Mindfulness Based Stress Reduction (MBSR) for Improving Health, Quality of Life, and Social Functioning in Adults

Abstract

Mind-body interventions to manage stress-related health problems are of widespread interest. One of the best known methods is mindfulness-based stress reduction (MBSR), andMBSR courses are now offered by health services, as well as in social and welfare settings. In this systematic review, we report on the effects of MBSR interventions on health, quality of life, and social functioning. From the more than 3,000 potentially relevant references identified in two extensive searches, we included 31 relevant studies with an overall total of 1,942 participants, each of whom had been randomised to receive MBSR or other treatment strategies (most often a waiting list control). We utilised all outcome data published in the selected studies using a new statistical method for calculating the effect size. This method addressed the problems presented by the interdependence of many measurements of outcomes.

26 of the 31 studies were identified as having data suitable for meta-analysis. MBSR was found to have a moderate and consistent positive effect on mental health outcomes in both patients selected with somatic problems and with mild to moderate psychological problems, and among participants recruited from community settings. MBSR interventions improved outcomes measuring different aspects of personal development and quality of life. The effects on somatic health outcomes were somewhat smaller. No adverse effects were described. Few studies were found that evaluated the impact of MBSR on social functioning, such as the ability to work.

Full text

Campbell Systematic Reviews
2012:3
First published: 01 February, 2012
Last updated: 11 January, 2012
Search executed: 21 September, 2010
Mindfulness Based Stress
Reduction (MBSR) for
Improving Health, Quality of
Life, and Social Functioning in
Adults
Michael de Vibe, Arild Bjørndal,
Elizabeth Tipton, Karianne Hammerstrøm, Krystyna
Kowalski

Colophon
Title
Mindfulness based stress reduction (MBSR) for improving health, quality of
life, and social functioning in adults.
Institution
The Campbell Collaboration
Authors
de Vibe, Michael
Bjørndal, Arild
Tipton, Elizabeth
Hammerstrøm, Karianne Thune
Kowalski, Krystyna
DOI
10.4073/csr.2012.3
No. of pages
127
Last updated
January 2012
Citation
de Vibe M, Bjørndal A, Tipton E, Hammerstrøm KT, Kowalski K. Mindfulness
based stress reduction (MBSR) for improving health, quality of life and social
functioning in adults.
Campbell Systematic Reviews 2012:3
DOI: 10.4073/csr.2012.3
Copyright
© de Vibe et al.
This is an open-access article distributed under the terms of the Creative
Commons Attribution License, which permits unrestricted use, distribution,
and reproduction in any medium, provided the original author and source are
credited.
Contributions
AB proposed the topic of this review to MV. MV wrote the first draft of the
protocol. KTH, a research librarian, developed the search strategies. AB wrote
the methods sections of the protocol and KK designed the forms. KTH
conducted the searches. MV, KTH and KK selected the studies and extracted
data, and AB acted as an arbitrator when additional debate and discussion
were needed. MV, ET and AB undertook the data analyses. MV and AB wrote
the review. All authors have commented on different versions of this
manuscript. MV will be responsible for updating this review as additional
evidence accumulates and as funding becomes available.
Editors for
this review
Editor: William Turner
Managing editor: Krystyna Kowalski
Support/funding
This study is supported by The Norwegian Medical Association, The
Norwegian Knowledge Centre for the Health Services, Centre for Child and
Adolescent Mental Health, Eastern and Southern Norway, and SFI Campbell
at The Danish National Centre for Social Research.
Potential c
onflicts
of interest
MV has conducted a research project on MBSR in Norwegian family practice
which was published in the Norwegian Medical Journal in 2006 and is also
an MBSR instructor. MV is leading an RCT of MBSR among students from
two universities; AB is his mentor. None of the authors stand to gain
financially from a positive or negative evaluation of MBSR.
Corresponding
author
Arild Bjørndal
Centre for Child And Adolescent Mental Health, Eastern and Southern
Norway
Postbox 4623 Nydalen, 0405 Oslo, Norway
E-mail: arb@r-bup.no

Campbell Systematic Reviews
Editors-in-Chief
Mark W. Lipsey, Vanderbilt University, USA
Arild Bjørndal, The Centre for Child and Adolescent Mental Health, Eastern
and Southern Norway & University of Oslo, Norway
Editors
Crime and Justice
David B. Wilson, George Mason University, USA
Education
Sandra Wilson, Vanderbilt University, USA
Social Welfare
William Turner, University of Bristol, UK
Geraldine Macdonald, Queen’s University, UK & Cochrane Developmental,
Psychosocial and Learning Problems Group
International
Development
Birte Snilstveit, 3ie, UK
Hugh Waddington, 3ie, UK
Managing Editor
Karianne Thune Hammerstrøm, The Campbell Collaboration
Editorial Board
Crime and Justice
David B. Wilson, George Mason University, USA
Martin Killias, University of Zurich, Switzerland
Education
Paul Connolly, Queen's University, UK
Gary W. Ritter, University of Arkansas, USA
Social Welfare
Aron Shlonsky, University of Toronto, Canada
International
Development
Peter Tugwell, University of Ottawa, Canada
Howard White, 3ie, India
Methods
Therese Pigott, Loyola University, USA
Ian Shemilt, University of Cambridge, UK
The Campbell Collaboration (C2) was founded on the principle that
systematic reviews on the effects of interventions will inform and help
improve policy and services. C2 offers editorial and methodological support to
review authors throughout the process of producing a systematic review. A
number of C2's editors, librarians, methodologists and external peer-
reviewers contribute.
The Campbell Collaboration
P.O. Box 7004 St. Olavs plass
0130 Oslo, Norway
www.campbellcollaboration.org

3 The Campbell Collaboration | www.campbellcollaboration.org
Table of contents
TABLE OF CONTENTS 3
KEY MESSAGES 6
EXECUTIVE SUMMARY/ABSTRACT 7
Background 7
Objectives 7
Search Strategy 7
Selection Criteria 7
Data collection and Analysis 8
Results 8
Authors’ Conclusions 8
1 BACKGROUND 10
1.1 Description of the condition 10
1.2 Description of the intervention 10
1.3 How the intervention might work 11
1.4 Why it is important to do this review 12
2 OBJECTIVES 13
3 METHODS 14
3.1 Criteria for considering studies for this review 14
3.2 Search methods for identification of studies 15
3.3 Data collection and analysis 16
3.4 Data synthesis 18
4 RESULTS 21
4.1 Results of the search 21
4.2 Description of the studies 21
4.3 Risk of bias in included studies 22
4.4 Effects of the interventions 23
5 DISCUSSION 27
5.1 Summary of the main results 27
5.2 Overall completeness and applicability of evidence 27
5.3 Quality of the evidence 28
5.4 Potential biases in the review process 29

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5.5 Agreements and disagreements with other studies or reviews 29
6 AUTHORS’ CONCLUSIONS 32
6.1 Implications for practice 32
6.2 Implications for research 32
7 ACKNOWLEDGEMENTS 34
8 DIFFERENCES BETWEEN THE PROTOCOL AND THE
REVIEW 35
9 SOURCES OF SUPPORT 36
10 REFERENCES 37
10.1 Included studies 37
10.2 Excluded studies 41
10.3 Studies awaiting classification 51
13.3 Additional references 52
11 TABLES 55
11.1 Characteristics of included studies 55
11.2 Characteristics of excluded studies 84
11.3 Study characteristics 91
11.4 Measurement scales, abbrevations 95
11.5 Effect sizes and outcomes 98
11.6 Subgroup analysis 100
11.7 Correlation matrix at post-intervention 101
12 APPENDICES 102
12.1 Study inclusion and exclusion form 102
12.2 Coding and data extraction form 103
12.3 Search terms 108
13 FIGURES 114
13.1 Methodological quality graph 114
13.2 Methodological quality summary 115
13.3 Search results and inclusion of studies 116
13.4 Effects on anxiety scores (using robust SE) 117
13.5 Effects on depression scores (using normal se) 118
13.6 Effects on stress scores (using robust SE) 119
13.7 Effects on other mental health scores (using robust SE) 120
13.8 Effects on composite mental health score (using robust SE) 121
13.9 Effects on personal development scores (using robust se) 122
13.10 Effects on quality of life scores (using robust se) 123
13.11 Effects on mindfulness measures (using robust se) 124
13.12 Effects on somatic health scores (using robust se) 125
13.13 Funnel plot of precision versus effect sizes 126

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13.14 GRADE scores 127

6 The Campbell Collaboration | www.campbellcollaboration.org
Key messages
Mind-body interventions to manage stress-related health problems are of
widespread interest. One of the best known methods is mindfulness-based stress
reduction (MBSR), and MBSR courses are now offered by health services, as well as
in social and welfare settings. In this systematic review, we report on the effects of
MBSR interventions on health, quality of life, and social functioning. From the more
than 3,000 potentially relevant references identified in two extensive searches, we
included 31 relevant studies with an overall total of 1,942 participants, each of whom
had been randomised to receive MBSR or other treatment strategies (most often a
waiting list control). We utilised all outcome data published in the selected studies
using a new statistical method for calculating the effect size. This method addressed
the problems presented by the interdependence of many measurements of
outcomes.
26 of the 31 studies were identified as having data suitable for meta-analysis. MBSR
was found to have a moderate and consistent positive effect on mental health
outcomes in both patients selected with somatic problems and with mild to
moderate psychological problems, and among participants recruited from
community settings. MBSR interventions improved outcomes measuring different
aspects of personal development and quality of life. The effects on somatic health
outcomes were somewhat smaller. No adverse effects were described. Few studies
were found that evaluated the impact of MBSR on social functioning, such as the
ability to work.

