Efficacy and moderators of mindfulness-based cognitive therapy (MBCT) in 'Difficult to Treat' depression: protocol for a systematic review and individual participant data meta-analysis of randomised controlled trials.


Por: Barnhofer T, Niemi M, Michalak J, Velana M, Williams JMG, Chiesa A, Eisendrath S, Delucchi K, Segal Z, Cladder-Micus M, Speckens A, Foroughi AA, García-Toro M, Montero J, Dunn B, Strauss C, Ruths FA, Ryan M and Harrer M

Publicada: 8 dic 2025 Ahead of Print: 8 dic 2025
Resumen:
INTRODUCTION: About 30% of depressed patients suffer from a protracted course in which the disorder continues to cause significant burden despite treatment efforts. While originally developed for relapse prevention, mindfulness-based cognitive therapy (MBCT) has increasingly been investigated in depressed patients with such 'difficult-to-treat' courses. This is a protocol for an individual participant data (IPD) meta-analysis aiming to determine efficacy and potential moderators of MBCT treatment effects in this group based on evidence from randomised controlled trials. METHODS AND ANALYSIS: Systematic searches in PubMed, Web of Science, Scopus, PsycINFO, EMBASE and the Cochrane Controlled Trials Register for randomised controlled trials were completed on 17 June 2024. Authors of identified studies have contributed IPD, and data extractions have been completed. An update search will be conducted immediately before the start of data analyses. We will investigate the following outcomes: (a) self-reported and observer-reported severity of depression symptomatology, (b) remission and (c) clinically meaningful improvement and deterioration. One-stage and two-stage IPD-MA will be conducted with one-stage models using the observed IPD from all studies simultaneously as the primary approach. One-stage IPD models will include stratified study intercepts and error terms as well as random effects to capture between-study heterogeneity. Moderator analyses will test treatment-covariate interactions for both individual patient-level and study-level characteristics. ETHICS AND DISSEMINATION: The results will inform understanding of the use of MBCT in patients with current 'difficult-to-treat' depression and will contribute to arguments in favour of or against implementing MBCT as a treatment for this group. They will be published in a peer-reviewed journal and made available to stakeholders in accessible formats. No local ethical review was necessary following consultation with the Ethics and Governance Board of the University of Surrey. Guidance on patient data storage and management will be adhered to throughout. PROSPERO REGISTRATION NUMBER: CRD42022332039.

Filiaciones:
Barnhofer T:
 University of Surrey, Guildford, UK

Niemi M:
 Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden

Michalak J:
 Department of Psychology and Psychotherapy, Witten/Herdecke University, Witten, Germany

Velana M:
 Department of Psychology and Psychotherapy, Witten/Herdecke University, Witten, Germany

Williams JMG:
 Department of Psychiatry, University of Oxford, Oxford, UK

Chiesa A:
 Università di Bologna, Bologna, Italy

Eisendrath S:
 University of California at San Francisco, San Francisco, California, USA

Delucchi K:
 University of California at San Francisco, San Francisco, California, USA

Segal Z:
 Graduate Department of Psychological Clinical Science, University of Toronto-Scarborough, Toronto, Ontario, Canada

Cladder-Micus M:
 Radboud University Nijmegen, Nijmegen, The Netherlands

Speckens A:
 Psychiatry, Radboudumc Instituut voor Wetenschappelijk Onderwijs en Opleidingen, Nijmegen, The Netherlands

Foroughi AA:
 Department of Clinical Psychology, Kermanshah University of Medical Sciences (KUMS), Kermanshah, Iran (the Islamic Republic of)

García-Toro M:
 Research Network on Chronicity, Primary Care and Health Promotion, Madrid, Spain

 University of the Balearic Islands, Palma, Spain

 Health Research Institute of the Balearic Islands, Balearic Islands, Spain

 Department of Medicine, University of the Balearic Islands, Palma, Spain

Montero J:
 Department of Psychiatry, University of Oxford, Oxford, UK

 Research & Innovation Unit, Parc Sanitari Sant Joan de Déu, Sant Boi de Llobregat, Spain

 Consortium for Biomedical Research in Epidemiology and Public Health, Madrid, Spain

Dunn B:
 University of Exeter, Exeter, UK

Strauss C:
 Sussex Partnership NHS Foundation Trust, Worthing, UK

 University of Sussex, Brighton, UK

Ruths FA:
 South London and Maudsley NHS Foundation Trust, London, UK

Ryan M:
 Royal college of psychiatrists, London, UK

Harrer M:
 Department of Psychiatry and Psychotherapy, Technical University of Munich, Munich, Germany

 Department of Clinical, Neuro and Developmental Psychology, World Health Organization Collaborating Center for Research and Dissemination of Psychological Interventions, Geneva, Switzerland

 Vrije Universiteit, Amsterdam, The Netherlands
ISSN: 20446055





BMJ Open
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BMJ PUBLISHING GROUP, BRITISH MED ASSOC HOUSE, TAVISTOCK SQUARE, LONDON WC1H 9JR, ENGLAND, Reino Unido
Tipo de documento: Article
Volumen: 15 Número: 12
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WOS Id: 001644393400001
ID de PubMed: 41365587
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