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Prospects for a Clinical Science of Mindfulness-Based Intervention Sona Dimidjian University of Colorado Boulder Zindel V. Segal University of Toronto Scarborough Mindfulness-based interventions (MBIs) are at a pivotal point in their future development. Spurred on by an ever- increasing number of studies and breadth of clinical ap- plication, the value of such approaches may appear self- evident. We contend, however, that the public health impact of MBIs can be enhanced significantly by situating this work in a broader framework of clinical psychological science. Utilizing the National Institutes of Health stage model (Onken, Carroll, Shoham, Cuthbert, & Riddle, 2014), we map the evidence base for mindfulness-based cognitive therapy and mindfulness-based stress reduction as exemplars of MBIs. From this perspective, we suggest that important gaps in the current evidence base become apparent and, furthermore, that generating more of the same types of studies without addressing such gaps will limit the relevance and reach of these interventions. We offer a set of 7 recommendations that promote an inte- grated approach to core research questions, enhanced methodological quality of individual studies, and increased logical links among stages of clinical translation in order to increase the potential of MBIs to impact positively the mental health needs of individuals and communities. Keywords: mindfulness, psychotherapy, mindfulness-based stress reduction, mindfulness-based cognitive therapy T he science and practice of mindfulness-based inter- vention (MBI) stands at a crossroads. It has wit- nessed exponential growth and interest in the last 15 years, with the establishment of research and clinical cen- ters dedicated to the study and delivery of MBIs and an attendant proliferation of academic journals, magazines, and books. Given this context of expansion, we invite a pause in the forward movement to reflect on the durability and public health impact of this work. Our view is that such reflection is best promoted by considering MBIs in the broader framework of clinical psychological science and the recently proposed National Institutes of Health (NIH) stage model (Onken et al., 2014). The NIH stage model emerged from an interest in shaping the training of future generations of clinical scientists by providing a well-artic- ulated view of the goals and process of clinical psycholog- ical science. Specifically, as presented by Onken and col- leagues (2014), the stage model is anchored in a vision intended to unify various aspects of clinical science toward the common goal of developing maximally potent and implementable interventions, while unveiling new avenues of science in which basic and applied goals are of equally high importance . . . to propel the field to fulfill the public health goal of producing implementable and effective treatment and prevention interven- tions. (p. 22) In this paper, we use this framework to map MBI research, identify gaps in our knowledge and methods, and under- score priority questions and dilemmas for the future. Doing so allows us to identify both strengths and early indications of fault lines in the foundation of this rapidly developing field. We first describe the use of the NIH stage model as a map for organizing the MBI evidence base. Next, with the aim of increasing the public health impact of MBI science and practice, we apply the NIH stage model. We identify strengths of the evidence base and its limitations, including stages that have been under or overemphasized and path- ways among stages that are weak or underdeveloped. We also outline seven stage-based sets of recommendations for ways in which the science and practice of MBI can be advanced to increase public health impact. It is our hope that by providing a broad and integrative framework at this critical juncture, we can help to chart a course that supports deliberate, intentional, effective, and coordinated work on MBIs. Mapping the MBI Evidence Base Articles were identified through searches of the PsycINFO and PubMed databases. Database records were queried using the search terms MBCT (i.e., mindfulness-based cog- nitive therapy), MBSR (i.e., mindfulness-based stress re- duction), and mindful* in the title or abstract fields for PubMed and in the title or subject fields for PsycINFO and Editor’s note. This article is one of four in the special issue, “The Emergence of Mindfulness in Basic and Clinical Psychological Science,” published in American Psychologist (October 2015). Richard J. Davidson and Sona Dimidjian provided scholarly lead for the special issue. Authors’ note. Sona Dimidjian, Department of Psychology and Neuro- science, University of Colorado Boulder; Zindel V. Segal, Department of Psychology, University of Toronto Scarborough. Sona Dimidjian and Zindel V. Segal receive royalties from Guilford Press for work related to mindfulness-based cognitive therapy and are on the advisory board of Mindful Noggin, which is part of NogginLabs, a private company specializing in customized web-based learning. Correspondence concerning this article should be addressed to Sona Dimidjian, Department of Psychology and Neuroscience, University of Colorado Boulder, 345 UCB, Boulder, CO 80309-0345. E-mail: [email protected] This document is copyrighted by the American Psychological Association or one of its allied publishers. This article is intended solely for the personal use of the individual user and is not to be disseminated broadly. 593 October 2015 American Psychologist © 2015 American Psychological Association 0003-066X/15/$12.00 Vol. 70, No. 7, 593– 620 http://dx.doi.org/10.1037/a0039589

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Prospects for a Clinical Science of Mindfulness-BasedIntervention

Sona Dimidjian University of Colorado BoulderZindel V. Segal University of Toronto Scarborough

Mindfulness-based interventions (MBIs) are at a pivotalpoint in their future development. Spurred on by an ever-increasing number of studies and breadth of clinical ap-plication, the value of such approaches may appear self-evident. We contend, however, that the public healthimpact of MBIs can be enhanced significantly by situatingthis work in a broader framework of clinical psychologicalscience. Utilizing the National Institutes of Health stagemodel (Onken, Carroll, Shoham, Cuthbert, & Riddle,2014), we map the evidence base for mindfulness-basedcognitive therapy and mindfulness-based stress reductionas exemplars of MBIs. From this perspective, we suggestthat important gaps in the current evidence base becomeapparent and, furthermore, that generating more of thesame types of studies without addressing such gaps willlimit the relevance and reach of these interventions. Weoffer a set of 7 recommendations that promote an inte-grated approach to core research questions, enhancedmethodological quality of individual studies, and increasedlogical links among stages of clinical translation in orderto increase the potential of MBIs to impact positively themental health needs of individuals and communities.

Keywords: mindfulness, psychotherapy, mindfulness-basedstress reduction, mindfulness-based cognitive therapy

The science and practice of mindfulness-based inter-vention (MBI) stands at a crossroads. It has wit-nessed exponential growth and interest in the last 15

years, with the establishment of research and clinical cen-ters dedicated to the study and delivery of MBIs and anattendant proliferation of academic journals, magazines,and books. Given this context of expansion, we invite apause in the forward movement to reflect on the durabilityand public health impact of this work. Our view is that suchreflection is best promoted by considering MBIs in thebroader framework of clinical psychological science andthe recently proposed National Institutes of Health (NIH)stage model (Onken et al., 2014). The NIH stage modelemerged from an interest in shaping the training of futuregenerations of clinical scientists by providing a well-artic-ulated view of the goals and process of clinical psycholog-ical science. Specifically, as presented by Onken and col-leagues (2014), the stage model is anchored in a vision

intended to unify various aspects of clinical science toward thecommon goal of developing maximally potent and implementableinterventions, while unveiling new avenues of science in which

basic and applied goals are of equally high importance . . . topropel the field to fulfill the public health goal of producingimplementable and effective treatment and prevention interven-tions. (p. 22)

In this paper, we use this framework to map MBI research,identify gaps in our knowledge and methods, and under-score priority questions and dilemmas for the future. Doingso allows us to identify both strengths and early indicationsof fault lines in the foundation of this rapidly developingfield.

We first describe the use of the NIH stage model as amap for organizing the MBI evidence base. Next, with theaim of increasing the public health impact of MBI scienceand practice, we apply the NIH stage model. We identifystrengths of the evidence base and its limitations, includingstages that have been under or overemphasized and path-ways among stages that are weak or underdeveloped. Wealso outline seven stage-based sets of recommendations forways in which the science and practice of MBI can beadvanced to increase public health impact. It is our hopethat by providing a broad and integrative framework at thiscritical juncture, we can help to chart a course that supportsdeliberate, intentional, effective, and coordinated work onMBIs.

Mapping the MBI Evidence BaseArticles were identified through searches of the PsycINFOand PubMed databases. Database records were queriedusing the search terms MBCT (i.e., mindfulness-based cog-nitive therapy), MBSR (i.e., mindfulness-based stress re-duction), and mindful* in the title or abstract fields forPubMed and in the title or subject fields for PsycINFO and

Editor’s note. This article is one of four in the special issue, “TheEmergence of Mindfulness in Basic and Clinical Psychological Science,”published in American Psychologist (October 2015). Richard J. Davidsonand Sona Dimidjian provided scholarly lead for the special issue.

