CLP 4143 USF Reenvisioning Clinical Science To Improve Public Health Discussion

  

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Reenvisioning clinical science

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Write a 250-500 word response that addresses the following:

Compare the portrayal of the mental healthcare system in this article to that of the Rosenhan article that you read last week.

What surprises you about the authors’ evaluation of the current state of the field? What is your response in general?

How do you think the changes proposed by the authors would impact the state of our current mental healthcare system if they were all successfully implemented? Why?

497932
research-article2013
CPXXXX10.1177/2167702613497932Onken et al.NIH Stage Model for Intervention Development
Special Series
Reenvisioning Clinical Science: Unifying
the Discipline to Improve the Public Health
Clinical Psychological Science
2014, Vol 2(1) 22­–34
© The Author(s) 2013
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DOI: 10.1177/2167702613497932
cpx.sagepub.com
Lisa S. Onken1, Kathleen M. Carroll2, Varda Shoham3,
Bruce N. Cuthbert3, and Melissa Riddle4
1
National Institute on Drug Abuse, 2Yale University, 3National Institute of Mental Health, and
National Institute of Dental and Craniofacial Research
4
Abstract
We present a vision of clinical science, based on a conceptual framework of intervention development endorsed by
the Delaware Project. This framework is grounded in an updated stage model that incorporates basic science questions
of mechanisms into every stage of clinical science research. The vision presented is 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. Training in this
integrated, translational model may help students learn how to conduct research in every domain of clinical science
and at each stage of intervention development. This vision aims to propel the field to fulfill the public health goal of
producing implementable and effective treatment and prevention interventions.
Keywords
intervention development, implementation, stage model, translation
Received 4/15/13; Revision accepted 6/23/13
This article presents a vision for clinical science that aims
to facilitate the implementation of scientifically supported
interventions and to enhance our understanding of why
interventions work, which interventions and implementation strategies work best, and for whom they work better.1 This vision also aims to enhance students’ training
with a conceptualization that unifies the field in pursuit
of these goals. Psychological clinical science encompasses broad and diverse perspectives (McFall, 2007), but
there is a fundamental commonality that binds psychological clinical science together: the relevance of its various scientific endeavors to producing and improving
treatment and prevention interventions. As such, all
domains of clinical science are integral to the intervention development process, and the vision we propose in
this article represents a comprehensive conceptual framework for the intervention development process and for
training the next generation of clinical scientists.
The framework described in the current article delineates specific stages of intervention development research
that is inspired by and consistent with calls to action to
identify mechanisms of change as a way of improving
interventions (e.g., Borkovec & Castonguay, 1998; Hayes,
Long, Levin, & Follette, in press; Kazdin, 2001; Kazdin &
Nock, 2003; Rounsaville, Carroll, & Onken, 2001a). This
framework inextricably links basic and applied clinical
science (Stokes, 1997) and sharpens the distinction
between implementation science that is focused on service delivery system research as opposed to intervention
generation, testing, and refinement research, while recognizing that both share the goal of getting interventions
into the service delivery system. Furthermore, the model
presented in this article defines the intervention development process as incomplete until an intervention is optimally efficacious and implementable with fidelity by
practitioners in the community. We contend that a reinvigorated stage model unites diverse and fragmented
fields of clinical psychological science and can serve as
Corresponding Author:
Lisa S. Onken, National Institutes of Health, National Institute on Drug
Abuse, 6001 Executive Boulevard, Room 3182 MSC 9593, Bethesda,
MD 20892-9593
E-mail: Lisa_Onken@nih.gov
NIH Stage Model for Intervention Development
an engine for the production of highly potent and implementable treatment and prevention interventions. We further contend that this framework can do this in such a
way as to enrich every aspect of clinical science and the
training of clinical scientists.
Where Has Clinical Science Succeeded?
The major accomplishments of psychological clinical science are well documented. Perhaps most remarkable is
the development of efficacious behavioral treatments in
the past half century. For many of the most severe behavioral health problems, there are efficacious treatments
where there once were none. Mid-20th-century reviews
of the child treatment literature by Levitt (1957, 1963)
and the adult treatment literature by Eysenck (1952)
were critical regarding the efficacy of psychotherapy.
Levitt (1963) confirmed his 1957 conclusion that “available evaluation studies do not furnish a reasonable basis
for the hypothesis that psychotherapy facilitates recovery from emotional illness in children” (p. 49), and
Eysenck (1952) stated that the adult studies “fail to support the hypothesis that psychotherapy facilitates recovery from neurotic disorder” (p. 662). As recently as four
decades ago, even after the articulation of behavioral
therapies for anxiety disorders, Agras, Chapin, and
Oliveau (1972) reported that untreated adults suffering
from phobia improve at the same rate as treated ones,
and Kringlen (1970) reported that most typical obsessional patients “have a miserable life” (p. 418). Today,
anxiety disorders are considered among the most treatable disorders, with behavioral interventions serving
as the gold standard, outperforming psychopharmacology (Arch & Craske, 2009; McHugh, Smits, & Otto, 2009;
McLean & Foa, 2011; Roshanaei-Moghaddam et al.,
2011). Efficacious behavioral interventions developed by
clinical scientists include treatments for cocaine addiction, autism, schizophrenia, conduct disorder, and many
others (e.g., Baker, McFall, & Shoham, 2008; Chambless
& Ollendick, 2001; DeRubeis & Crits-Christoph, 1998;
Kendall, 1998).
These advances in developing behavioral treatments
are especially impressive given that each of these treatments attempts to address seemingly discrete, albeit often
overlapping diagnostic categories (Hyman, 2010). In
spite of obstacles created by a diagnostic system in which
categories based on clinical consensus exhibit considerable heterogeneity (British Psychological Society, 2011;
Frances, 2009a, 2009b), our understanding of the basic
processes of psychopathology that should be addressed
in targeted treatments has substantially increased (T. A.
Brown & Barlow, 2009; Cuthbert & Insel, 2013; Insel,
2012). With this better understanding of mechanisms of
disorders, the promise for a new generation of more efficient and implementable interventions is improved.
23
We now have solid basic behavioral science and neuroscience, good psychopathology research, innovative
intervention development, numerous clinical trials producing efficacious treatment and prevention interventions, an extensive set of effectiveness trials aimed to
confirm the value of these interventions, and a robust
research effort in implementation science. Many clinical
psychology training programs include the teachings of
empirically supported treatments or at least engage in
debating their value (Baker et al., 2008; Follette & Beitz,
2003). All these notable accomplishments raise a question: What is broken that needs fixing?
What Are the Problems and Who
Should Fix Them?
