South Asians With Type 2 Diabetes at Risk for Depression
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CHW-led T2D Intervention.
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Community-Engaged Approach to Supporting South Asians With Type 2 Diabetes at Risk for Depression
Overview
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.
Detailed description
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.
Interventions
- Behavioral CHW-led T2D Intervention
CHW-led T2D intervention that includes mental health and digital health components.
Primary outcome measures
- Change in HbA1c Levels [Time frame: Baseline, Month 3]
- Change in Diabetes Distress Scale (DDS) Score [Time frame: Baseline, Month 3]
- Change in Patient Health Questionnaire-9 (PHQ-9) Score [Time frame: Baseline, Month 3]
Eligibility criteria
Inclusion criteria
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
Exclusion criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 1 center
- NYU Langone Health — New York
Identifiers
NCT: NCT07219667 · 25-00438 · 1K01DK140613-01A1