Authors’ note. Sona Dimidjian, Department of Psychology and Neuro-science, University of Colorado Boulder; Zindel V. Segal, Department ofPsychology, University of Toronto Scarborough.

Sona Dimidjian and Zindel V. Segal receive royalties from GuilfordPress for work related to mindfulness-based cognitive therapy and are onthe advisory board of Mindful Noggin, which is part of NogginLabs, aprivate company specializing in customized web-based learning.

Correspondence concerning this article should be addressed to SonaDimidjian, Department of Psychology and Neuroscience, University ofColorado Boulder, 345 UCB, Boulder, CO 80309-0345. E-mail:[email protected]

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593October 2015 ● American Psychologist© 2015 American Psychological Association 0003-066X/15/$12.00Vol. 70, No. 7, 593–620 http://dx.doi.org/10.1037/a0039589

were limited to studies conducted with human subjects andpublished between January 1, 1985, and December 31,2013, in English, and in a peer-reviewed journal. Recordsfor the total number of articles returned from each querywere compiled and duplicates were removed, yielding3,217 articles in the initial search. Research assistants re-viewed the title and abstract of these records to confirmrelevance to the topic based on the article title and abstract.Articles were included if they addressed or MBCT orMBSR using case reports, open trials, controlled trials, ordevelopment of intervention fidelity measurement tools.Articles were excluded if they primarily examined topicssuch as trait or state mindfulness, trait or state mindfulnessrating scales, basic research on mindfulness techniqueswithout a clinical focus, or samples of experienced medi-tators. Interviews, personal essays or narratives, theoreticaland review articles, and meta-analyses also were excluded.Final inclusion decisions were made by the authors, result-ing in a total of 308 articles (MBCT n � 117, MBSR n �191). These were categorized by the authors for interven-tion type and target problem or population, and within eachtreatment model, by the appropriate stage based on Onkenet al. (2014) using the descriptions that follow. See Tables1 and 2 for the categorizations of the evidence base forMBCT and MBSR, respectively.

Specifically, we map at Stage 0 studies that use neu-roscience and behavioral, cognitive, affective, and socialscience methods to explicate the target of intervention andmechanisms of change. Two broad categories of basicresearch are relevant to clinical intervention. First, basicresearch studies can be conducted “upstream,” or tempo-rally preceding the other stages of research at any level ofanalysis that informs intervention development or modifi-cation. This work can offer a critical scientific foundation

for why and how an intervention may be helpful for aparticular problem or population. Second, basic researchmethods can be conducted in an integrated manner intandem with intervention research by assessing interven-tion outcomes on levels that extend beyond mental healthsymptom report and by answering questions about how anintervention works and for whom.

The scope of “upstream” basic research on the prob-lems targeted by MBIs is vast and beyond the scope of thisreview (e.g., studies identifying the pathophysiology ofmajor depression or anxiety disorders, etc.). Thus, ourmapping focuses on the second category of basic re-search—that which is integrated with applied research atStages I–V. These studies encompass varying degrees ofmethodological rigor; however, they share the commonelement of seeking to understand whether an MBI worksbeyond simply symptom report, as well as how and forwhom. Because this work integrates basic research para-digms as part of later stage intervention studies, it ismapped with an asterisk at the relevant later-stage study.

We include studies that examine multiple units ofanalysis to measure treatment outcome (e.g., measurementof neural circuits, physiology, performance on behavioralor cognitive tasks, etc.). For example, in a study testingMBSR with HIV-positive patients, Creswell, Myers, Cole,and Irwin (2009) examined the effects on biological mark-ers of disease progression (e.g., CD4 � T lymphocytes); asthis study integrates basic research methods to characterizeprecise biological outcomes within the context of a Stage IIstudy, it is denoted with an asterisk in Table 2. We alsoinclude studies that test mediation or moderation of inter-vention outcomes (even if only limited to one unit ofanalysis such as self-report). For example, Arch and Ayers(2013) measured self-report of baseline clinical severityand examined the extent to which such information couldidentify which treatment worked better for which patients;as this study integrated a focus on treatment moderation inthe context of a Stage II study, it is denoted in Table 2 withan asterisk.

Onken et al. (2014) define Stage I as “all activitiesrelated to the creation of a new intervention, or the modi-fication, adaptation, or refinement of an existing interven-tion (Stage IA), as well as feasibility and pilot testing(Stage IB)” (p. 28). This stage is also defined to encompassa focus on the development of training, supervision, andfidelity promotion materials. Our mapping at this stageincludes mainly feasibility and pilot testing studies includ-ing nonrandomized open-trial designs of an MBI, whetherconducted in the research lab or community settings. Mostof these studies focus on extending the MBI to a novelproblem or population, although some also represent earlyphase work in extending an MBI to a new setting. Some ofthese studies also examine the relationship between inter-vention exposure and outcome (e.g., dosage effects).

As defined by Onken et al. (2014),

Stage II research consists of testing of promising behavioralinterventions in research settings, with research therapists/pro-viders . . . Stage III is similar to Stage II research, except that

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594 October 2015 ● American Psychologist

instead of research providers and settings, it consists of testing ina community context while maintaining a high level of controlnecessary to establish internal validity. (pp. 28–29)

We map at Stage II efficacy trials of promising MBIsconducted in research settings, and at Stage III efficacytrials conducted in community settings, using communityproviders. These studies place a premium on internal va-lidity, and focus on testing efficacy and identifying mech-anisms of change. We extend the NIH model by mappingseparately at Stage II studies that use randomized designsthat test efficacy, with comparisons often to treatment-as-usual (TAU) or waitlist control (WLC) conditions andrandomized designs that test comparative or specific effi-cacy, with comparisons to an active control or an estab-lished treatment. Although the distinction between activecontrol and other comparison groups is relevant for StagesIII–V, we have not mapped those separately due to thepaucity of work at those stages. As more studies at thesestages are conducted, it will be vital for future efforts tomap the nature of the control and comparison conditions infiner granularity. Although Onken et al. (2014) allow forthe inclusion of nonrandomized designs at Stage II, wesuggest that the methodological rigor of randomized con-trolled trials has specific value for the future of research onMBI; thus, we map all nonrandomized designs at Stage I.

Stages IV and V cover effectiveness research andimplementation and dissemination research, respectively.As defined by Onken et al. (2014), effectiveness research(Stage IV) places a premium on external validity, as re-searchers examine interventions as implemented by com-munity providers under routine conditions “in the realworld.” Stage V places relatively less emphasis on theintervention itself and instead foregrounds the study ofmethods to increase the adoption, integration, scaling up,and sustainability of an intervention in everyday settings.An important contribution of the NIH model is defining

these stages as integral components of the clinical scienceendeavor. The inclusion of these stages codifies an inherentvalue that “intervention development is incomplete untilthe intervention is maximally potent and implementable forthe population for which it was developed” (Onken et al.,2014, p. 25).

The Clinical Application ofMindfulness and Current EvidenceBase: A “Bird’s Eye View”MBSR originated in the work of Jon Kabat-Zinn and col-leagues in 1979 at the University of Massachusetts MedicalCenter (Kabat-Zinn, 1990). Nearly a decade later, Segal,Williams, and Teasdale (2002) built upon this early foun-dation with the development of MBCT, extending andintegrating the framework and practices of MBSR withcognitive–behavioral therapy. Both of these interventionsare organized around the use of mindfulness meditation asa core intervention component, and engage such specificpractices as sitting meditation, walking meditation, bodyscan meditation, yoga, and a range of forms of daily infor-mal practice (e.g., mindful eating). These practices aretaught to support participants in developing mindfulness asskills or means to personal goals (e.g., prevention of de-pression or reduction of stress) and, to borrow from Lutz,Jha, Dunne, and Saron (2015), “a way of life.” Each sessionis delivered using an eight-session, weekly structure fea-turing extended experiential practice and inquiry aboutpractice. The essential role of daily formal and informalmindfulness practice is emphasized throughout. The role ofthe instructor in these interventions is multilayered andcomprises guiding practice (e.g., in person during classesand via audio recorded practice guides for participants touse between classes), embodying “mindfulness” using thebroadest conceptualization of this term (J. M. G. Williams& Kabat-Zinn, 2011), and delivering intervention specificcontent (e.g., about stress or depression risk). Instructorsare asked to teach from a foundation of their own personalmindfulness meditation practice.