7 The Campbell Collaboration | www.campbellcollaboration.org
Executive summary/Abstract
BACKGROUND
Stress and distress are common experiences central to many of the problems
occupying health and social services and efforts to improve both health and quality
of life are receiving increasing attention. Evaluative research on mind-body
interventions is also growing and one of the best studied efforts to reduce stress is
mindfulness-based stress reduction (MBSR). Developed by Kabat-Zinn in 1979,
MBSR is based on old spiritual traditions and includes regular meditation.
Mindfulness is a way of intentionally attending to the present moment in a non-
judgemental way. A number of reviews and meta-analyses on MBSR have been
conducted, but few have adhered to the meta-analytic protocol stipulated by the
Cochrane and Campbell collaborations. The last review of all relevant target groups
was published in 2004.
OBJECTIVES
To evaluate the effect of mindfulness-based stress reduction (MBSR) on health,
quality of life, and social functioning in adults.
SEARCH STRATEGY
We searched all relevant databases: MEDLINE, AMED, PsycINFO, EMBASE, Ovid
Nursing Full Text Plus, the British Nursing Index and Archive, the Cochrane Central
Register of Controlled Trials (CENTRAL), SIGLE, Web of Science®, SveMed+,
Dissertation Abstracts International, ERIC, Social Services Abstracts, Sociological
Abstracts, the International Bibliography of Social Sciences, and ProQuest. The
searches were conducted in July 2008 and again in September 2010.
SELECTION CRITERIA
Randomised controlled trials on all target groups were included where the
intervention followed the MBSR protocol developed by Kabat-Zinn, allowing for
variations in the length of the MBSR courses. We accepted all types of control
groups and no language restrictions were imposed.

8 The Campbell Collaboration | www.campbellcollaboration.org
DATA COLLECTION AND ANALYSIS
Two reviewers independently read the titles, retrieved the studies, and extracted
data from all the included studies. We calculated standardised mean differences
(expressed as Hedges’ g-values) from all of the study outcomes using
Comprehensive Meta Analysis. The meta-analyses were undertaken using the
Metafor Package which is part of the statistical program ‘R’; we used a newly
developed technique (Robust Standard Errors) to address the statistical challenge
presented by clusters of internally correlated effect estimates.
RESULTS
We identified 31 RCTs with an overall total of 1,942 participants. Seven studies
included people with mild to moderate psychological problems, 13 studies targeted
people with various somatic conditions, and 11 studies recruited people from the
general population. 26 of the 31 RCTs were used for the meta-analyses (an overall
total of 1,456 persons). All effect sizes are expressed using Hedges’ g-values, and
positive values indicate beneficial effects. Post-intervention effect sizes were as
follows: for measures of anxiety 0.53 (95% CI 0.43, 0.63), for depression 0.54 (95%
CI 0.35, 0.74), and for stress/distress 0.56 (95% CI 0.44, 0.67). The overall effect
size post-intervention for the combined outcome ‘mental health’ was 0.53 (95% CI -
0.43, 0.64). Heterogeneity was low and tau square-values (for between-study
variance) ranged from 0 to 0.03. The results for measures of personal development
were 0.50 (95% CI 0.35, 0.66), quality of life 0.57 (95% CI 0.17, 0.96), mindfulness
0.70 (95% CI 0.05, 1.34), and somatic health 0.31 (95% CI 0.10, 0.52). Results for
quality of life and mindfulness showed moderate to large heterogeneity.
Effect sizes for the combined mental health outcomes were relatively similar across
the range of target groups: 0.50 for clinical and 0.62 for non-clinical populations
and this difference is not significant. Likewise the effect size was 0.51 both for
people recruited because of a somatic condition and for those with a mental health
problem. Effect sizes for mental health were not particularly influenced by the
length of intervention, self-reported practice, risk of bias, or whether analyses were
done as intention to treat or per protocol, but they were positively correlated with
course attendance. Only nine studies included follow-up data; the effects diminished
over time except in one study in which refresher classes were held. Very little data
were found on social functioning, and no information at all on side effects and costs.
AUTHORS’ CONCLUSIONS
MBSR has a moderate and consistent effect on a number of measures of mental
health for a wide range of target groups. It also appears to improve measures of
personal development such as empathy and coping, and enhance both mindfulness,
quality of life and improve some aspects of somatic health. Hardly any included

9 The Campbell Collaboration | www.campbellcollaboration.org
studies measured either social function or work ability. There is a paucity of data on
long-term effects.

10 The Campbell Collaboration | www.campbellcollaboration.org
1 Background
1.1 DESCRIPTION OF THE CONDITION
Stress is ubiquitous in modern life. While some people are prompted to respond
positively to it, more often than not it exerts a negative influence. At its worst, stress
destroys lives. The demands of life are external but stress is generated from within
and stressors may be real or imagined. How we handle situations, persons and
emotions – in other words, how we become stressed or manage to keep calm – is
central to staying healthy, coping with illness and enjoying life. These are skills that
can be practised and exercised.
Prevalence rates for distress and mild to moderate psychological problems are high
among children, adolescents and adults, and associated chronic musculoskeletal
pain is common. While our understanding of such widespread problems is limited,
we do know that stress is probably both a cause and a consequence of them.
Stress is also part of our everyday working life. In a series of surveys undertaken at
five year intervals in the European Union, stress was identified as the second most
common threat posed by working environments and an issue affecting a fifth of the
workforce at any time (European Risk Observatory, 2009). Stress can lead to an
increased risk of disease, including cardiovascular disease (Cohen, 2007; Chandola,
2008). Likewise there is mounting evidence that stress caused by traumatic life
events increases the risk of chronic somatic and psychological problems affecting
health and quality of life (McEwen, 2008); adverse childhood experiences are
especially harmful (Brown, 2009).
1.2 DESCRIPTION OF THE INTERVENTION
Mindfulness-Based Stress Reduction, or MBSR, is a well described group-based
mind-body intervention programme that has received considerable research
attention (Kabat-Zinn 1990). ‘Mindfulness’ may be defined as the ability to non-
judgementally observe sensations, thoughts, emotions, and the environment while,
at the same time, encouraging openness, curiosity and acceptance. An MBSR
programme to develop and strengthen this skill was developed by the University of
Massachusetts Medical Center in 1979 as an intervention designed to relieve stress

11 The Campbell Collaboration | www.campbellcollaboration.org
and help people cope with illness. This programme is now offered at several hundred
healthcare institutions in the USA and Europe (Santorelli, 1999). Target groups
include people with chronic physical pain, illnesses such as cancer, or mental
illnesses, including anxiety, depression or burnout. In addition, the programme has
been applied to non-clinical populations, including students, therapists and prison
inmates.
The standard MBSR mindfulness training is an eight week group programme with
weekly sessions of between 2-2 ½ hours and an all-day session in the last two weeks.
Shorter weekly sessions (30-90 minutes) may be offered as an alternative, and some
programmes omit the all day session entirely. Weekly sessions include mental and
physical mindfulness exercises as standardised core elements. These include: body
scan exercises in which ‘neutral attention’ is directed towards sensations from the
different parts of the body when sitting or lying still (in other words, participants
observe these sensations without trying to achieve any particular objective); mental
exercises focusing attention on breathing; physical exercises focussing on an
awareness of bodily sensations; and practising being fully aware during everyday
activities by using breathing as an anchor for attention. Essential to all parts of the
programme is the development of an accepting and non-reactive attitude to what
one experiences in each moment. The intervention is rooted in ancient Buddhist
Vipassana (‘insight’) and Shamatha (‘focussed’) meditation and yoga exercises.
However, it is free from religious purpose or affiliation and is described using only
Western terminology.
In addition to the exercises, information (and a discussion) is provided and
discussion is facilitated on the topics of stress, stress management, and how to apply
mindfulness to interpersonal communication and everyday situations. Each group
session includes time for participants to reflect together on what they experience
while practising mindfulness. Outside the sessions, participants are encouraged to
practice each day for 30-45 minutes while listening to audiotapes and using the
guided exercises (these include body-scanning, the mindfulness sitting exercise
which focuses on breathing, as well as yoga stretching exercises). The group usually
includes 10-30 members and is led by one or two trained instructors.
1.3 HOW THE INTERVENTION MIGHT WORK
The MBSR programme provides systematic training in mindfulness as a self-
regulation strategy to reduce stress and manage emotion. The programme is
intended to foster greater awareness of what happens in each moment through the
application of an attitude of acceptance. MBSR is designed to help people avoid
habitual negative thoughts, emotions and behavioural patterns. Instead, increased
awareness and acceptance is seen as allowing for new ways to respond and cope
both in relation to oneself and the wider world. Mindfulness training has been
linked to changes in areas of the brain responsible for affect regulation, and to stress
impulses reactions; in turn, these changes influence body functions such as

