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PPSXXX10.1177/1745691620968771Goldberg et al.Empirical Status of Mindfulness

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The Empirical Status of Mindfulness-Based 1­–23


© The Author(s) 2021
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DOI: 10.1177/1745691620968771
https://doi.org/10.1177/1745691620968771

44 Meta-Analyses of Randomized www.psychologicalscience.org/PPS

Controlled Trials

Simon B. Goldberg1,2 , Kevin M. Riordan1,2, Shufang Sun3,


and Richard J. Davidson1,2,3
1
Center for Healthy Minds, University of Wisconsin-Madison; 2Department of Counseling Psychology,
University of Wisconsin-Madison; 3Department of Psychiatry and Human Behavior, Alpert Medical
School of Brown University; 4Department of Psychology, University of Wisconsin-Madison; and
5
Department of Psychiatry, University of Wisconsin-Madison

Abstract
In response to questions regarding the scientific basis for mindfulness-based interventions (MBIs), we evaluated their
empirical status by systematically reviewing meta-analyses of randomized controlled trials (RCTs). We searched six
databases for effect sizes based on four or more trials that did not combine passive and active controls. Heterogeneity,
moderators, tests of publication bias, risk of bias, and adverse effects were also extracted. Representative effect sizes
based on the largest number of studies were identified across a wide range of populations, problems, interventions,
comparisons, and outcomes (PICOS). A total of 160 effect sizes were reported in 44 meta-analyses (k = 336 RCTs,
N = 30,483 participants). MBIs showed superiority to passive controls across most PICOS (ds = 0.10–0.89). Effects were
typically smaller and less often statistically significant compared with active controls. MBIs were similar or superior
to specific active controls and evidence-based treatments. Heterogeneity was typically moderate. Few consistent
moderators were found. Results were generally robust to publication bias, although other important sources of bias
were identified. Reporting of adverse effects was inconsistent. Statistical power may be lacking in meta-analyses,
particularly for comparisons with active controls. Because MBIs show promise across some PICOS, future RCTs and
meta-analyses should build on identified strengths and limitations of this literature.

Keywords
mindfulness, meditation, meta-analysis, evidence-based treatments

Mindfulness meditation has entered mainstream culture The term mindfulness derives from the Pali word sati
in the United States and many other countries in the (or smrti in Sanskrit). The cultivation of sati is empha-
past several decades. Meditation instructions are pub- sized across Buddhist traditions, defined in part as the
lished by The New York Times (Gelles, n.d.), and poten- development of receptive, present-moment awareness 1
tial benefits are discussed by Fox News (Miller & (Analayo, 2018; Goldstein, 2013). As has been acknowl-
Zaharna, 2018) and Al Jazeera (2016). Mindfulness edged (Davidson & Kaszniak, 2015; Grossman & Van
meditation has been embraced by business (Wieczner, Dam, 2011; Van Dam et al., 2018), mindfulness has a
2016), schools (Magra, 2019), and health care providers variety of meanings in the scientific literature, with the
(Mayo Clinic Staff, 2020). Hundreds of smartphone term used to reference a mental trait, a spiritual path
applications offer mindfulness-related content (Mani
et al., 2015). Data on utilization mirror this increased
Corresponding Author:
cultural visibility; the number of U.S. adults meditating Simon B. Goldberg, Department of Counseling Psychology, University
in the past 12 months more than tripled between 2012 of Wisconsin-Madison
and 2017 (from 4.1% to 14.2%; Clarke et al., 2018). E-mail: sbgoldberg@wisc.edu
2 Goldberg et al.

for cultivating well-being and relieving suffering, and a Other concerns raised with the MBI evidence base include
cognitive process or mental faculty that can be trained. an overreporting of trials demonstrating statistically sig-
In the psychotherapeutic literature, mindfulness-based nificant effects (Coronado-Montoya et al., 2016), limita-
interventions (MBIs) often adopt Kabat-Zinn’s (1994) tions associated with a reliance on self-report measures
definition of mindfulness as the intentional self-regulation (especially of mindfulness itself; Davidson & Kaszniak,
of attention to the present moment without judgment. 2015; Grossman, 2008), and a host of study design fea-
Mindfulness meditation was initially introduced in tures that have largely not improved over time (e.g.,
the Western biomedical context for the treatment of small sample sizes, lack of active controls, lack of treat-
chronic pain (Kabat-Zinn, 1982). Since then, numerous ment fidelity assessment; Goldberg et al., 2017). Because
interventions based on the cultivation of mindfulness of these concerns, some researchers have questioned
through various forms of meditation practice have been whether evidence actually supports beneficial effects of
developed and tested in randomized controlled trials these practices and, if so, for whom (Farias et al., 2016).
(RCTs). The prototypical MBI, mindfulness-based stress Thus, it seems the question raised by Bishop (2002)
reduction (MBSR; Kabat-Zinn, 2013), has been widely almost two decades ago remains: What do we really
studied and, to some extent, disseminated in clinical and know about MBIs?
nonclinical populations (Bohlmeijer et al., 2010; Chiesa
& Serretti, 2009). Although mindfulness meditation was
not originally developed to treat illness (Harrington &
Evaluating the Evidence Base for MBIs
Dunne, 2015), MBIs have been used for the treatment The confluence of hundreds of RCTs testing MBIs
of various psychiatric disorders (e.g., mindfulness- (Strohmaier, 2020) with ongoing criticism of the evi-
based cognitive therapy for depression; Segal et  al., dence base highlights the need for a comprehensive and
2013) and physical health conditions (e.g., mindfulness- systematic evaluation of this literature. Meta-analysis has
based cancer recovery; Carlson et al., 2013) and as a become the gold standard method for quantitatively
prevention strategy in the general population (e.g., synthesizing experimental research in medicine, psy-
university students; Galante et  al., 2018). Extensive chology and many other disciplines (Higgins & Green,
experimental research has examined the effects of 2008). Indeed, meta-analyses have become an increas-
MBIs, including through large-scale RCTs (Kuyken ingly large proportion of the MBI literature. In 2019, 46
et al., 2015; Segal et al., 2020). A growing number of studies appeared in PubMed with the term mindfulness
meta-analyses have aggregated the effects of MBIs (see and the publication type meta-analysis, whereas only
Fig. S1 in the Supplemental Material available online). 149 studies appeared with the publication type clinical
Because of the evidence derived from RCTs and meta- trial (see Fig. S1 in the Supplemental Material). The
analyses, one MBI—mindfulness-based cognitive ther- sheer number of RCTs and meta-analyses makes it dif-
apy (MBCT; Segal et al., 2013)—is included in the United ficult to draw firm conclusions. Moreover, meta-analyses
Kingdom’s National Institute for Health and Care Excel- of this literature have at times come to contrasting con-
lence (2009) guidelines for depression treatment and clusions even when evaluating theoretically similar con-
listed as an evidence-based treatment for depression with structs and presumably somewhat overlapping primary
strong research support by the American Psychological studies (e.g., prosocial effects of meditation; Donald
Association Society of Clinical Psychology (Goldberg & et al., 2019; Kreplin et al., 2018). Given the volume of
Segal, n.d.). research in this area, a review of meta-analyses can
In tandem with growing popular and scientific inter- provide a comprehensive depiction of the literature far
est surrounding mindfulness meditation and MBIs, there beyond a single meta-analysis while also identifying
has been ongoing criticism of these approaches and potential gaps and highlighting methodological trends
their evidence base. A recent consensus statement from to guide both future RCTs and meta-analyses. System-
15 researchers working in this area highlighted impor- atic reviews of meta-analyses have been conducted to
tant conceptual issues related to how mindfulness has evaluate the empirical status of other commonly used
been defined and persistent methodological shortcom- psychological interventions (e.g., cognitive behavioral
ings in the empirical literature (Van Dam et al., 2018). therapy; Butler et al., 2006; Hofmann et al., 2012). To
Van Dam and colleagues (2018) argued that public con- our knowledge, no such review exists for MBIs.
sumers may be “harmed, misled, and disappointed” In the current study, we aimed to systematically review
(p. 36) by the gap between popular media representa- meta-analyses of RCTs testing MBIs. The overall goal was
tions of mindfulness meditation and actual engagement to clarify strengths and weaknesses of both the primary
with these practices and interventions. The authors RCTs and the meta-analyses themselves, highlighting
(and more recently, Baer et  al., 2019) also noted the areas of consistency and inconsistency. We hoped to
lack of acknowledgment of potential adverse effects. assess the empirical status of MBIs using methods similar
Empirical Status of Mindfulness 3