Although other conceptually and clinically related in-terventions were developed in parallel to MBSR andMBCT (e.g., acceptance and commitment therapy; Hayes,Strosahl, & Wilson, 1999; and dialectical behavior therapy;Linehan, 1993), MBSR and MBCT are distinguished by thepredominant focus on mindfulness meditation practices,the 8-week course structure, active daily home practice ofmindfulness meditation, and the role and training require-ments of the instructor. Moreover, since the first studies ofMBCT and MBSR were published, multiple “next-gener-ation” MBI models have been developed. We focus, how-ever, on MBCT and MBSR as the target interventions forthis review because each has amassed a sufficient empiricalrecord to enable mapping of this nature. In a final section,we offer reflections about next-generation interventionsand recent findings that reflect promising advancements inthe field. As the field develops, we expect that updates toour mapping will be required for MBSR, MBCT, andrelated as well as next-generation interventions.

Zindel V.Segal

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595October 2015 ● American Psychologist

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V:Im

plem

enta

tion

and

diss

emin

atio

nW

aitli

stor

treat

men

t-as-u

sual

cont

rol

Act

ive

cont

rol

Hea

lthca

restu

dent

sC

olla

rdet

al.,

2008

——

——

—H

opki

nset

al.,

2013

Rim

eset

al.,

2011

Ruth

set

al.,

2013

Het

erog

eneo

us/

Uns

peci

fied

R.S.

Cra

neet

al.,

2013

——

——

Gre

enet

al.,

2012

Hee

ren

etal

.,20

09*

Her

dtet

al.,

2012

Lang

don

etal

.,20

11Re

eet

al.,

2007

Schr

oeve

rset

al.,

2010

Troy

etal

.,20

13*

Med

ical

com

orbi

dity

Cha

mbe

rset

al.,

2012

Brot

toet

al.,

2012

*Ph

ilipp

otet

al.,

2012

N.J

.Tho

mps

onet

al.,

2010

van

Rave

steijn

etal

.,20

13—

Fitz

patri

cket

al.,

2010

Fole

yet

al.,

2010

Grif

fiths

etal

.,20

09Pa

rra-

Del

gado

etal

.,20

13O

’Hav

erD

ay,&

Hor

ton-

Deu

tsch,

2004

Rim

eset

al.,

2013

Shar

plin

etal

.,20

10Sk

ovbj

erg

etal

.,20

12va

nde

rLe

eet

al.,

2012

van

Son

etal

.,20

13*

Preg

nanc

yD

unn

etal

.,20

12—

——

——

Prob

lem

gam

blin

gde

Lisle

etal

.,20

11—

——

——

Psyc

hosi

s—

Lang

eret

al.,

2012

——

——

Slee

pYo

oket

al.,

2008

Britt

onet

al.,

2010

*—

——

—Br

itton

,Hay

nes,

etal

.,20

12*

Britt

on,S

haha

r,et

al.,

2012

*

*St

udie

sth

atin

tegr

ate

basi

cre

sear

chas

part

ofla

ter

stage

inte

rven

tion

studi

esar

ede

note

dat

the

rele

vant

late

rsta

gew

ithan

aste

risk.

Thi

sdo

cum

ent

isco

pyri

ghte

dby

the

Am

eric

anPs

ycho

logi

cal

Ass

ocia

tion

oron

eof

itsal

lied

publ

ishe

rs.

Thi

sar

ticle

isin

tend

edso

lely

for

the

pers

onal

use

ofth

ein

divi

dual

user

and

isno

tto

bedi

ssem

inat

edbr

oadl

y.

598 October 2015 ● American Psychologist

Table

2N

atio

nalI

nstit

utes

ofH

ealth

Stag

eM

odel

Cla

ssifi

catio

nof

Min

dful

ness

-Bas

edSt

ress

Redu

ctio

nEv

iden

ceBa

se

Stag

e0:

Basi

c*

Targ

etpr

oble

mor

popu

latio

nSt

age

I:In

terv

entio

nge

nera

tion/

refin

emen

t

Stag

eII:

Effic

acy

inre

sear

chcl

inic

Stag

eIII

:Effi

cacy

inco

mm

unity

clin

icSt

age

IV:E

ffect

iven

ess

Stag

eV:

Impl

emen

tatio

nan

ddi

ssem

inat

ion

Wai

tlist

ortre

atm

ent-a

s-usu

alco

ntro

lA

ctiv

eco

ntro

l

Ado

lesc

ents

Jastr

owsk

iMan

oet

al.,

2013

Bieg

elet

al.,

2009

Sibi

nga

etal

.,20

13*

——

Anx

iety

Gol

din

etal

.,20

09*

Vølle

stad

etal

.,20

11*

Arc

h&

Aye

rs,2

013*

——

—G

oldi

net

al.,

2010

*A

rch

etal

.,20

13H

azle

tt-St

even

set

al.,

2012

Gol

din

etal

.,20

12*

Mill

er19

95G

oldi

net

al.,

2013

*Pa

tele

tal.,

2007

Hog

eet

al.,

2013

*Ra

pgay

etal

.,20

11Ja

zaie

riet

al.,

2012

Kosz

ycki

etal

.,20

07A

rthrit

is—

Prad

han

etal

.,20

07*

——

——

Asth

ma

——

Pber

teta

l.,20

12*

——

—C

ance

rA

berc

rom

bie

etal

.,20

07A

nder

sen

etal

.,20

13H

ende

rson

etal

.,20

12—

——

Alts

chul

eret

al.,

2012

Brän

ström

etal

.,20

13*

Birn

ie,G

arla

nd,&

Car

lson,

2010

Hof

fman

,Ers

ser,

Hop

kins

on,N

icho

lls,

etal

.,20

12C

ampb

elle

tal.,

2012

*La

belle

etal

.,20

10*

Car

lson

etal

.,20

03*

Leng

ache

ret

al.,

2009

Car

lson

etal

.,20

04*

Leng

ache

r,Re

ich,

etal

.,20

12C

arlso

n&

Gar

land

,20

05*

Leng

ache

ret

al.,

2013

*

Car

lson

etal

.,20

07*

Lerm

anet

al.,

2012

Deg

ieta

l.,20

13W

ürtz

en,D

alto

n,El

sass

,et

al.,

2013

Dob

kin

etal

.,20

08G

arla

ndet

al.,

2007

Gar

land

etal

.,20

13H

offm

an,E

rsse

r,&

Hop

kins

on,2

012

Kiev

iet-S

tijne

net

al.,

2008

(table

continues)

Thi

sdo

cum

ent

isco

pyri

ghte

dby

the

Am

eric

anPs

ycho

logi

cal

Ass

ocia

tion

oron

eof

itsal

lied

publ

ishe

rs.

Thi

sar

ticle

isin

tend

edso

lely

for

the

pers

onal

use

ofth

ein

divi

dual

user

and

isno

tto

bedi

ssem

inat

edbr

oadl

y.