Although efficacious behavioral treatments for many
mental disorders exist, patients who seek treatment in
community settings rarely receive them (Institute of
Medicine, 2006). Several factors converge to create this
widely acknowledged science-to-service gap, or what
Weisz et al. (Weisz, Jensen-Doss, & Hawley, 2006; Weisz,
Ng, & Bearman, 2014) call the implementation cliff. For
one, we can trace the implementation cliff back to the
effect size drop evident in many effectiveness trials
(Curtis, Ronan, & Borduin, 2004; Henggeler, 2004; Miller,
2005; Weisz, Weiss, & Donenberg, 1992). There is a clear
disconnect between efficacy research that values internal
validity and effectiveness research that prioritizes external validity at the expense of internal validity. Despite
this gap, many investigators still move directly from traditional efficacy studies (with research therapists) to effectiveness studies, without first conducting an efficacy (i.e.,
controlled) study with community therapists to ensure
that the intervention being studied is implementable with
fidelity when administered by community practitioners.
This strategy is particularly puzzling in light of the fact
that so many efficacious behavioral interventions do not
make their way down the pipeline through implementation (Carroll & Rounsaville, 2003, 2007; Craske, RoyByrne, et al., 2009).
A major factor that can explain this drop in effect size
is treatment fidelity (also known as treatment integrity),
which refers to the implementation of an intervention in
a manner consistent with principles outlined in an established manual (Henggeler, 2011; Perepletchikova, Treat,
& Kazdin, 2007). To wit, only a small fraction of clinicians
who routinely provide interventions such as cognitive
behavioral therapy (CBT) are able to do so with adequate
fidelity (Beidas & Kendall, 2010; Olmstead, Abraham,
Martino, & Roman, 2012). For instance, in one study CBT
concepts were mentioned in fewer than 5% of sessions
based on direct observation (Santa Ana, Martino, Ball,
Nich, & Carroll, 2008). This may reflect the insufficiency
of commonly used training and dissemination methods
Onken et al.
24
such as workshops and lectures, which by themselves
effect little substantive change in clinician behavior
(Miller, Yahne, Moyers, Martinez, & Pirritano, 2004;
Sholomskas et al., 2005). Furthermore, even documented
acquisition of fidelity skills under close supervision does
not guarantee continued, postsupervision fidelity maintenance. Direct supervision, via review of clinicians’ levels
of fidelity and skill in delivering evidence-based practice,
is rarely provided in community-based settings and is
also not reimbursed or otherwise incentivized (Olmstead
et al., 2012; Schoenwald, Mehta, Frazier, & Shernoff,
2013).
Moreover, community providers’ motivation and comfort level with empirically supported treatments is lower
than that of research therapists (Stewart, Chambless, &
Baron, 2012). For example, in a study of clinical psychologists’ use of exposure therapy for posttraumatic
stress disorder, only 17% of therapists reported using the
evidence-based treatment, and 72% reported a lack of
comfort with exposure therapy (Becker, Zayfert, &
Anderson, 2004). Research therapists tend to be committed to the therapy they are administering and to the
research process, and they are directly incentivized to
implement treatments with skill and fidelity. There is no
similar incentive system for community therapists.
These and other barriers to implementation contribute
to a mounting sentiment that business as usual must
change (Institute of Medicine, 2006). Authors such as
B. S. Brown and Flynn (2002) have exclaimed that clinical
science can and should do much more to implement efficacious treatment and prevention interventions (see also
Glasgow, Lichtenstein, & Marcus, 2003; Hoagwood, Olin,
& Cleek, 2013). Some even suggested a 10-year moratorium on efficacy trials (Kessler & Glasgow, 2011).
On the other side of the translation-implementation
continuum (Shoham et al., 2014), we are missing a tighter
link between basic and applied clinical science (Onken &
Blaine, 1997; Onken & Bootzin, 1998). Despite substantial advances in the understanding of neurobiological,
behavioral, and psychological mechanisms of disorders,
these understandings are not sufficiently linked to mechanisms of action in intervention development research
(Kazdin, 2007; Murphy, Cooper, Hollon, & Fairburn,
2009). In the absence of better understanding of how
interventions work, efforts to adapt interventions (e.g.,
dose reduction), a common practice in community settings, may render the interventions devoid of their original efficacy.
A meta-level problem is that these problems fall
between scientific cracks. Perhaps a reason why there
has been such difficulty implementing empirically supported interventions is that no subgroup of clinical scientists have a defined role for ensuring implementability of
interventions: Is it the responsibility of basic behavioral
scientists to ensure that interventions get implemented?
Surely that is not their job! Their mission is to understand
basic normal and dysfunctional behavioral processes,
not to directly develop interventions or ensure their
implementability.
What about the researchers who generate, refine, and
test interventions in efficacy trials? Would they say that it
is their mission to develop and test the best interventions
possible, but it is not their job to strive toward the implementability of those interventions? Would they argue that
ensuring implementability is the responsibility of someone else, such as researchers who conduct effectiveness
trials? If effectiveness is not sufficiently strong, could it
not be that the problem lies within the way the intervention was delivered, or within the design of the effectiveness trial, not with the efficacious intervention?
Conversely, effectiveness researchers claim responsibility for real-world testing of interventions that have initial scientific support. If these empirically supported
interventions are not viable for use in the real world, is
not this the fault of the intervention developers? Should
not the intervention developers produce interventions
that can be sustained effectively in the real world?
Finally, consider the implementation scientists (e.g.,
Proctor et al., 2009). One can assume that implementation researchers must be responsible for implementation!
These scientists are doing all they can to determine how
to get interventions adopted and have identified a multitude of program- and system-level constraints and barriers to implementation (e.g., Fixsen, Naoom, Blase,
Friedman, & Wallace, 2005; Hoagwood et al., 2013;
Lehman, Simpson, Knight, & Flynn, 2011). When systemlevel barriers are addressed by community practitioners
who adapt empirically supported interventions for the
populations they serve, intervention developers assert
that these adapted interventions are no longer the same
interventions that were shown to have efficacy. As it turns
out, nobody takes charge, and the cycle continues.
Possible Solutions
Changing the System
Suggestions to solve the science-practice gap by changing the service delivery system have encountered formidable barriers. The infrastructure of existing delivery
systems may be too weak to provide the complex, albeit
high-quality empirically supported therapies practiced in
efficacy studies (McLellan & Meyers, 2004). For example,
implementation of such treatments may require fundamental changes in the training and ongoing supervision
of community-based clinicians (Carroll & Rounsaville,
2007), smaller numbers of patients assigned to each clinician, and increased time allotted per patient. Another
NIH Stage Model for Intervention Development
particularly unfortunate barrier is that empirically supported therapies are not always preferentially reimbursed,
whereas some interventions that have been shown to
be ineffective or worse (e.g., repeated inpatient detoxification without aftercare) continue to be reimbursed
(Humphreys & McLellan, 2012). Any one of these systemic barriers could be difficult to change, and a synthesis
of the literature suggests that successful implementation
necessitates a sustained, multilevel approach (Damschroder
et al., 2009; Fairburn & Wilson, 2013; Fixsen et al., 2005),
requiring that multiple barriers be addressed simultaneously for implementation to be successful. In the meanwhile, we turn the spotlight to an alternative and
complementary solution.
