Status:
NOT_YET_RECRUITING
South Asians With Type 2 Diabetes at Risk for Depression
Lead Sponsor:
NYU Langone Health
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 feasibi...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT07219667
Start Date
November 1 2025
End Date
December 1 2028
Last Update
October 22 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
NYU Langone Health
New York, New York, United States, 10016