to those that have been used to evaluate other psycho- MBIs as training that includes the cultivation of a pres-
therapeutic approaches (e.g., cognitive behavioral ther- ent-moment focus through the engagement in sustained
apy; Butler et al., 2006). Specifically, we aimed to catalog meditation practice (i.e., not a single mindfulness
and summarize (a) effect size estimates, (b) heterogene- induction; Leyland et al., 2018). Like Dunning et al., we
ity, (c) tests of moderation, (d) assessment of bias (pub- required mindfulness practice to be the central compo-
lication bias and risk of bias), and (e) reports of adverse nent of the intervention (i.e., unlike acceptance and
effects. Following recommendations from the Cochrane commitment therapy, Hayes et al., 1999, or dialectical
Collaboration, these features were examined across behavior therapy, Linehan, 1993, which would be con-
populations, problems, interventions, comparisons, and sidered “mindfulness-informed,” Crane et  al., 2017,
outcomes (i.e., PICOS; Higgins & Green, 2008). In addi- p. 991). Beyond these requirements, no restrictions were
tion, similar to recent evaluations of statistical power in placed on the specific type of MBI (i.e., not restricted
neuroscience (Button et  al., 2013), we also sought to to MBSR or MBCT) or the delivery format (e.g., training
assess the statistical power of meta-analyses conducted could be delivered through mobile health technology;
in this area. We hoped such a comprehensive review Spijkerman et al., 2016).
could provide guidance for both RCTs and meta-analyses For comparisons, meta-analyses including both pas-
in this area. sive (e.g., waitlist) and active (e.g., other therapies) con-
trol conditions were eligible. However, meta-analyses
were excluded if they reported only results that com-
Method bined passive and active controls because the inferences
that each type of comparison allows differ markedly.
Protocol and registration Passive controls estimate intervention effects relative to
This systematic review was registered through the OSF the passage of time or related potential confounds (e.g.,
(https://osf.io/eafy7/). We made four deviations to the regression to the mean, normal recovery), and active
protocol. First, we restricted our review to meta-analyses controls additionally estimate intervention effects beyond
of RCTs because a reasonably large number of eligible nonspecific treatment ingredients (e.g., meeting with an
meta-analyses were available to allow this more strin- instructor or group, expectancy; Wampold & Imel, 2015).
gent requirement. Second, we did not code meta-analyst Robust meta-analytic evidence confirms that the strength
allegiance or meta-analysis quality because we were of the comparison group moderates the magnitude of
unable to find established methods for doing so that effects in MBIs (Goldberg et al., 2018). No restrictions
we felt would meaningfully add to the review. Third, were placed on outcome type.
we reported representative effect sizes by PICOS along To characterize the evidence base across PICOS,
with the range of effect sizes (rather than the range results were summarized by PICOS subcategory. To
alone) to more accurately estimate the effects of MBIs. strengthen the precision of our results, we adopted the
Fourth, we reported additional data beyond effect sizes Agency for Healthcare Research and Quality recom-
(heterogeneity, moderators, publication bias, risk of mendation of requiring at least four primary studies (Fu
bias, adverse effects, statistical power). We followed the et al., 2011). No restriction was placed on the publica-
Preferred Reporting Items for Systematic Reviews and tion status of the meta-analysis (i.e., dissertations were
Meta-Analyses (PRISMA) guidelines (Moher et al,. 2009). eligible), and results were not restricted by publication
language.
Eligibility criteria
We aimed to include all meta-analyses examining the Information sources
effects of MBIs tested through RCTs across the range
We searched six databases (PubMed, Scopus, Web of
of PICOS subcategories (with the exception of study
Science, Cochrane Database of Systematic Reviews,
design, which was restricted to RCTs). Eligible studies
CINAHL, PsycINFO) for meta-analyses published up to
had to report effect sizes in standardized units that
September 12, 2019.
could be converted to Cohen’s d (e.g., odds ratio, cor-
relation coefficient; Borenstein et al., 2009) along with
a 95% confidence interval (CI). In terms of PICOS sub-
Search
categories, no restrictions were made regarding the
population or problem being studied. Interventions We used the search terms “mindful*” and “meta-analy*.”
were restricted to MBIs. We followed definitional Search terms and fields searched for each of the six
boundaries of MBIs laid out by Crane et al. (2017) and databases are included in Table S1 in the Supplemental
implemented by Dunning et al. (2019) that characterize Material.
4 Goldberg et al.

Study selection instances in which Cohen’s d was adjusted for small


sample bias (i.e., yielding Hedges’s g; Borenstein et al.,
Titles and/or abstracts of potentially eligible studies 2009), the adjusted effect size was used. Alternative
were independently coded by S. B. Goldberg and K. M. standardized effect sizes (e.g., odds ratio, correlation
Riordan. Disagreements were discussed until a consen- coefficient) were converted into Cohen’s d using stan-
sus was reached. dard methods (Borenstein et al., 2009). I 2 was used as
the metric of heterogeneity, reflecting the proportion
Data collection process of variance in effects that occurs between studies
(Borenstein et al., 2009). The magnitude of Cohen’s d
Standardized spreadsheets were developed for coding and I 2 were interpreted according to established guide-
all study-level data. Two coders with doctoral degrees lines (Cohen, 1988; Higgins et al., 2003). As discussed
in psychology and experience conducting meta-analysis below, second-order meta-analysis (Schmidt & Oh,
coded all study data. Data were extracted independently 2013) was not possible because of the overlap of pri-
by S. B. Goldberg and S. Sun. Interrater reliabilities were mary studies (i.e., first-order meta-analyses were not
in the good to excellent range (i.e., κs and intraclass independent). However, all extracted effect sizes were
correlation coefficients > .60; Cicchetti, 1994). When a themselves based on nonoverlapping primary studies
meta-analysis was otherwise eligible but necessary data (i.e., per standard meta-analytic methods, primary stud-
for computing a standardized effect size and associated ies are not duplicated in meta-analyses; Borenstein
CI were not available, we contacted study authors. et al., 2009).
Similar to procedures used by Button et al. (2013) to
Data items evaluate primary studies in neuroscience, we examined
the statistical power for the included meta-analytic
All eligible effect sizes (i.e., based on four or more RCTs effect size estimates using standard formulas for a ran-
testing MBIs vs. a passive or active control condition) dom effect meta-analysis (Valentine et al., 2010). Spe-
were extracted. To evaluate the strength of the evi- cifically, we determined the observed statistical power
dence, for each effect size, we also coded the associated provided for each effect size on the basis of the size of
confidence interval, estimate of heterogeneity (i.e., I 2), the effect, sample size (number of studies, number of
number of studies and participants represented, and participants), and degree of heterogeneity.
results of publication bias tests (i.e., influence of poten-
tially unpublished studies). To evaluate potential mod-
erating variables, for each effect size, we also coded Synthesis of results
results of moderation tests (i.e., study-level character- We considered a variety of approaches for synthesizing
istics predicting effect sizes; Borenstein et al., 2009). To effect sizes and other data extracted from the eligible
characterize effects on the basis of PICOS, for each studies. As noted by Cooper and Koenka (2012), no
effect size, we coded the sample population according definitive, established method for this task exists.
to demographic characteristics (e.g., children and ado- Although some previous reviews have conducted a
lescents) and/or problem (e.g., breast cancer), the second-order meta-analysis by quantitatively combining
assessment time point (i.e., at posttreatment or follow- results across included meta-analyses (e.g., Wilson &
up), the intervention type, the comparison type, and the Lipsey, 2001), this approach has the substantial limita-
outcome assessed (e.g., pain intensity, depression). Com- tion of overrepresenting studies published earlier (that
parison type was coded as passive or active, with active may be more likely to appear in multiple meta-analyses)
comparisons further disaggregated into other therapies and overestimating the precision of the observed effects
(i.e., specific active controls; Goyal et  al., 2014) and (by allowing duplicating of individual studies). Second-
evidence-based treatments (i.e., cognitive behavioral order meta-analysis has been recommended for litera-
therapy, antidepressants; Goldberg et al., 2018). tures that are entirely distinct (e.g., validity of personality
Meta-analysis-level characteristics were also coded, measures across countries; Schmidt & Oh, 2013). More-
including the focus of the review (i.e., PICOS), MBI over, we were specifically interested not only in evalu-
type, sample population and/or problem, and, when ating MBIs but also in evaluating the meta-analytic
available, risk of bias (e.g., selective reporting, blinding; literature itself, examining patterns in findings and
Higgins & Green, 2008) and reports of adverse events. methodologies across often independently conducted
meta-analyses (in some ways akin to replications across
research labs; Open Science Collaboration, 2012). In
Summary measures an effort to balance representing the breadth and vari-
The primary effect size measure used was the standard- ability in the meta-analytic literature with providing
ized mean difference (i.e., Cohen’s d; Cohen, 1988). In interpretable estimates of the magnitude of effects, we
Empirical Status of Mindfulness 5

