The validation of an active control intervention for Mindfulness Based Stress Reduction (MBSR)
Open accessAbstract
Most of the extant literature investigating the health effects of mindfulness interventions relies on wait-list control comparisons. The current article specifies and validates an active control condition, the Health Enhancement Program (HEP), thus providing the foundation necessary for rigorous investigations of the relative efficacy of Mindfulness Based Stress Reduction (MBSR) and for testing mindfulness as an active ingredient. 63 participants were randomized to either MBSR (n = 31) or HEP (n = 32). Compared to HEP, MBSR led to reductions in thermal pain ratings in the mindfulness- but not the HEP-related instruction condition (η(2) = .18). There were significant improvements over time for general distress (η(2) = .09), anxiety (η(2) = .08), hostility (η(2) = .07), and medical symptoms (η(2) = .14), but no effects of intervention. Practice was not related to change. HEP is an active control condition for MBSR while remaining inert to mindfulness. These claims are supported by results from a pain task. Participant-reported outcomes (PROs) replicate previous improvements to well-being in MBSR, but indicate that MBSR is no more effective than a rigorous active control in improving these indices. These results emphasize the importance of using an active control condition like HEP in studies evaluating the effectiveness of MBSR.
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For the past 10 years, more and more meditation studies have used longitudinal RCT design with active controls such as relaxation training, health education or enhancement programs, physical exercise, and cognitive tasks.
“consequently, for the past 10 years, more and more meditation studies have used longitudinal Rct design with active controls such as relaxation training, health education or enhancement programs, physical exercise, and cognitive tasks (Davidson, 2010;Maccoon et al., 2012;2014;Rosenkranz et al., 2013;terburg et al., 2009).”
From Salivary testosterone and cortisol response in acute stress modulated by seven sessions of mindfulness meditation in young males (2024) · cites this paper as Maccoon et al., 2012
The Abstract reports a randomized comparison of MBSR with an active Health Enhancement Program control. It also describes earlier studies using physical exercise or social support/relaxation controls. It does not establish an increasing trend over the past 10 years or document the full range of controls listed; instead, it says most existing mindfulness studies used wait-list controls. Page numbers were not supplied in our copy. (LLM, conf=0.86)
Experimental — accuracy not yet measuredLater rigorous RCT studies using an active control failed to replicate the positive results of meditation versus waitlist control.
“however, later rigorous Rct studies using an active control failed to replicate these results.”
From Salivary testosterone and cortisol response in acute stress modulated by seven sessions of mindfulness meditation in young males (2024) · cites this paper as Maccoon et al., 2012
The Abstract reports that MBSR was no more effective than an active control on participant-reported well-being measures, despite earlier positive comparisons with wait-list controls. But this paper reports one randomized comparison, not multiple later RCTs; it also says the well-being improvements were replicated and reports an MBSR advantage on a thermal-pain measure. (LLM, conf=0.88)
Experimental — accuracy not yet measuredOther longitudinal RCTs showed no sustained attention differences between MBSR and HEP, comparable post-training stress-evoked cortisol responses, and equivalent reductions in self-reported psychological distress and physical symptoms.
“Other longitudinal Rcts also showed no sustained attention differences between MBsR and heP, MBsR and heP had comparable post-training stress-evoked cortisol responses, as well as equivalent reductions in self-reported psychological distress and physical symptoms (Davidson, 2010;Maccoon et al., 2012;2014;Rosenkranz et al., 2013).”
From Salivary testosterone and cortisol response in acute stress modulated by seven sessions of mindfulness meditation in young males (2024) · cites this paper as Maccoon et al., 2012
The Results (SCL-90-R and Medical Symptom Checklist; page unavailable) report decreases in self-reported psychological distress and medical symptoms, with no overall group difference on the primary distress measure. But the Discussion notes that distress increased in MBSR participants from post-training to follow-up while it decreased in HEP participants, so the reductions were not uniformly equivalent. Our copy does not report MBSR–HEP comparisons of sustained attention or post-training stress-evoked cortisol responses. (LLM, conf=0.88)
Experimental — accuracy not yet measuredThe waitlist control has been intensively investigated in the meditation field.
“the waitlist control has been intensively investigated in the meditation field (Davidson, 2010;Maccoon, Maclean, Davidson, saron, & lutz, 2014;Maccoon et al., 2012;Rosenkranz et al., 2013;terburg et al., 2009).”
From Salivary testosterone and cortisol response in acute stress modulated by seven sessions of mindfulness meditation in young males (2024) · cites this paper as Maccoon et al., 2012
A series of studies used MBSR versus HEP to validate the active control in meditation.
“For example, a series of studies used MBsR vs. health enhancement Program (heP) to validate the active control in meditation (Davidson, 2010;Maccoon et al., 2012;2014;Rosenkranz et al., 2013).”
From Salivary testosterone and cortisol response in acute stress modulated by seven sessions of mindfulness meditation in young males (2024) · cites this paper as Maccoon et al., 2012
Non-specific factors are frequently treated mainly as confounds in MBI mechanism research and as reasons to strengthen comparison conditions to isolate specific effects.
“Yet, non-specific factors are often viewed primarily as a confound in studies of MBI mechanisms (but see33–35) and used as motivation for increasing the rigor of comparison conditions to isolate the specific effects of MBIs28,36–38.”
From A common factors perspective on mindfulness-based interventions (2022) · cites this paper as [38]
Although the HEP and mindfulness conditions were effective at improving mood, stress, and cognition, they did not significantly differ.
“Although the HEP and mindfulness conditions were effective at improving mood, stress, and cognition, they did not significantly differ.”