Changing the Interventions: Adapting
Square Pegs to Fit Into Round Holes
Multiple unsuccessful attempts to change service delivery
systems bring up the possibility that what needs to change
is the intervention. Perhaps instead of forcing the square
pegs of our evidence-based interventions into the round
holes of the delivery system (Onken, 2011) we should
consider making our interventions somewhat more round.
If efficacy findings are to be replicated in effectiveness
studies, perhaps it is time for clinical scientists to accept
the responsibility of routinely and systematically creating
and adapting interventions to the intervention delivery
context as an integral part of the intervention development process. Knowing how to adapt an intervention so
that the intervention retains its effects while at the same
time fitting in the real world requires knowledge about
mechanisms and conditions in relevant settings. This solution may require the participation of practitioners in a
research team that is ready to ask hard questions regarding why the intervention works and how to preserve its
effective ingredients while adapting the intervention to fit
broader and more varied contexts (Chorpita & Viesselman,
2005; Lilienfeld et al., 2013).
Unfortunately, clinical scientists are not usually the
conveyers of such modifications, nor do they always
have the tools necessary to retain effective intervention
ingredients while guiding adaptation efforts. Often, community practitioners modify the intervention, including
those participating in effectiveness studies of sciencebased interventions (Stewart, Stirman, & Chambless,
2012). Such alterations typically involve delivering the
intervention in far fewer sessions, in group versus individual format, and other shortcuts that could diminish
potency. Changes to interventions are made with good
intentions, often due to necessity (e.g., insurers’ demands),
and they are frequently based on clinical intuition, clinical experience, or clinician or patient preferences, but
25
not on science (Lilienfeld et al., 2013). Adapting the intervention in response to practical constraints is an inherently risky endeavor: The intervention may or may not
retain the elements that make it work. Whether done by
clinicians attempting to meet real-world demands or by
scientists lacking evidence of the intervention’s mechanism of action, practical alteration of evidenced-based
interventions could very well diminish or eliminate the
potency of the (no-longer-science-based) interventions.
On the other hand, when clinical scientists uncover
essential mechanisms of action, they may be able to
package the intervention in a way that is highly implementable. For example, with an understanding of mechanisms, Otto et al. (2012) were able to create an ultra-brief
treatment for panic disorder. Another example is the
computerized attention modification program that
directly targets cognitive biases operating in the most
prevalent mood disorders (Amir & Taylor, 2012).
Redefining When Intervention
Development Is Incomplete
Intervention development is incomplete until the intervention is maximally potent and implementable for the
population for which it was developed. Intervention
developers need to address issues of fit within a service
delivery system, simplicity, fidelity and supervision, therapist training, and everything else that relates to implementability before the intervention development is
considered complete. For example, intervention development is incomplete if community providers are expected
to deliver the intervention, but there are no materials
available that ensure that they administer the intervention
with fidelity, or know the level of fidelity required to
deliver the intervention effectively. Therefore, materials
to ensure fidelity of intervention delivery (e.g., training
and supervision materials) are an essential part of any
intervention for which they are required and can be
developed even after an intervention has proven efficacious in a research setting.
Efficacy Testing in the Real-World
Settings
As noted, complex interventions administered with a
high degree of fidelity in research settings with research
providers seem destined to weaken when implemented
in community settings with community providers. There
is a need for research between traditional efficacy and
effectiveness research where an intervention is tested for
efficacy in a community setting, with community providers, such as in the model described by Weisz, Ugueto,
Cheron, and Herren (2013). For such testing to occur, the
Onken et al.
26
intervention will likely need to be further developed or
“adapted” for community providers. The conceptual
framework presented here includes a stage (Stage III) of
research where a therapy is tested, with high internal
validity, in a community setting with community practitioners, and where fidelity assurance is included as part
of the treatment before the therapy is tested in high
external validity effectiveness trials.
Identifying Mechanisms of Change
It is entirely possible to develop highly potent, implementable interventions without understanding mechanisms of change. But is it likely to be a highly successful
or tenable strategy? Decades of research with little attention to change mechanisms have produced very few
interventions that are efficacious, effective, and implementable. We argue that an understanding of change
mechanisms is often critical for developing the most
effective interventions that can be scaled up and trimmed
down. First, understanding mechanisms can guide
the enhancement and simplification of interventions
(Kazdin & Nock, 2003). If we understood how and why
an intervention is working, we are better positioned to
emphasize what is potent. Simplification of interventions
could help with training, cost, and transportability.
Understanding mechanism could help to clarify scientifically based principles of interventions, and imparting
these principles may help practitioners deliver interventions with a higher level of fidelity than requiring a strict
adherence to intervention manuals. Knowing principles
could also help clarify when it is important to intervene
in one particular way, or to intervene in any number of
ways, as long as the intervention is faithful to the mechanism of action. As Kazdin (2008) pointed out, “There are
many reasons to study mechanisms, but one in particular
will help clinical work and patient care” (p. 152).
There have been numerous calls for research on
mechanisms of change. Indeed, one recent announcement, “Use-Oriented Basic Research: Change Mechanisms
of Behavioral Social Interventions” (http://grants.nih
.gov/grants/guide/pa-files/PA-12-119.html), called for
research to study putative mechanisms of action of
behavioral, with the ultimate goal of simplifying and creating more implementable interventions. The idea of useoriented basic research was inspired by Louis Pasteur,
who saw little differentiation between the ultimate goals
of basic and applied science and who viewed all science
as essential to achieve practical goals (Stokes, 1997). A
similar perspective with regard to psychotherapy research
was described by Borkovec and Miranda (1999).
Understanding mechanism of action and the principles
behind an intervention may involve basic science expertise, but can have pragmatic effects, such as helping to
(a) strengthen the effects of interventions; (b) pare down
interventions to what is essential, which can make the
intervention more implementable and cut costs; and (c)
simplify interventions for easier transportability, such as
computerizing parts of the intervention (e.g., Bickel,
Marsch, Buchhalter, & Badger, 2008; Carroll et al., 2008;
Carroll & Rounsaville, 2010; Craske, Rose, et al., 2009).
Despite these frequent calls for studying change
mechanisms in intervention development research, many
clinical scientists are not yet taking this approach. What
is new about the emphasis on mechanism propounded
here? We suggest that a major reason for the relative lack
of attention to mechanisms in prior research may be an
unfortunate consequence of largely disconnected areas
of clinical science. Questions regarding mechanisms of
disorders and mechanisms of change are conceptually
similar to questions asked within basic behavioral science. Hence, basic science questions and relevant
research paradigms should not be limited to research that
occurs prior to intervention development; they are integral to the entire behavioral intervention development
process. We suggest that the development of potent and
implementable behavioral interventions could be revolutionized if the field were unified around fundamental
mechanisms of behavior change and if all types of clinical scientists were trained to address mechanism of action
of behavioral interventions at every stage of the intervention development process.
Could a new vision for clinical science help bridge the
science-practice gap? To that end we propose a conceptual framework for intervention development that (a)
defines intervention development as incomplete if the
intervention is not implementable and (b) propels all
clinical science to examine mechanisms of behavior
change. This framework inherently integrates all components of clinical science—from basic to applied.