report both the range of effect sizes and a representa- Note that a single meta-analysis could have multiple
tive effect size estimate for each PICOS subcategory. areas of focus (e.g., effects of MBCT in the prevention
The representative effect size estimate was based on of depressive relapse has an intervention and problem
the largest number of studies, which in theory should focus; Kuyken et al., 2016). For both comparisons with
provide the most precise and reliable effect size for active and passive controls, the most common popula-
each PICOS subcategory. 2 tion was adults (k = 39 meta-analyses), the most com-
The specific PICOS subcategories examined were mon problem was psychiatric conditions (k = 20), the
determined using an inductive approach based on the most common intervention included more than one
eligible meta-analyses. We aimed to maximize repre- type of MBI (k = 23), and the most common outcome
sentation of the included meta-analyses while avoiding was psychiatric symptoms (k = 33).
an overwhelming number of subcategories. Thus, we Of the 160 effect sizes, most were posttreatment
examined six population types, 11 problem types, five effects (k = 118), with 42 representing effects at follow-
intervention types, and eight outcome types. Results up. For meta-analyses including follow-up effect sizes,
were subdivided by comparison type (passive, active, when reported, the average length of follow-up was
specific active, and evidence-based treatment). 7.19 months (SD = 3.30, range = 2.25–12.00). Approxi-
Estimates of heterogeneity were reported for PICOS mately half of the effect sizes were from comparisons
subcategories and summarized for passive and active with passive controls (k = 82), with the remainder from
controls. Results of moderator tests, publication bias, comparisons with active controls (k = 78). Of the active
risk of bias, and adverse effects reporting were sum- controls, 46 comparisons were with specific active con-
marized across the included meta-analyses (i.e., across trols, and 11 were with evidence-based treatments.
PICOS). Statistical power was summarized for passive Primary studies included across the 44 meta-analyses
and active controls separately. had an average sample size of 90.72 (SD = 83.99, range =
13–551). The majority of primary studies were con-
ducted in North America (52.7%), with 28.0% in Europe,
Results 8.1% in Asia, 5.4% in Oceania (e.g., Australia or New
Zealand), 4.8% in the Middle East, 0.6% in multiple
Study selection regions, and 0.3% in Africa.
A total of 2,037 citations were retrieved and evaluated.
After application of the exclusion criteria (see PRISMA
Results of individual studies
flow diagram in Fig. S2 in the Supplemental Material),
44 meta-analyses were retained for analysis with 160 For each included meta-analysis, effect size estimates
effect size estimates. Thirty-nine potentially eligible and CIs are reported in Table S3 in the Supplemental
meta-analyses were excluded because of combined pas- Material. All included PICOS and their associated sub-
sive and active controls. A total of 336 unique primary categories are reported in Table S4 in the Supplemental
studies and 30,483 participants were represented across Material.
the 44 meta-analyses. As shown in Figure S3 in the
Supplemental Material, there was considerable overlap
Synthesis of results
in the primary studies included across meta-analyses,
making second-order meta-analysis not feasible. Effect sizes by PICOS.  Effect sizes separated by PICOS
Included studies were published between 2010 and and time point are reported in Tables 1 to 4, Figures 1 to
2019. 3, Tables S5 to S8 in the Supplemental Material, and Fig-
ures S1 to S4 in the Supplemental Material. As shown in
Figure S4, there was wide variability across PICOS sub-
Study characteristics categories in the number of available meta-analyses
All meta-analysis-level and effect-size-level data are (range = 1–26) and effect size estimates (range = 1–53).
shown in Tables S2 and S3 in the Supplemental Material. Likewise, for the representative effect sizes (i.e., those
Meta-analyses included an average of 17.68 studies based on the largest number of studies for each PICOS
(SD = 25.14, range = 4–142) and 1,657 participants subcategory), there was wide variability in the number of
(SD = 2,203, range = 115–12,005). The majority (56.8%) primary studies (range = 4–89) and the sample size from
of the included meta-analyses were focused on a spe- these primary studies (range = 115–5,748; Tables 1–4).
cific problem, 15.9% on a particular population, 31.8%
on a particular intervention (e.g., MBCT) or intervention Comparison with passive controls.
delivery format (e.g., mobile health), 15.9% on a par- Posttreatment. Representative effect sizes indicated
ticular comparison, and 20.5% on a particular outcome. that MBIs, on the whole, compared favorably with passive
6
Table 1.  Posttreatment Comparisons With Passive Controls Across PICOS

ESall
PICOS category and
subcategory kall ESall Min Max Rep study krep nrep ESrep 95% CIrep I 2rep
Population  
 Children 1 2 0.10 0.38 Dunning et al. (2019) 11 1,501 0.10 [0.04, 0.16] 67.99
 Adults 26 53 0.21 1.27 Goldberg et al. (2018) 89 5,748 0.55 [0.47, 0.63] 58
  Older adults 1 1 0.74 0.74 Li & Bressington (2019) 4 330 0.74 [−0.20, 1.68] 92
 Employees 1 1 0.43 0.43 Phillips et al. (2019) 4 — 0.43 [0.20, 0.66] 17.14
  Health care 1 1 0.39 0.39 Chen et al. (2019) 4 624 0.39 [0.09, 0.68] 41
 Students 2 2 0.39 0.49 Halladay et al. (2019) 20 1,266 0.49 [0.30, 0.68] 59
Problem  
 Psychiatric 11 22 0.24 1.27 Goldberg et al. (2018) 89 5,748 0.55 [0.47, 0.63] 58
 Physical 13 32 0.21 1.13 Goldberg et al. (2018) 24 1534 0.45 [0.30, 0.60] 46
 Cancer 6 20 0.21 1.13 Cillessen et al. (2019) 20 2,346 0.40 [0.29, 0.52] 38.9
 Pain 5 9 0.24 0.78 Goldberg et al. (2018) 24 1534 0.45 [0.30, 0.60] 46
 Weight/eating 1 1 0.79 0.79 Goldberg et al. (2018) 5 226 0.79 [0.44, 1.15] 82
 Psychotic 1 1 0.50 0.5 Goldberg et al. (2018) 7 456 0.50 [0.23, 0.76] 46
 Anxiety 1 1 0.89 0.89 Goldberg et al. (2018) 8 472 0.89 [0.62, 1.17] 81
 Depression 4 4 0.49 1.27 Goldberg et al. (2018) 30 2,369 0.59 [0.46, 0.73] 35
  MDD relapse — — — — — — — — — —
  Substance use 1 1 0.35 0.35 Goldberg et al. (2018) 5 149 0.35 [−0.06, 0.76] 69
 Smoking — — — — — — — — — —
Interventions  
  Various MBIs 17 28 0.08 1.27 Goldberg et al. (2018) 89 5,748 0.55 [0.47, 0.63] 58
 MBSR 7 16 0.29 1.05 Teleki (2010) 12 613 0.54 [0.33, 0.75] —
 MBCT 2 2 0.49 0.76 Lenz et al. (2016) 16 — 0.76 [0.56, 0.95] 51.08
 MBSR/MBCT 12 29 0.21 1.05 Lenz et al. (2016) 16 — 0.76 [0.56, 0.95] 51.08
 mHealth 2 2 0.43 0.54 Spijkerman et al. (2016) 7 1,174 0.54 [0.27, 0.82] 85.18
Outcome  
  Psychiatric symptoms 20 36 0.08 1.27 Goldberg et al. (2018) 89 5,748 0.55 [0.47, 0.63] 58
 Stress 3 3 0.33 0.54 Cillessen et al. (2019) 20 2,346 0.40 [0.29, 0.52] 38.9
  Physical symptoms 7 9 0.23 0.78 Goldberg et al. (2018) 24 1,534 0.45 [0.30, 0.60] 46
 Physiology 1 1 0.48 0.48 Sanada et al. (2016) 4 115 0.48 [−0.39, 1.35] 79
 Well-being 1 1 0.21 0.21 Haller et al. (2017) 7 958 0.21 [0.04, 0.39] 41
 Mindfulness 5 5 0.24 0.52 Goldberg et al. (2019) 25 1,415 0.52 [0.40, 0.64] 17.45
 Objective 1 1 0.48 0.48 Sanada et al. (2016) 4 115 0.48 [−0.39, 1.35] 79
 Sleep 2 2 0.23 0.38 Haller et al. (2017) 4 504 0.23 [0.05, 0.40] 0

Note: PICOS = populations, problems, interventions, comparisons, outcomes, and study design; subcategory = PICOS subcategory; kall = number of meta-analyses
providing effect size for PICOS subcategory; min = minimum effect size for subcategory; max = maximum effect size for subcategory; rep study = meta-analysis
that included the effect size based on the largest number of studies for PICOS subcategory; krep = number of studies in representative effect size; nrep = number
of participants for representative effect size; ESrep = representative effect size; 95% CIrep = confidence interval for representative effect size; I 2rep = heterogeneity
for representative effect size; MDD = major depressive disorder; MBIs = mindfulness-based interventions; MBSR = mindfulness-based stress reduction; MBCT =
mindfulness-based cognitive therapy; mHealth = mobile health.
Table 2.  Follow-Up Comparisons With Passive Controls Across PICOS

ESall
PICOS category and
subcategory kall ESall Min Max Rep study krep nrep ESrep 95% CIrep I 2rep
Population  
 Adults 12 22 0.19 1.18 Goldberg et al. (2018) 37 5,748 0.50 [0.36, 0.65] 80
 Employees 2 2 0.32 0.34 Spinelli et al. (2019) 7 — 0.34 [0.17, 0.52] 0
  Health care 1 1 0.34 0.34 Spinelli et al. (2019) 7 — 0.34 [0.17, 0.52] 0
Problem  
 Psychiatric 6 11 0.27 1.18 Goldberg et al. (2018) 37 5,748 0.50 [0.36, 0.65] 80
 Physical 5 10 0.19 0.48 Goldberg et al. (2018) 12 1,534 0.48 [0.19, 0.78] 54
 Cancer 4 9 0.19 0.32 Cillessen et al. (2019) 11 1,435 0.30 [0.14, 0.45] 46.1
 Pain 1 1 0.48 0.48 Goldberg et al. (2018) 12 1,534 0.48 [0.19, 0.78] 54
 Psychotic 1 1 1.18 1.18 Goldberg et al. (2018) 4 456 1.18 [0.71, 1.65] 97
 Depression 5 6 0.45 0.97 Goldberg et al. (2018) 12 2,369 0.55 [0.25, 0.84] 60
  MDD relapse 1 1 0.65 0.65 Galante et al. (2013) 4 307 0.65 [0.38, 0.89] 0
Intervention  
  Various MBIs 5 9 0.27 1.18 Goldberg et al. (2018) 37 5,748 0.50 [0.36, 0.65] 80
 MBSR 1 4 0.27 0.32 Schell et al. (2019) 7 1,094 0.28 [0.07, 0.49] —
 MBCT 4 5 0.45 0.97 Chiesa & Serretti (2011) 4 326 0.66 [0.32, 0.98] 39
 MBSR/MBCT 7 13 0.19 0.97 Schell et al. (2019) 7 1,094 0.28 [0.07, 0.49] —
 mHealth 1 1 0.32 0.32 Stratton et al. (2017) 4 215 0.32 [−0.09, 0.73] 0
Outcome  
  Psychiatric symptoms 11 18 0.19 1.18 Goldberg et al. (2018) 37 5,748 0.50 [0.36, 0.65] 80
 Stress 2 2 0.3 0.32 Cillessen et al. (2019) 11 1,435 0.30 [0.14, 0.45] 46.1
  Physical symptoms 2 2 0.27 0.48 Goldberg et al. (2018) 12 1,534 0.48 [0.19, 0.78] 54
 Mindfulness 2 2 0.34 0.52 Spinelli et al. (2019) 7 — 0.34 [0.17, 0.52] 0
 Sleep 1 1 0.27 0.27 Schell et al. (2019) 4 654 0.27 [−0.08, 0.63] —

