Key result
Fluoxetine, mindfulness therapy, and their combination did not demonstrate superiority over treatment as usual in reducing depressive symptoms among patients with T2DM and mild depression.
Why the study?
Evidence comparing pharmacological and psychological interventions for mild depression in type 2 diabetes mellitus within primary care settings remains limited.
Does fluoxetine, mindfulness therapy, or their combination improve depressive symptoms in individuals with Type 2 Diabetes Mellitus and mild depression compared to treatment as usual?
RCT (n=200)
single-blind
parallel-group
Yes
Does fluoxetine, mindfulness therapy, or their combination improve depressive symptoms in individuals with Type 2 Diabetes Mellitus and mild depression compared to treatment as usual?
Answers are grounded in this paper and cite their sources.
In patients with T2DM and mild depression, neither fluoxetine, mindfulness therapy, nor their combination demonstrated superiority over treatment as usual in reducing depressive symptoms over 4 months.
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: = 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.
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Raveendranathan et al. (2026) conducted an RCT in Type 2 Diabetes Mellitus and mild depression (n=200). Fluoxetine, Mindfulness therapy, or combination Fluoxetine + Mindfulness vs. Treatment as usual (TAU) was evaluated on Reduction in depressive symptoms (Effect size 0.48 for Mindfulness, 0.45 for Fluoxetine, 0.31 for combination). Fluoxetine, mindfulness therapy, and their combination did not demonstrate superiority over treatment as usual in reducing depressive symptoms among patients with T2DM and mild depression.
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