NIH Stage Model
Various conceptualizations of research on intervention
development share the notion of phases or stages of
intervention development.2 Many stress the importance
of translational research. Most intervention development
models generally agree that efficacy and effectiveness
research vary along a continuum, from maximizing internal validity to maximizing generalizability. However, not
all models explicitly highlight the same stages or designate the same “numbering” system for the stages of
research. Models also differ in terms of the relevance of
basic research to intervention development and, if relevant, where to place it. In addition, they differ in terms of
how much focus is given to implementability, and how to
achieve implementable interventions. The conceptual
framework of intervention development described in this
NIH Stage Model for Intervention Development
article is an update of the model described by Onken,
Blaine, and Battjes (1997) and Rounsaville, Carroll, and
Onken (2001a, 2001b). A visual representation of this
model can be viewed in Figure 1.
The updated model, a “stage model,” asserts that the
work is not complete until an intervention reaches its
highest level of potency and is implementable with the
maximum number of people in the population for which
it was developed. One can begin at any stage, and go
back and forth as necessary to achieve this goal; the
model is not prescriptive, nor is it linear. That is, there is
no requirement that research be done in any particular
order, other than one that is logical and scientifically justifiable. This model is an iterative, recursive model of
behavioral intervention development. The focus of this
model is on adapting interventions (square pegs) not
only until they are simply maximally potent, but also
until they can most easily fit into the service delivery system (round hole). The model includes a basic science
component, as something that can be done separately
(e.g., prior to intervention development, or after intervention development to clarify mechanism), but also
something that can be done within the context of every
other stage of intervention development, to ascertain
27
information about mechanism during the intervention
development process. The efficacy/effectiveness gap is
addressed, with a stage that involves efficacy trials, with
an emphasis on internal validity, but conducted in community settings with community practitioners (Stage III).
Why is it important to have stages of research and a
conceptual framework if it is not prescriptive? There are
many reasons, but one that stands out is that defining
stages of behavioral intervention development highlights
the value and frequent necessity of a particular type of
research endeavor. For example, defining treatment generation and refinement helped to legitimize this necessary part of behavioral treatment research. Moreover,
defining a stage in between efficacy and effectiveness,
where interventions can be tested with high internal
validity, with research therapists in research settings,
draws attention to the importance of this stage of intervention development, and also provides more clarity
when the words efficacy and effectiveness are used.
Finally, defining the stages creates a common language
through which behavioral intervention development can
be discussed across clinical, academic, and research settings. This common language facilitates research grant
proposal writing and review, ultimately leading to a more
Stage I:
Intervention
Generation/
Refinement
Caution
*Stage 0:
Basic
research
Stage II:
Efficacy
(Research
Clinics)
Stage V:
Implementation
& Dissemination
Stage III:
Efficacy
(Community
Clinics)
Stage IV:
Effectiveness
Fig. 1. NIH stage model: common and cautionary pathways.
Note: Dotted arrow indicates the importance of using caution when considering this
pathway.
Onken et al.
28
coherent, efficient, and progressive science. So even
though the stages of behavioral intervention development do not always—or even usually—occur in a prescribed order, and even though it is not always—or even
usually—necessary to progress through every stage, it
facilitates communication and helps clarify research
activities and necessary next steps when the stages of
intervention development research are defined.
Stage 0
Basic science, considered to be Stage 0, plays a major
role in intervention development. Stage 0 can precede
and provide the basis for the generation of a new intervention, or the modification of an existing one. Basic science could include any basic behavioral, cognitive,
affective, or social science or neuroscience that is being
conducted with the ultimate goal of informing the development of behavioral intervention development.
Basic science can also be incorporated into all other
stages of intervention development. Specifically, the
mechanism of action, mediator, and moderator research
is an integral part of Stage I, Stage II, Stage III, and Stage
IV research. Asking questions about mechanisms of
change involves asking basic science questions to answer
basic behavioral, cognitive, or social science or biological
questions about how an intervention produces its effects,
and for whom the intervention works best. As discussed
earlier, we believe that understanding the basic principles
of behavior change for an intervention will fuel every
stage of intervention development and will facilitate
the creation of ever more potent and implementable
interventions.
Stage I
Stage I encompasses all activities related to the creation
of a new intervention, or the modification, adaptation, or
refinement of an existing intervention (Stage IA), as well
as feasibility and pilot testing (Stage IB). Stage I research
can be conducted to develop, modify, refine, adapt, or
pilot test (a) behavioral treatment interventions, (b)
behavioral prevention interventions, (c) medication
adherence interventions, and (d) components of behavioral interventions. In addition, Stage I research includes
the development, modification, refinement, adaptation,
and pilot testing of therapist/provider training, supervision, and fidelity-enhancing interventions (considered
integral to all interventions), and interventions to ensure
maintenance of the fidelity of intervention delivery (also
considered integral to all).
Stage I research can be conducted in research settings
with research therapists/providers, as well as in “realworld” or community settings with community therapists/
providers. Usually a goal of a Stage I project is to provide
necessary materials and information to proceed to a
Stage II or Stage III project. An equally important goal is
to obtain scientific knowledge of the processes that lead
to behavior change (i.e., behavioral, cognitive, social, or
biological mechanism of behavior change). That is, Stage
I goals encompass obtaining basic science information
about how the intervention might be exerting its effects
(Rounsaville et al., 2001a).
Stage I is an iterative process that involves multiple
activities. Stage IA includes (a) identifying promising
basic or clinical scientific findings relevant to the development or refinement of an intervention; (b) generating/
formulating theories relevant to intervention development; (c) operationally defining and standardizing new
or modified principle-driven interventions; and (d) as
necessary, further refining, modifying, or adapting an
intervention to boost effects or for ease of implementation in real-world settings. Initial or pilot testing of the
intervention is considered to be Stage IB. Stage I involves
testing the theory on which the intervention is based to
understand the mechanisms and principles of behavior
change.
It cannot be stressed enough that therapist/provider
training and fidelity assessment and enhancement methods are an integral part of behavioral intervention development. Intervention development is incomplete if there
are no materials and methods for administering that
intervention. Research on the development, modification,
and pilot testing of training and fidelity intervention/procedures for community providers is considered to be
Stage I, whether conducted prior to taking the intervention to an efficacy study or after an intervention has
proven efficacious.
Stage II
Stage II research consists of testing of promising behavioral interventions in research settings, with research therapists/providers. Stage II does not specify a particular
research design. Testing of interventions may be done in
randomized clinical trials, but may also be conducted
using other methodologies (e.g., adaptive designs, multiple-baseline single-case designs, A-B-A designs, etc.).
Stage II also involves basic science (Stage 0), in that Stage
II involves examining mechanisms of behavior change.
Indeed, a Stage II study can provide an ideal opportunity
to experimentally manipulate and test mechanisms. Stage
II studies may include examination of intervention components, dose response, and theory-derived moderators.