Note: Rows for children, older adults, students, weight/eating, anxiety, substance use, smoking, physiology, well-being, and objective are not included
because there were no applicable data. PICOS = populations, problems, interventions, comparisons, outcomes, and study design; subcategory = PICOS
subcategory; kall = number of meta-analyses providing effect size for PICOS subcategory; min = minimum effect size for subcategory; max = maximum effect
size for subcategory; rep study = meta-analysis that included the effect size based on the largest number of studies for PICOS subcategory; krep = number of
studies in representative effect size; nrep = number of participants for representative effect size; ESrep = representative effect size; CIrep = confidence interval for
representative effect size; I 2rep = heterogeneity for representative effect size; MDD = major depressive disorder; MBIs = mindfulness-based interventions; MBSR =
mindfulness-based stress reduction; MBCT = mindfulness-based cognitive therapy; mHealth = mobile health.

7
8
Table 3.  Posttreatment Comparisons With Active Controls Across PICOS

ESall
PICOS category and
subcategory kall ESall Min Max Rep study krep nrep ESrep 95% CIrep I 2rep
Population  
 Children 1 10 −0.07 0.47 Dunning et al. (2019) 17 1,762 0.20 [0.14, 0.26] 67.08
 Adults 18 42 −0.22 0.63 Goldberg & Tucker (2020) 58 5,627 0.13 [0.03, 0.23] 69.7
 Employees 1 1 0.22 0.22 Spinelli et al. (2019) 9 — 0.22 [0.03, 0.42] 0
  Health care 1 1 0.22 0.22 Spinelli et al. (2019) 9 — 0.22 [0.03, 0.42] 0
 Students 1 3 −0.13 0.08 Halladay et al. (2019) 9 830 −0.04 [−0.22, 0.13] 29
Problem  
 Psychiatric 13 31 −0.18 0.63 Goldberg & Tucker (2020) 58 5,627 0.13 [0.03, 0.23] 69.7
 Physical 4 8 −0.02 0.24 Khoo et al. (2019) 17 1,221 0.02 [−0.53, 0.59] —
 Cancer 1 2 0.09 0.15 Cillessen et al. (2019) 5 518 0.15 [−0.02, 0.32] 0
 Pain 3 5 −0.02 0.24 Khoo et al. (2019) 17 1,221 0.02 [−0.53, 0.59] —
 Weight/eating 1 1 0.08 0.08 Goldberg et al. (2018) 5 437 0.08 [−0.24, 0.39] 0
 Anxiety 2 3 −0.18 0.17 Goldberg et al. (2018) 5 362 −0.18 [−0.41, 0.06] 38
 Depression 4 5 −0.01 0.54 Lenz et al. (2016) 16 — 0.54 [0.36, 0.73] 46.15
  Substance use 2 4 0.27 0.63 Goldberg et al. (2018) 7 900 0.27 [0.02, 0.53] 18
 Smoking 1 1 0.42 0.42 Goldberg et al. (2018) 4 587 0.42 [0.20, 0.64] 11
Intervention  
  Various MBIs 17 52 −0.22 0.63 Goldberg & Tucker (2020) 58 5,627 0.13 [0.03, 0.23] 69.7
 MBSR 1 3 −0.02 0.24 Khoo et al. (2019) 17 1,221 0.02 [−0.53, 0.59] —
 MBCT 2 2 0.002 0.54 Lenz et al. (2016) 16 — 0.54 [0.36, 0.73] 46.15
 MBSR/MBCT 4 6 −0.02 0.54 Khoo et al. (2019) 17 1,221 0.02 [−0.53, 0.59] —
 mHealth 1 1 0.32 0.32 Martin et al. (2018) 4 386 0.32 [−0.01, 0.66] 63
Outcome  
  Psychiatric symptoms 17 37 −0.18 0.63 Goldberg & Tucker (2020) 58 5,627 0.13 [0.03, 0.23] 69.7
 Stress 3 4 0.08 0.18 Dunning et al. (2019) 9 844 0.18 [0.05, 0.31] 0
  Physical symptoms 5 6 −0.03 0.33 Khoo et al. (2019) 17 1,221 0.02 [−0.53, 0.59] —
 Physiology 1 6 0.04 0.26 Pascoe et al. (2017) 5 298 0.16 [−0.07, 0.39] 0
 Mindfulness 3 3 0.1 0.42 Goldberg et al. (2019) 30 2,863 0.25 [0.11, 0.38] 59.85
 Objective 2 8 0.04 0.26 Dunning et al. (2019) 7 958 0.10 [−0.03, 0.23] 5.1
 Sleep 1 1 −0.03 −0.03 Rusch et al. (2019) 7 716 −0.03 [−0.49, 0.43] 88

Note: Rows for older adults, psychotic, major depressive disorder relapse, and well-being are not included because there were no applicable data. PICOS = populations,
problems, interventions, comparisons, outcomes, and study design; subcategory = PICOS subcategory; kall = number of meta-analyses providing effect size for PICOS
subcategory; min = minimum effect size for subcategory; max = maximum effect size for subcategory; rep study = meta-analysis that included the effect size based on
the largest number of studies for PICOS subcategory; krep = number of studies in representative effect size; nrep = number of participants for representative effect size;
ESrep = representative effect size; CIrep = confidence interval for representative effect size; I 2rep = heterogeneity for representative effect size; MBIs = mindfulness-based
interventions; MBSR = mindfulness-based stress reduction; MBCT = mindfulness-based cognitive therapy; mHealth = mobile health.
Table 4.  Follow-Up Comparisons With Active Controls Across PICOS

ESall
PICOS category and
subcategory kall ESall Min Max Rep study krep nrep ESrep 95% CIrep I2rep
Population  
 Adults 7 18 −0.14 0.52 Goldberg et al. (2018) 29 3810 0.29 [0.13, 0.45] 72
Problem  
 Psychiatric 6 16 −0.14 0.52 Goldberg et al. (2018) 29 3810 0.29 [0.13, 0.45] 72
 Physical 2 3 0.01 0.18 Goldberg et al. (2018) 8 946 0.18 [−0.07, 0.44] 51
 Cancer 1 1 0.01 0.01 Cillessen et al. (2019) 7 772 0.01 [−0.14, 0.15] 0
 Pain 1 1 0.18 0.18 Goldberg et al. (2018) 8 946 0.18 [−0.07, 0.44] 51
 Weight/eating 1 1 0.18 0.18 Goldberg et al. (2018) 5 437 0.18 [−0.16, 0.53] 74
 Depression 4 6 0.04 0.35 Goldberg et al. (2018) 7 1,064 0.04 [−0.13, 0.20] 0
  MDD relapse 1 2 0.16 0.17 Kuyken et al. (2016) 5 892 0.16 [0.01, 0.31] 0
  Substance use 1 1 0.38 0.38 Goldberg et al. (2018) 4 900 0.38 [0.00, 0.76] 73
Intervention  
  Various MBIs 5 15 −0.14 0.52 Goldberg et al. (2018) 29 3,810 0.29 [0.13, 0.45] 72
 MBCT 3 4 0.16 0.26 Lenz et al. (2016) 7 — 0.16 [0.01, 0.30] 0
 MBSR/MBCT 3 4 0.16 0.26 Lenz et al. (2016) 7 — 0.16 [0.01, 0.30] 0
Outcome  
  Psychiatric symptoms 8 17 −0.14 0.52 Goldberg et al. (2018) 29 3,810 0.29 [0.13, 0.45] 72
 Stress 1 1 0.01 0.01 Cillessen et al. (2019) 7 772 0.01 [−0.14, 0.15] 0
  Physical symptoms 2 2 −0.14 0.18 Goldberg et al. (2018) 8 946 0.18 [−0.07, 0.44] 51
 Mindfulness 1 1 0.1 0.1 Goldberg et al. (2019) 13 1430 0.1 [−0.08, 0.28] 58.54
 Sleep 1 1 −0.14 −0.14 Rusch et al. (2019) 4 527 −0.14 [−0.62, 0.34] 84

Note: Rows for children, older adults, employees, health care, students, psychotic, anxiety, smoking, mindfulness-based stress reduction, mobile health, physiology,
well-being, and objective are not included because there were no applicable data. PICOS = populations, problems, interventions, comparisons, outcomes, and study
design; subcategory = PICOS subcategory; kall = number of meta-analyses providing effect size for PICOS subcategory; min = minimum effect size for subcategory;
max = maximum effect size for subcategory; rep study = meta-analysis that included the effect size based on the largest number of studies for PICOS subcategory;
krep = number of studies in representative effect size; nrep = number of participants for representative effect size; ESrep = representative effect size; CIrep = confidence
interval for representative effect size; I 2rep = heterogeneity for representative effect size; MDD = major depressive disorder; MBIs = mindfulness-based interventions;
MBCT = mindfulness-based cognitive therapy.

