Mental Health Outcomes in Patients with Type 2 Diabetes Enrolled for the Diabetes Remission Study in India (DiRemI)

The proposed study is a single-arm pre-post design intervention trial that aims to assess the prevalence of depression, anxiety, and diabetes distress in patients with T2DM enrolled in a diabetes remission program and to determine the effect of the program in improving their mental health outcomes (anxiety, depression, and diabetes distress). Specific Objectives are: 1) To assess the prevalence of anxiety, depression, and diabetes distress in patients with T2D enrolled at the Freedom from Diabetes clinic for diabetes management through a lifestyle modification program. 2) To deliver an online intervention to improve mental health in those who have depression and anxiety. 3) To evaluate the effect of this intervention in reducing the prevalence of anxiety, depression, and diabetes distress scores among patients with T2D. 4) To study the effect of mental health on the outcome of the intervention in terms of remission and overall improvement in diabetes management. The intervention comprises lifestyle modification with a plant-based diet, exercise, psychological support, and medical management. Trained psychologists will provide a targeted intervention focusing on those with anxiety and depression through group therapy as well as individual counseling. The intervention will be 12 months (6-month intervention + 6-month follow-up). Data (socio-demographic data, administration of PHQ-9 scale, GAD-7, and T2-DDAS) will be collected at two-point times, at the baseline and end-line at the end of 6 months after the delivery of the intervention. Compliance data will be collected from patients based on their levels of both anxiety and depression. Adherence data will be collected from patients.