South Asians With Type 2 Diabetes at Risk for Depression

May 14, 2026 updated by: NYU Langone Health

Community-Engaged Approach to Supporting 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • NYU Langone Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: CHW-led T2D Intervention
CHW-led T2D intervention that includes mental health and digital health components.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1c Levels
Time Frame: Baseline, Month 3
Change in glycated hemoglobin (HbA1c).
Baseline, Month 3
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.
Baseline, Month 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.
Baseline, Month 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Collaborators

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

Investigators

  • Principal Investigator: Naheed Ahmed, PhD, NYU Langone Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2027

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

October 21, 2025

First Submitted That Met QC Criteria

October 21, 2025

First Posted (Actual)

October 22, 2025

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 14, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-00438
  • 1K01DK140613-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All of the individual participant data collected during the trial, after deidentification, will be shared with researchers who provide a methodologically sound proposals, provided the requesting researcher executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Study data will be deposited into the repository at the time of an associated study publication or end of performance period, whichever comes first. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.

IPD Sharing Time Frame

Study data will be deposited into the repository at the time of an associated study publication or end of performance period, whichever comes first.

IPD Sharing Access Criteria

Data are available for 5 years at a third party website (Link to be included).

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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