After conducting a Stage I study, proceeding to Stage
II (or Stage III in the case of an intervention developed in
a community setting) presumes that promising pilot data
of feasibility and outcomes exist. If sufficiently strong
NIH Stage Model for Intervention Development
evidence of promise does not exist, but if there is a good
rationale for additional modification of the intervention,
such modification can be done in a Stage I study.
Information obtained from Stage II studies may be used
to inform future Stage I studies. For example, if it is
shown that an intervention works for some people, but
not for others, a Stage II study may lay the groundwork
for a Stage I proposal aimed at generating an intervention
(or modifying the intervention) for people who were
unresponsive to the initial intervention.
Stage III
Why should there be an expectation that an intervention
showing efficacy will also show effectiveness? Complex
treatments administered with a high degree of fidelity in
research settings with research therapists seem destined to
weaken when implemented in community settings with
community providers. It is not reasonable to expect that a
positive efficacy study will automatically or even usually
lead to a positive effectiveness study (Flay, 1986). Before
proceeding to effectiveness testing, it may be practical and
logical to test that intervention for efficacy in a community
setting, and a need has been identified for research
between traditional efficacy and effectiveness research
(Carroll & Rounsaville, 2007; Weisz et al., 2013). Of course,
prior to this testing the intervention will likely need to be
further developed or adapted (i.e., in Stage I) for community providers. This new vision of intervention development includes an additional stage, Stage III, of research
where an intervention is tested in a well-controlled, internally valid study in a community setting with community
therapists/providers, and where community-friendly fidelity monitoring and enhancement procedures are included
as part of the intervention before testing in an externally
valid effectiveness trial (see Henggeler, 2011).
Stage III research is unique to the current revision of
the model. Stage III is similar to Stage II research, except
that instead of research providers and settings, it consists
of testing in a community context while maintaining a
high level of control necessary to establish internal validity (Carroll & Rounsaville, 2003). As is the case in all of
the stages, examination of the mechanism of action of
interventions is considered integral. Like Stage II, Stage
III does not specify a particular research design. Testing
of interventions may be done in randomized clinical trials, but may also be conducted using other methodologies (e.g., adaptive designs, multiple-baseline single-case
designs, A-B-A designs, etc.). Stage III studies may include
examination of intervention components, dose response,
and theory-derived moderators.
Proceeding to Stage III requires Stage I research to be
promising. In addition, Stage III research demands that
29
the intervention generated in the Stage I research is an
intervention believed to be implementable or “community-friendly.” This could mean that the intervention was
pilot tested in a community setting with community therapists/providers, and should mean that fidelity and therapist training measures have been handled and/or
incorporated into the intervention.
Immediately and directly proceeding from Stage II to
Stage III is not a typical path within the stage model.
Generally, when Stage II (rather than Stage III) is proposed, it is because the intervention is not ready to be
tested in the community: If the intervention was ready to
be tested in the community, logic dictates that Stage III
would have been proposed. If positive results have been
obtained from a Stage II study, usually additional community-friendly Stage I work is needed to make the intervention ready for a Stage III trial. An exception might be
a highly computerized intervention that requires little
attention to provider training or fidelity. As is the case
for Stage II, information obtained from Stage III studies
may be used to inform future Stage I studies. For example, if it is shown in Stage III that an intervention works
for some people, but not for others, a Stage III study
may lay the groundwork for a Stage I proposal aimed at
developing an intervention (or modifying the intervention) for people who were unresponsive to the initial
intervention.
Stage IV
Stage IV is effectiveness research. Stage IV research
examines behavioral interventions in community settings,
with community therapists/providers, while maximizing
external validity. It is generally considered necessary to
show that an intervention is effective before proceeding
to implementation and dissemination in the real world.
As is the case in all of the stages, examination of the
moderators and the mechanism of action of interventions
and/or training procedures is considered to be an integral part of Stage IV. It may be more complex to incorporate Stage 0 (basic science) into Stage IV than into Stages
I to III, but there may be methods for doing so (Collins,
Dziak, & Li, 2009; Doss & Atkins, 2006).
Skipping Stage III and proceeding from Stage II to
Stage IV is not a typical path within the stage model.
Moving to an effectiveness study from Stage II, without
validated measures to train community providers and
ensure fidelity, increases the likelihood of a failed effectiveness trial. A successful Stage III trial shows that it is
possible to deliver faithfully an intervention in the community, and that the intervention retains efficacy. Stage III
is meant to maximize the chances of a successful Stage IV
study.
Onken et al.
30
Stage V
Stage V is implementation and dissemination research.
Implementation concerns methods of adopting scientifically supported interventions and incorporating them into
community settings. Dissemination refers to the distribution of information and materials about these interventions
to relevant groups. Generally speaking, dissemination and
implementation (D&I) research focuses at least as much if
not more on the service delivery system as opposed to the
intervention itself. Although relevant to intervention development, not all D&I research looks at the intervention per
se, except as something to be adopted by the system. This
does not imply, however, that interventions at this stage
are exempt from the desiderata regarding mechanism that
are discussed in previous sections: It is important to understand how implementation strategies work.
What About Training of Clinical
Scientists?
The thrust of our arguments for a new vision and longterm change culminates in training. Realistically, the large
majority of clinical researchers, sympathetic as they may
be to this sort of integrative vision, were not trained in
this kind of outlook and are far too ensconced in the
intense pressure of contemporary clinical research to
change rapidly. Moreover, clinical science training now
produces excellent basic scientists, intervention generators and testers, effectiveness researchers, and implementation scientists. What we need to do is produce excellent
scientists of all these sorts, but also train them to see
where they fit as the science moves into practice, and
how they can contribute to it. They need to be trained to
understand the entire process of intervention development (Stages 0 through V), not just one particular aspect
of it. In a sense, they need multi-subdisciplinary training.
Basic scientists need to continue to be trained to do great
basic science, but they also need to know how to conduct such science within applied intervention development studies. Efficacy researchers and researchers who
generate and refine interventions need to understand the
importance of determining mechanisms of behavior
change, and also need to continue their efforts to strive
to make an intervention more implementable, beyond
the point of establishing efficacy. Effectiveness researchers need to know how to conduct great effectiveness
studies, but they need to know from efficacy researchers
when interventions are ready (not until after Stage III—
usually), and they need to know what kind of methodologies can get them the most information about
mechanisms and mediators. Researchers from the most
basic realm of clinical science to the most applied realm
of intervention development not only can help each
other, but also can help themselves by opening up new
avenues of research pursuits, and asking and answering
new research questions—all while fostering the public
health.
Such training is substantive and not trivial. Therefore,
hard work will be needed to determine what sort of curricula can be developed that provide students with this
necessary background without detracting unnecessarily
from their core research training. Just as many clinical
science programs have considered alternative accreditation systems to avert onerous requirements for class work
and clinical hours that do not fit the needs of their students, clinical science programs need to avoid simply
substituting another set of overly time-consuming requirements. However, the need for students to acquire a more
integrative vision of the entire field, to see themselves as
part of it, and to understand how to interact with scientists in other parts of the clinical science system is critical
for clinical science to flourish in the long term, and to
achieve its rich potential for exerting a positive impact on
public health.
