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Implications of a “Null” Randomized Controlled Trial of Mindfulness and Compassion Interventions in Healthy Adults

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Abstract

Objectives

Extensive research suggests that short-term meditation interventions may hold therapeutic promise for a wide range of psychosocial outcomes. In response to calls to subject these interventions to more methodologically rigorous tests, a randomized controlled trial tested the effectiveness of a mindfulness meditation intervention and a compassion meditation intervention against an active control in a demographically diverse sample of medically and psychiatrically healthy adults.

Methods

Two hundred and four participants completed a battery of questionnaires to assess psychological experience, participated in a laboratory stress test to measure their biological stress reactivity, and wore the Electronically Activated Recorder (EAR) to assess daily behaviors before and after an eight-week intervention (mindfulness meditation intervention, compassion meditation intervention, or health education discussion group).

Results

Neither meditation intervention reliably impacted participants’ subjective psychological experience, biological stress reactivity, or objectively assessed daily behaviors. Furthermore, post hoc moderation analyses found that neither baseline distress nor intervention engagement significantly moderated effects.

Conclusions

Results from this trial—which was methodologically rigorous and powered to detect all but small effects—were essentially null. These results are an important data point for the body of research about meditation interventions. Implications of these non-significant effects are discussed in the context of prior studies, and future directions for contemplative intervention research are recommended.

Clinical Trial Registry

Registry Number: NCT01643369.

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Data Availability

Open access to the data and materials associated with this study are provided on the Open Science Framework at: https://osf.io/6jt9q/.

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Acknowledgements

The authors would like to acknowledge and thank the participants who contributed to this research, as well as the numerous Research Assistants in the Naturalistic Observation of Social Interactions (NOSI) lab at the University of Arizona who worked for years to code the behavioral data.

Funding

This research was supported by the National Institutes of Health grants 3R01AT004698 (Charles Raison), 5R01AT004698 (Charles Raison), UL1TR000454 (David Stephens, Emory University). The preparation of this manuscript was supported by the National Institutes of Health grant 1F32HL154751 (Kaplan).

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Authors and Affiliations

  1. Department of Psychology, University of Arizona, Tucson, AZ, USA

    Deanna M. Kaplan & Matthias R. Mehl

  2. Department of Behavioral and Social Sciences, Brown University, Providence, RI, USA

    Deanna M. Kaplan

  3. Department of Psychiatry, College of Medicine, University of Arizona, Tucson, AZ, USA

    Thaddeus W. W. Pace

  4. College of Nursing, University of Arizona, Tucson, AZ, USA

    Thaddeus W. W. Pace

  5. Center for Contemplative Science and Compassion-Based Ethics, Emory University, Atlanta, GA, USA

    Lobsang Tenzin Negi, Brendan Ozawa-de Silva & Tom Comstock

  6. Courage of Care Coalition, Oakland, CA, USA

    Brooke D. Lavelle

  7. Metropolitan Counseling Services, Atlanta, GA, USA

    Teri Sivilli

  8. Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA, USA

    Allison Williams & W. Edward Craighead

  9. Telemed Solutions LLC, Atlanta, GA, USA

    Bryan Price

  10. School of Social Work, University of Washington, Seattle, WA, USA

    Vicente Medrano

  11. Department of Psychology, University of California at Riverside, Riverside, CA, USA

    Megan L. Robbins

  12. Research Design Associates, Yorktown Heights, Yorktown, NY, USA

    Steven P. Cole

  13. Department of Human Development and Family Studies, School of Human Ecology, University of Wisconsin-Madison, Madison, WI, USA

    Charles L. Raison

  14. Department of Psychiatry, School of Medicine and Public Health, University of Wisconsin-Madison, Madison, WI, USA

    Charles L. Raison

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  1. Deanna M. Kaplan
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Contributions

DMK: Supported the data analyses and drafted this manuscript with assistance from MRM and CLR. MRM: Collaborated on the design and execution of the study, supported the data analysis, and contributed to writing the manuscript. TWWP: Collaborated on the design and execution of the study and contributed to writing the manuscript. LTN: Collaborated on the design of the study and editing of the manuscript. BOS: Collaborated on the design of the study and editing of the manuscript. BDL: Collaborated on the execution of the study and editing of the manuscript. TS: Collaborated on the execution of the study and editing of the manuscript. AW: Collaborated on the execution of the study and editing of the manuscript. TC: Collaborated on the execution of the study and editing of the manuscript. BP: Collaborated on the execution of the study and editing of the manuscript. VM: Provided data management oversight for the study and contributed to writing the manuscript. MLR: Provided data management oversight for the study and contributed to writing the manuscript. SPC: Conducted statistical analyses for the manuscript, with assistance from DMK and MRM. WEC: Collaborated on the design of the study and editing of the manuscript. CLR: Secured funding, designed and executed the study, and assisted with writing and editing of the manuscript.

Corresponding author

Correspondence to Charles L. Raison.

Ethics declarations

Ethics Statement

All procedures for this study were approved by Institutional Research Boards at Emory University and the University of Arizona.

Informed Consent Statement

All participants in this research provided informed consent for participating in this trial.

Conflict of Interest

DMK is a certified instructor of Cognitively Based Compassion Training (CBCT®) and has taught CBCT® on behalf of the University of Arizona’s Center for Compassion Studies. LTN is the Executive Director and BOS is an Associate Director for the Center for Contemplative Science and Compassion-Based Ethics at Emory University. The Center holds a registered trademark for CBCT® and offers trainings in the procedure. CLR serves as a consultant for Usona Institute, Sage Pharmaceuticals, Novartis, and Emory Healthcare. The other authors declared that they had no conflicts of interest with respect to their authorship or the publication of this article.

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Kaplan, D.M., Mehl, M.R., Pace, T.W.W. et al. Implications of a “Null” Randomized Controlled Trial of Mindfulness and Compassion Interventions in Healthy Adults. Mindfulness 13, 1197–1213 (2022). https://doi.org/10.1007/s12671-022-01861-3

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