9
10
a b
Older Adults Adults
Adults
Healthcare
Students
Population

Employees Employees

Population
Healthcare
Children Psychotic

Anxiety MDD relapse


Weight/Eating Depression
Depression
Psychiatric
Psychiatric
Problem

Psychotic Pain

Problem
Pain
Physical
Physical
Cancer Cancer
Substance Use
MBCT
MBSR/MBCT
Various MBIs
MBCT
Various MBIs mHealth
Interv

Interv
mHealth
MBSR/MBCT
MBSR
MBSR
Psych Symptoms
Mindfulness Psych Symptoms
Objective
Phys Symptoms
Physiology
Phys Symptoms Mindfulness
Outcome
Outcome

Stress
Stress
Sleep
Well-Being Sleep

0.0 0.5 1.0 1.5 0.0 0.5 1.0 1.5


Effect Size (d ) Effect Size (d )

Fig. 1.  Comparisons with passive controls at posttreatment (a) and at follow-up (b) based on the largest number of studies. The size of each point is relative to the number of primary
studies it represents. MBSR = mindfulness-based stress reduction; MBCT = mindfulness-based cognitive therapy; mHealth = mobile health; PMDD = major depressive disorder; Interv =
intervention.
a b
Older Adults Employees
Adults Healthcare
Students Children
Employees
Population

Adults

Population
Healthcare Students
Children
Depression
Anxiety
Smoking
Weight/Eating
Substance Use
Depression
Psychiatric Cancer
Psychotic Psychiatric
Problem

Problem
Pain Weight/Eating
Physical Pain
Cancer Physical
Substance Use Anxiety

MBSR/MBCT MBCT
MBCT mHealth
Various MBIs Various MBIs

Interv
Interv

mHealth MBSR/MBCT
MBSR
MBSR
Psych Symptoms
Mindfulness
Mindfulness
Stress
Objective
Physiology Physiology
Phys Symptoms Psych Symptoms
Outcome
Outcome

Stress Objective
Sleep Phys Symptoms
Well-Being Sleep
0.0 0.5 1.0 −0.25 0.00 0.25 0.50
Effect Size (d ) Effect Size (d )

Fig. 2.  All meta-analytic effect size estimates for comparisons with passive controls (a) and active controls (b) at posttreatment. The representative estimate for each PICOS (i.e.,
based on the largest number of studies) is displayed as a red triangle. PICOS = populations, problems, interventions, comparisons, and outcomes; MBSR = mindfulness-based stress

11
reduction; MBCT = mindfulness-based cognitive therapy; mHealth = mobile health; Psych sx = psychiatric symptoms; Phys = physical symptoms; Interv = intervention.
12
a b
Employees Adults Pop
Healthcare
Children
Substance Use

Population
Adults
Students Psychiatric

Depression Weight/Eating
Smoking
Pain
Substance Use
Problem

Cancer Physical
Psychiatric
MDD Relapse

Problem
Weight/Eating
Pain Depression
Physical
Cancer
Anxiety

MBCT Various MBIs


mHealth
MBCT
Interv

Various MBIs

Interv
MBSR/MBCT MBSR/MBCT
MBSR

Mindfulness Psych Symptoms


Stress Phys Symptoms
Physiology
Psych Symptoms Mindfulness
Outcome

Outcome

Objective Stress
Phys Symptoms
Sleep Sleep

−0.50 −0.25 0.00 0.25 0.50 0.75 −0.4 0.0 0.4 0.8
Effect Size (d ) Effect Size (d )

Fig. 3.  Comparisons with active controls at posttreatment (a) and at follow-up (b) based on the largest number of studies. The size of each point is relative to the number of pri-
mary studies it represents. MBSR = mindfulness-based stress reduction; MBCT = mindfulness-based cognitive therapy; mHealth = mobile health; MDD = major depressive disorder;
Pop = population; Interv = intervention.
Empirical Status of Mindfulness 13

controls across a wide range of PICOS, with some excep- compared with active controls (which ranged from atten-
tions (see Table 1 and Fig. 1). MBIs showed superiority tional controls to evidence-based treatments; see Table
to passive controls for children and adolescents, health 3 and Fig. 3). MBIs showed superiority to active con-
care professionals/trainees, employees, students (i.e., trols for adults, children, employees, and health care
postsecondary or allied health care students), and adults. professionals/trainees (ds = 0.13–0.22). MBIs did not
Statistically significant meta-analytic effect sizes ranged differ from active controls for students (d = −0.04, 95%
from very small (d = 0.10 for children and adolescents) to CI = [−0.22, 0.13]). MBIs showed superiority to active
moderate (d = 0.55, for adults). Although largest in mag- controls for psychiatric disorders, substance use, smok-
nitude (d = 0.74, 95% CI = [−0.20, 1.68]), the effect size for ing, and depression (ds = 0.13–0.42). MBIs did not differ
older adults did not differ from zero and was based on from active controls for physical health conditions, pain,
a small number of studies (k = 4; Table 1). MBIs showed weight/eating-related conditions, cancer, or anxiety (ds =
superiority to passive controls across most problems 0.02–0.15). MBIs showed superiority to active controls
assessed. Statistically significant effect sizes ranged from for MBCT and various MBIs (ds = 0.13–0.54) but not for
small (d = 0.40 for cancer) to large (d = 0.89 for anxiety mobile health, MBSR, or MBSR/MBCT (i.e., meta-analyses
disorders). MBIs did not differ from passive controls for that included either MBSR, MBCT, or a combination of
substance use disorders (d = 0.35, 95% CI = [−0.06, 0.76]). these; ds = 0.02–0.32). MBIs showed superiority to active
MBIs showed superiority to passive controls across all controls for mindfulness, stress, and psychiatric symp-
MBI types (ds = 0.54–0.76). MBIs showed superiority to toms (ds = 0.16–0.25) but not for sleep, physical health
passive controls for most outcome types, with the excep- symptoms, objective measures, or physiological mea-
tion of objective measures and physiological measures sures (ds = −0.03–0.16).
(d = 0.48, 95% CI = [−0.39, 1.35]). Statistically significant Representative effect sizes again tended to occur
meta-analytic effect sizes ranged from small (d = 0.21 for toward the middle of the distribution, with some excep-
well-being) to moderate (d = 0.55 for psychiatric symp- tions (Fig. 2). The effect size for depression appears at
toms). the higher end, and the effect sizes for pain, physical
Figure 2 displays the range of meta-analytic effect health conditions, physical health symptoms, and
size estimates across PICOS. As can be seen, some MBSR/MBCT appear at the lower end.
PICOS subcategories were much more densely repre-
sented by the included meta-analyses than others. When Follow-up.  Similar to passive controls, fewer estimates
multiple meta-analytic estimates were available, the rep- were available at follow-up for active controls. Similar
resentative effect size tended to occur toward the middle to at-posttreatment effect size estimates were generally
of the distribution. One exception was the effect size smaller and less often statistically significant when MBIs
for mindfulness, which appeared at the high end. were compared with active controls (see Table 4 and Fig.
3). MBIs continued to show superiority to active controls
Follow-up. Fewer estimates were available at follow- for adults at follow-up (d = 0.29). MBIs showed superiority
up, although they followed a pattern similar to that to active controls for psychiatric disorders and prevention
found at posttreatment (Table 2). MBIs again compared of relapse in major depressive disorder (ds = 0.16–0.29)
favorably with passive controls across a range of PICOS, but did not differ from active controls for substance use,
with two exceptions (Fig. 1). MBIs showed superiority depression, weight/eating-related disorders, cancer, pain,
to passive controls for adults, health care professionals/ or physical health conditions (ds = 0.01–0.38). All MBI
trainees, and employees (ds = 0.34–0.50). MBIs showed types assessed showed statistically significant effects at
superiority to passive controls across problems assessed, follow-up (ds = 0.16–0.18). In contrast, the effect of MBIs
including physical health conditions, cancer, depression, across outcomes at follow-up may be less uniform. MBIs
pain conditions, psychiatric disorders, relapse of major showed sustained benefits only over active controls for
depressive disorder, and psychotic disorders (ds = 0.30– psychiatric symptoms (d = 0.29) and did not differ from
1.18). MBIs showed superiority to passive controls across active controls on measures of physical health, mindful-
MBI types (ds = 0.28–0.66), with the exception of mobile ness, stress, or sleep (ds = −0.14–0.18).
health (d = 0.32, 95% CI = [−0.09, 0.73]). MBIs showed
superiority to passive controls across outcome types (ds = Comparison with specific active controls.
0.30–0.50), with the exception of sleep (d = 0.27, 95% Posttreatment.  Comparisons with specific active con-
CI = [−0.08, 0.63]). trols followed a pattern similar to active controls gener-
ally (see Table S5 and Fig. S5 in the Supplemental Material).
Comparison with active controls. MBIs showed superiority to specific active controls for all
Posttreatment.  As expected, effect sizes were smaller four populations assessed (children/adolescents, health care
and less often statistically significant when MBIs were professionals/trainees, employees, adults; ds = 0.13–0.26).
14 Goldberg et al.