Clinical scientists need to be trained to understand
that it is everyone’s job to produce potent, well-understood, efficacious, effective, and implementable interventions. They all have a role to play. The stage model is
intended to underscore the interconnectedness of the
multiple domains of clinical science, to bring an awareness of the importance of mechanisms, to define essential aspects of intervention development, to promote the
use of a common language, and to underscore the importance of fully developing potent interventions all the way
through to implementation. Training students to use the
stage model as a heuristic can help to foster all of these
goals.
Concluding Remarks
A new vision for clinical science is, in a sense, equivalent
to a new vision for intervention development, in that the
ultimate goal of both is interventions that promote
the physical and mental health of individuals. Although
the ultimate goal may be applied, basic science is an
integral part of that goal because basic and all types of
applied clinical scientists are necessary to fully achieve it.
For the vision to be realized, clinical science students
need to be taught how to integrate the subdisciplines of
basic behavioral science, efficacy and effectiveness
research, and implementation science.
In a world in which it is becoming increasingly the
norm to conduct multidisciplinary translational team science, and where quite frequently students are already
being trained in more than one discipline, is it reasonable
to ask them to achieve fluency in the subdisciplines of
clinical science? Basic science divorced from applied
NIH Stage Model for Intervention Development
science can yield fascinating findings, but if basic science
can inform and be informed by applied clinical science,
the field can expand and can help solve public health
problems, and be noticed for doing so. Efficacy and
effectiveness research divorced from the science of how
and why interventions work can yield interventions that
work, and in some cases that can be good enough. On
the other hand, without an understanding of mechanisms, endless questions can arise when clinical trials fail
(e.g., questions about appropriateness of design, delivery, fidelity, population, providers, etc.) and even when
they succeed (Does the intervention need to be given
exactly as is? Will the intervention work if partially administered or if delivered in another form? Does the intervention require adaptation for another population or another
setting? etc.). Questions will still arise if the field is integrated, but the science will be better positioned to coherently progress. Given the likely benefits, it seems
unreasonable not to ask them to achieve fluency in the
subdisciplines of clinical science.
What steps can be taken to integrate these subdisciplines? Perhaps students need not be trained as an expert
in more than one subdiscipline; perhaps it is enough that
they be trained to contribute in a meaningful way to
other subdisciplines, and to understand how other subdisciplines can contribute to their own. For example, scientists who conduct basic research on psychopathology
need not be trained to conduct clinical trials, but need to
know enough about clinical trials to know how to design
studies that can inform these trials, and substudies that
can be included with those clinical trials, such as substudies on mechanisms of change. This benefits the psychopathology researcher by opening up new avenues to
test theories about behavior and behavior change, and it
benefits clinical trials researchers by giving them insight
into the reasons why their interventions work, or do not
work. Conversely, clinical trials researchers might not
need to be trained as experts in basic behavioral science,
but they can be trained to understand how to appreciate
and include the right basic behavioral science and scientists to help them develop more potent and more implementable interventions.
What else needs to be done? The vision presented
here demands that clinical scientists understand and train
their students to understand that intervention development is far from complete when an intervention shows
efficacy in Stage II. They need to expect that successful
research setting–based efficacy trials are not likely to
directly result in successful effectiveness trials, and should
understand the frequent necessity of further developing
an intervention (e.g., in Stages I and III) toward implementability. If an intervention is not implementable in the
community, there is more work to be done—even if that
31
work ends up showing that there is no conceivable way
currently to change the intervention into a more implementable form.
Finally, students need to be trained to understand the
importance of using a common language. A common
language fosters a progressive discipline, creating the
groundwork to solve public health problems. With a
common language, the (oftentimes) missing link of Stage
III defined, and a mind-set that includes an appreciation
of basic science and implementability within intervention
development, we expect to replace the merry-go-round
of efficacy and effectiveness trials that go nowhere with
a map that leads toward implementation of effective
interventions.
We hope that this new vision—anchored in a stage
model of intervention development—not only will bring
the field together in the pursuit of a common goal, but
also will foster the successful realization of that goal.
Emphasizing that interventions are not fully developed
until they are implementable and underscoring the
importance of research on change mechanisms have
been two pillars of this vision. Training the next generation of clinical scientists to embrace this new vision could
mean a new generation of powerful and implementable
interventions for the public health.
Author Contributions
The order of authorship reflects the authors’ relative
contribution.
Declaration of Conflicting Interests
The authors declared that they had no conflicts of interest with
respect to their authorship or the publication of this article.
Funding
K. M. Carroll was supported by NIDA awards P50-DA09241,
R01 DA015969, and U10 DA015831 (Carroll, PI). The other
authors are federal employees who did not receive federal or
foundation grants to support this work.
Notes
1. As defined by the Academy of Psychological Clinical Science,
clinical science is “a psychological science directed at the
promotion of adaptive functioning; at the assessment, understanding, amelioration, and prevention of human problems in
behavior, affect, cognition or health; and at the application of
knowledge in ways consistent with scientific evidence” (http://
acadpsychclinicalscience.org/mission/).
2. We are using stages for a model of psychosocial intervention development to differentiate it from biomedical treatments,
where phases are defined for medication development by
the FDA (see http://www.fda.gov/drugs/resourcesforyou/
consumers/ucm143534.htm).
32
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On Being Sane in Insane Places
Author(s): D. L. Rosenhan
Source: Science , Jan. 19, 1973, New Series, Vol. 179, No. 4070 (Jan. 19, 1973), pp. 250258
Published by: American Association for the Advancement of Science
Stable URL: https://www.jstor.org/stable/1735662
REFERENCES
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personal communication; K. P. Lamb, E.
100, 637 (1966).
Hassan, D. P. Scoter, Ecology 52, 178 (1971).
12. J. M. Thoday, Nature 181, 1124 (1958); -For localized distribution and problem of
and T. B. Boam, Heredity 13, 204 (1959); E.
establishment see also: W. F. Blair, Ann.
Millicent and J. M. Thoday, Ibid. 16, 219
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(1961); J. M. Thoday and J. B. Gibson, Amer.
253 (1950); L. R. Dice, Amer. Natur. 74, 289
Natur. 105, 86 (1971).
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(1961); Th. Dobzhansky and B. Spassky, Proc.
personal communication; J. T. Marshall, Jr.,
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7. J. B. S. Haldane, J. Genet. 48, 277 (1948).
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Kimura, Annu. Rep. Nat. Inst. Genet.
, J. Sved, ibid. 173, 191 (1969); Th.
Dobzhansky, H. Levene, B. Spassky, ibid. 180,
21 (1972).
14. M. Slatkin, thesis, Harvard University (1971).
15. S. K. Jain and A. D. Bradshaw, Heredity
21, 407 (1966).
