Type 2 Diabetes
Conditions
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.
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.
Interventions
BEHAVIORALCHW-led T2D Intervention
CHW-led T2D intervention that includes mental health and digital health components.
Sponsors
NYU Langone Health
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c Levels | Baseline, Month 3 | Change in glycated hemoglobin (HbA1c). |
| Change in Diabetes Distress Scale (DDS) Score | 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. |
| Change in Patient Health Questionnaire-9 (PHQ-9) Score | 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. |
Countries
United States
Contacts
CONTACTNaheed Ahmed, PhD
PRINCIPAL_INVESTIGATORNaheed Ahmed, PhD
NYU Langone Health
Outcome results
None listed