South Asians With Type 2 Diabetes at Risk for Depression

NYU Langone Health

Status: Not yet enrolling

Conditions: Type 2 Diabetes

Treatments: Behavioral: CHW-led T2D Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07219667

1K01DK140613-01A1 (U.S. NIH Grant/Contract)

25-00438

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Adult South Asian patients in the New York City (NYC) region

Experimental group

Description:

In Aim 3, CHWs will provide culturally and linguistically tailored health education to South Asian participants on the management of T2D and depressive symptoms.

Treatment:

Behavioral: CHW-led T2D Intervention