16. Parapatric divergence is divergence between
adjacent but genetically continuous popula-
tions. See H. M. Smith, Syst. Zool. 14, 57
(1965); ibid. 18, 254 (1969); M. J. D. White,
R. E. Blackith, R. M. Blackith, J. Cheney,
Aust. J. Zool. 15, 263 (1967); M. J. D. White,
Science 159, 1065 (1968); K. H. L. Key,
Syst. Zool. 17, 14 (1968).
17. J. S. Huxley, Nature 142, 219 (1938); Bijdr.
Dierk. Leiden 27, 491 (1939).
18. F. B. Sumner, Bibliogr. Genet. 9, 1 (1932).
19. F. Salomonsen, Dan. Biol. Medd. 22, 1
(1955).
20. E. B. Ford, Biol. Rev. Cambridge Phil. Soc.
20, 73 (1945).
21. Examples of morph-ratio clines include:
H. B. D. Kettlewell and R. J. Berry, Heredity
16, 403 (1961); ibid. 24, 1 (1969); H. B. D.
Kettlewell, R. J. Berry, C. J. Cadbury,
G. C. Phillips, Ibid., p. 15; H. N. Southern,
J. Zool. London Ser. A 138, 455 (1966);
A. J. Cain and J. D. Currey, Phil. Trans.
Roy. Soc. London Ser. B. 246, 1 (1962);
loci makes the net selection stronger, compared to autosomal loci, for the population
as a whole. See C. C. Li, Population Genetics
30. The equilibrium configurations are not significantly altered if the emigrants from the
end demes do not return, unless the number
of demes (d) is very small (J. A. Endler,
unpublished data).
31. See, for example, the models of B. C.
Clarke [Amer. Natur. 100, 389 (1966)] and
those in (14).
32. This model incorporates Clarke’s model of
frequency-dependence; see B. C. Clarke,
Evolution 18, 364 (1964).
33. R. A. Fisher and F. Yates, Statistical Tables
for Biological, Agricultural, and Medical Research (Oliver & Boyd, Edinburgh, 1948);
R. R. Sokal and F. J. Rohlf, Biometry
(Freeman, San Francisco, 1969).
34. See, for example, C. G. Johnson, Migration
and Dispersal of Insects by Flight (Methuen,
London, 1969); J. Antonovics, Amer. Sci. 59,
593 (1971).
35. E. C. Pielou, An Introduction to Mathematical
Ecology (Wiley-Interscience, New York, 1969).
36. W. F. Blair, Contrib. Lab. Vertebrate Biol.
Univ. Mich. No. 36, 1 (1947).
37. P. A. Parsons, Genetica 33, 184 (1963).
38. G. Hewitt and B. John, Chromosoma 21,
140 (1967); Evolution 24, 169 (1970); G.
Amer. Zool. 10, 53 (1970); P. Voipio, Ann.
Zool. Fenn. 15, 1 (1952); P. K. Anderson,
Hewitt, personal communication; H. Wolda,
J. Anim. Ecol. 38, 305, 623 (1969).
Science 145, 177 (1964).
24. N. W. Timofeeff-Ressovsky, in The New
39. L. R. Dice, Contrib. Lab. Vertebrate Genet.
Systematics, J. S. Huxley, Ed. (Oxford Univ.
Univ. Mich. No. 8 (1939), p. 1; ibid. No. 15
(1941), p. 1.
Press, Oxford, 1940), p. 73.
40.
I.
C. J. Galbraith, Bull. Brit. Mus. Natur.
25. The null point is the position at which
Hist. Zool. 4, 133 (1956).
selection changes over from favoring one
41. I am grateful to the National Science Foundatype to favoring another.
26. J. A. Endler, in preparation.
tion for a graduate fellowship in support
27. L. M. Cook, Coefficients of Natural Selection of this study. I thank Prof. Alan Robertson
(Hutchinson Univ. Library, Biological Sciand the Institute of Animal Genetics, Uniences No. 153, London, 1971); F. B. Livingversity of Edinburgh, for the Drosophila, and
stone, Amer. J. Phys. Anthropol. 31, 1 (1969). for kindly providing me with fresh medium
throughout the study. Criticism of the manu28. W. C. Allee, A. E. Emerson, 0. Park, T.
script by Professors John Bonner and Jane
Park, K. P. Schmidt, Principles of Animal
Ecology (Saunders, Philadelphia, 1949); H. C.
Potter, Dr. Philip Ashmole, Peter Tuft, Dr.
Andrewartha and L. C. Birch, The DistribuDavid Noakes, Dr. John Godfrey, Dr. Caryl
tion and Abundance of Animals (Univ. of
P. Haskins, and M. C. Bathgate was very
welcome. In particular, I thank my supervisor,
Chicago Press, Chicago, 1954); G. L. Clarke,
Professor Bryan C. Clarke, for help and critiElements of Ecology (Wiley, New York,
1954); R. Geiger, The Climate Near the
cism throughout this study. Any errors or
omissions are entirely my own. I thank the
Ground (translation, Harvard Univ. Press,
Edinburgh Regional Computing Center and
Cambridge, 1966).
29. Results for autosomal and sex-linked systems
the Edinburgh University Zoology Department
Condor 50, 193, 233 (1948); R. K. Sealander,
do not differ for the models to be discussed,
except that, for a given amount of selection,
the sex-linked system is loss sensitive to
for generous computer time allowances. I will
supply the specially written IMiP language
program upon request.
What is viewed as normal in one cul-
ture may be seen as quite aberrant in
On
On Being
Being Sane
Sanein
inInsane
InsanePlaces
Places
another. Thus, notions of normality and
abnormality may not be quite as accurate as people believe they are.
To raise questions regarding normal-
ity and abnormality is in no way to
question the fact that some behaviors
D. L. Rosenhan
are deviant or odd. Murder is deviant.
So, too, are hallucinations. Nor does
raising such questions deny the existence of the personal anguish that is
often associated with “mental illness.”
tradictedby
byequally
equally
eminent
eminent
psychiapsychia-Anxiety and depression exist. PsychoIf
If sanity
sanityand
and
insanity
insanity
exist,
exist,
how shall
how tradicted
shall
we know them?
trists
trists for
forthe
theprosecution
prosecution
on on
thethe
matter
matter
logical suffering exists. But normality
of
of the
the defendant’s
defendant’ssanity.
sanity.
More
More
gengenand abnormality, sanity and insanity,
The question is neither capricious nor
erally,
erally, there
thereare
area agreat
great
deal
deal
of of
conflictconflictitself insane. However much we may
and the diagnoses that flow from them
ing
ing data
dataon
onthe
thereliability,
reliability,
utility,
utility,
andand
be personally convinced that we can
tell the normal from the abnormal, the
meaning
meaningof
ofsuch
suchterms
terms
as as
“sanity,”
“sanity,”
“in-“in-The author is professor of psychology and law
at Stanford University, Stanford, California 94305.
sanity,””mental
“mentalillness,”
illness,”
and
and
“schizo”schizoevidence is simply not compelling. It is sanity,”
Portions of these data were presented to collo-
phrenia”
phrenia”(1).