599October 2015 ● American Psychologist

Table

2(c

ontinued)

Stag

e0:

Basi

c*

Targ

etpr

oble

mor

popu

latio

nSt

age

I:In

terv

entio

nge

nera

tion/

refin

emen

t

Stag

eII:

Effic

acy

inre

sear

chcl

inic

Stag

eIII

:Effi

cacy

inco

mm

unity

clin

icSt

age

IV:E

ffect

iven

ess

Stag

eV:

Impl

emen

tatio

nan

ddi

ssem

inat

ion

Wai

tlist

ortre

atm

ent-a

s-usu

alco

ntro

lA

ctiv

eco

ntro

l

Kvill

emo

etal

.,20

11Le

ngac

her

etal

.,20

11Le

ngac

her,

Kip,

etal

.20

12*

Mac

kenz

ieet

al.,

2007

Mat

chim

etal

.,20

11*

Mat

ouse

ket

al.,

2011

*Sa

xeet

al.,

2001

*Sh

apiro

etal

.,20

03Ta

cón

etal

.,20

04Ta

cón

etal

.,20

11Ts

ang

etal

.,20

12W

eitz

etal

.,20

12W

itek-

Janu

sek

etal

.,20

08*

Wür

tzen

,Dal

ton,

And

erse

n,et

al.,

2013

*C

areg

iver

sEp

stein

-Lubo

wet

al.,

2011

—W

hite

bird

etal

.,20

13—

——

Min

oret

al.,

2006

Chr

onic

pain

Rose

nzw

eig

etal

.,20

10—

Esm

eret

al.,

2010

——

Plew

s-Oga

net

al.,

2005

Won

get

al.,

2011

Dep

ress

ion

histo

ryRa

mel

etal

.,20

04—

——

——

Dia

bete

sRo

senz

wei

get

al.,

2007

*H

artm

ann

etal

.,20

12*

——

——

Dis

orde

red

eatin

gKe

arne

y,M

ilton

,eta

l.,20

12—

——

——

Smith

etal

.,20

06Fi

brom

yalg

iaG

ross

man

etal

.,20

07Se

phto

net

al.,

2007

Schm

idte

tal.,

2011

——

—Ka

plan

etal

.,19

93Lu

shet

al.,

2009

*W

eiss

beck

eret

al.,

2002

Thi

sdo

cum

ent

isco

pyri

ghte

dby

the

Am

eric

anPs

ycho

logi

cal

Ass

ocia

tion

oron

eof

itsal

lied

publ

ishe

rs.

Thi

sar

ticle

isin

tend

edso

lely

for

the

pers

onal

use

ofth

ein

divi

dual

user

and

isno

tto

bedi

ssem

inat

edbr

oadl

y.

600 October 2015 ● American Psychologist

Table

2(c

ontinued)

Stag

e0:

Basi

c*

Targ

etpr

oble

mor

popu

latio

nSt

age

I:In

terv

entio

nge

nera

tion/

refin

emen

t

Stag

eII:

Effic

acy

inre

sear

chcl

inic

Stag

eIII

:Effi

cacy

inco

mm

unity

clin

icSt

age

IV:E

ffect

iven

ess

Stag

eV:

Impl

emen

tatio

nan

ddi

ssem

inat

ion

Wai

tlist

ortre

atm

ent-a

s-usu

alco

ntro

lA

ctiv

eco

ntro

l

Hea

lthca

recl

inic

ians

orstu

dent

s

Barb

osa

etal

.,20

13Sh

apiro

etal

.,20

05Sh

apiro

etal

.,20

08*

——

—Ba

zark

oet

al.,

2013

Bedd

oeet

al.,

2004

Berg

en-C

ico

etal

.,20

13Br

ady

etal

.,20

12C

ohen

-Kat

z,W

iley,

Cap

uano

,Bak

er,

Dei

trick

,eta

l.,20

05C

ohen

-Kat

z,W

iley,

Cap

uano

,Bak

er,

Kim

mel

etal

.,20

05G

eary

etal

.,20

11*

Mar

tín-A

suer

oet

al.,

2010

Rose

nzw

eig

etal

.,20

03Sh

apiro

etal

.,19

98Sh

apiro

etal

.,20

07Sh

apiro

etal

.,20

12Yo

ung

etal

.,20

01H

ealth

yin

divi

dual

sN

aran

joet

al.,

2012

*A

nder

son

etal

.,20

07*

Jens

enet

al.,

2012

*—

——

Keng

etal

.,20

12*

Kilp

atric

ket

al.,

2011

*Kl

atte

tal.,

2009

*N

yklí�

ek,M

omm

erste

eg,

etal

.,20

13*

Hea

rtdi

seas

eTa

cón

etal

.,20

03Ro

bert-

McC

omb

etal

.,20

04*

Palta

etal

.,20

12*

——

Het

erog

eneo

usor

unsp

ecifi

edBa

eret

al.,

2012

Farb

etal

.,20

13*

Mac

Coo

net

al.,

2012

*—

——

Birn

ie,S

peca

,&C

arlso

n,20

10N

yklíc

ek&

Kuijp

ers,

2008

*O

man

etal

.,20

08

Car

mod

y&

Baer

,200

8Ro

bins

etal

.,20

12Ro

senk

ranz

etal

.,20

13*

Car

mod

yet

al.,

2008

Shap

iroet

al.,

2011

*Sm

ithet

al.,

2008

(table

continues)

Thi

sdo

cum

ent

isco

pyri

ghte

dby

the

Am

eric

anPs

ycho

logi

cal

Ass

ocia

tion

oron

eof

itsal

lied

publ

ishe

rs.

Thi

sar

ticle

isin

tend

edso

lely

for

the

pers

onal

use

ofth

ein

divi

dual

user

and

isno

tto

bedi

ssem

inat

edbr

oadl

y.

601October 2015 ● American Psychologist

Table

2(c

ontinued)

Stag

e0:

Basi

c*

Targ

etpr

oble

mor

popu

latio

nSt

age

I:In

terv

entio

nge

nera

tion/

refin

emen

t

Stag

eII:

Effic

acy

inre

sear

chcl

inic

Stag

eIII

:Effi

cacy

inco

mm

unity

clin

icSt

age

IV:E

ffect

iven

ess

Stag

eV:

Impl

emen

tatio

nan

ddi

ssem

inat

ion

Wai

tlist

ortre

atm

ent-a

s-usu

alco

ntro

lA

ctiv

eco

ntro

l

Car

mod

y&

Baer

,200

9Si

mps

onet

al.,

2011

Car

mod

yet

al.,

2009

*C

hang

etal

.,20

04C

ordo

net

al.,

2009

*de

lRe

etal

.,20

13D

eyo

etal

.,20

09D

obki

net

al.,

2011

Evan

set

al.,

2011

Fang

etal

.,20

10*

Flug

elet

al.,

2010

Fris

vold

etal

.,20

12G

rees

onet

al.,

2011

*H

awtin

etal

.,20

11H

ölze

leta

l.,20

11*

Imel

etal

.,20

08*

Jha

etal

.,20

07*

Kerr

etal

.,20

11Ke

rrig

anet

al.,

2011

Mel

loni

etal

.,20

13*

Mor

one

etal

.,20

12Re

ibel

etal

.,20

01Ro

th19

97Ro

th&

Cre

aser

,199

7Ro

thet

al.,

2002

Roth

etal

.,20

04Sa

lmoi

rago

-Blo

tche

ret

al.,

2013

Thom

pson

etal

.,20

09W

eiss

etal

.,20

05H

IVJa

met

al.,

2010

*D

unca

net

al.,

2012

Cre

swel

leta

l.,20

09*

——

Robi

nson

etal

.,20

03*

Gay

ner

etal

.,20

12Se

yedA

linag

hiet

al.,

2012

*Si

bing

aet

al.,

2008

Sibi

nga

etal

.,20

11H

otfla

shes

Car

mod

yet

al.,

2006

Car

mod

yet

al.,

2011

——

——

Irrita

ble

bow

elsy

ndro

me

Kear

ney

etal

.,20

11Ze

rnic

keet

al.,

2013

Gar

land

etal

.,20

12*

Inso

mni

a—

—G

ross

etal

.,20

11*

——

Thi

sdo

cum

ent

isco

pyri

ghte

dby

the

Am

eric

anPs

ycho

logi

cal

Ass

ocia

tion

oron

eof

itsal

lied

publ

ishe

rs.

Thi

sar

ticle

isin

tend

edso

lely

for

the

pers

onal

use

ofth

ein

divi

dual

user

and

isno

tto

bedi

ssem

inat

edbr

oadl

y.

