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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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“Individual participant data (IPD) meta-analyses can address this limitation by using raw, participant-level data, enabling a more precise examination of moderators and associations (e.g. Galante et al., 2023; Riley et al., 2021).”
Self-citationKamollimsakul, S., von Bormann, S. M., & Triamchaisri, S. K. (2026) · PLoS ONE · doi:10.1371/journal.pone.0350556 · Cited by 1
“Conventional Mindfulness-Based Programs (MBPs), most notably Mindfulness-Based Stress Reduction (MBSR) or Mindfulness-Based Cognitive Therapy (MBCT), function primarily by anchoring the individual in non-judgmental awareness, leveraging top-down cognitive reappraisal to regulate distress [8,9].”
Personalized prediction of response to three meditation practices: A randomized controlled trial
Simonsson, O., Webb, C. A., Ruiz, M., Osika, W., Narayanan, J., Dahlén, M., Lutz, W., Schwartz, B., Ren, B., Dahl, C. J., et al. (2026) · Behaviour Research and Therapy · doi:10.1016/j.brat.2026.105141 · Cited by 1
Self-citationТерапевтическое присутствие: взгляд через созерцательные практики
Ярмолюк, Р. (2024) · Психологические исследования · doi:10.54359/ps.v17i94.1585
Ueki, S., Kaneda, Y., Ozaki, A., Kotera, Y., Tanimoto, T. E., Omoto, Y., Kurosaki, K., Yamazaki, H., Yoshida, T., Mizoue, N., et al. (2024) · SN Comprehensive Clinical Medicine · doi:10.1007/s42399-024-01722-1 · Cited by 1
“Still, mental health issues are significant concerns, and self-administered mental health interventions, such as mindfulness practices and self-compassion techniques, could prove beneficial in maintaining optimal psychological well-being [26, 27].”
Luο, X. (2024) · American Journal of Health Behavior · doi:10.5993/ajhb.48.5.13 · Cited by 1
Sun, S., Pisani, C., Pellowski, J. A., Go, M., & Loucks, E. B. (2025) · Mindfulness · doi:10.1007/s12671-025-02699-1 · Cited by 1
“…(MBCT), encompass practices such as body awareness, gentle yoga, mindful walking, and self-kindness, and they have been shown to improve psychological health, reduce food craving, improve sleep quality, and facilitate a healthy lifestyle (Galante et al., 2023; Mace et al., 2024; Tapper, 2022).”
Mindfulness and rumination: stress pathways for caregivers of persons living with dementia.
Savla, J., Mansoor, M., Kim, N., Hagemann, L., Luci, K., & Sapra, M. (2026) · The Gerontologist · doi:10.1093/geront/gnag103
“…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), although effects are often comparable to those observed in strong active controls such as…”
A comprehensive matrix of factors contributing to depression
Medvedev, O. N., & Krägeloh, C. U. (2023) · Nature Mental Health · doi:10.1038/s44220-023-00126-9
Self-citationFriedrich, C., Fairbairn, T., Denton, G., Geddes, M., Thomas-Carr, D., Jones, P. B., & Galante, J. (2023) · doi:10.31234/osf.io/jpu9c
Self-citationFriedrich, C., Fairbairn, T., Denton, G., Geddes, M., Thomas-Carr, D., Jones, P. B., & Galante, J. (2024) · Systematic Reviews · doi:10.1186/s13643-024-02601-5
Self-citationPrevost, V., Razafimandimby, A., Leclair, M., Sesboüé, A., Bui, É., Bocca, M., Delamillieure, P., & Lechevrel, M. (2025) · Annales Médico-psychologiques revue psychiatrique · doi:10.1016/j.amp.2024.12.008
Katzenelenbogen, O., & Aisenberg-Shafran, D. (2025) · Behavioral Sciences · doi:10.3390/bs15040466
“Mindfulness has been widely recognized for its role in promoting emotional well-being and cognitive functions across different age groups (Jha et al., 2015; Goldberg et al., 2022; Galante et al., 2023; Zenner et al., 2014).”
Borgers, C., Karremans, J., & Speckens, A. E. M. (2025) · Mindfulness · doi:10.1007/s12671-025-02589-6
“These include reduced distress levels (Galante et al., 2023), attenuations in depression and psychiatric symptoms, smoking and substance use (Goldberg et al., 2022), and improvements in cognitive functioning (Im et al., 2021), happiness and productivity (Coo & Salanova, 2018), and social…”
Self-citationAdams, J. A., Davies, J. N., Wattanatakulchat, P., Galante, J., D’Alfonso, S., & Dam, N. T. V. (2025) · doi:10.2196/preprints.79366
Self-citationGarofalo, C., Billen, E., Adams, C. F., Velotti, P., Mazzeschi, C., Delvecchio, E., & Gillespie, S. M. (2025) · Assessment · doi:10.1177/10731911251365742
“…perhaps unsurpris-ingly, the application of mindfulness-based interventions has skyrocketed across various contexts (Fulambarkar et al., 2023; Galante et al., 2023; Zhang et al., 2021) Initially applied mainly to target internalizing symptoms, mindfulness may also hold promise for studying…”
Cullen, D., Cavanagh, K., & Strauss, C. (2025) · PLoS ONE · doi:10.1371/journal.pone.0331196
Pedersen, L. B., Ramsdal, N. B., Fjorback, L. O., Ravn, S. L., Kolls, M., & Skovbjerg, S. (2025) · PLOS mental health. · doi:10.1371/journal.pmen.0000412
Strengthening Public Health in Portugal: The Value of Behavioural Science
Godinho, C. I. A., & Marques, M. M. (2025) · Portuguese Journal of Public Health · doi:10.1159/000548677
ADINDU, K. N., Alao, O. J., Ige, T., Nwudele, U., OHANU, C., ONAKOYA, A., Anadu, J. U., Awoyemi, B., Chukwunonye, C., & Riches, A. (2025) · British journal of healthcare and medical research · doi:10.14738/bjhr.1204.19102
Olarza, A., Nyklíček, I., Mindeguia, R., Soroa, G., & Aritzeta, A. (2025) · Mindfulness · doi:10.1007/s12671-025-02742-1
Mindfulness and Psychological Growth
Wajanatinapart, P. (2025) · Springer eBooks · doi:10.1007/978-981-95-3133-2_12
Sun, Y., Xu, Y., Kwok, T. T.-O., Sit, S. M.-M., & Lai, A. Y. K. (2026) · Mindfulness · doi:10.1007/s12671-026-02780-3 · Cited by 1
Burić, I., Žderić, L., Bögels, S. M., & de Bruin, E. I. (2026) · Mindfulness · doi:10.1007/s12671-026-02779-w
Self-citationTrauma und sexuelle Gesundheit
Hocke, A. (2026) · Die Gynäkologie · doi:10.1007/s00129-026-05481-z
Cui, X. (2026) · Revista da Escola de Enfermagem da USP · doi:10.1590/1980-220x-reeusp-2025-0379en
“…a positive nurse–patient relationship and providing psychological counseling and cognitive reconstruction help patients recognize and modify negative cognitive patterns and maladaptive thinking habits, improve emotional regulation abilities, and relieve depressive and anxious symptoms (19) .”