MBIs showed superiority to active controls for psychiatric moderation. Although other tests of moderation were
disorders, substance use, smoking, and depression (ds = reported, these tests were not associated with eligible
0.16–0.54) but not for physical health conditions, pain, effect sizes (e.g., were conducted using both passive and
weight/eating-related conditions, cancer, or anxiety active controls; Kuyken et al., 2016). Therefore, they were
(ds = −0.18–0.09). MBIs showed superiority to active not considered interpretable. Across the seven meta-anal-
controls for MBCT and various MBIs (ds = 0.13–0.54) yses reporting eligible tests of moderation, 73 tests were
but not for mobile health, MBSR, or MBSR/MBCT (ds = conducted (see Table S9 in the Supplemental Material). A
0.02–0.32). MBIs showed superiority to active controls for minority (17.8%, k = 13) of the moderators tested were
mindfulness and psychiatric symptoms (ds = 0.13–0.25) statistically significant.
but not for stress, physical health symptoms, or sleep Across 29 moderator tests focused on study quality,
(ds = −0.03–0.09). four were statistically significant, and all indicated
smaller effects associated with higher quality studies.
Follow-up.  Available comparisons with specific active Across 13 moderator tests focused on intervention dos-
controls followed an identical pattern to active controls at age, one was statistically significant and indicated a
follow-up (see Table S6 and Fig. S6 in the Supplemental larger effect in longer interventions. Across 13 modera-
Material). This was because representative effect sizes for tor tests that examined participant characteristics, four
active controls at follow-up all used comparisons with were statistically significant, with two finding larger
specific active controls (with the exception of Cillessen effects with younger samples, one finding smaller effects
et al., 2019, leading to an absence of an estimate related with higher percentage female, and one finding larger
to cancer). effects in studies conducted in Asia or South African
compared with other locations. Across 12 moderator
Comparison with evidence-based treatments. tests focused on comparison type, one found larger
Posttreatment.  MBIs did not differ from evidence-based effects when MBIs were compared with nonevidence-
treatments for any PICOS subcategory at posttreatment, based treatments as opposed to when MBIs were com-
with one exception. MBIs showed superiority to evidence- pared with evidence-based treatments. Across three
based treatments for smoking (d = 0.42). All other effect moderator tests comparing effects of MBSR compared
size estimates ranged from d = −0.18 to d = 0.02 (see Table with MBCT, one found no difference, and two found
S7 and Fig. S7 in the Supplemental Material). larger effects in MBCT. In a single moderator test each,
analysis method and therapist experience did not pre-
Follow-up. MBIs did not differ from evidence-based dict outcomes, although higher researcher allegiance to
treatments at follow-up in most PICOS (adults, depres- MBIs was associated with larger effects in favor of MBIs.
sion, psychiatric conditions, various MBIs, psychiatric
symptoms; see Table S8 and Fig. S8 in the Supplemental Publication bias.  The majority of meta-analyses (70.5%,
Material). MBCT, however, did show superiority over evi- k = 31 out of 44; see Table S10 in the Supplemental Mate-
dence-based treatments for the prevention of depressive rial) did not conduct tests of publication bias on an eligible
relapse (d = 0.17; Kuyken et al., 2016). effect size. Among those that did report an eligible test, 13
meta-analyses used a test related to funnel plot asymmetry
Heterogeneity.  Heterogeneity estimates (I 2) were avail- (e.g., Egger’s test). Six studies reported a fail-safe N (i.e.,
able for most of the effect sizes in the included meta- the number of unpublished null findings that would need
analyses (k = 136 out of 160, 85.0%; see Figs. S9 and S10 to exist to nullify an observed effect; Rosenberg, 2005).
in the Supplemental Material). On average, heterogeneity At the effect size level, quantitative assessment of
was moderate at posttreatment and at follow-up for com- publication bias was reported for 41.3% of estimates
parisons with both passive and active controls, although (k = 66 out of 160). Among these, most reported no
also fairly variable (passive controls at posttreatment = evidence of publication bias (57.6%, k = 38), 27.3%
44.81%, SD = 33.46; passive controls at follow-up = 37.60%, indicated an upwardly biased original estimate (“true”
SD = 37.60; active controls at posttreatment = 37.41%, effect size is smaller than estimate; k = 18), 10.6% indi-
SD = 29.85; active controls at follow-up = 44.09%, SD = cated a downwardly biased original estimate (“true”
33.74). When restricted to estimates of heterogeneity effect size is larger than estimate; k = 7), and 4.5% (k =
based on the representative effect sizes, heterogeneity at 3) reported bias but did not indicate the direction. The
posttreatment was high for comparisons with passive significance test for the publication bias adjusted effect
controls (53.40%, SD = 22.12) and moderate for compari- size changed in four instances (ks = 2 for upwardly and
sons with active controls (35.72%, SD = 31.18). downwardly biased original estimates, respectively).

Moderators.  A surprisingly small number of meta- Risk of bias. A measure related to risk of bias was
analyses (k = 7 out of 44; 15.9%) reported eligible tests of included in most meta-analyses (63.6%, k = 28 out of 44;
Empirical Status of Mindfulness 15

see Table S11 in the Supplemental Material). Studies used Statistical power. Data necessary for computing the
several different tools designed to detect risk of bias, meta-analytic statistical power were available for 76.3%
assess methodological quality, and/or evaluate the over- of effect sizes. The average statistical power was exam-
all strength of the evidence. The Cochrane risk-of-bias ined for comparisons with passive and active controls
tool was by far the most commonly used (k = 18), fol- separately (see Fig. S13 in the Supplemental Material). As
lowed by the grading of recommendations, assessment, would be expected, statistical power was typically higher
development, and evaluations tool (k = 5). Four studies for comparisons with passive controls (β = 0.78, SD =
used a version of the Jadad criteria, and six used other 0.29) than comparisons with active controls (β = 0.52,
assessment methods. SD = 0.39). A majority (62.3%) of tests had statistical
Results of Cochrane risk-of-bias assessment were power of at least .80 for comparisons with passive con-
tabulated across meta-analyses (see Table S12 and Fig. trols, whereas 34.4% of tests has statistical power of at
S11 in the Supplemental Material). In no domain was least .80 for comparisons with active controls.
risk of bias consistently rated as low, although the
degree of potential bias varied across domains. Areas
Discussion 
most commonly rated as having high risk for bias were
blinding of personnel/participants (43.6%) and blinding In the current study, we sought to rigorously evaluate
of outcome assessment (39.3%). Examination of meta- the empirical status of MBIs through systematically
analysis-level ratings in these domains reveals a further reviewing the available meta-analytic literature. Our
concern about this aspect of the literature—that is, search yielded 44 meta-analyses that represent 336
potential inconsistency across meta-analysts in how RCTs with 30,483 participants. This literature base is
these domains are interpreted. As reported by Kuyken similar in magnitude to that used in previous large-scale
et  al. (2016), the nature of a behavioral intervention evaluations of psychotherapy generally (k = 375; Smith
such as an MBI made blinding of personnel and par- & Glass, 1977) and cognitive behavioral therapy specifi-
ticipants not possible (see Wampold & Imel, 2015). In cally (k = 332; Butler et al., 2006). Note that unlike these
addition, as reported in the one eligible Cochrane previous reviews, the current review is restricted to
review (Schell et al., 2019), the use of self-report mea- RCTs. Perhaps the most obvious conclusion that can be
sures made blinding of outcomes not possible (i.e., the drawn is simply that the experimental literature for
“assessor” was the participant, who within behavioral MBIs is quite large. This is not a family of interventions
interventions cannot readily be blinded to their group that has gone untested. Thus, the question becomes
assignment; Higgins & Green, 2008). However, as what does the evidence suggest? And what are the
shown in Fig. S11 in the Supplemental Material, these limitations of the literature?
domains were commonly coded as a low or unclear
risk for bias, including in instances in which all out-
Estimates of efficacy
come measures were self-reported (e.g., depression
symptoms; Martin et al., 2018). We evaluated the efficacy of MBIs by assessing the
magnitude of treatment effects relative to passive con-
Adverse effects. Adverse effects were discussed in trols (e.g., waitlist) and active controls (e.g., attentional
34.1% (k = 15 out of 44) of the meta-analyses (see Table control, other therapies). Meta-analytic effect sizes
S13 in the Supplemental Material). Of these, 11 noted a based on the largest number of studies available sug-
lack of reporting of adverse events in primary studies. gest that MBIs compare favorably with passive controls
Five meta-analyses discussed serious adverse events, with across several, but not all, PICOS (Higgins & Green,
four reporting that no serious adverse events occurred 2008). The magnitude of effects at posttreatment ranged
and one reporting serious adverse events did occur. considerably from very small (d = 0.10 for children/
Within the meta-analysis that reported serious adverse adolescents) to large (d = 0.89 for anxiety disorders),
events occurred, Kuyken et  al. (2016) concluded the with most near the moderate range. Effects at follow-up
adverse events were not attributable to the MBI (MBCT). also showed a wide range (ds = 0.30–1.18), with most
Rusch et  al. (2019) also concluded that the nonserious small to moderate in magnitude. On the whole, the
adverse events reported (e.g., worsening of sleep quality, pattern of comparisons with passive controls suggests
muscle soreness) did not indicate increased risk of harm that MBIs may have transdiagnostic relevance, with
for various MBIs for sleep. One meta-analysis reported effects persisting at follow-up. Note that not all PICOS
mild adverse events associated with MBIs for treating low subcategories showed significant effects. In particular,
back pain but did not specify whether this indicated that MBIs did not differ from passive controls for older
MBIs increased risk of harm (e.g., increased pain; Anheyer adults or substance use disorders, or on objective or
et al., 2017). physiological measures at posttreatment, or for sleep
16 Goldberg et al.