12 The Campbell Collaboration | www.campbellcollaboration.org
breathing, heart rate and immune function (Davidson, 2003; Lazar, 2005; Hölzel,
2010).
1.4 WHY IT IS IMPORTANT TO DO THIS REVIEW
MBSR is increasingly widespread and it is important therefore to find out whether it
is effective, for whom, and under what circumstances. Knowing such details can help
to guide future research. A number of recent published reviews have suggested
overall that MBSR may be effective in reducing the symptoms of anxiety, depression
and stress. However, most such reviews have been narrative reviews rather than
meta-analyses. This has led Hofmann et al. (Hofmann, 2010) to argue that “the field
has become saturated with qualitative reviews” (p.170).
Quantified effect sizes in other meta-analyses we have identified were based on
randomised controlled trials combined with quasi-experimental design studies
(Baer, 2003; Carmody, 2009; Grossman, 2004; Ledesma, 2009; Hofmann, 2010).
Baer found an overall Hedges’ g-value of effect size of 0.59 for all outcomes, but this
included both MBSR and Mindfulness Based Cognitive Therapy (MBCT) studies.
Similarly, Carmody calculated an overall Hedges’ g-value for effect size of 0.63 for
psychological outcomes, but included control groups with both treatment-as-usual,
waiting-list, and alternative treatments. Grossman reported an overall Cohen’s d-
value of effect size of 0.5 for studies of MBSR with combined outcomes of physical
and mental well-being. Hofmann also included MBSR and other interventions like
mindfulness based cognitive therapy in the same meta-analysis, reporting an overall
Hedges’ g-value of effect size for anxiety of 0.63 and 0.59 for mood symptoms.
Bohlmeijer et al. (2010) included only controlled MBSR studies, and calculated an
overall Hedges’ g-value of effect size of 0.47 for anxiety outcomes and 0.32 for
psychological distress outcomes. However the authors grouped together studies
using waiting-list controls and studies where the control group was offered
alternative active treatment.
A health technology assessment report from 2007 (searches conducted up to 2005)
identified five broad categories of meditation practices of which mindfulness
meditation was one (Ospina, 2007). In this instance, the meta-analysis was focussed
on effects on hypertension, cardiovascular disease and substance abuse, and it did
not specifically evaluate MBSR.

13 The Campbell Collaboration | www.campbellcollaboration.org
2 Objectives
To assess the effectiveness of MBSR in improving health, quality of life, and social
functioning in adults.

14 The Campbell Collaboration | www.campbellcollaboration.org
3 Methods
3.1 CRITERIA FOR CONSIDERING STUDIES FOR THIS
REVIEW
3.1.1 Types of studies
Studies of mind-body interventions such as MBSR are especially prone to bias
introduced by the self-selection of study participants to intervention or control
groups. For this reason, we have only included RCTs in this systematic review. We
expected to find a sufficient number of such studies.
3.1.2 Types of participants
MBSR is a general method for self-regulation that has been applied to a variety of
target groups: we therefore included all populations. There were two exceptions to
this approach: both children (under the age of 18) and persons with cognitive
impairment or severe mental illness were not included. This was because children
are less able to be self-aware; MBSR is dependent on the ability of individuals to pay
attention and to be able to remember from one moment to the next.
3.1.3 Types of interventions
We included studies of MBSR training programmes which had been based on the
protocol elements specified by John Kabat-Zinn (Kabat-Zinn, 1990). This meant
that to be considered, the intervention had to be explicitly termed ‘MBSR’ and
contain all four of the requisite core elements, namely: body-scan exercises, mental
exercises focusing attention on breathing, physical exercises focussing on the
awareness of bodily sensations, and the practice of being fully aware during
everyday activities. Studies of varying MBSR course duration and intensity were
included. Studies that combined MBSR with other therapeutic approaches, such as
cognitive therapy or art therapy, were excluded.
Waiting lists and treatment-as-usual were acceptable control groups. RCTs in which
the control group had been offered alternative active treatment were also included,
but these were analysed separately.

15 The Campbell Collaboration | www.campbellcollaboration.org
3.1.4 Types of outcomes
Primary outcomes were measures of mental health (anxiety, depression and
stress/distress), somatic health (self-reported physical health inventories and
somatic measures related to antibodies, heart rate or respiratory functions) and
quality of life (only including measures designed specifically to measure quality of
life, such as the WHO Quality Of Life Inventory). Secondary outcomes were social
functioning (such as the ability to work, sickness rates, and self-reported measures
of social functioning e.g., The Social Functioning Questionnaire SFQ) and measures
of personal development (e.g., self-acceptance, empathy, coping and forgiveness).
The different measurement scales and outcome groups are listed in additional
Tables 4 and 5.
3.2 SEARCH METHODS FOR IDENTIFICATION OF STUDIES
3.2.1 Electronic searches
Electronic searches of bibliographic databases and open websites were conducted.
We examined reference lists from the articles under consideration and asked key
researchers within the field for information. In addition, we searched for ‘grey
literature’ trials and for ongoing studies registered at www.clinicaltrials.gov. No
publication, geographic, or language restrictions were applied.
3.2.2 Search terms
The following sources were searched at the outset of the project in July 2008 and
again in September 2010:
MEDLINE
AMED (Allied and Complementary Medicine)
PsycINFO
EMBASE
Ovid Nursing Full Text Plus
British Nursing Index and Archive
Cochrane Central Register of Controlled Trials (CENTRAL)
SIGLE
Web of Science®
SveMed+
Dissertation Abstracts International
ERIC
Social Services Abstracts
Sociological Abstracts
International Bibliography of Social Sciences
ProQuest

16 The Campbell Collaboration | www.campbellcollaboration.org
The Cochrane Collaboration’ search strategy includes a RCT search filter for
identifying randomised trials in MEDLINE and this was used when searching this
database. This filter was subsequently modified for other database searches.
Appendix 15.1 contains full documentation of all the search terms used.
3.3 DATA COLLECTION AND ANALYSIS
3.3.1 Selection of studies
Two reviewers independently read the titles and available abstracts of the studies in
order to exclude those that were obviously irrelevant. Any citation deemed
potentially relevant by at least one reviewer was retrieved in full text form. Multiple
papers reporting on the same study were linked together. Two reviewers (one with
content expertise and the other with methodological expertise) independently read
all the retrieved studies in order to determine whether they met the selection criteria
(Appendix 12.1). The reviewers were not blinded to journal names, author names,
author affiliations or the study results. Disagreements about the relevance of
particular studies were resolved during discussions with a third reviewer with
methodological expertise. Correspondence with investigators, where necessary,
helped to clarify study eligibility. Those studies that met the screening criteria but
did not meet all the inclusion criteria are listed in Section 11.2 (Characteristics of
Excluded Studies), together with the reasons for their exclusion.
3.3.2 Data extraction and management
Information on study design and implementation, sample characteristics,
intervention characteristics, and outcomes was extracted from studies. This
information was entered on a paper form (see Appendix 15.3). The data extraction
form included a coding list which was piloted on two of the selected studies at the
outset of the data extraction phase. Two reviewers independently extracted data
from all the studies. Disagreements were resolved through discussions with a third
reviewer with relevant methodological expertise.
3.3.3 Assessment of risk of bias in included studies
Risk of bias was evaluated according to the criteria stated in the Cochrane Handbook
(Higgins, 2008). Two independent reviewers assessed the issues of sequence
generation, allocation concealment, the blinding of outcome assessors, the
completeness of outcome data, outcome reporting, and any other potential sources
of bias. Using the GRADE approach, further analysis of the quality of evidence was
undertaken related to each of the key outcomes (Guyatt, 2008; Higgins, 2009). The
quality of the body of evidence for each key outcome was rated as ‘High’, ‘Moderate’,
‘Low’, or ‘Very Low’.

