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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)

Study at a glance

AI-extracted from the abstract
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 findings 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.

Comparable studies

Other randomized controlled trials on depression, most cited first.

Study Year Design Participants
A Randomized Trial of an N-methyl-D-aspartate Antagonist in Treatment-Resistant Major Depression Subjects with DSM-IV major depression (treatment resistant) 2006 Randomized, placebo-controlled, double-blind crossover study n = 18
Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. Recovered recurrently depressed patients 2000 Randomized controlled trial n = 145
Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer: A randomized double-blind trial Cancer patients with life-threatening diagnoses and symptoms of depression and/or anxiety 2016 Randomized controlled trial n = 51
Rapid and sustained symptom reduction following psilocybin treatment for anxiety and depression in patients with life-threatening cancer: a randomized controlled trial Patients with cancer-related anxiety and depression 2016 Double-blind, placebo-controlled, crossover trial n = 29
Mindfulness-Based Cognitive Therapy for Depression: Replication and Exploration of Differential Relapse Prevention Effects. Recovered recurrently depressed patients 2004 Randomized controlled trial n = 73

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