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Systematic review and individual participant data meta-analysis of randomized controlled trials assessing mindfulness-based programs for mental health promotion
Open accessAbstract
Introduction: Mindfulness-based programmes (MBPs) are widely used to prevent mental ill-health that is becoming the leading global cause of morbidity. Evidence suggests beneficial average effects but wide variability. We aimed to confirm the effect of MBPs on psychological distress, and to understand whether and how baseline distress, gender, age, education, and dispositional mindfulness modify the effect of MBPs on distress among adults in non-clinical settings. Methods: We conducted a pre-registered systematic review and individual participant data (IPD) meta-analysis (PROSPERO CRD42020200117). Thirteen databases were searched in December 2020 for randomised controlled trials satisfying a quality threshold and comparing in-person, expert-defined MBPs in non-clinical settings with passive control groups. Two researchers independently selected, extracted, and appraised trials using the revised Cochrane Risk-of-Bias Tool (RoB2). Anonymised IPD of eligible trials were sought from collaborating authors. The primary outcome was psychological distress (unpleasant mental or emotional experiences including anxiety and depression) at 1 to 6 months after programme completion. Data were checked and imputed if missing. Pairwise, random-effects, two-stage IPD meta-analyses were conducted. Effect modification analyses followed a within-studies approach. Public and professional stakeholders were involved in the planning, conduct and dissemination of this study. Results: Fifteen trials were eligible, 13 trialists shared IPD (2,371 participants representing 8 countries, median age 34 years-old, 71% women, moderately distressed on average, 20% missing outcome data). In comparison with passive control groups, MBPs reduced average distress between one- and six-months post-intervention with a small to moderate effect size (standardised mean difference (SMD) -0.32; 95% confidence interval (CI) -0.41 to -0.24; p-value < 0.001; 95% prediction interval (PI) -0.41 to -0.24 (no heterogeneity)). Results were robust to sensitivity analyses, and similar for the other psychological distress time point ranges. Confidence in the primary outcome result is high. We found no clear indication that this effect is modified by baseline psychological distress, gender, age, education level, or dispositional mindfulness. Conclusions: Group-based teacher-led MBPs generally reduce psychological distress among community adults who volunteer to receive this type of intervention. More research is needed to identify sources of variability in outcomes at an individual level.
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“Meta-analyses and randomized trials indicate that mindfulness-based interventions can reduce depressive symptoms, perceived stress, and rumination among caregivers (Galante et al., 2023; Kor et al., 2021; Oh et al., 2022)”
From Mindfulness and rumination: stress pathways for caregivers of persons living with dementia. (2026) · cites this paper as Galante et al., 2023
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Cited by
Sorted by citations
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“Increases in accessibility 52 , evidence regarding health and wellbeing benefits 10–12 , and barriers to accessing conventional mental health services 38,39 may be contributing to increases in use across all practices.”
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Mental health disorders and their impact on cardiovascular health disparities
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“73 Mantra-based meditation such as transcendental meditation have also shown potential efficacy, but studies on psychiatric patients are limited.”
Metadata
- Authors
- Galante, J., Friedrich, C., Collaboration of Mindfulness Trials (CoMinT), Aeamla-Or, N., Arts-de Jong, M., Barrett, B., Bögels, S. M., Buitelaar, J. K., Checovich, M. M., Christopher, M. S., Davidson, R. J., Errazuriz, A., Goldberg, S. B., Greven, C. U., Hirshberg, M. J., Huang, S.-L., Hunsinger, M., Hwang, Y.-S., Jones, P. B., Medvedev, O. N., Rosenkranz, M. A., Schellekens, M. P. J., Siebelink, N. M., Singh, N. N., Speckens, A. E. M., Tang, F.-C., Tomfohr-Madsen, L., Dalgleish, T., Jones, P. B., & White, I. R.
- Affiliations
- The University of Melbourne (AU)
- University of Cambridge (GB)
- University of Phayao (TH)
- University of Wisconsin–Madison (US)
- University of Amsterdam (NL)
- Radboud University Nijmegen (NL)
- Pacific University Oregon (US)
- Chung Shan Medical University Hospital (TW)
- Australian Catholic University (AU)
- University of Waikato (NZ)
- Radboud University Medical Center (NL)
- Augusta University (US)
- Chaoyang University of Technology (TW)
- MRC Cognition and Brain Sciences Unit (GB)
- MRC Clinical Trials Unit at UCL (GB)
- Corresponding author
- Galante, Julieta
- ORCID
- Galante, Julieta
- Friedrich, Claire
- Arts-de Jong, Marieke
- Barrett, Bruce
- Bögels, Susan M.
- Buitelaar, Jan K.
- Checovich, Mary M.
- Christopher, Michael S.
- Davidson, Richard J.
- Errazuriz, Antonia
- Goldberg, Simon B.
- Greven, Corina U.
- Hirshberg, Matthew J.
- Huang, Shu-Ling
- Hunsinger, Matthew
- Hwang, Yoon-Suk
- Medvedev, Oleg N.
- Rosenkranz, Melissa A.
- Schellekens, Melanie P. J.
- Siebelink, Nienke M.
- Singh, Nirbhay N.
- Speckens, Anne E. M.
- Tang, Feng-Cheng
- Dalgleish, Tim
- White, Ian R.
- Venue
- Nature Mental Health
- Published
- 2023-07-10
- Volume
- 1
- Issue
- 7
- Pages
- 462-476
- ISSN
- 2731-6076 (ISSN-L)
- PMC
- PMC7615230
- OpenAlex
- W4383815381
- Cited by
- 113
- References
- 116
- Citations by year
- 2026: 43 · 2025: 37 · 2024: 23 · 2023: 9
- FWCI
- 5.67
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Locations
- Nature Mental Health (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- Research portal (Tilburg University) (publishedVersion, cc-by)
- PubMed (publishedVersion)
- UvA-DARE (University of Amsterdam) (submittedVersion, cc-by)
- Research Commons (University of Waikato) (submittedVersion, cc-by)
- Greater South Information System
- Funders
- DH | National Institute for Health Research (PDF-2017-10-018, BRC-1215-20014, NA)
- Cambridgeshire & Peterborough NHS Foundation Trust
- U.S. Department of Health & Human Services | NIH | National Center for Complementary and Integrative Health (K23AT010879)
- Hope for Depression Research Foundation
- RCUK | Medical Research Council (SUAG/043 G101400, MR/N019067/1, MC_UU_00004/06)
- Topics
- Social Sciences › Psychology › Clinical Psychology › Mindfulness and Compassion Interventions
- Social Sciences › Psychology › Applied Psychology › Digital Mental Health Interventions
- Social Sciences › Psychology › Clinical Psychology › Psychotherapy Techniques and Applications
- Keywords
- mental health promotion, psychological distress, anxiety, depression, non-clinical adults, community-based intervention, teacher-led intervention, effect modification, trait mindfulness, gender differences, age and education effects, heterogeneous effects
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