602 October 2015 ● American Psychologist

Table

2(c

ontinued)

Stag

e0:

Basi

c*

Targ

etpr

oble

mor

popu

latio

nSt

age

I:In

terv

entio

nge

nera

tion/

refin

emen

t

Stag

eII:

Effic

acy

inre

sear

chcl

inic

Stag

eIII

:Effi

cacy

inco

mm

unity

clin

icSt

age

IV:E

ffect

iven

ess

Stag

eV:

Impl

emen

tatio

nan

ddi

ssem

inat

ion

Wai

tlist

ortre

atm

ent-a

s-usu

alco

ntro

lA

ctiv

eco

ntro

l

Intim

ate

partn

ervi

olen

ce/A

buse

Berm

udez

etal

.,20

13—

——

——

Dut

ton

etal

.,20

13Ki

mbr

ough

etal

.,20

10O

lder

adul

tsEr

nste

tal.,

2008

Cre

swel

leta

l.,20

12*

——

——

Gal

lego

s,H

oerg

er,

Talb

ot,K

rasn

er,e

tal

.,20

13*

Gal

lego

s,H

oerg

er,

Talb

ot,M

oyni

han,

etal

.,20

13*

Szan

ton

etal

.,20

11M

oyni

han

etal

.,20

13*

Youn

get

al.,

2010

Pers

onal

itydi

sord

ersy

mpt

oms

—N

yklíc

ek,v

anBe

ugen

,&D

enol

let,

2013

*—

——

Preg

nant

wom

en—

Viet

enet

al.,

2008

——

——

Pris

oner

sSa

mue

lson

etal

.,20

07—

——

——

Psor

iasi

s—

—Ka

bat-Z

inn

etal

.,19

98*

——

Postt

raum

atic

stres

sdi

sord

er/

Trau

ma

(am

ong

vete

rans

)

—Ke

arne

y,M

cDer

mot

t,et

al.,

2012

—N

iles

etal

.,20

12—

Kear

ney

etal

.,20

13

Smok

ing

Dav

iset

al.,

2007

*—

——

——

Som

atiz

atio

n—

—Fj

orba

ck,A

rend

t,et

al.,

2013

—Fj

orba

ck,C

arste

nsen

,et

al.,

2013

Stre

ssH

ölze

leta

l.,20

10*

——

——

—W

alac

het

al.,

2007

Stro

ke/T

raum

atic

brai

nin

jurty

Azu

lay

etal

.,20

13*

Joha

nsso

net

al.,

2012

*—

——

—Bé

dard

etal

.,20

03Bé

dard

etal

.,20

05Su

bsta

nce

abus

eC

arro

llet

al.,

2008

——

——

—La

nge

etal

.,20

11M

arcu

set

al.,

2003

*Va

llejo

etal

.,20

09Te

ache

rsG

old

etal

.,20

10—

——

——

Tinn

itus

Gan

set

al.,

2013

——

——

—Tr

ansp

lant

Gro

sset

al.,

2004

—G

ross

etal

.,20

10—

——

Krei

tzer

etal

.,20

05

*St

udie

sth

atin

tegr

ate

basi

cre

sear

chas

part

ofla

ter

stage

inte

rven

tion

studi

esar

ede

note

dat

the

rele

vant

late

rsta

gew

ithan

aste

risk.

Thi

sdo

cum

ent

isco

pyri

ghte

dby

the

Am

eric

anPs

ycho

logi

cal

Ass

ocia

tion

oron

eof

itsal

lied

publ

ishe

rs.

Thi

sar

ticle

isin

tend

edso

lely

for

the

pers

onal

use

ofth

ein

divi

dual

user

and

isno

tto

bedi

ssem

inat

edbr

oadl

y.

603October 2015 ● American Psychologist

Multiple meta-analytic studies including MBSR andMBCT trials have been published in recent years (Goyal etal., 2014; Hofmann, Sawyer, Witt, & Oh, 2010; Piet &Hougaard, 2011), with generally convergent findings.These meta-analyses have been focused largely on thequestion, “do MBIs work?” And, although most have em-phasized problems with the methodological quality ofmany individual studies, the overall consensus appears tobe “yes.” We concur with these interpretations, and build-ing on this foundation, we think the field is ripe for con-sidering the evidence base from the broader “bird’s eyeview” of the NIH stage model.

Figure 1 illustrates the core stages of the NIH modelwith the color saturation of each stage corresponding to theproportional amount of published research on MBCT andMBSR, considered together, at each given stage. The NIHstage model was proposed not as a fixed and linear set ofsteps to take in chronological order, but rather as a set ofoverlapping and mutually informing points along a contin-uum of research. Within this context, there are indicationsthat some stages and links between stages warrant greaterattention. The greatest focus of activity in the MBI field hasbeen dedicated to the development and exploration of ap-plications of MBIs with novel populations and target prob-lems. This pattern may be implicit in the early developmentof a field; however, it also represents a point of vulnera-bility. If the weight of clinical and scientific attention

remains devoted to increasing the range of applicationsrather than the depth of the evidence base, public healthimpact may be limited. Or, put simply, with reference toTables 1 and 2, it would be misguided to prioritize increas-ing the number of rows in each table, without emphasizingsimultaneously the development and integration of studiesacross the columns. Here, we offer a set of seven recom-mendations for increasing the public health impact of thiswork.

Stage-Based Recommendations toIncrease the Public Health Impact ofMBI ResearchRecommendation 1. Attend to the Basics:Specify Intervention Targets and PopulationsA close link between basic and intervention research existsin the foundation of clinical innovation and research onMBIs. For example, the first application of mindfulnessmeditation for the prevention of depression was rooted inbasic research on the nature of depressive relapse. In suchstudies, formerly depressed patients were compared tohealthy controls before and after a sad mood induction;formerly depressed patients showed greater increases indepressogenic thinking styles, suggesting that a history ofdepression was associated with increased access to depres-sive cognition in the context of mild sad mood (Teasdale,1988). Moreover, studies suggested that such increasedaccess prospectively predicted relapse risk (Segal et al.,2006). This work identified a potential target for interven-tion (i.e., ruminative emotion-linked cognitive processes),a population for whom this target was relevant and identi-fiable (i.e., individuals with histories of recurrent depres-sion), and a logical basis for the application of mindfulnessmeditation (i.e., to enable regulation of dysphoric moodstates in ways that inhibited the activation of habitual,mood-linked mental content; Teasdale, Segal, & Williams,1995).

The rapid proliferation of new potential indications forMBIs risks neglecting the link between Stage 0 and sub-sequent stages. In an era in which specification of clearintervention targets and mediating processes of change isincreasingly prioritized, failure to attend to the “basics”may undermine the potential public health impact of re-search on MBIs. A glance at the range of problems forwhich MBIs are being applied suggests possible vulnera-bility in this regard. For example, recent studies haveextended MBCT to other populations and problems (e.g.,bipolar disorder, psychosis) based on the evidence of care-gaps in the psychosocial treatment of these groups; how-ever, such efforts have less frequently identified the targetsthat mindfulness practice is intended to engage, or thedegree to which the interventions alter (or fail to alter) suchtargets when they achieve their intended clinical effects.Although intervention studies suggest that MBCT haspromise for such patients, the basic research necessary tosupport a rationale for “why” is often lacking (although,see final section for recent exceptions).

Figure 1Evidence Base for Mindfulness-Based Interventions(i.e., Mindfulness-Based Stress Reduction andMindfulness-Based Cognitive Therapy) MappedAccording to the Adapted National Institutes of HealthStage Model

Note. Recommended pathways between stages are represented with solidarrows; pathways that should be undertaken with caution are represented withdotted arrows. Color saturation represents the proportion of the total number ofpublished studies of mindfulness-based interventions mapped at a given stage,with the specific percentage indicated at each stage.

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604 October 2015 ● American Psychologist

Moreover, our mapping indicates that only a smallnumber of studies have explored candidate mediators ormoderators of outcome, and of these, even fewer havetested mediation formally or incorporated recent methodsthat move the field closer to a personalized medicine frame-work in which patient characteristics determine treatmentselection (e.g., DeRubeis et al., 2014). Exceptions includethe work of Vøllestad, Sivertsen, and Nielsen (2011), whodescribe a well-conceived analysis in which mindfulnessstatistically mediated changes in anxiety symptoms follow-ing MBSR, but owing to the absence of temporal prece-dence for these changes did not demonstrate true media-tion. Such efforts represent an advance beyond work thatsimply reports the magnitude of pre–post interventionchange of a potential mediator. Arch and Ayers (2013)provide another instructive example, in which patients withanxiety disorders were randomized to MBSR or cognitive–behavioral therapy, with results indicating the response tointervention depended in part on baseline depressive symp-tom severity comorbidity and anxiety sensitivity. Similarly,studies of MBCT suggest that effects may be moderated byvulnerability factors, including recurrent depressive epi-sode histories (Ma & Teasdale, 2004; Teasdale et al., 2000)and residual depressive symptoms (Segal et al., 2010).

