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

Caroline Krauser, Eduardo Jardim Simões, Chester Schmaltz, Luiz Roberto Ramos, Erika Blamires Santos Porto, Lucas Petri Damiani, Marcelo Demarzo

SSM - Mental Health June 16, 2026 DOI: 10.1016/j.ssmmh.2026.100608 (opens in new tab) via DOAJ

Summary

AI-generated from the abstract

Depression and anxiety symptoms are a major cause of disability worldwide. Mindfulness-based interventions are proven treatments for mild-to-moderate cases, but evidence on their real-world feasibility and effectiveness is limited, especially in low- and middle-income countries. This paper describes a randomized stepped-wedge trial with qualitative analysis that will evaluate the implementation and effectiveness of Mindfulness-Based Cognitive Therapy for depression symptoms in primary care patients in Brazil. The study aims to generate context-sensitive evidence to improve public health strategies and inform sustainable depression treatments in low- and middle-income countries.

Study at a glance

Characteristics Randomized stepped-wedge design with qualitative analysis Peer reviewed
Population Primary health care patients in a low- and middle-income country (Brazil)
Intervention Mindfulness-Based Cognitive Therapy
Topics Depression Meditation
Keywords Primary health care Implementation science
Key finding Describes a planned trial to evaluate the implementation and effectiveness of Mindfulness-Based Cognitive Therapy for depression symptoms in primary care patients in a low- and middle-income country.

Abstract

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.

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