or mobile health MBIs at follow-up. In each of these (Goldberg et al., 2018; Kuyken et al., 2016). In general,
cases, the meta-analytic estimates were based on five MBIs performed on par with these therapies at both
or fewer RCTs. Depending on the degree of heterogene- posttreatment and at follow-up. MBIs may outperform
ity (which in some cases was high, e.g., Li & Bressington, evidence-based treatments for smoking cessation and for
2019), such tests are very likely underpowered to detect the prevention of depressive relapse. MBIs may be less
even moderate effects (e.g., post hoc power to detect effective than evidence-based treatments for anxiety,
d = 0.74 in Li and Bressington was 47.9%). although the effect size did not differ from zero (d =
Comparisons with active controls showed less con- −0.18, 95% CI = [−0.41, 0.06]; Goldberg et al., 2018).
sistent evidence for the superiority of MBIs. Significant
effects were observed across several PICOS, with MBIs
Potential sources of bias
outperforming active controls for adults, children/ado-
lescents, depression, smoking, substance use, and psy- In the absence of other potential sources of bias and
chiatric conditions, and on measures of mindfulness, unreliability, these effect sizes support the notion that
stress, and psychiatric symptoms (ds = 0.13–0.54). 3 MBIs may hold promise across a range of PICOS, in
However, many effect sizes for comparisons with active most cases outperforming passive controls and per-
controls were very small and nonsignificant, including forming on par or better than active controls, including
for students, anxiety disorders, cancer, pain, physical other therapies and evidence-based treatments. How-
health conditions, MBSR, mobile health, physiology, ever, additional factors are important to consider when
objective measures, and sleep (ds = −0.18–0.32). Over- evaluating the strength of this evidence. One essential
all, this pattern of evidence suggests that MBIs some- factor to consider is the degree of heterogeneity
times, but not always, show effects beyond those (Higgins & Green, 2008). Although the degree of het-
associated with nonspecific factors (e.g., instructor erogeneity itself was quite variable, on average, the
attention, expectancy; Wampold & Imel, 2015). A simi- meta-analytic estimates reviewed showed a moderate
lar pattern emerged at follow-up, with MBIs showing to high degree of heterogeneity (25 ≥ I 2 ≥ 75%). This
superiority to active controls for some PICOS (e.g., magnitude of heterogeneity is similar to estimates found
adults, psychiatric disorders, depression relapse) but in large-scale meta-analyses of evidence-based psycho-
not others (e.g., weight/eating-related disorders, pain, therapies (e.g., cognitive behavioral therapy, interper-
cancer, stress, sleep). At follow-up, the effect of MBIs sonal psychotherapy; Cuijpers et  al., 2011, 2013). It
for substance use disorders was one of the larger effect nonetheless suggests that there is considerable vari-
sizes (d = 0.38, 95% CI = [0.00, 0.76]) but did not differ ability across the RCTs represented by each effect size.
from zero and was based on only four studies (Goldberg Furthermore, our review of moderators detected no
et al., 2018). study-level characteristics that have been consistently
Comparisons with other therapies provide a more shown to account for this heterogeneity. 4 The degree
rigorous test of efficacy and can address the question of heterogeneity and absence of consistent moderators
facing clinicians and patients who may consider these highlights the need for future meta-analytic work clari-
instead of other interventions. MBIs tended to perform fying study characteristics that explain this variability.
similarly to specific active controls (i.e., other interven- Publication bias and risk of bias are two additional
tions) at posttreatment and at follow-up, with effect potential sources of uncertainty. Unfortunately, publica-
sizes often close to zero (e.g., for cancer, weight/eating- tion bias was formally tested for only 41.3% of the
related conditions, pain, physical health conditions, included effect sizes (k = 66). Among these tests, a
sleep). MBIs did show superiority with very small to sizable minority (27.3%, k = 18) found evidence for
small effect sizes in some PICOS subcategories (across publication bias suggesting upwardly biased original
populations, for depression, substance use, smoking, estimates, although only two of these (i.e., 3.0% of the
psychiatric symptoms, for MBCT), suggesting there may tests conducted) resulted in modified significance tests.
be instances in which MBIs are a preferred approach. Eight publication bias tests suggested downwardly
The pattern was similar at follow-up, with some evi- biased original estimates. Taken together, it seems that
dence of superiority (e.g., for psychiatric disorders and effect sizes may be modestly inflated because of pub-
prevention of depressive relapse). MBIs may be less lication bias, but this source of bias alone is unlikely
effective than other therapies for sleep at follow-up, to account for the observed pattern of findings.
although the effect size did not differ from zero (d = Other sources of bias may be more influential. Per-
−0.14, 95% CI = [−0.62, 0.34]; Rusch et al., 2019). haps the most pernicious is a lack of blind outcome
The theoretically most rigorous test of MBIs is com- assessment, which leaves much of the MBI literature
parison with evidence-based treatments, which included vulnerable to social desirability and other biases associ-
primarily cognitive behavioral therapy or antidepressants ated with self-report. Of course, including nonself-report
Empirical Status of Mindfulness 17

measures is not straightforward for all outcome types. meta-analysts, journal editors, and reviewers will evaluate
Valid behavioral measures are not always available. this important aspect of meta-analyses carefully. Variation
Clinician-rated measures are another option (e.g., in item interpretation makes it impossible to accurately
Kuyken et al., 2016), although these can be costly. None- evaluate these sources of bias.
theless, this is an important future direction for increas- One important criticism raised by Van Dam et  al.
ing the rigor of work in this area both in primary studies (2018) and others (e.g., Baer et al., 2019) is the potential
and meta-analyses (for recent meta-analyses of objective for MBIs to cause harm. Unfortunately, reporting of this
measures, see Pascoe et al., 2017; Treves et al., 2019). was inconsistent both in primary studies and the
Other commonly noted sources of bias in the included included meta-analyses. Better reporting of these out-
studies were incomplete outcome data and selective comes is vital for definitively evaluating safety.
reporting. As is increasingly discussed, selective report- Finally, we assessed meta-analytic statistical power.
ing in particular allows opportunistic bias and can sub- In keeping with concerns regarding small sample sizes
stantially reduce the scientific integrity of a body of in RCTs testing MBIs (Baer, 2003; Goldberg et al., 2017),
literature (DeCoster et  al., 2015). It is crucial that it appears that many meta-analyses are also underpow-
researchers embrace the spirit of open science to ered. Because we restricted our sample to estimates
address these biases (Open Science Collaboration, based on at least four studies, we likely overestimated
2012). We commend those who have begun doing so the average statistical power for meta-analytic effect
(e.g., Lindsay et al., 2019). sizes in this literature, therefore providing an upper
The remaining potential sources of bias are, from bound on the typical power. Tests of moderation within
our perspective, either less influential or unavoidable. these studies are almost certainly commonly underpow-
Random sequence generation and allocation conceal- ered (Borenstein et al., 2009).
ment were commonly rated as of unclear risk of bias,
indicating authors of primary studies are omitting these
aspects of their design in published reports. We hope
Key areas for improvement
that clinical trialists along with journal editors and There is clearly room for improving the evidence base
reviewers become attuned to the necessity of reporting for MBIs. However, on the whole, it seems unlikely the
these details of randomization. sources of bias reviewed here undermine the pattern
The lack of blinding of personnel (e.g., instructors) of efficacy observed for MBIs across numerous, but not
and participants seems largely unavoidable. With few all, PICOS.5 On the basis of the comparisons with active
exceptions (e.g., comparison conditions that involve controls, MBIs appear to hold promise for both adults
sham or dismantled meditation; Lindsay et  al., 2019; and child/adolescent samples and may be particularly
Zeidan et al., 2010), it is typically not possible to blind promising for addressing some psychiatric symptoms
participants and mindfulness instructors to the condi- and disorders (e.g., depression, depressive relapse, sub-
tion they are receiving or providing. Moreover, instruc- stance use, smoking). Evidence was weaker for the
tors delivering treatments that they think will actually superiority of MBIs over active controls for health-
work has been recognized as an important factor com- related conditions and outcomes (e.g., cancer, pain,
mon across various forms of psychological intervention sleep).
(Wampold & Imel, 2015). The challenge of applying the Our results suggest several fruitful directions for
double-blind placebo-controlled design is not unique future RCTs (Table 5). Given the known biases associ-
to MBIs but exists for all behavioral interventions ated with small samples (Button et al., 2013), large-scale
(Wampold et  al., 2005). One potential solution are RCTs conducted and reported in ways that minimize
designs that compare MBIs with other therapies that risk for bias are essential. RCTs focused on older adults,
are intended to be therapeutic (i.e., bona fide treat- mobile health delivery, and physiological measures may
ments; Wampold et al., 1997). However, even for these be particularly valuable given that these areas showed
comparisons, it is crucial that researcher allegiance to promising effect sizes but wide confidence intervals
MBIs be balanced with allegiance to the comparison because they were based on a small number of RCTs.
condition (Goldberg & Tucker, 2020; Munder et  al., Necessary steps for improving the strength of this evi-
2013). dence base include reporting adverse events, including
A final note of concern regarding risk of bias is vari- nonself-report outcomes, conducting intention-to-treat
ability in how these items are interpreted across meta- analyses, and including follow-up assessments. For
analyses. For example, some authors coded self-report MBIs with established efficacy (e.g., MBCT for preven-
outcomes as blinded (e.g., Martin et  al., 2018), which tion depression relapse), dissemination and implemen-
seems inaccurate when the participant is aware of tation RCTs may be appropriate (Dimidjian & Segal,
the received intervention. Again, we hope that future 2015).
18 Goldberg et al.

