NYU Langone Health
New York, 10016, United States
NCT Number: NCT07219667
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 opening soon.
Get Notified18 year–75 year
All sexes
Interventional
Not applicable
New York, 10016, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Aim 1 (Qualitative Component):
Aim 3: Pilot Intervention:
Exclusion criteria
Aim 1 (Qualitative Component):
Aim 3: Pilot Intervention:
CHW-led T2D intervention that includes mental health and digital health components.
Time frame: Baseline, Month 3
Change in glycated hemoglobin (HbA1c).
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.
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.
Contact information is provided by the study sponsor or research team.
NYU Langone Health
Other
Community-Engaged Approach to Supporting South Asians With Type 2 Diabetes at Risk for Depression
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