South Asians With Type 2 Diabetes at Risk for Depression (NCT07219667) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
South Asians With Type 2 Diabetes at Risk for Depression
United States100 participantsStarted 2027-08-01
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in HbA1c Levels
Timeframe: Baseline, Month 3
2
Change in Diabetes Distress Scale (DDS) Score
Timeframe: Baseline, Month 3
3
Change in Patient Health Questionnaire-9 (PHQ-9) Score