17 The Campbell Collaboration | www.campbellcollaboration.org
3.3.4 Measures of treatment effect
As expected, only outcome data from (a number of) ordinal scales were found; no
binary data were identified. We therefore calculated standardised mean differences
(as Hedges’ g-values) using the Comprehensive Meta Analysis program which is able
to accept a variety of different data formats (Borenstein, 2009). Effect sizes were
calculated for gain scores (post-minus pre-measurements in the control group were
subtracted from post-minus pre-measurements in the treatment group). These
results were then standardised using the post-test pooled standard deviation. In four
studies the effect sizes were calculated from other data; in Astin (1997) from the F-
values for the difference in change in the MBSR and control group; in Cohen-Katz
(2005) and Creswell (2008) from the difference in mean change between the MBSR
and control group and the corresponding p-values; and in Grossman (2010) from
the difference in mean change between the intervention and control group and the
corresponding F- values.
3.3.5 Unit of analysis issues
We assessed the unit of analysis of all the trials: one study was found to have
randomised couples rather than individuals. The robust standard error analysis we
used (see below) was able to process the data while accommodating for such
dependencies.
3.3.6 Dealing with missing data and incomplete data
Study authors were contacted if missing information was needed (related, for
example, to standard deviations). Most authors did not respond or were unable to
retrieve the data. Some studies presented data visually and this made it possible to
read data from the graphs (Anderson, 2007; Davidson, 2003; Plews-Ogan, 2005;
Shapiro, 1998; Williams, 2001). In other instances we calculated standard
deviations using standard errors, confidence intervals, t-values or p-values that
related to the differences between the means in two groups (Anderson, 2007;
Davidson, 2003; Lengacher, 2009; Moritz, 2006; Plews-Ogan, 2005; Williams,
2001). In only one instance was a study excluded from the analysis due to a lack of
information (no SD or SE) (Alterman, 2004).
Means and standard deviations values were based on those stated in the original
study publications, irrespective of how such missing data may have been processed
in the primary analysis.
3.3.7 Assessment of heterogeneity
The degree of heterogeneity was evaluated both informally (by checking the overlap
of the confidence intervals), and statistically (by estimating the total heterogeneity
using tau2 values (where <0.05 indicates low heterogeneity). The percentage of the
total variability due to heterogeneity was estimated using I2 values; 0% representing

18 The Campbell Collaboration | www.campbellcollaboration.org
no heterogeneity, 50% indicating moderate heterogeneity and 75% indicating high
heterogeneity (Higgins, 2003).
3.3.8 Assessment of publication bias
We investigated possible reporting biases using funnel plots and tested for funnel
plot asymmetry using Egger’s regression test (Egger, 1997).
3.4 DATA SYNTHESIS
All analyses were conducted with random effects models. When evaluating the
outcomes for mental health, the results were first grouped separately into four
constructs, namely: anxiety, depression, stress/distress and other measures of
mental health (see Table 13.4). The majority of the studies identified included
multiple measures of the same construct, and the sizes of effect were typically
calculated for the same individuals. Since the covariance structure of these effect
sizes was not reported in any of the studies, we used a newly developed robust
statistical technique for estimating standard errors under such circumstances
(Hedges, 2010).
This technique calculates standard errors using an empirical estimate of the
variance: it does not require any assumptions regarding the distribution of the effect
size estimates. Those assumptions that are required are minimal and generally met
in practice. Simulation studies show that both confidence intervals and p-values
generated this way typically reflect the correct size in samples, requiring as few as
ten studies for the estimation of an average effect size, or between 20-40 studies for
the estimation of a slope. This more robust technique is therefore beneficial because
it allows all of the effect size estimates to be included in meta-analyses.
An important feature of this more robust standard error analysis is that the results
are valid regardless of the weights used. For efficiency purposes, we calculated the
weights using a method proposed by Hedges et al (Hedges, 2010). This method
assumes a simple random-effects model in which study average effect sizes vary
across studies (τ2) and the effect sizes within each study are equicorrelated (ρ). The
method is approximately efficient, since it uses approximate inverse-variance
weights: they are approximate given that ρ is, in fact, unknown and the correlation
structure may be more complex. For the results we calculated, weights were used
based on estimates of τ2 and I2, where ρ =0.80. Though not reported here,
sensitivity tests were also conducted using a variety of ρ values; these indicated that
the general results and estimates of the heterogeneity (τ2 and I2) were robust to the
choice of ρ.
In addition to estimating an average effect for each of the four mental health
constructs, we also calculated an average effect for mental health across all the
studies and measures. Clinicians commonly view anxiety, depression and
psychological stress/distress as different constructs. However, the actual questions

19 The Campbell Collaboration | www.campbellcollaboration.org
used in the different inventories (many of which were often fairly similar) and the
measurement of correlation (which were consistently high) cast doubt on whether
the standard methods of measuring anxiety and depression do, in fact, always tap
into different constructs in practice. The described analyses are therefore an explicit
attempt to look at this difficult issue using both such approaches.
This robust standard error approach was also used to evaluate the outcomes of
somatic health, quality-of-life measures, personal development and mindfulness, as
well as for varying lengths of follow-up.
3.4.1 Subgroup analysis, moderator analysis and investigation of
heterogeneity
Theoretical and empirical reasons suggest that, by and large, one may expect similar
effects across chosen target groups, varieties of an intervention, and relevant
outcomes. Nevertheless the following subgroup analysis was undertaken in order to
explore potential differences in effects on mental health:
• Clinical and non-clinical samples (expecting a somewhat larger effect in studies
of patients with established health problems compared to studies where
participants were recruited from the general population)
• Psychological and somatic conditions (expecting a somewhat larger effect in
studies of participants with psychological distress compared to studies of
people with somatic problems)
• Effect of length of the MBSR intervention (expecting a somewhat smaller effect
in studies that used a shorter MBSR programme compared to a standard
approach)
• Effect of compliance (expecting a somewhat larger effect in studies where
participants generally attended most of the programme versus studies where
attendance was lower, and in studies where people spent more rather than less
time practising at home)
• Effect of follow-up time (expecting effect sizes to diminish over time in studies
with a longer follow-up period)
• Risk of bias (expecting a larger effect in studies with higher risk of bias). In this
particular analysis we used the risk of bias scores as a scale
• Whether or not the authors claimed to have done an intention to treat (ITT)
analysis (expecting somewhat lower effect estimates in studies that reported
ITT analyses).
Each of these questions was investigated using a separate bivariate regression
model. Each model was estimated using the robust standard error method outlined
above (Hedges, 2010). Since this robust standard error method uses degrees of
freedom based on the number of studies (rather than the total number of effect
sizes), we elected to apply individual regression models instead of combined models.
In Appendix 12.4 we provide a correlation matrix for the following variables: clinical
(vs. non-clinical) samples, clinical somatic (vs. clinical psychological) samples,

20 The Campbell Collaboration | www.campbellcollaboration.org
length of MBSR invention, attendance, follow-up time, risk of bias, and if the
analysis was based on an intention-to-treat effect.

21 The Campbell Collaboration | www.campbellcollaboration.org
4 Results
4.1 RESULTS OF THE SEARCH
The original search in July 2008 identified 2,162 potentially relevant articles; a
second search in September 2010 found 972 additional references. Based on our
screening and inclusion criteria 31 studies were included in the review.
4.2 DESCRIPTION OF THE STUDIES
4.2.1 Included studies
The characteristics of the included studies are listed in Table 10.1 and 11.1. 20
studies recruited people with health problems: 13 of these included patients with
somatic conditions (musculoskeletal disease, cancer, other chronic illness, HIV,
cardiovascular disease and substance abuse (Bränström, 2010; Creswell, 2007; de
Vibe, 2006; Grossman, 2010; Lengacher, 2009; Monrone, 2008; Plews-Ogan, 2008;
Pradhan, 2007; Sephton, 2007; Speca, 2000; Speca, 2000; Surawy, 2005; Tacon,
2003). Seven studies included persons with psychological conditions
(stress/distress, anxiety, mood disorder, aggression and stuttering) (Alterman,
2004; de Veer, 2009: Koszycki, 2007; Moritz, 2006; Nyclicek, 2008; Vieten, 2008;
Willliams, 2001). 11 studies included people from the general population (Anderson,
2007; Carson, 2004; Cohen-Katz, 2005; Davidson, 2003; Klatt, 2009; Shapiro,
2005); five such studies used student samples (Astin,1997; Jain, 2007; Murrey,
2004; Oman, 2008; Shapiro, 2005). One study included prisoners (Murphy, 1995).
Altogether 1,942 persons were randomised; 26 studies compared MBSR with
waiting-list or treatment-as-usual controls.
Three of the studies included another intervention group in addition to the waitlist
control group (Jain, 2007; Moritz, 2006; Plews-Ogan, 2005) and in these cases we
used only the data from the comparison of MBSR with the waitlist controls. The
results of four additional included studies were reported separately because they
compared MBSR with other active interventions. Creswell (Creswell, 2008), for
example, compared a standard eight-week MBSR course with a one-day MBSR
course. Koszycki (Koszycki, 2007) compared MBSR with MBCT. Murphy (1994)
compared MBSR with progressive relaxation training. And Oman (2008) compared
MBSR with a generally similar mindfulness training called Easwaran’s Eight-Point

