The validation of an active control intervention for Mindfulness Based Stress Reduction (MBSR)

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Abstract

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 (η2 = .18). There were significant improvements over time for general distress (η2 = .09), anxiety (η2 = .08), hostility (η2 = .07), and medical symptoms (η2 = .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.

Highlights

► We validate an active control for Mindfulness Based Stress Reduction (MBSR). ► Pre-post behavioral pain ratings are lower for MBSR compared to control. ► No group differences for changes in anxiety and hostility or medical symptoms. ► Group × Time for general mental distress and depression show improvements in control over MBSR. ► Control is first that allows rigorous test of MBSR, including mindfulness as active ingredient.

Section snippets

Participants and procedures

Participants provided their written informed consent for study procedures that were approved by the UW-Madison Health Sciences Internal Review Board. Participants were recruited for a study on “health and well-being” through advertisements in Madison, WI area newspapers. Advertisements offered $475 plus a free “8-week Health Enhancement Program” or “8-week Mindfulness Based Stress Reduction Class”. People were informed about study requirements and screened for exclusion/inclusion criteria (see

Results

Analyses for all PROs except thermal pain ratings are based on participants with complete data for the time points included in the analyses. Intent-to-treat (ITT) analyses with multiple imputation (using 5 imputed datasets) were conducted and no meaningful differences were found between the pooled results under multiple imputation and our original results. Therefore, we do not report ITT analyses.

A univariate General Linear Model (GLM) with intervention as the between-participant variable and a

Discussion

This is the first study comparing MBSR to an active control condition that was designed to be inert with respect to mindfulness, while being structurally equivalent to MBSR and credible to both patients and providers. The fact that an MBSR-relevant instruction condition moderated pain ratings relative to HEP-relevant instructions in the MBSR participants compared to the HEP participants (see Fig. 2) suggests that mindfulness was, indeed, an active ingredient in MBSR but not in HEP (hypothesis 1)

Acknowledgments

Donal MacCoon was responsible for developing the HEP intervention and various aspects of study design and analysis. Dr. MacCoon had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Zac Imel was a close collaborator on ensuring the HEP intervention design met the highest standards of scientific rigor from a common factors perspective and also helped with aspects of study design and analysis. Melissa Rosenkranz

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