South Asians With Type 2 Diabetes at Risk for Depression

Not Applicable

Not yet recruiting

• Conditions: Type 2 Diabetes

• Registration Number: NCT07219667
• Lead Sponsor: NYU Langone Health

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 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.

Study Timeline

• Status Verified: 2025-10
• Study First Submitted: 2025-10-21
• Study First Submitted QC: 2025-10-21
• Last Update Submitted: 2025-10-21
• Study First Posted: 2025-10-22
• Last Update Posted: 2025-10-22
• Study Start: 2025-11-01
• Primary Completion: 2028-12
• Study Completion: 2028-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in HbA1c Levels	Baseline, Month 3	Change in glycated hemoglobin (HbA1c).
Change in Diabetes Distress Scale (DDS) Score	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	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.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States