South Asians With Type 2 Diabetes at Risk for Depression
NCT ID: NCT07219667
Last Updated: 2025-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
100 participants
INTERVENTIONAL
2025-11-30
2028-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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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.
CHW-led T2D Intervention
CHW-led T2D intervention that includes mental health and digital health components.
Interventions
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CHW-led T2D Intervention
CHW-led T2D intervention that includes mental health and digital health components.
Eligibility Criteria
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Inclusion Criteria
* 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
• 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.
18 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Naheed Ahmed, PhD
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Locations
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NYU Langone Health
New York, New York, United States
Countries
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Central Contacts
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Other Identifiers
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25-00438
Identifier Type: -
Identifier Source: org_study_id
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