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Mindfulness-based programmes for mental health promotion in adults in non-clinical settings: protocol of an individual participant data meta-analysis of randomised controlled trials

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Galante, Mariana 
Friedrich, claire 
Dalgleish, Tim 
White, Ian 


Introduction With mental ill health listed as a top cause of global disease burden, there is an urgent need to prioritise mental health promotion programmes. Mindfulness–based programmes (MBPs) are being widely implemented to reduce stress in non-clinical settings. In a recent aggregate-level meta-analysis we found that, compared with no intervention, these MBPs reduce average psychological distress. However, heterogeneity between studies impedes generalisation of effects across every setting. Study-level effect modifiers were insufficient to reduce heterogeneity; studying individual–level effect modifiers is warranted. This requires individual participant data (IPD) and larger samples than those found in existing individual trials. Methods and analysis We propose an IPD meta–analysis. Our primary aim is to see if, and how, baseline psychological distress, gender, age, education, and dispositional mindfulness moderate the effect of MBPs on distress. We will search 13 databases for good-quality randomised controlled trials (RCTs) comparing in–person, expert–defined MBPs in non-clinical settings with passive controls. Two researchers will independently select, extract, and appraise trials using the revised Cochrane Risk–of–Bias Tool (RoB2). Anonymised IPD of eligible trials will be sought from authors, who will be invited to collaborate. The primary outcome will be psychological distress measured using psychometrically-validated questionnaires at 1 to 6 months after programme completion. Pairwise random-effects two-stage IPD meta-analyses will be conducted. Moderator analyses will follow a “deft” approach. We will estimate subgroup-specific intervention effects. Secondary outcomes and sensitivity analyses are pre-specified. Multiple imputation strategies will be applied to missing data. Ethics and dissemination The findings will refine our knowledge on the effectiveness of MBPs and help improve the targeting of MBPs in non-clinical settings. They will be shared in accessible formats with a range of stakeholders. Public and professional stakeholders are being involved in the planning, conduct and dissemination of this project. PROSPERO registration number CRD42020200117



complementary medicine, mental health, public health, Adult, Data Analysis, Health Promotion, Humans, Meta-Analysis as Topic, Mindfulness, Randomized Controlled Trials as Topic

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BMJ Open

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BMJ Journals
Department of Health (via National Institute for Health Research (NIHR)) (PDF-2017-10-018)
Cambridgeshire and Peterborough NHS Foundation Trust (CPFT) (Unknown)
Wellcome Trust (095844/Z/11/Z)
Medical Research Council (MR/N019067/1)
Wellcome Trust (via University of Oxford) (107496/Z/15/Z?)
Wellcome Trust (104908/Z/14/Z)
MRC (MC_UU_00030/5)
This publication presents independent research funded by the National Institute for Health Research (NIHR). The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care. JG is funded by a NIHR Post-doctoral Fellowship for this research project (salary and all project costs, PDF-2017-10-018, CF’s salary for this research project was funded by a Cambridgeshire & Peterborough NHS Foundation Trust grant awarded to JG (RNAG/552, IRW was supported by the UK Medical Research Council (MC_UU_12023/21, TD was supported by the UK Medical Research Council (SUAG/043 G101400,, the Wellcome Trust (104908/Z/14/Z, 107496/Z/15/Z,, and the NIHR Cambridge Biomedical Research Centre (RG85446, 247730, PBJ is supported by the Wellcome Trust (095844/Z/11/Z,, the UK Medical Research Council (MR/N019067/1,, and the NIHR ARC East of England (RNAG/564, The funders had no role in study design, data collection and analysis, decision to publish, or preparation of this protocol.