South Asians With Type 2 Diabetes at Risk for Depression
Community-Engaged Approach to Supporting South Asians With Type 2 Diabetes at Risk for Depression
2 other identifiers
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable type-2-diabetes
Started Aug 2027
Shorter than P25 for not_applicable type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 21, 2025
CompletedFirst Posted
Study publicly available on registry
October 22, 2025
CompletedStudy Start
First participant enrolled
August 1, 2027
ExpectedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2028
Study Completion
Last participant's last visit for all outcomes
June 1, 2028
May 19, 2026
May 1, 2026
10 months
October 21, 2025
May 14, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
Change in HbA1c Levels
Change in glycated hemoglobin (HbA1c).
Baseline, Month 3
Change in Diabetes Distress Scale (DDS) Score
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
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
Study Arms (1)
Adult South Asian patients in the New York City (NYC) region
EXPERIMENTALIn Aim 3, CHWs will provide culturally and linguistically tailored health education to South Asian participants on the management of T2D and depressive symptoms.
Interventions
CHW-led T2D intervention that includes mental health and digital health components.
Eligibility Criteria
You may qualify if:
- Aim 1 (Qualitative Component):
- South Asian ethnicity based on self-report information
- 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
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NYU Langone Health
New York, New York, 10016, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Naheed Ahmed, PhD
NYU Langone Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 21, 2025
First Posted
October 22, 2025
Study Start (Estimated)
August 1, 2027
Primary Completion (Estimated)
June 1, 2028
Study Completion (Estimated)
June 1, 2028
Last Updated
May 19, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- 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.
- Access Criteria
- Data are available for 5 years at a third party website (Link to be included).
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.