Implementation and effectiveness of Mindfulness-Based Cognitive Therapy for mild depression in primary care: Protocol for a stepped-wedge cluster RCT

Depressive and anxiety symptoms are one of the leading causes of years lived with disability worldwide. Mindfulness-based interventions (MBIs) have been shown to be one of the proven treatments for improving mild and moderate cases of depression and anxiety. However, there is still a gap regarding the feasibility and effectiveness of MBIs in the real world, especially in low- and middle-income countries. This study uses a randomized stepped-wedge design with qualitative analysis to evaluate the implementation and effectiveness of Mindfulness-Based Cognitive Therapy for symptoms of depression in primary health care patients in a LMIC. Through implementation research, we aim to bridge the gap between research and practice and advance mixed methods studies by generating actionable and context-sensitive evidence. This approach aims to improve public health strategies and inform more effective and sustainable treatments for depression in low- and middle-income countries. This trial is registered in the Brazilian Registry of Clinical Trials as “Implementation and Effectiveness of an Integrative Practice Protocol for Reducing Depression Symptoms in Primary Care” (RBR-4qv57kj), accessible at https://ensaiosclinicos.gov.br/rg/RBR-4qv57kj. • First real-world study assessing mindfulness-based interventions (MBIs) for depressive symptoms in primary care. • Novel insights from a middle-income country , highlighting the potential of MBIs as scalable public health strategies for depression. • Bridging a key research gap : Evaluates the impact of reinforcing mindfulness strategies post-intervention to enhance long-term benefits. • Integrating MBIs into stepped care : Qualitative analysis of healthcare professionals’ training provides critical insights for implementation in primary care settings.