Reporting of Positive Results in Randomized Controlled Trials of Mindfulness-Based Mental Health Interventions

PLoS One. 2016 Apr 8;11(4):e0153220. doi: 10.1371/journal.pone.0153220. eCollection 2016.

Abstract

Background: A large proportion of mindfulness-based therapy trials report statistically significant results, even in the context of very low statistical power. The objective of the present study was to characterize the reporting of "positive" results in randomized controlled trials of mindfulness-based therapy. We also assessed mindfulness-based therapy trial registrations for indications of possible reporting bias and reviewed recent systematic reviews and meta-analyses to determine whether reporting biases were identified.

Methods: CINAHL, Cochrane CENTRAL, EMBASE, ISI, MEDLINE, PsycInfo, and SCOPUS databases were searched for randomized controlled trials of mindfulness-based therapy. The number of positive trials was described and compared to the number that might be expected if mindfulness-based therapy were similarly effective compared to individual therapy for depression. Trial registries were searched for mindfulness-based therapy registrations. CINAHL, Cochrane CENTRAL, EMBASE, ISI, MEDLINE, PsycInfo, and SCOPUS were also searched for mindfulness-based therapy systematic reviews and meta-analyses.

Results: 108 (87%) of 124 published trials reported ≥1 positive outcome in the abstract, and 109 (88%) concluded that mindfulness-based therapy was effective, 1.6 times greater than the expected number of positive trials based on effect size d = 0.55 (expected number positive trials = 65.7). Of 21 trial registrations, 13 (62%) remained unpublished 30 months post-trial completion. No trial registrations adequately specified a single primary outcome measure with time of assessment. None of 36 systematic reviews and meta-analyses concluded that effect estimates were overestimated due to reporting biases.

Conclusions: The proportion of mindfulness-based therapy trials with statistically significant results may overstate what would occur in practice.

MeSH terms

  • Bias
  • Cognitive Behavioral Therapy / methods
  • Databases, Factual / statistics & numerical data
  • Humans
  • Meta-Analysis as Topic
  • Mindfulness / methods*
  • Publication Bias*
  • Randomized Controlled Trials as Topic / statistics & numerical data*
  • Review Literature as Topic
  • Stress, Psychological / therapy

Grant support

The authors have no support or funding to report.