Are randomized controlled trials the “gold standard” of evidence for mindfulness-based interventions?
Agnes Bolinska
Synthese September 25, 2026 DOI: 10.1007/s11229-026-05823-3 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Theoretical or philosophical paper Randomized Peer reviewed |
|---|---|
| Topics | Meditation |
| Key points | Argues that RCT study design, though advantageous, embodies reductionistic assumptions—especially that an intervention's effects come from a single, isolable "active ingredient"—that do not fit mindfulness-based interventions, whose attitudes and forms of effort are not readily decomposable into "ingredients." Contends that a prominent attempt to isolate mindfulness as an active ingredient (MacCoon et al., 2012) did not succeed, so RCTs should not be treated as the gold standard for MBIs or other complex behavioral interventions. |
Abstract
Abstract Mindfulness-based interventions (MBIs) are behavioral programs, often involving practices like meditation, that aim to cultivate mindfulness , the nonjudgmental awareness of present-moment experience. A growing body of evidence suggests that they are effective for treating a range of physical and mental health conditions. Critics, however, argue that much of this evidence is biased, relying heavily on uncontrolled or poorly controlled studies, and is therefore insufficient to warrant the widespread clinical adoption of MBIs. More randomized controlled trials (RCTs)—widely regarded as the “gold standard” of scientific evidence—are needed (Van Dam et al., 2018). In this paper, I argue that, although RCT study design has several advantages, it also embodies reductionistic assumptions about how and why an intervention produces its effects. In particular, it assumes that such effects can be attributed to a single, isolable “active ingredient.” In contrast, the features of MBIs, including the attitudes and forms of effort they require, are not readily decomposable into “ingredients.” Moreover, a prominent attempt to isolate mindfulness as an active ingredient (MacCoon et al., 2012) ultimately does not succeed. I conclude that RCTs should not be treated as the gold standard of evidence for MBIs or other complex behavioral interventions for which these assumptions may not hold. Doing so undermines the value of evidence for nonreductionistic hypotheses about how they function and risks underestimating their effectiveness.
Comparable studies
Other theoretical and historical papers on meditation, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Mindfulness: A proposed operational definition. | 2004 | Theoretical or philosophical paper | |
| Mechanisms of mindfulness | 2005 | Theoretical or philosophical paper | |
| How Does Mindfulness Meditation Work? Proposing Mechanisms of Action From a Conceptual and Neural Perspective | 2011 | Theoretical or philosophical paper | |
| Mindfulness-based cognitive therapy for depression | 2006 | Theoretical or philosophical paper | |
| Self-awareness, self-regulation, and self-transcendence (S-ART): a framework for understanding the neurobiological mechanisms of mindfulness | 2012 | Theoretical or philosophical paper |
Citations in the library
Cites 17
- The benefits of being present: Mindfulness and its role in psychological well-being. Journal of Personality and Social Psychology 2003
- Using Self-Report Assessment Methods to Explore Facets of Mindfulness Assessment January 27, 2006
- Meditation Programs for Psychological Stress and Well-being JAMA Internal Medicine January 6, 2014
- Effectiveness of a meditation-based stress reduction program in the treatment of anxiety disorders American Journal of Psychiatry July 1, 1992
- Mind the Hype: A Critical Evaluation and Prescriptive Agenda for Research on Mindfulness and Meditation Perspectives on Psychological Science October 10, 2017
and 12 more in the library