22 The Campbell Collaboration | www.campbellcollaboration.org
Program (EPP), and with treatment-as-usual. In this paper, only combined data
from the groups receiving MBSR or EPP were reported.
In addition, we included – but could not use – data from one study (Alterman,
2004; see ‘Studies where data could not be used in the meta-analysis’). Two studies
were reported in two publications: Sephton (Sephton, 2007) also presented results
in Weissbecker (Weissbecker, 2002), and one study was presented both by Tacon
(2002) and Robert-McComb (2004).
4.2.2 Excluded studies
188 studies were excluded either because they were neither primary studies nor
RCTs, or because the intervention did not conform to the MBSR protocol. Reasons
for exclusion are listed in Table 11.2.
4.2.3 Studies awaiting classification
Four studies are awaiting classification (Esmer, 2010; Schmidt, 2011; Vøllestad,
2011; Wong, 2011).
4.3 RISK OF BIAS IN INCLUDED STUDIES
4.3.1 Allocation concealment
The quality item with the lowest score was allocation concealment. Only nine studies
reported adequate concealment of allocation. Most studies failed to state clearly
how randomisation had been achieved.
4.3.2 Blinding
Blinding of participants and providers is impossible to achieve in studies where
people receive stress reduction interventions. It is, however, possible to blind the
assessors and this was done in ten studies.
4.3.3 Incomplete outcome data
Attrition was 15% overall and 25 studies reported all data, while only four studies
had a definite incomplete reporting of all results. Nine studies reported intention to
treat analyses data, and they used the last observation carried forward as the method
for imputing missing data.
4.3.4 Selective reporting
Assessing publication bias, we detected no important funnel plot asymmetry (see
Figure 13.13 ) and the Egger’s r-test for funnel plot symmetry indicated an intercept
value of 0.95 (95% CI -0.24, 2.15). When applied, a Fail-Safe N (Rosenthal,1979)
analysis showed that the number of missing trials needed to raise the p-value to
>0.05 was 689; a Fail- safe N (Orwin, 1983) analysis showed that the number of

23 The Campbell Collaboration | www.campbellcollaboration.org
missing studies with zero effect – that would reduce the Hedges’s g-value to <0.2
(indicating a small effect) – was 44.
4.3.5 Other sources of bias
Many studies are carried out by researchers believing in the intervention and who
also provide the intervention and are responsible for the assessment. Other sources
of bias were different assessors doing semi-structured interviews with the
participants at baseline and after the intervention (Alterman, 2004), baseline
differences between groups not accounted for (de Veer, 2009), some participants
changed group after randomization (Oman, 2008), and some participants were
given additional sessions with a therapist (Surawy, 2005).
4.4 EFFECTS OF THE INTERVENTIONS
4.4.1 MBSR vs. waiting-list/treatment-as-usual
All effect sizes are expressed using Hedges’ g-values (Hedges 1985), and
conventionally a value of 0.2-0.5 signifies a small effect, 0.5-0.8 a moderate effect
and values >0.8 signifies a large effect of the intervention (Cohen, 1988). Positive
values indicate beneficial effects.
Converting effect sizes to percentile values is a useful way to illustrate possible
clinical importance: an effect size of 0.53, for example, indicates that the average
person in the intervention group will be placed at the 30th score percentile for the
control group.
Table 11.5 and Figures 13.4-13.7 show that the average effects were fairly similar for
anxiety (0.53, 95% CI 0.43, 0.63), depression (0.54, 95% CI 0.35, 0.74),
stress/distress (0.56, 95% CI 0.44, 0.67) and other measures of mental health (0.48,
95% CI 0.34, 0.61). Values for heterogeneity, from tau square analysis, were very
small and ranged from 0 to 0.003. 26 studies with 79 different outcome variables (of
anxiety, depression, stress/distress and various other measures of psychological
functions) contributed to the meta-analysis of mental health in which the robust
standard error approach was used (Figure 13.8). The overall effect size for the
composite measure of ‘mental health’ was 0.53 (95% CI 0.46, 0.61). Again,
heterogeneity across the studies was low: the values were tau2 = 0 and I2 = 0.
The effects on measures of personal development (0.50, 95% CI 0.35, 0.66), quality
of life (0.57, 95% CI 0.17, 0.96), and mindfulness (0.70, 95% CI 0.05, 1.34) were also
of moderate size (Figures 13.9-13.11). However, as shown in Figure 13.12, the effect
size was somewhat smaller for measures of somatic health (0.31, 95% CI 0.10, 0.52).
Results for quality of life and mindfulness were somewhat heterogeneous across
trials with tau2 values of 0.07 and 0.40.

24 The Campbell Collaboration | www.campbellcollaboration.org
For mental health as a composite outcome, there was an insignificant difference in
effect size between studies in which persons were recruited because of stress or
diagnosed problems (in other words, from clinical populations) and target groups
which had been recruited from the general population (p=0.19). Likewise, studies of
people with somatic problems as entry criteria achieved a very similar effect on
average to those studies in which people with psychological difficulties were
recruited (p=0.96) (Table 11.6).
The effect size for ‘mental health’ rose slightly with increasing intervention length
(between 6 and 28 hours), but again this increase was not statistically significant
(p=0.16).
18 studies reported on course attendance which ranged from 65% to 92%. There was
a significant increase in effect on mental health for each hourly increase in
attendance (reported as averages per study) (p <0.01). Only 13 studies described
self-reported time spent practising MBSR techniques at home (with an average
range per study of between 7 and 45 minutes). In this analysis, length of self-
reported time spent practicing MBSR techniques at home did not appear to increase
mental health outcome scores (p=0.44).
For follow-up time, we first compared the effect at post-intervention in studies with
data (9 studies) and without follow-up data (17 studies) and found no difference. We
then assessed the effect of the number of months of follow-up on the reported effect
size. There was a slight, but statistically significant, decrease in effect size on ‘mental
health’ for each additional month of follow-up (p<0.05).
A slight decrease in effect size was seen as risk of bias increased, but this finding was
not statistically significant (p=0.29). Neither were there significant differences in
effect sizes between those studies reporting results as intention to treat (ITT)
analyses and studies reporting per protocol data (p=0.13).
Mindfulness was measured in seven studies (measures used are listed in additional
Tables 2 and 3): six reported increases at the post-intervention stage, while one
study showed an increase only at four months follow-up (Pradhan, 2007). Two
studies performed mediation analysis, suggesting that the effect on the outcomes
were mediated by the increase in mindfulness scores (Bränström, 2010, Nycklicek,
2008). Because few studies measured mindfulness and because we do not have
access to data on individuals in the studies, further mindfulness
mediator/moderator analyses could not be performed.
Unfortunately, very few studies measured social functioning. One study reported on
ability to work, but the numbers of people involved were too small to allow
conclusions to be drawn. There were no reports on adverse events or costs in any of
the studies.