From The neural mechanisms of mindfulness-based pain relief: a functional magnetic resonance imaging-based review and primer (2019) · cites this paper as [74]
The mindfulness program was more effective at reducing inflammatory markers in response to a social stress test and pain.
“However, the mindfulness program was more effective at reducing inflammatory markers in response to a social stress test95 and pain.74”
From The neural mechanisms of mindfulness-based pain relief: a functional magnetic resonance imaging-based review and primer (2019) · cites this paper as [74]
MBSR outperformed HEP in lowering inflammatory responses after social stress and in reducing experimentally induced pain ratings.
“However, the MBSR program was more effective at reducing inflammatory responses following social stress141 and experimentally-induced pain ratings.139”
From Mindfulness meditation-based pain relief: a mechanistic account (2016) · cites this paper as [139]
Both HEP and MBSR reduced self-reported anxiety, distress, hostility, and attentional stability, with no significant group differences.
“Although the HEP and MBSR program were effective at reducing self-reports of anxiety, distress, hostility,139 and attentional stability,140 there were no significant differences between groups.”
From Mindfulness meditation-based pain relief: a mechanistic account (2016) · cites this paper as [139]
The control intervention, HEP, was validated and designed to match MBSR on non-specific effects.
“a validated, active control condition (the health enhancement program; HEP) that was matched for intervention effects non-specific to mindfulness meditation (MacCoon et al., 2012).”
From Impact of short- and long-term mindfulness meditation training on amygdala reactivity to emotional stimuli (2018) · cites this paper as MacCoon et al., 2012
The randomization and intervention procedures followed those described by MacCoon et al. (2012).
“The intervention and randomization procedures were identical to that detailed by MacCoon et al. (2012)”
From Impact of short- and long-term mindfulness meditation training on amygdala reactivity to emotional stimuli (2018) · cites this paper as MacCoon et al., 2012
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“The subjects in the MBSR course were compared to an active control intervention carefully matched to the structure and non-specific social context of MBSR, where the program for the active control group that has itself been shown to promote well-being without explicitly training mindfulness (Health Enhancement Program…”
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“In line with general recommendations in the field (Davidson, 2010; MacCoon et al., 2012) and in light of the finding that mindfulness training showed smaller effects when compared to active rather than no training controls (see Table 2), it is important for future studies to use well-matched active…”
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“…Life (6) Waitlist (1) Post–int Ma 2019 [190], China (HK) 43 Stressed adults (3) 39 (15.1) 83% Anx, Cog, Dep, Dis, Mindf MBCT (2) Physical exercise program (3) Post–int, 2 m MacCoon 2012 [191–194], US 63 General adults (1) 48 (10.7) 63% Cog, Dis, WB, Mindf, Somat MBSR (3) a) Health…”
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“Because provider enthusiasm and confidence in the efficacy of the intervention is related to its degree benefits (Davidson & Kaszniak, 2015; MacCoon et al., 2012), it was important to find instructors who were not only capable of delivering the intervention but also particularly enthusiastic about their intervention (…”
A Systematic Review of Mindfulness Interventions on Psychophysiological Responses to Acute Stress
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“Our findings agree with past studies, which are largely consistent in reporting changes in neural connectivity following MBSR.”
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“For example, Goldberg et al. (2016) found that FFMQ scores showed similar increases in MBSR and in the Health Enhancement Program (HEP; MacCoon et al., 2012), an active control designed to match many aspects of MBSR (group size, session time, home practice, etc.) while including no mindfulness training.”
ResultBlunted amygdala activity is associated with depression severity in treatment-resistant depression
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- Authors
- MacCoon, D. G., Imel, Z. E., Rosenkranz, M. A., Sheftel, J. G., Weng, H. Y., Sullivan, J. C., Bonus, K. A., Stoney, C. M., Salomons, T. V., Davidson, R. J., & Lutz, A.
- Affiliations
- University of Wisconsin–Madison (US)
- University of Washington (US)
- University of Wisconsin Health (US)
- National Institutes of Health (US)
- Corresponding author
- MacCoon, Donal G.
- Venue
- Behaviour Research and Therapy
- Publisher
- Elsevier BV
- Published
- 2012-01
- Volume
- 50
- Issue
- 1
- Pages
- 3-12
- ISSN
- 0005-7967 (ISSN-L)
- PMC
- PMC3257026
- OpenAlex
- W2145128570
- Cited by
- 335
- References
- 61
- Citations by year
- 2026: 9 · 2025: 19 · 2024: 12 · 2023: 22 · 2022: 41 · 2021: 34 · 2020: 34 · 2019: 27 · 2018: 17 · 2017: 18 · 2016: 21 · 2015: 34 · 2014: 19 · 2013: 17 · 2012: 10
- FWCI
- 15.89
- Type
- journal article
- Language
- en
- Open access
- green
- europepmc.org
- Locations
- Behaviour Research and Therapy (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Center for Complementary and Alternative Medicine (U01AT002114-01A1)
- National Institute of Mental Health (P50-MH069315-03)
- Fetzer Institute, and gifts
- John W. Kluge Foundation and the Impact Foundation
- Topics
- Social Sciences › Psychology › Clinical Psychology › Mindfulness and Compassion Interventions
- Life Sciences › Neuroscience › Cognitive Neuroscience › Pain Management and Placebo Effect
- Social Sciences › Psychology › Clinical Psychology › Psychotherapy Techniques and Applications
- Keywords
- mindfulness-based stress reduction, active control, mindfulness-based interventions, waitlist control, thermal pain, anxiety, hostility, general distress, clinical symptoms, well-being, intervention efficacy
- MeSH terms
- Adult, Female, Humans, Male, Middle Aged, Pain Measurement, Stress, Psychological, Treatment Outcome, Meditation
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