Table 5.  Recommendations for Future Research

Recommendations for randomized controlled trials


  Increase sample sizes
  Report details of randomization procedure
  Use intention-to-treat analyses
  Embrace open science practices
  Study MBIs for older adults
  Test mHealth delivery formats
  Include nonself-report and physiological measures
  Assess and report adverse events
  Study dissemination and implementation for established MBIs (e.g., MBCT)
Recommendations for meta-analyses
  Avoid combining passive and active controls
  Test and report moderators based on theory
  Code risk of bias based on standard methods
  Formally assess publication bias
  Consider impact of statistical power in study planning and interpretation
  Study objective measures
  Assess effects at follow-up
  Create publicly available database of MBI RCTs with effect sizes

Note: mHealth = mobile health; MBIs = mindfulness-based interventions; MBCT =


mindfulness-based cognitive therapy.

Several of these recommendations have been voiced focused on objective outcomes and assessing effects at
elsewhere, with little evidence that practices have follow-up would also be welcome contributions. Hav-
improved over time (Goldberg et al., 2017). This signals ing a publicly available database of MBI RCTs with
a need to clearly evaluate barriers to implementing best associated effect sizes (as has been done for psycho-
practices and strategies for encouraging their adoption. therapies for depression; Cuijpers et  al., 2020) could
There are likely influences throughout the research facilitate future large-scale, open science meta-analyses
pipeline (e.g., from graduate training to grant review of this literature.
study sections). Although a full discussion of these fac-
tors is outside the scope of this review, we note that
journal policies are a powerful way to effect change.
Limitations
Strategies adopted to incentivize open science (e.g., Just as meta-analyses are limited by the available pri-
badges for preregistration, methodology disclosure mary studies, our review was likewise limited by both
statements; Eich, 2014) are promising models. If journal the available meta-analyses and the RCTs of which the
editors accept manuscripts using intention-to-treat anal- meta-analyses were composed. Gaps in both meta-
yses with null findings over those using completer analyses and primary studies (e.g., reporting of adverse
analyses with statistically significant findings, we events) necessarily resulted in gaps in our review. One
believe authors will modify their practices. especially troubling gap is a lack of primary studies and
Our results also suggest fruitful directions for future meta-analyses focused on the efficacy of MBIs for
meta-analyses. One important recommendation is that underserved and underrepresented groups (Waldron
meta-analysts avoid combining passive and active con- et  al., 2018), which limits the generalizability of our
trol conditions (and avoid testing moderators based on results to these populations. Second, our decision to
a combination of passive and active control conditions). require a minimum of four studies for effect sizes to be
Combining passive and active controls yields results included resulted in some estimates being based on
that are inherently ambiguous and potentially mislead- only four studies (and likely less reliable as a result;
ing.6 Other steps to strengthen the meta-analytic litera- Pereira & Ioannidis, 2011) and other estimates being
ture include more consistent coding of risk of bias, excluded because of an insufficient number of available
systematic testing and reporting of theoretically impor- studies (and therefore not represented in the current
tant moderators, formal assessment of publication bias, review). A third limitation was the moderate degree of
and consideration of statistical power when conducting heterogeneity within the included studies (compounded
and interpreting meta-analytic results. Meta-analyses by uncertainty in the I 2 estimates themselves given the
Empirical Status of Mindfulness 19

small number of studies for some effect sizes; von Hippel, ORCID iDs
2015). There was likewise variability across meta- Simon B. Goldberg https://orcid.org/0000-0002-6888-0126
analytic estimates for a given PICOS. This variability Richard J. Davidson https://orcid.org/0000-0002-8506-4964
decreases confidence in the pattern of findings, sug-
gesting that systematic variation may exist both between Acknowledgments
RCTs and between meta-analyses. In the absence of We are grateful to Scott A. Baldwin for comments on our
second-order meta-analysis (Schmidt & Oh, 2013), we study design and Zachary G. Daily for assisting with gathering
could not evaluate sources of this variability directly. information regarding primary studies. We are grateful to
A fourth limitation was the need to choose a method Willem Kuyken, Fiona Warren, Christina Spinelli, and
for determining representative effect sizes. Our decision Michaela Pascoe for sharing supplemental data from their
to report representative effect sizes based on the largest meta-analyses. This systematic review was registered through
number of studies seemed likely to provide the most OSF and is available at https://osf.io/eafy7. Study data are
precise estimate, but a different metric (e.g., effect sizes included in the Supplemental Material.
with the smallest confidence intervals) may have
yielded a somewhat different pattern of findings. Fur- Supplemental Material
thermore, selecting the largest meta-analysis may have Additional supporting information can be found at http://
neglected smaller but perhaps more homogeneous journals.sagepub.com/doi/suppl/10.1177/1745691620968771
meta-analyses (e.g., MBCT for depression relapse;
Kuyken et al., 2016). Notes
1. See Analayo (2018) for a discussion of the aspects of sati that
connote memory or remembering.
Conclusion 2. We considered the possibility of reanalyzing the included pri-
On the basis of 44 meta-analyses examining the effects mary RCTs. Ultimately, we concluded that the value of doing so
of MBIs across 336 unique RCTs with 30,483 partici- (i.e., to provide updated estimates of the effects of MBIs) would
be better served by a future large-scale meta-analysis with an
pants, it appears that interventions based on mindful-
independent literature search. Such a review would be useful,
ness meditation indeed hold substantial transdiagnostic particularly for testing moderators that are frequently under-
potential, albeit with stronger evidence for some PICOS powered. Reanalyzing the included studies and replicating the
than others. Therefore, the utilization of MBIs as a fam- tests reported across the included meta-analyses seemed to us
ily of interventions is at least partially supported by both unwieldly and unlikely to yield results dissimilar from rep-
scientific evidence. Ongoing, rigorous experimental resentative effect sizes based on the largest number of studies.
research evaluating these interventions, with attention Given that most of the representative effect sizes were based
to limitations of the existing literature, is warranted. on recent meta-analyses, it is likely a reanalysis drawn from the
included meta-analyses would have almost entirely the same
studies and presumably very similar results.
Transparency 3. In only one instance was an effect significant relative to active
Action Editor: Joshua Hicks but not passive controls (substance use disorders at posttreat-
Editor: Laura A. King ment). Statistical power is again a likely explanation; only five
Declaration of Conflicting Interests studies were available for comparisons with passive controls
R. J. Davidson is the founder and president and serves on (n = 149) compared with seven studies (n = 900) available for
the board of directors for the nonprofit organization active controls.
Healthy Minds Innovations, Inc. The remaining authors 4. Butler et al. (2006) also failed to find consistent moderators
declared that there were no conflicts of interest with respect beyond researcher allegiance in their review of meta-analyses
to the authorship or the publication of this article. of cognitive behavioral therapy.
Funding 5. Psychotherapy research provides a valuable point of com-
This research was supported by National Institute of Men- parison for interpreting these sources of bias because many of
tal Health Grants R01-MH43454 (to R. J. Davidson) and the same potential biases appear. For example, meta-analyses
T32-MH078788 (to S. Sun), National Center for Comple- widely cited as evidence for the empirically supported status
mentary and Integrative Health Grants P01-AT004952 (to of cognitive behavioral therapy have shown a similar degree
R. J. Davidson) and K23-AT010879 (to S. B. Goldberg), of heterogeneity (Cuijpers et al., 2013), have relied exclusively
and the University of Wisconsin-Madison, Office of the on self-report measures (Gloaguen et  al., 1998), have been
Vice Chancellor for Research and Graduate Education with composed of studies primarily using completer rather than
funding from the Wisconsin Alumni Research Foundation intention-to-treat analyses (Hofmann & Smits, 2008), and have
(S. B. Goldberg). The content is solely the responsibility shown high risk of bias in numerous domains in Cochrane
of the authors and does not necessarily represent the offi- reviews (e.g., Henschke et  al., 2010). Like RCTs of MBIs, the
cial views of the National Institutes of Health. vast majority of psychotherapy trials do not report adverse
20 Goldberg et al.

effects ( Jonsson et al., 2014). Nonetheless, presumably because supportive expressive group therapy for distressed sur-
of the improvements experienced by patients (Minami et  al., vivors of breast cancer. Journal of Clinical Oncology, 31,
2008), cognitive behavioral therapy and other psychotherapies 3119–3126.
are widely perceived as efficacious by the research community Chen, D., Sun, W., Liu, N., Wang, J., Guo, P., Zhang, X., &
and general public, recommended by providers, and paid for Zhang, W. (2019). Effects of nonpharmacological inter-
by managed care organizations (Beronio et al., 2014; Seligman, ventions on depressive symptoms and depression among
1995; Wampold & Imel, 2015). nursing students: A systematic review and meta-analysis.
6. Specifically, interventions that have been tested using more Complementary Therapies in Clinical Practice, 34, 217–228.
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sants; Kuyken et al., 2016) can appear less effective than those reduction for stress management in healthy people: A
that have not been as rigorously evaluated (e.g., mHealth MBIs; review and meta-analysis. Journal of Alternative and
Spijkerman et al., 2016). Complementary Medicine, 15, 593–600. https://doi
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