25 The Campbell Collaboration | www.campbellcollaboration.org
4.4.2 MBSR vs. Alternative active interventions
The data from these studies are treated separately and the effect sizes are not
pooled.
Koszycki et al. (2007) compared an eight-week (27.5 hour) MBSR course with a 12-
week (30 hours) cognitive behavioural therapy course for 53 patients with
moderately severe social anxiety disorder. All sessions were videotaped and
reviewed to assess protocol fidelity. Homework forms were reviewed each week.
Both interventions produced meaningful clinical changes. The MBSR group showed
high to moderate beneficial effect judged by within group Hedges’ g-value effect
sizes on measures of social anxiety (1.42, CIs not given), mood (0.66), disability
(0.63), and quality of life (0.53). Patients in the cognitive therapy group improved
significantly more than those in the MBSR group in terms of social anxiety. There
were no between-group differences in the other outcomes. The MBSR programme
had a dropout rate of only 15%.
Oman et al. (2008) compared an eight-week (12 hour) MBSR course with an
alternative eight week (12 hour) programme (on Easwaran 8-point mindfulness),
while the third group was a wait-list control group of 44 college students. Because
the unreported data results were similar for both the MBSR and EPP participants,
both groups were analysed together and compared to the wait-list control group.
The between-group Hedges’ g-values for effect sizes for the main outcomes at post-
intervention (and at the eight weeks follow-up) were 0.44 (0.50) for perceived
stress, 0.33 (0.44) for rumination, and 0.33 (0.30) for forgiveness (confidence
intervals not given). There were no significant changes in measures of hope.
Murphy (1994) compared the effect of a six-session (12 hour) MBSR course with six
two-hour sessions of progressive muscle relaxation (PMR) for 31 inmates who had
alcohol abuse and aggression problems. No substantial differences were found on
measures of anger (using the State Trait Anger Expression Inventory), egocentricity
(using Self Focus Sentence Completion), and stress reactivity measured by the post-
stress testing of salivary cortisol at the post-intervention stage.
Creswell et al. (2008) compared an eight week (24 hour) MBSR course with a one
day (6 hour) MBSR course among 48 HIV+ people experiencing distress and scores
of >4 on the Patient Health Questionnaire-9 scale). CD4+ T lymphocyte counts were
shown to decrease in the one-day control group, but not among participants in the
full MBSR course. The between-group Hedges’ g-value of effect size was 0.74 (CI not
given).
4.4.3 Studies where data could not be used in the meta-analysis
Alterman et al. (2004) compared the effect of an eight-week (23 hour) MBSR course
with treatment-as-usual for 31 substance-abuse recovery inpatients at post-
intervention and at five months follow-up (Alterman, 2004). The data were analysed
using repeated measures analysis of variance at three time points. The intervention

26 The Campbell Collaboration | www.campbellcollaboration.org
group improved more than the control group in terms of self-reported medical
problems when analysed as a group over three follow-up times (p=0.007). However,
because only mean values were reported, a Hedges’ g-value of effect size could not
be calculated. No significant group differences were found for measures of
psychological health.

27 The Campbell Collaboration | www.campbellcollaboration.org
5 Discussion
5.1 SUMMARY OF THE MAIN RESULTS
It is encouraging to see that the MBSR mind-body intervention has been analysed in
substantial numbers of randomised controlled trials. This review has reported on
more trials than ever before: 31 RCTs were selected, with a combined total of 1,942
participants. The overall effect size for the combined outcome of mental health was
moderately large (Hedges’ g-values = 0.53, 95% CI 0.46, 0.61). The effect sizes were
remarkably similar across a range of target groups (with mild to moderate distress),
intervention forms, outcome measures and settings. Heterogeneity was therefore
low.
Many of the studies we included provided several different measures of the same
construct and outcome measurements that were obviously interdependent. Failure
to account for such dependencies – in other words, calculating an average ‘anxiety
effect’ based on measurements with different anxiety scales – necessarily results in
erroneous standard errors and will compromise any inferential statistics generated.
Deciding on a criterion for electing only one outcome measure to include in the
meta-analysis can be equally problematic. Statistical dependencies were also evident
in follow-up measures post-test. As far as we know, this study is amongst the first to
utilise a new method for estimating robust standard errors under such
circumstances. This method makes it possible to use more information in the data-
set than has traditionally been the case (Hedges, 2010).
5.2 OVERALL COMPLETENESS AND APPLICABILITY OF
EVIDENCE
A number of MBSR evaluations have been published in this specialist knowledge
field in the last decade. Baer identified four randomised trials in 2003 (Baer, 2003)
and all of these are included in our study. Grossman (Grossman, 2004) reported on
seven RCTs in 2004: one of these we classified as not being a randomised trial
(Perkins, 1998). Carmody (2009) found 11 controlled studies: nine were classified by
us as RCTs.
Later reviews have focussed on specific target groups. Ledesma & Kumano, for
example, identified four trials on cancer patients (Ledesma, 2009). We have
excluded three of these from our analyses – two because they included elements

28 The Campbell Collaboration | www.campbellcollaboration.org
other than those stipulated in the traditional MBSR protocol (Herbert, 2001; Monti,
2005), and one because it took the form of a quasi-experimental study (Shapiro
2003). Hofmann identified seven randomised trials measuring anxiety or
depression (Hofmann, 2010) and all of these are included in our study. Bohlmeijer
identified eight RCTs studying patients with a chronic medical condition
(Bohlmeijer, 2010). Seven of these are included in this work, while one was excluded
because it deviated from the standard MBSR protocol (Monti, 2005). Chiesa
(Chiesa, 2009) included seven trial studies of healthy people, and all of these are
included in our study.
Of the 26 studies used in our meta-analysis, five included persons with various
psychological problems; 11 of the studies targeted people with various somatic
conditions; and ten recruited people from the general population. The intervention
effect has thus been evaluated across a broad spectrum of target groups. Study
settings in a number of different countries (Norway, Sweden, Germany, Switzerland,
Holland and the USA) contributed to the analysis, further serving to increase the
applicability of the evidence.
Studies that implemented major modifications to the standard MBSR protocol were
not included. However, studies of varying intervention length were accepted if the
researchers had adhered to the MBSR principles as stated by Kabat-Zinn (Kabat-
Zinn, 1990). Relatively few studies included follow-up data, and none included long-
term follow-up data: the evidence therefore for the long-term effects of the
intervention is clearly limited. All control groups received no treatment or
treatment-as-usual. Control conditions therefore varied and it was often difficult to
determine what the alternative conditions had been.
Unfortunately, only two trials provided data on social functioning (Nyklicek, 2008;
de Vibe, 2006) and the ability to work (de Vibe, 2006) and there was a paucity of
data related to functional outcomes. No explicit reporting on possible adverse effects
or costs was provided. Such information should be addressed in future trials.
5.3 QUALITY OF THE EVIDENCE
The quality of the studies varied and the overall risk of bias was high for several
studies (Davidson, 2003; Cohen-Katz 2005; Alterman, 2004; Astin, 1997;
Lengacher, 2009; Murray 2004; Plews-Ogan, 2005; Shapiro, 2005; Weissbecker,
2002). However, it was encouraging that high-quality trials were also found
(Bränstöm, 2010; Grossman, 2010; Jain, 2007; Moritz, 2006; Morone, 2008;
Nyklicek, 2008; Pradhan, 2007; Speca, 2000). Effect sizes did not, however, differ
significantly between studies carrying different risk of bias (p = 0.32, see additional
tables 4). Judgements about evidence and recommendations in healthcare are
complex. The GRADE system has been developed to improve judgements about the
quality of evidence (GRADE, 2008). Grading of the evidence showed that the quality
is high for evidence of effect on the composite score of mental health as well as for

29 The Campbell Collaboration | www.campbellcollaboration.org
measurements of stress/distress, but low for measurements of effect on quality of
life, and moderate for effects on other outcomes (Figure 13.14).
5.4 POTENTIAL BIASES IN THE REVIEW PROCESS
All steps in the analyses were undertaken by researchers with content and
methodological expertise.
Estimation of effects using the more robust method of variance estimation we
applied showed typically similar effect size estimates compared to estimates made
using the conventional method. The confidence intervals, however, were narrower.
It was notable that we were able to make use of most of the data provided in the
studies. We also avoided the often haphazard choice of which outcome to include in
a meta-analysis in those instances where several measures of the same construct
were presented in the primary studies. We anticipate that this new statistical
method will become a standard technique in future meta-analysis.
5.5 AGREEMENTS AND DISAGREEMENTS WITH OTHER
STUDIES OR REVIEWS
Overall, the effect sizes we estimated are relatively similar to the findings presented
in other review evaluations of MBSR. This holds true for measures of anxiety,
depression, stress, somatic health, and quality of life. This was not the case,
however, with regard to Toneatto’s study in which MBSR was shown to have no
effect on depression and anxiety (Toneatto, 2007). Toneatto’s finding though, we
would contend, was due to comparisons of MBSR being made with alternative
interventions in studies with varying designs. We suggest that the effect size
compares favourably with a recent meta-analysis of psychological treatments of
depressive symptoms in patients with medical disorders (van Straten, 2010). After
removing two outliers, the data showed an overall effect size of d=0.42 (95% CI 0.27,
0.58) for the 15 controlled studies comparing psychological treatments with a wait-
list or care-as-usual control group. Likewise, the effect size is in the same range as
those recently reported for interpersonal psychotherapy for depression (Cuijpers,
2011). The potential for MBSR as a useful intervention for improving mental health,
we argue, is therefore promising.
Based on the assumption that many self-reported mental health outcomes are
actually rooted in similar aspects of mental functions, we developed a single
composite measure of mental health based on the outcomes for anxiety, depression,
stress/distress and other mental health outcomes. These latter outcomes included
measures of emotional disturbance and regulation, anger, worry, rumination,
relaxation, and life orientation. This mental health measure captured data from all
26 studies; the measure included 79 of the 132 outcomes. Three other reviews (that
also included non-randomised studies) measured ‘mental health’ as a single