Cui, X. (2026) · Revista da Escola de Enfermagem da USP · doi:10.1590/1980-220x-reeusp-2025-0379es
Lamas-Morales, P., García-Rubio, C., Beltrán-Ruiz, M., Barceló‐Soler, A., del Hoyo, Y. L., & García‐Campayo, J. (2026) · Mindfulness · doi:10.1007/s12671-026-02825-7
“anxiety, and depression (Galante et al., 2023; Zhang et al., 2021).”
Kanda, J., & Rani, R. (2026) · Emerald Group Publishing Limited eBooks · doi:10.1108/978-1-83708-156-120261014
Adachi, K., Kurosawa, T., & Takizawa, R. (2026) · Scientific Reports · doi:10.1038/s41598-026-46317-z
Türer, O. U., Özcan, M., Alkaya, B., Demirbilek, F., Kayhan, H. G., Dağlıoğlu, G., Totik, N., Şeydaoğlu, G., & Haytac, M. C. (2026) · BMC Psychology · doi:10.1186/s40359-026-04571-w
Saha, S., Singh, M. K., Tiwari, U., Prasad, B., Choudhary, P. K., & Astuti, Y. (2026) · Pedagogy of Physical Culture and Sports · doi:10.15561/26649837.2026.0205
“A recent individual participant data meta-analysis of 13 trials conducted across eight countries (N = 2,371) reported that mindfulness-based programs produce small-to-moderate reductions in psychological distress [41].”
Ariza, M., Cano, N., Carnes, A., Gelonch, O., Plana, Y., Porras-García, B., López-Soley, E., Moron, S., Piñol‐Ripoll, G., Garolera, M., et al. (2026) · Digital Health · doi:10.1177/20552076261428205
“30 Mindfulness training in VR has been associated with signi fi cant mindfulness improvements in individuals with mental health disorders, but not in those with chronic physical conditions.”
Trusculescu, L.-M., Kiș, A. M., Popovici, R. A., Sălcudean, A., Pitic, D. E., Feher, A., Enache, A., & Olariu, I. (2026) · Digital · doi:10.3390/digital6020034
Zhang, H., & Li, X. (2026) · International Journal of Human-Computer Interaction · doi:10.1080/10447318.2026.2674839
Miksic, I., Muza, E., Marijanovic, I., Kišiček, S., & Burić, I. (2026) · Mindfulness · doi:10.1007/s12671-026-02876-w
“While the beneficial effects of MBIs on adults are rigorously established through numerous meta-analyses and systematic reviews (Galante et al., 2023; Tan et al., 2022; Virgili, 2015), when it comes to children and adolescents, the results remain mixed.”
Simard, A., F.-Dufour, I., Goulet, S., & Hudon, C. (2026) · Canadian Journal on Aging / La Revue canadienne du vieillissement · doi:10.1017/s0714980826100701
Михайловна, Б. П., Smith, L. M., Riordan, K. M., Simonsson, O., Dottori, L. T., Song, H. Q., Shashko, N. S., Tatar, R., Baldwin, S. A., Bernstein, A., et al. (2026) · JMIR Mental Health · doi:10.2196/90602
“Meditation-based interventions (MBIs) have become widely recognized treatments for a range of mental and physical health conditions, with comparable efficacy to established psychological treatments [1-4].”
Self-citationArgungu, Z. M., Alhaiti, A. H., & Jibreel, E. A. (2026) · European Archives of Psychiatry and Clinical Neuroscience · doi:10.1007/s00406-026-02288-w
“These findings align with those of Galante et al. (2023), who reported similar effect sizes in their individual patient data meta-analysis of MBCT for relapse prevention in recurrent depression [58].”
InfluentialThe effects of mindfulness levels on menstrual symptoms and irritability in university students
Ceylan, S., Buyrukoğlu, R. C., & Sevinç, A. M. (2026) · Turkish Journal of Family Practice · doi:10.54308/tjfp.2026.902
Siew, S. K. H., & Yu, J. (2026) · PLoS ONE · doi:10.1371/journal.pone.0352195
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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