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NCT Number: NCT07219667

South Asians With Type 2 Diabetes at Risk for Depression

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CHW-led T2D Intervention

Behavioral

CHW-led T2D intervention that includes mental health and digital health components.

Primary outcomes

  1. Change in HbA1c Levels

    Time frame: Baseline, Month 3

    Change in glycated hemoglobin (HbA1c).

  2. Change in Diabetes Distress Scale (DDS) Score

    Time frame: 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.

  3. Change in Patient Health Questionnaire-9 (PHQ-9) Score

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Naheed Ahmed, PhD

CONTACT

[email protected]

646-501-3751

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Community-Engaged Approach to Supporting South Asians With Type 2 Diabetes at Risk for Depression

Important dates

Study start
2027
Primary completion
2028
Study completion
2028
First posted
Oct 22, 2025
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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