30 The Campbell Collaboration | www.campbellcollaboration.org
construct and the results were in the same range as our own (Baer, 2003; Grossman,
2004; Carmody, 2009).
5.5.1 Subgroup analyses
All subgroup analyses were conducted using the single composite mental health
outcome measure as the dependent variable. The correlation matrix of the variables
is shown in additional Table 11.6. A somewhat larger effect size among patient
populations (16 studies) than non-clinical populations (ten studies) was expected.
We hypothesised that effects would be larger in clinical populations with
psychological problems (five studies) than in somatic clinical populations (11
studies). However, neither of the comparisons showed any significant difference,
and both Grossman (2004) and Carmody (Carmody, 2009) reported similar
findings. A possible explanation for this is that all the studies included participants
who were self-selected. Given that the MBSR intervention is a well-known
intervention for stress-related problems, those included in the studies might
therefore be expected to be more similar in terms of their level of mental health
problems than the different group categories might suggest. Another explanation for
the similarity of effects across the different groups in terms of distress is because the
studies on somatic health problems mainly included patients with chronic
musculoskeletal problems, and the studies on psychological problems included only
patients with minor mental problems.
However, there is evidence to suggest that the effect is larger for people who have
substantially higher levels of mental health problems. One study which included
patients with clinical psychiatric diagnoses (Koszycki, 2007) found a larger effect
size, as did Grossman (2010) and de Vibe (2006), for subgroups of patients with
higher levels of psychological symptoms. More studies should therefore attempt to
elucidate which groups would benefit most from MBSR interventions and whether
or not there is a floor effect (i.e., a particular level of symptoms that would be
needed to demonstrate an effect).
Among the nine studies with follow-up data at 1-6 months, the effect size was shown
to decrease slightly over time. More studies with longer follow-up periods are thus
needed. Most trials offered the intervention to the control group immediately after
the end of the intervention period. While this may be understandable from a
practical or perhaps an ethical point of view, doing this destroys the possibility of
examining evidence on long-term effects. One study (Pradhan, 2007), for example,
gave three refresher classes in the four months follow-up period. A significant
increase in the effects on psychological distress, well-being and mindfulness at
follow-up was found when compared to post-intervention. We recommend further
investigation to identify what will be required to maintain such treatment effects
over time.
We expected the lengths of the intervention, attendance and home practice to
influence the effect size to some degree, but only found this to be true for

31 The Campbell Collaboration | www.campbellcollaboration.org
attendance. The length required for MBSR course interventions to have an effect is
thus still unknown. It should also be noted that the effect may occur due to moments
of insight which lead to a change in the way people view themselves and the world.
This may be due as much to a person’s readiness to change as from the length of an
MBSR course. In a more detailed analysis of dose-response, Carmody (2009) did not
find any significant effect from the length of an MBSR course or assigned home
practice. But we do not know, however, anything about the quality of the actual
practice undertaken. One could argue therefore that a 30-minute daily practice
routine which lacks attention or focus may actually be less effective than learning
instead to be mindful in everyday life – this would be very difficult to measure and
evaluate.
Furthermore, different types of practice may have different effects on different
outcomes, as shown in a pre-post study of 174 participants assigned to different
types of MBSR classes (Carmody, 2008). When analysed on the basis of more
careful recording, Rosenzweig (2010) showed that the effect varied both as a
function of clinical condition and compliance. A recent uncontrolled study showed
that home practice predicted not only reductions in self-reported stress, but also
changes in brain grey matter density in the right amygdala, an area involved in
stress reactions (Hölzel, 2010).
Attendance was found to be associated positively with the effect of the MBSR
intervention in seven of the 11 studies examining this possible predictor. Attendance
may be a measure of motivation or an indicator that participants found the
intervention useful. It may simply be that seeing a course through to the end is
necessary for a course to have effect. We suggest that this issue should be
investigated further. This could be achieved by, for instance, trying to measure
motivation, interviewing those who complete the courses as well as any dropouts,
and measuring the effect of MBSR several times during the course period in order to
explore whether attendance mediates the effects.
Eight studies reported intention to treat (ITT) data, and showed a slightly smaller
mental health effect size (0.47) relative to the 18 studies with non-ITT data (0.59).
The difference, however, was not significant. On the whole, attrition was low (ca.
15%). The data suggested no significant differences in average mental health effect
size due to variations in risk of bias. However, it was somewhat difficult to
distinguish between inadequate reporting and a de facto high risk of bias.

32 The Campbell Collaboration | www.campbellcollaboration.org
6 Authors’ conclusions
6.1 IMPLICATIONS FOR PRACTICE
There is moderate- to high-quality evidence of a consistent and moderately large
effect of Mindfulness Based Stress Reduction (MBSR) on health and quality of life.
The intervention appears to improve measures of personal development, including
empathy, coping, and a sense of coherence, as well as enhancing mindfulness.
Consistent effects across different populations, intervention forms and comparisons
further enhance the relevance of the intervention. While MBSR clearly alleviated
symptoms of stress and distress (and mental health more broadly defined), it also
had effects on measures of personal development and quality of life. MBSR might be
an attractive option for those interested in improving the way they cope with stress.
MBSR is group-based and can be delivered by non-medical personnel who have
been given sufficient training and have experience in teaching and practising
mindfulness.
6.2 IMPLICATIONS FOR RESEARCH
Further studies should explore ways to enhance the effects of MBSR interventions.
To achieve this, qualitative design studies may prove to be valuable in gaining
insight into participant perception and help to identify ways to involve participants
more, thus strengthening the effects. However, when evaluating actual effects, RCTs
must remain the preferred design; further uncontrolled studies are not needed.
Longer follow-up periods are also required in order to assess and address long-term
effects. Better reporting of randomised controlled trials is also urgently needed and
future research should include head-to-head comparisons with other interventions.
Well-designed primary studies ought to explore the effects of the length of the
intervention as well as reported home practice. As this field rapidly evolves, we
anticipate further combinations of both applied and basic approaches.
Investigations of changes in brain and body functions may, for example, be
embedded within trials. Such designs could potentially shed new light on
mechanisms and interventions for change. New trials should include measures of
mindfulness, preferably using the Five Facet Mindfulness Questionnaire (Baer,

33 The Campbell Collaboration | www.campbellcollaboration.org
2006). All trialists should attempt to share data, as many topics related to
mechanisms may be explored in individual patient data meta-analyses.

34 The Campbell Collaboration | www.campbellcollaboration.org
7 Acknowledgements
The review draft was improved thanks to content and methods peer-reviewers, our
English language consultant Simon Goudie, and the librarians Sølvi Biedilæ and
Brynhildur Axelsdottir.

35 The Campbell Collaboration | www.campbellcollaboration.org
8 Differences between the
protocol and the review
The use of the robust standard error approach in the analysis was not described in
the protocol. This was because the method was published after the protocol had
been accepted.
The suggested sensitivity analysis was processed using subgroup analysis (which
relates to risks of bias and the application of ITT-analysis). We did not impute any
missing information as attrition rates were low, and because neither risk of bias
scores nor whether ITT-analysis was done, influenced the results.
Compliance was suggested both as a moderator and as part of the set of subgroup
analyses. We chose the latter route.
Only seven studies measured mindfulness (in two different ways) and we chose not
to perform the suggested moderator analysis.
With hindsight we should probably have avoided the mixture of concepts ´subgroup
analysis´, ´moderator analysis´, and ´sensitivity analysis´. We had some real
subgroups (e.g. clinical vs. non-clinical target groups), some study level variables
(e.g. risk of bias) and variables on the individual level (e.g. compliance and self-
reported practice). While it seemed meaningful to investigate heterogeneity in
effects by means of subgroup analysis for the first two groups (as described in the
main text), in our judgement the latter variables can be treated as moderators in a
meaningful way only if access to individual patient data is possible.

36 The Campbell Collaboration | www.campbellcollaboration.org
9 Sources of support
This study is supported by The Norwegian Medical Association, The Norwegian
Knowledge Centre for the Health Services, Centre for Child and Adolescent Mental
Health, Eastern and Southern Norway, and SFI Campbell at The Danish National
Centre for Social Research.

