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Community health workers may help south asians with diabetes fight depression

NCT ID NCT07219667

Disease control Sponsor: NYU Langone Health Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study will adapt a community health worker-led program to include mental health and digital tools for South Asians with type 2 diabetes who are at risk for depression. Researchers will test whether the program is feasible and acceptable to participants. The study involves 100 adults in New York City and measures changes in blood sugar levels, diabetes distress, and depressive symptoms.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
community health worker-led behavioral intervention with mental health and digital components
What this could lead to
If successful, this could provide a practical, culturally tailored support program to help South Asians with type 2 diabetes manage their condition and reduce depression risk.
What could go wrong
This is a small, early feasibility study with only 100 participants, so results may not apply broadly. The intervention is behavioral and may not produce significant medical changes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2027

An estimate. Start dates often move.

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Type 2 diabetes

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • NYU Langone Health

    New York, New York, 10016, United States

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