Effectiveness of fluoxetine and mindfulness therapy in improving depression in people with Type 2 Diabetes Mellitus in Primary Care Settings (DIAMAND)-A single-blind, parallel-group, randomized controlled trial from Bengaluru.

Abstract

Background: Depression and type 2 diabetes mellitus (T2DM) share a bidirectional relationship. This comorbidity is associated with poor glycemic control, reduced medication adherence, and impaired quality of life. Evidence comparing pharmacological and psychological interventions for mild depression in T2DM within primary care settings remains limited.

Objectives: To compare the effectiveness of Fluoxetine, Mindfulness therapy, combination Fluoxetine + Mindfulness, and treatment as usual (TAU) in reducing depressive symptoms among individuals with T2DM and mild depression.

Methods: This single-blind randomized controlled trial (RCT) was conducted among individuals (n = 200) with T2DM and mild depression recruited from the Bengaluru site of the multi-center diabetes mellitus and depression (DIAMAND) study. Participants were randomized to Fluoxetine, Mindfulness therapy, combination treatment, or TAU. Depression severity, medication adherence, diabetes self-management, quality of life, HbA1c, and random blood sugar (RBS) were tested over 4 months. Repeated Measures ANOVA (RMANOVA) and effect size estimates were used for analysis.

Results: Depressive symptoms improved significantly over time across all study arms; and no significant between-group differences were observed in depression outcomes. No significant differences were found between groups for glycemic control, medication adherence, diabetes self-management, or quality of life. Effect sizes for reduction in depressive symptoms compared with TAU were 0.48 for Mindfulness, 0.45 for fluoxetine, and 0.31 for combination treatment.

Conclusions: In this RCT, depressive symptoms and medication adherence improved across all study arms; however, none demonstrated superiority over TAU. Mindfulness-based interventions may represent feasible, scalable, low-intensity approaches for mild depression in primary care settings. Future adequately powered studies with longer follow-up are needed to evaluate long-term effectiveness of psychological and pharmacological interventions.