti-depressant medication or receiving counseling services.
研究组 & 干预措施
Adult South Asian patients in the New York City (NYC) region
In Aim 3, CHWs will provide culturally and linguistically tailored health education to South Asian participants on the management of T2D and depressive symptoms.
干预措施: CHW-led T2D Intervention (Behavioral)
结局指标
主要结局
Change in HbA1c Levels
时间窗: Baseline, Month 3
Change in glycated hemoglobin (HbA1c).
Change in Diabetes Distress Scale (DDS) Score
时间窗: Baseline, Month 3
The Diabetes Distress Scale (DDS) is a 17-item psychological questionnaire designed to assess the emotional and psychological distress experienced by individuals with diabetes. Each item is rated on a scale of 0 to 6. The total score is calculated by summing up the scores of all 17 items and ranges from 0-102; higher scores indicate greater distress.
Change in Patient Health Questionnaire-9 (PHQ-9) Score
时间窗: Baseline, Month 3
The PHQ-9 is a 9-item questionnaire to assess depressive symptoms. Each item is scored from 0 (not at all) to 3 (nearly every day). The total score ranges from 0 to 27. Higher scores indicate greater severity of depression.
次要结局
未报告次要终点