37 The Campbell Collaboration | www.campbellcollaboration.org
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10.3 STUDIES AWAITING CLASSIFICATION
Esmer G, Blum J, Rulf J, Pier J. Mindfulness-based stress reduction for failed back
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Comparing the effectiveness of mindfulness-based stress reduction and
multidisciplinary intervention programs for chronic pain: a randomized
comparative trial. Clin J Pain. 2011;27:724-34.

52 The Campbell Collaboration | www.campbellcollaboration.org
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55 The Campbell Collaboration | www.campbellcollaboration.org
11 Tables
11.1 CHARACTERISTICS OF INCLUDED STUDIES
Alterman 2004
Methods RCT
Participants Drug abusers in resident treatment for >2 months, Exclusion criteria:
schizophrenia and borderline personality disorders, AIDS, hepatitis, regular
mind-body practice in last two months
Interventions MBSR vs. treatment-as-usual
MBSR: 8 x 2 hours per week + 7 hour all-day session. 30-45 minutes of daily
practice in a group
Outcomes Semi-structured psychiatric interview measured problems in the following
seven areas: medical, employment, alcohol, drug, legal, family-social and
psychiatric. In addition, the following were also measured: spirituality,
optimism, positive and negative mood, vitality, physical and mental health,
drug and alcohol use, and meditation practice
Key conclusions Addiction Severity Index indicated greater improvement in MBSR group in
medical problems over a five month follow-up period, and a positive trend for
psychological problems, but no other group differences and no difference in
urine toxicology
Notes Analysis by repeated measures of variance to look for group and time
interactions. Because statistical power was low, effect sizes for group
differences were also given
Risk of bias table
Bias Authors’
judgement Support for judgement
Random sequence generation
(selection bias) Low risk Random number sequence
Allocation concealment Unclear risk Not specified

56 The Campbell Collaboration | www.campbellcollaboration.org
Bias Authors’
judgement Support for judgement
(selection bias)
Blinding (performance bias and
detection bias) High risk University technicians administered interview at
post-intervention and follow-up but not at baseline
stage
Incomplete outcome data
(attrition bias) Low risk Only three people dropped out of each group
Selective reporting (reporting
bias) High risk No SD given
Other bias High risk Treatment staff administered interview at baseline,
technical staff at other times
Anderson 2007
Methods RCT
Participants 86 healthy adults
Interventions MBSR vs. wait-list control
MBSR: 8 x 2 hours per week, no all-day retreat
Outcomes Attention control, depression, affect, anxiety, anger, rumination, worry,
mindfulness and
four attention tasks
Key conclusions MBSR did not affect attentional control, but was associated with
improvements (p<0.01) in emotional well-being (as measured by depression,
anxiety, anger, positive affect, general rumination, anger rumination and
anger sensitivity) and mindfulness. Changes in mindfulness predicted
changes in emotional well-being in the MBSR group, and improved
mindfulness enhanced awareness of present experience
Notes
Intention to treat (ITT) analysis not conducted as the number of dropouts in
each group was equal (n=7). Greater negative affect, depression and anger
rumination in MBSR group at baseline. Therefore multivariate ANOVA
undertaken using baseline differences as covariates

57 The Campbell Collaboration | www.campbellcollaboration.org
Risk of bias table
Bias Authors’
judgement Support for judgement
Random sequence
generation (selection
bias)
Unclear risk Not specified
Allocation
concealment (selection
bias)
Unclear risk Not specified
Blinding (performance
bias and detection
bias)
Unclear risk Not specified
Incomplete outcome
data (attrition bias) Low risk The number of dropouts in each group was the same (n=7)
hence the most conservative estimate of post-test scores
would not have affected group mean differences post-test
Selective reporting
(reporting bias)
Low risk All outcomes reported
Other bias Low risk No other bias detected
Astin 1997
Methods RCT
Participants Students
Interventions MBSR vs. wait-list control
MBSR: 8 x 2 hours per week, no all-day retreat
Outcomes Psychological distress, control and spiritual experience
Key conclusions MBSR significantly reduced psychological distress p<0.002, representing a
64% reduction in the MBSR group vs. 14 % in the control group. Increased
overall sense of control (p<0.02), and use of more accepting/yielding mode
of control p<0.03. Increase in measure of self as source of control p<0.008.
Increased scores on the outcome of spiritual experiences p<0.03
Notes Intention to treat (ITT) analysis not reported. ANOVA analysis was
performed using change scores as dependent variable and baseline values
as covariates. Wrote to author but further data unavailable
Risk of bias table
Bias Authors’
judgement Support for judgement
Random sequence
generation
Low risk Coin flipping (confirmed after request for further
information sent to author)

58 The Campbell Collaboration | www.campbellcollaboration.org
Bias Authors’
judgement Support for judgement
(selection bias)
Allocation concealment
(selection bias) Unclear risk Person who did the coin flipping not specified
Blinding (performance bias
and detection bias) High risk Most likely not blinded given that the researcher was
acting as both instructor and data collector
Incomplete outcome data
(attrition bias) Unclear risk Large dropout from control group
Selective reporting (reporting
bias) Unclear risk Missing raw data from all facets of SCI (Sense Of
Control Index)
Other bias Low risk No other bias detected
Bränström 2010
Methods RCT
Participants 71 patients with varying cancer diagnoses who were not currently
undergoing radiation or chemotherapy treatment
Interventions MBSR vs. wait-list control
MBSR: 8 x 2 hours per week, without all-day session
Outcomes Stress, anxiety and depression, impact on event scale, mood states and
mindfulness. Home-based meditation practice. All measured both before
MBSR and one month after completion
Key conclusions Significant decrease in stress, post-traumatic avoidance symptoms, and
increased profile of mood states. Significant increase in mindfulness – this
mediated the effects
Notes Wrote to author who confirmed that the figures in Table 2 of the publication
were generated using Intention to treat (ITT) analysis (32 persons in the
MBSR group and 39 persons in the control group)
Risk of bias table
Bias Authors’
judgement Support for judgement
Random sequence generation
(selection bias) Low risk Software used for random selection
procedure
Allocation concealment (selection Low risk

59 The Campbell Collaboration | www.campbellcollaboration.org
bias)
Blinding (performance bias and
detection bias) Unclear risk No blinding of group assignment
Incomplete outcome data (attrition
bias) Low risk Intention to treat (ITT) analysis
Selective reporting (reporting bias) Low risk All reported, six month follow-up to be
reported later
Other bias Low risk No other bias detected
Carson 2004
Methods RCT
Participants White couples either married or cohabitating >2 years, non-distressed (<58
on the global marital satisfaction inventory and <65 on the brief symptom
inventory), not practising yoga or meditation regularly
Interventions MBSR vs. wait-list control
MBSR: 8 x 2.5 hours per week + 7 hour all-day session, couple focus in the
exercises
Outcomes Global marital satisfaction inventory, brief symptom inventory, relationship
satisfaction, autonomy, closeness, acceptance of partner, optimism,
spirituality, individual relaxation index
Key conclusions Favourable impact on relationship satisfaction, autonomy, relatedness,
closeness, acceptance and relationship distress, same on individual
optimism, spirituality, relaxation and distress, and results maintained at three
months follow-up. Those who practised had better outcome
Notes
Sessions videotaped and rated for fidelity, daily practice diaries, experienced
MBSR teachers
Risk of bias table
Bias Authors’
judgement Support for judgement
Random sequence
generation
(selection bias)
Unclear risk Method of randomisation not specified, randomisation
stratified for couples

60 The Campbell Collaboration | www.campbellcollaboration.org
Allocation concealment
(selection bias) Unclear risk Not specified, wrote to author
Blinding (performance bias
and detection bias) Unclear risk Not specified,wrote to author
Incomplete
outcome data
(attrition bias)
Low risk Equal dropout numbers in both groups, and
differences between completers and dropouts
analysed
Selective reporting (reporting
bias) Low risk All outcomes reported
Other bias Low risk No other bias detected
Cohen-Katz 2005
Methods RCT
Participants 27 hospital staff, mainly nurses
Interventions MBSR vs. wait-list control
MBSR: 8 x 2.5 hours per week + 6 hour all-day session
Outcomes Burnout, distress and mindfulness
Key conclusions Significant increase in mindfulness, significant decrease in emotional
exhaustion (p=0.05) and increase in personal accomplishment (p=0.014).
Trend for depersonalisation (p=0.063), but no significant difference in
distress
Notes More people with elevated distress in control group (7/13) than MBSR group
(3/12) at pre-intervention
Risk of bias table
Bias Authors’
judgement Support for judgement
Random sequence generation
(selection bias) Unclear risk Not specified
Allocation concealment
(selection bias) Unclear risk Not specified
Blinding (performance bias