Underemphasizing links to basic research and precisespecification of for whom and how a treatment works riskssituating the study of MBI less as science and more aspseudoscience in which mindfulness is seen as a panaceafor all problems. Absence of clear attention to both “bound-ary conditions” and “scientific plausibility” is often cited asa hallmark of pseudoscience (Lilienfeld, Lynn, & Lohr,2003). Future work on MBI will be strengthened by attend-ing to these requirements—specifying both what mindful-ness is not likely to help and, not only predicting that anMBI will produce clinical benefit, but also specifying plau-sible mechanisms by which such benefits are attained.Moreover, extensions of MBSR, MBCT, and other MBIs tonew populations and conditions may require modificationsand tailoring to address their salient pathogenic mecha-nisms; such work represents the heart of Stage I but re-quires close and iterative links to Stage 0 methods andconcepts. Many basic research studies have investigatedcorrelates of mindfulness meditation (see Lutz et al., 2015)and provide methods or proxy markers to consider forintegration in applied trials. In Tables 1 and 2, studiesidentified with asterisks in Stages I–V provide examples ofmovement to such integration.

Recommendation 2. Do Not ConflatePromise With EfficacyIn contrast to the relative paucity of Stage 0 studies, re-search efforts have saturated heavily Stage I. The nonran-domized and, most often, uncontrolled studies, mappedhere at Stage I, clearly support valid excitement about theuse of MBI in clinical settings across a wide range of targetpopulations and problems. This excitement, however, mustbe tempered, given the risk that the field will fail to ad-vance if Stage I research is seen as a sufficient “green light”to proceed to broad dissemination and implementation of

MBI, or if the field “stalls out” by simply amassing morestudies at Stage I. Thus, the NIH stage model underscoresthe value of the full cycle of research stages, and notablydoes not specify a direct pathway from Stage I to Stages IVor V. Among problems targeted by MBCT, only work ondepression and comorbid health and mental health condi-tions, and within MBSR studies, primarily work with pa-tients with cancer, show incremental progression fromStage I to subsequent stages. The sheer quantity of prom-ising uncontrolled studies cannot substitute for later stagestudies; researchers, practitioners, and the public must becautious not to conflate the fact that many studies exist atStage I with indications of efficacy or effectiveness.

Moreover, as the field focuses more on the incremen-tal progression of MBI research from Stage I to V, it willbe important to consider directly indications of both failureand harm. In fact, a “failed” individual trial in which theMBI does not outperform the comparator intervention maybe a “success” when viewing the advancement of the fieldbroadly. Such findings help to inform the “boundary con-ditions” necessary for scientific progress and strengthen thepathway between Stage I and Stage 0, in which failures inone context create fertile ground in the other. The field willbe well served by frank acknowledgment of failure ratherthan obscuring such findings with multiple or ambiguousprimary and secondary outcomes or falling victim to the“file drawer” problem in which failed trials simply are notpublished. An instructive example is provided by Craigie,Rees, Marsh, and Nathan (2008) regarding the relativelypoor performance of MBCT in an open trial when com-pared to benchmarks of cognitive–behavioral therapy inother studies targeting generalized anxiety disorder. Theyhighlight valuable questions that can be “sent back” toStage 0 about potential maintaining factors in generalizedanxiety disorder. In addition to addressing directly “failed”trials, it also will be important to consider potential harmfuleffects of MBI. With the exception of recent work byBritton and colleagues (2012), it is notable that few publi-cations have reported data on adverse effects of MBI. Thisarea will be important for future investigators to addressdirectly, consistent with recommendations for psychother-apy interventions generally (e.g., Dimidjian & Hollon,2010).

Recommendation 3. Engage the ThornyQuestion of Clinician TrainingTo be considered “complete,” Stage I work requires atten-tion not only to questions of “promise” but also to thethorny questions of clinician training. These questions areof particular salience given the unique expectations forMBI instructors, which require a personal practice in mind-fulness meditation in addition to professional training in theclinical approach. This element may challenge future im-plementation efforts and has received surprisingly littleattention to date in the scientific literature. Operationalizingthis requirement and developing scaffolding resources forinstructors learning MBIs are gaps that exist currently atStage I. In fact, few studies have examined measures ofinstructor fidelity (R. S. Crane et al., 2013; Segal, Teasdale,

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Williams, & Gemar, 2002). The lack of attention to devel-oping formal measures, methods, and standards for deter-mining instructor quality may have its roots in core guidingprinciples about how MBIs are best delivered. For exam-ple, in a cautionary note about overreliance on formalguidelines, Kabat-Zinn (2011) expressed,

It has always felt to me that MBSR is at its healthiest and bestwhen the responsibility to ensure its integrity, quality, and stan-dards of practice is being carried by each MBSR instructor him orherself . . . to keep it very real and close to our everyday experi-ence held in awareness with kindness and discernment. (p. 295)

It will be important for the field to grapple directly withtensions that may exist in the very foundation of the sci-entific study of MBI and that may be accentuated as re-search on these interventions expands from early Stage Iwork to larger, more distributed later stage studies.

Recommendation 4. It’s Time to Get SpecificAbout the Specific Effects of MBIThe main strength of Stage II research is the use of ran-domized designs and intervention controls that supportinference about causality. As Tables 1 and 2 illustrate, suchwork has been conducted with a greater emphasis on ran-domized comparisons to WLC or TAU than to activecontrols. Such designs permit valid inference aboutwhether the MBI produces an effect on the measuredoutcome but not about what, specifically, is driving theeffect. MBIs are multimodal interventions. Although itoften is assumed that mindfulness meditation is the “activeingredient,” findings are equivocal.

Segal et al. (2010) compared MBCT to maintenancepharmacotherapy, the current standard of care for prevent-ing depressive relapse, and a pill placebo condition. Thelack of differences in relapse prevention between MBCTand maintenance pharmacotherapy among patients withresidual depressive symptoms suggested that MBCT offersbenefit on par with pharmacological treatment, and thesuperiority of MBCT relative to the placebo control sug-gested that such benefits are specific to components ofMBCT rather than factors common to clinical care thatwere also present in the placebo condition—a crediblerationale, clear guidelines for action, expectancies for im-provement, and a positive working alliance with a treat-ment provider. However, this comparison did not controlfor other relevant dimensions such as time with clinicians,group support, and specific home practices. Thus, the ques-tion remains: is the mindfulness meditation componentspecifically efficacious?

MBCT showed no significant benefit as compared toan educational control for caregivers of dementia patients,although both active treatments outperformed a respite onlycontrol (Oken et al., 2010). In contrast, MBCT demon-strated superiority to psychoeducational controls for treat-ment refractory depressed patients (Chiesa, Mandelli, &Serretti, 2012), and specific benefits on some outcomes ascompared to a relaxation control for patients with tinnitus(Philippot, Nef, Clauw, de Romree, & Segal, 2012).

Studies of MBSR provide similarly complex findings,reporting failure to outperform an active control on primaryoutcomes but often mixed results on secondary outcomes.Studies of MBSR among patients with chronic pain havereported no significant differences on subjective reports,such as pain intensity, distress, quality of life, and mood, ascompared to a multidisciplinary pain intervention (Wong etal., 2011) or active control or waitlist (Schmidt et al.,2011). A comparison of MBSR and stress managementeducation among patients with generalized anxiety disorderalso found no evidence of superiority for MBSR on theprimary outcome of anxiety symptom severity, but reportedadvantage on secondary anxiety outcomes (Hoge et al.,2013). Finally, among nonclinical participants, comparisonbetween MBSR and an active control, the Health Enhance-ment Program, which was matched to MBSR in elementsthat were known to reduce stress but were not tied to thepractice of mindfulness (e.g., group support, physical ac-tivity), indicated no significant benefit associated withMBSR on subjective reports of wellbeing, some benefit ona behavioral pain task (MacCoon et al., 2012), and benefiton biological indices of stress provoked inflammatory re-sponse (Rosenkranz et al., 2013).

