Managing Depression in Diabetes Mellitus: A Multicentric Randomized Controlled Trial Comparing Effectiveness of Fluoxetine and Mindfulness in Primary Care: Protocol for DIAbetes Mellitus ANd Depression (DIAMAND) Study.

Background: Suboptimal management of depression in type 2 diabetes mellitus (T2DM) often translates into poor glycemic control, medical complications, and impaired quality of life. Feasibility and effectiveness of collaborative care models of depression in diabetes in low- and middle-income countries (LMICs) remain unexplored. DIAbetes Mellitus ANd Depression (DIAMAND) study, a multicentric single-blind randomized controlled trial (SBRCT) comparing effectiveness of fluoxetine and mindfulness in primary care settings, addresses this gap in scientific literature.

Methods: This trial conducted in diverse geographic settings of New Delhi, Bengaluru, and Bhubaneswar will comprise module-based training of primary care providers (PCPs) for screening, diagnosing, and managing depression in diabetes in phase I. Phase II will involve four-arm parallel group RCT on 350 participants with T2DM with comorbid depressive episode randomly allocated to receive fluoxetine, mindfulness therapy, fluoxetine plus mindfulness therapy, or treatment as usual at primary care settings. Interventions would include fluoxetine (up to 60 mg/day) and/or sessions of mindfulness for 16 weeks. Primary outcomes on standardized rating scales include depression scores (Hamilton Depression Rating Scale), treatment adherence (Adherence to Refill and Medication Scale), self-care (Diabetes Self-Management Questionnaire), diabetes-related distress (Diabetes Distress Scale), and glycemic control. Secondary outcomes include quality of life (World Health Organization Quality of Life Brief version [WHO-QOL BREF]) and mindfulness (Five Facets Mindfulness Questionnaire).

Discussion: This RCT will investigate the effectiveness of module-based training of PCPs and feasibility of collaborative care model for managing depression in T2DM in primary care settings in LMICs and effectiveness of fluoxetine and/or mindfulness in improving diverse outcomes of T2DM with major depression.