Interpretation of the mixed findings from studies usingactive control conditions is complicated even further by thefact that few active controls have been truly matched toMBSR or MBCT on all components except mindfulnessmeditation. For example, the degree to which participantsin control conditions are provided with equivalent supportfor home practice is difficult to determine from manypublished reports; MBSR and MBCT protocols typicallyinclude written and audio guide support for daily homepractice and it is not clear whether active controls matchthis element. Moreover, although some active controlscarefully match the frequency and duration of sessions(e.g., Philippot et al., 2012), others are structurally differ-ent, involving shorter sessions (e.g., Y. W. Kim et al.,2009). Also, few studies have tested the degree to whichinstructors find the interventions they are delivering to becredible, thus introducing the possibility of allegiance ef-fects contributing to differences in outcomes across groups.Even comprehensive active controls such as the HealthEnhancement Program introduce different teachers for eachmodule of the curriculum, unlike MBSR or MBCT inwhich the same teacher guides the group for the entire eightsessions (MacCoon et al., 2012). The challenge of devel-oping credible and structurally equivalent psychosocialprotocols to control for common factors is not new topsychotherapy research, but it is an important task for thefield in order to answer clearly the question of whethermindfulness meditation is an “active ingredient” of MBI.This recommendation is consistent with a recent meta-analysis of the clinical applications of meditation (Goyal etal., 2014), which reported small to moderate effects andlittle evidence of specific efficacy.

Testing the assumption that mindfulness meditation isspecifically efficacious is necessary but not sufficient toadvance the field. It is important also to understand moreprecisely about the nature of mindfulness meditation prac-

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tice itself. Just how much meditation (if any) is required toachieve clinical benefit? The studies that touch upon thisquestion are mapped currently at Stage I because they relylargely on post hoc analyses of the association betweenpractice time or class attendance and change in symptomsor self-reported mindfulness skill. Findings are mixed, withsome studies supporting an association between amount ofpractice and clinical outcomes (Beddoe & Murphy,2004; Carmody & Baer, 2008; Collard, Avny, & Boni-well, 2008; del Re, Flückiger, Goldberg, & Hoyt, 2013;Farb, Segal, & Anderson, 2013; Gross et al., 2004;Rosenzweig et al., 2010; Shapiro, Bootzin, Figueredo,Lopez, & Schwartz, 2003; Shapiro, Jazaieri, & Goldin,2012), but not all (Carlson, Speca, Patel, & Goodey,2004; Dobkin & Zhao, 2011; A. Hopkins & Proeve,2013; MacCoon et al., 2012). The field requires Stage IIrandomized controlled trials that manipulate dosage orintervention duration as a primary aim. Similarly, basicresearch studies that examine the validity of methods ofassessing practice time and quality are essential. Suchfindings will bear directly on subsequent stages of research.One can easily imagine patients, referring providers, andhealth plan administrators asking questions such as, “Canwe deliver this in six sessions instead of eight?” or, “Doesit really matter if I practice 10 min a day rather than 45min?” Stage II studies are well poised to answer suchquestions.

Recommendation 5. Consider Skipping tobut Not Over Stage IIIStage III has been underemphasized in studies of MBI(and clinical psychological science generally). As de-fined by Onken et al. (2014), a Stage III study is “awell-controlled, internally valid study in a communitysetting with community therapists/providers” (p. 29).This stage of work has two primary functions in thedomain of MBI. First, it is well suited for efficacy testsof the type of self-guided materials that are widelyavailable, including workbooks and audio guides, and isrelevant for testing future applications of MBI usingweb-based or other technology-based delivery tools.Such interventions do not require clinician training ma-terials because they target the patient directly; thus, itmay be warranted, in some cases, for interventions toproceed directly from Stage I to Stage III. In such cases,the recommendations regarding appropriate control con-ditions at Stage II are of particular importance at StageIII. Stage III studies of self-guided materials may benefitfrom comparison to TAU to establish evidence of equiv-alent or superior benefit to standard of care in varioushealthcare domains. However, comparisons to activecontrols are critical to validate the specific efficacy ofthe mindfulness components over and above expectan-cies, contact time, and other potentially active ingredi-ents. Although there were insufficient studies at Stage IIIto allow us to map them at this level of granularity, wethink such distinctions are critical for the future devel-opment of the field. Second, tests of efficacy of instruc-tor delivered MBI in the community will help to deter-

mine whether results from Stage II studies “hold up”when the MBI is delivered in routine settings by com-munity providers. Thus, researchers are cautionedagainst “skipping” this stage of work; it is crucial forinforming which interventions justify movement toStage IV.

Of the studies we reviewed, only two were identi-fied that approached the criteria for Stage III. Thisclassification is arguable given the pilot nature of thework and the hybrid use of community and researchclinicians; however, both studies provide instructive ex-amples of the ways in which an MBI can be delivered inan innovative manner directly to recipients in the com-munity. N. J. Thompson et al. (2010) compared “dis-tance delivery” of MBCT via telephone or Internet forpatients with epilepsy and depressive symptoms (N �40), as compared to WLC, and the intervention wascofacilitated by a layperson with epilepsy and a master’sof public health student. Similarly, Niles and colleagues(2012) conducted a feasibility test (N � 33) of a mixeddelivery format in which veterans with posttraumaticstress disorder were randomized to either an MBSRintervention or a psychoeducation control, both of whichincluded two in person and six telephone-based sessions.

Recommendation 6. Efficacy Is Necessarybut Not Sufficient for EffectivenessOnly two trials of MBCT and one of MBSR were pub-lished prior to 2014 that addressed questions of effec-tiveness, with two focused specifically on economicoutcomes. Specifically, Kuyken et al. (2008) examinedthe effects of MBCT as compared to maintenance phar-macotherapy among patients treated in primary care,with results suggesting comparable relapse preventionand cost effectiveness as well as advantage of MBCT onindices of reducing residual depressive symptoms, psy-chiatric comorbidity, and quality of life. van Ravesteijn,Lucassen, Bor, van Weel, and Speckens (2013) exam-ined the cost-effectiveness of MBCT compared withTAU among patients with persistent medically unex-plained symptoms, with results indicating lower hospitalcosts and higher mental healthcare costs among patientsreceiving MBCT. Fjorback and colleagues (2013) alsoexamined economic outcomes of MBSR as compared tocare as usual for somatic symptom disorders, and sig-nificant benefits for MBSR were reported on disabilitypension outcomes.

Studies like these make good use of the “care-as-usual” control groups that can be a progress-limitingfactor for earlier stage work. The frequent calls for morerigorous active control groups and caution about care-as-usual comparisons miss the public health relevance ofsuch designs at Stage IV. Care-as-usual comparisons,particularly in the context of healthcare settings in whichsuch care can be precisely described, allow us to deter-mine whether an MBI adds incremental benefit to whatis available. Such studies provide a necessary foundationfor Stage IV and V work.

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Recommendation 7. Beware of DevelopingOrphan Innovations, Falling Off theImplementation Cliff, and Getting Caught in“Implementation Limbo”

Only three studies, two of which are purely descriptive,addressed as a primary aim questions relevant to the dis-semination or broad implementation of MBI. Specifically,R. S. Crane and Kuyken (2013) conducted a survey withparticipants in a workshop on implementation of MBCTand an online national survey of MBCT teachers and stake-holders. Results described a range of barriers and facilita-tors to MBCT implementation, including structural, polit-ical, cultural, educational, emotional and physical ortechnological factors. Lau and colleagues (2012) examinedpreferences of employees from large healthcare organiza-tions for MBCT targeting depression relapse preventiondelivered by in-person group, online group, in-person in-dividual, and telephone-based individual format. Finally,Patten and Meadows (2009) examined data from the Ca-nadian Community Health Survey to construct a simulationmodel that estimated the population density required tosupport sustained delivery of in-person MBCT. Resultssuggested that implementation of such group-based in-person approaches may be challenging in small populationcenters.

The lack of attention to Stage V work is a serious gapin an effort to develop a clinical science of MBI. Currentestimates suggest that, at best, only one in three people whostruggle with mental health problems will receive “at leastminimally adequate treatment” (Wang et al., 2005). Thereis a tremendous unmet need for care. If MBI approachesare to have a meaningful impact, they must overcome notonly barriers to dissemination and implementation that arecommon to other approaches (e.g., service costs, waitinglists, and distance to access intervention), but also uniquebarriers due to instructor competencies.

Given its early stage of development as a field, re-searchers and practitioners of MBIs may benefit from les-sons learned in the study of efforts to disseminate andimplement other psychosocial interventions. Three cau-tions are particularly salient. First, based on their experi-ence developing and disseminating a method of redistrib-uting “edible but not sellable” fresh produce to low incomepopulations, Evans and Clarke (2011) describe the problemof “orphan innovations,” in which effort is dedicated to thedesign and initial testing of an intervention but little care isallocated to the task of studying the reach of the interven-tion to contexts of need. Second, Weisz, Ng, and Bearman(2014) refer to the “implementation cliff” to describe the“voltage drop” that often occurs as interventions movethrough the clinical science process. As interventions are“scaled up” for dissemination in community settings orare delivered in successive generations following the orig-inal intervention developer, outcomes suffer. Third, Weisz(2014) also describes the problem of “implementationlimbo” in which resource constraints set the “bar” fortraining providers at ever lower levels:

If there is no evidence that 4 days of expert-led training, andsubsequent individual clinician supervision, are required to main-tain fidelity and benefit, then why not reduce cost with a 2-daytraining and group supervision and have local clinical staff con-duct the training and supervision? (p. 60)

Although it is too early to render definitive judgment on theclinical science of MBI, the saturation of studies at Stage Iand Stage II using WLC or TAU controls, and the relativepaucity of studies at later stages, highlights the risk ofneglecting promising interventions as “orphans” early inthe research process. Moreover, the relative lack of atten-tion to studying methods of training instructors that can bebroadly implemented may make MBI approaches vulnera-ble to both the implementation cliff and limbo. Fortunately,the emerging field of MBI also stands to learn from thesuccesses of others. Recent discussions have focused, inparticular, on the model of “disruptive innovation,” inwhich new technologies may be integrated in the service ofincreasing reach and access of MBI. Recommendationswithin general psychotherapy domains have included theexamination of novel delivery formats such as self-man-agement and self-help formats, brief or more parsimoniousadaptations, technology and media-driven delivery for-mats, and integration within broader healthcare packages(Kazdin & Blase, 2011; Rotheram-Borus, Swendeman, &Chorpita, 2012). Such avenues may represent great promisefor the dissemination and implementation of MBI; how-ever, they are likely also to raise complex questions that thefield must tackle. As Simon and Ludman (2009) note in adiscussion of disruptive innovation for cognitive–behav-ioral treatments,

Traditional therapists might be horrified by the prospect of anoverseas cognitive behavioral call center or live-chat center, avail-able whenever patients choose. But the expectations of health-care providers are not the same as evidence. And the evidence thatmatters concerns clinical benefit and economic value to patients,rather than appeal or value to providers. (p. 595).

It will be essential for clinical innovators and researchers toexamine methods of delivery for MBI that will providesuch evidence.

Indications of PromiseThere are encouraging indications that the field is movingin the directions highlighted in this review. Although ourcomprehensive mapping was limited to studies publishedthrough 2013, the field is advancing rapidly, and an exam-ination of notable studies published since 2014 indicatessignificant advances in three domains.

First, we find indicators that the field is becomingmore programmatic in its approach by anchoring clinicalintervention in basic research that specifies clear targets ofintervention and by testing proposed mechanisms ofchange. This is evident, for example, in recent work onsubstance use disorders that represent novel next-genera-tion interventions combining elements of MBSR or MBCT,singly, or with other interventions in novel ways. Forexample, Garland and colleagues (2014) tested both clini-cal outcomes and mediators of an MBI developed specifi-cally for chronic pain and prescription opioid misuse(mindfulness-oriented recovery enhancement) in the con-

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text of a Stage II randomized clinical trial with an activecontrol (supportive group therapy). It may be valuable touse the mapping approach undertaken here to chart thedevelopment of these next-generation MBIs and the waysin which the structure and content of the interventions aremodified to fit the nature of the target problem or popula-tion. Moreover, an increased recent emphasis on identify-ing mediators of change in MBI represents an importantstep in advancing research in an integrated and systematicmanner (Gu, Strauss, Bond, & Cavanagh, 2015; van derVelden et al., 2015).

Second, more studies are incorporating active controlconditions that can help to address questions of specificefficacy. J. M. G. Williams et al. (2014) compared MBCTto TAU and to a cognitive psychoeducation program de-veloped to emphasize the didactic elements of relapseprevention without the experiential mindfulness practice.The results indicated no difference in relapse rates over a1-year follow-up among the three groups—a finding thatchallenges the specific efficacy of the mindfulness medita-tion component of MBCT. A subgroup analysis of patientswith histories of childhood trauma, however, indicatedsignificant benefit for MBCT. It is possible that MBCTmay show specific benefit for more vulnerable individuals,as was the case in the original studies that examined inter-vention differences by number of prior episodes (Ma &Teasdale, 2004; Teasdale et al., 2000). Although cautionshould be exercised in the interpretation of post hoc sub-group analyses, such findings may warrant “returning” towork at Stage 0 to help understand the nature of suchvulnerabilities, including mechanisms that might be pref-erentially addressed through training in mindfulness med-itation for such individuals.

Third, given that the stage model was developed tomaximize the public health impact of psychosocial treat-ments, it is encouraging that investigators are extendingpromising work at Stage I and II to examine questions ofeffectiveness, dissemination, and implementation. Thework of Bowen et al. (2014) provides an excellent exampleof rigorous movement toward Stage III research in whichthe MBI developed for preventing relapse in substanceabuse disorders (mindfulness-based relapse prevention)was tested in a randomized clinical trial with comparison toan active control (cognitive–behavioral relapse prevention)and TAU. This study represents a hybrid of Stage II and IIIresearch because research clinicians delivered the 8-weekintervention in community chemical dependency treatmentfacilities. Moreover, although TAU comparison groupshave been highly heterogeneous in prior studies, this studyrepresents an advance by implementing the study in thecontext of a specific healthcare setting that allowed TAU tobe clearly defined and measured. The use of comparisonconditions that address questions of high relevance tohealthcare consumers also signals an important advance.For example, the trial comparing MBCT (with support todiscontinue antidepressant medication) to maintenance an-tidepressant medication (Kuyken et al., 2015) has the po-tential to address the questions that are at the forefront formany patients seeking care. Specifically, patients and pro-

viders want to know how the MBI compares to otheravailable options. Findings from Kuyken et al. (2015)indicate that relapse rates are statistically equivalent inMBCT and maintenance antidepressant medication, thecurrent standard of care for recurrent depression. Finally,the potential for broad dissemination via web-based deliv-ery also may help to accelerate the pace of Stage III–Vresearch (Boettcher et al., 2014; Dimidjian et al., 2014).

SummaryThe science and practice of MBI has reached an importantpoint in its development. The last decade has witnessed anexponential rate of increase in the number of studies andthe breadth of clinical problems and populations targeted.We contend that the public health impact of this work islikely to be enhanced by situating work on MBI in abroader framework of clinical psychological science. Do-ing so highlights important lessons and gaps in our currentevidence base. Simply accumulating a greater number ofthe same types of studies without addressing such gaps isunlikely to advance the field. Although there are indica-tions from recent studies that the field is moving in apositive direction, an integrated and systematic approach tocore research questions, to the methodological quality ofindividual studies at each stage, and to increasing logicallinks among the stages will enhance our ability to impactpositively the mental health needs of individuals and com-munities.

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620 October 2015 ● American Psychologist