(1).Finally,
Finally,
as as
early
early
as 1934,
as 1934,
quiums of the psychology departments at the
University of California at Berkeley and at Santa
Benedict
Benedictsuggested
suggested
that
that
normality
normality
andand
Barbara; University of Arizona, Tucson; and
Harvard University, Cambridge, Massachusetts.
abnormality are not universal (2).
psychiatrists for the defense are con-
commonplace, for example, to read
about murder trials wherein eminent
SCIENCE, VOL. 179
250
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may be less substantive than many believe them to be.
This article describes such an experiold and shabby, some were quite new.
ment. Eight sane people gainedSome
secret
were research-oriented, others
At its heart, the question of whetheradmission to 12 different hospitals
not. (6).
Some had good staff-patient ratios,
the sane can be distinguished from theTheir diagnostic experiences constitute
others were quite understaffed. Only
article;
insane (and whether degrees of insanitythe data of the first part of this one
was a strictly private hospital. All
can be distinguished from each other) the remainder is devoted to a descripof the others were supported by state
is a simple matter: do the salient char-tion of their experiences in psychiatric
or federal funds or, in one instance, by
acteristics that lead to diagnoses resideinstitutions. Too few psychiatrists
and
university
funds.
in the patients themselves or in the enpsychologists, even those who have
After calling the hospital for an apvironments and contexts in which obworked in such hospitals, know whatpointment, the pseudopatient arrived at
servers find them? From Bleuler,
the experience is like. They rarely talkthe admissions office complaining that
through Kretchmer, through the formuabout it with former patients, perhapshe had been hearing voices. Asked what
lators of the recently revised Diagnostic
because they distrust information com-the voices said, he replied that they
and Statistical Manual of the American
ing from the previously insane. Those were often unclear, but as far as he
Psychiatric Association, the belief haswho have worked in psychiatric hospi- could tell they said “empty,” “hollow,”
been strong that patients present symptals are likely to have adapted so thor- and “thud.” The voices were unfamiliar
toms, that those symptoms can be cateoughly to the settings that they areand were of the same sex as the pseudogorized, and, implicitly, that the saneinsensitive to the impact of that expe-patient. The choice of these symptoms
are distinguishable from the insane.rience. And while there have been ocwas occasioned by their apparent simcasional reports of researchers who ilarity to existential symptoms. Such
More recently, however, this belief has
submitted themselves to psychiatric hos-symptoms are alleged to arise from
been questioned. Based in part on theopitalization (7), these researchers have painful concerns about the perceived
retical and anthropological considerations, but also on philosophical, legal,
commonly remained in the hospitals formeaninglessness of one’s life. It is as
short periods of time, often with the if the hallucinating person were saying,
and therapeutic ones, the view has
grown that psychological categorization knowledge of the hospital staff. It is”My life is empty and hollow.” The
difficult to know the extent to which
of mental illness is useless at best and
choice of these symptoms was also dedownright harmful, misleading, andthey were treated like patients or liketermined by the absence of a single
research colleagues. Nevertheless, theirreport of existential psychoses in the
pejorative at worst. Psychiatric diagnoses, in this view, are in the minds of
reports about the inside of the psychi-literature.
the observers and are not valid sum-
maries of characteristics displayed
the observed (3-5).
Gains can be made in deciding which
of these is more nearly accurate by
getting normal people (that is, people
who do not have, and have never suffered, symptoms of serious psychiatric
disorders) admitted to psychiatric hospitals and then determining whether
they were discovered to be sane and, if
so, how. If the sanity of such pseudopatients were always detected, there
would be prima facie evidence that a
sane individual can be distinguished
from the insane context in which he is
atric hospital have been valuable. This Beyond alleging the symptoms and
falsifying name, vocation, and employ-
article
extends those efforts.
by
ment, no further alterations of person,
Pseudopatients and Their Settings
history, or circumstances were made.
The significant events of the pseudopatient’s life history were presented as
The eight pseudopatients were a they had actually occurred. Relationvaried group. One was a psychologyships with parents and siblings, with
graduate student in his 20’s. The respouse and children, with people at
maining seven were older and “estab- work and in school, consistent with the
lished.” Among them were three psy- aforementioned exceptions, were dechologists, a pediatrician, a psychiatrist, scribed as they were or had been. Frusa painter, and a housewife. Three
trations and upsets were described
pseudopatients were women, five were
along with joys and satisfactions. These
men. All of them employed pseudofacts are important to remember. If
nyms, lest their alleged diagnoses emanything, they strongly biased the subfound. Normality (and presumably ab-barrass them later. Those who were insequent results in favor of detecting
normality) is distinct enough that it
mental health professions alleged ansanity, since none of their histories or
can be recognized wherever it occurs,
other occupation in order to avoid the
current behaviors were seriously pathofor it is carried within the person. If,special attentions that might be aclogical in any way.
on the other hand, the sanity of the
corded by staff, as a matter of courtesyImmediately upon admission to the
pseudopatients were never discovered,or caution, to ailing colleagues (8).psychiatric ward, the pseudopatient
serious difficulties would arise for those
With the exception of myself (I was the
ceased simulating any symptoms of abwho support traditional modes of psy- first pseudopatient and my presence was
normality. In some cases, there was a
chiatric diagnosis. Given that the hospi-known to the hospital administrator and
brief period of mild nervousness and
tal staff was not incompetent, that thechief psychologist and, so far as I can
anxiety, since none of the pseudopapseudopatient had been behaving as tell, to them alone), the presence tients
of really believed that they would be
sanely as he had been outside of the
pseudopatients and the nature of the readmitted so easily. Indeed, their shared
hospital, and that it had never been search program was not known to the
fear was that they would be immedipreviously suggested that he belonged hospital staffs (9).
ately exposed as frauds and greatly
in a psychiatric hospital, such an un- The settings were similarly varied. embarrassed.
In
Moreover, many of them
likely outcome would support the view order to generalize the findings, admishad never visited a psychiatric ward;
that psychiatric diagnosis betrays little sion into a variety of hospitals was
even those who had, nevertheless had
about the patient but much about the sought. The 12 hospitals in the sample
some genuine fears about what might
environment in which an observer finds
were located in five different states on
happen to them. Their nervousness,
him.
the East and West coasts. Some were
then, was quite appropriate to the nov19 JANUARY 1973
251
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elty of the hospital setting, and it abated
rapidly.
Apart from that short-lived nervousness, the pseudopatient behaved on the
ward as he “normally” behaved. The
pseudopatient spoke to patients and
labeled schizophrenic, the pseudopatient
was stuck with that label. If the pseudopatient was to be discharged, he must
naturally be “in remission”; but he was
not sane, nor, in the institution’s view,
them personal, legal, and social stigmas
(12). It was therefore important to see
whether the tendency toward diagnosing
the sane insane could be reversed. The
following experiment was arranged at
a research and teaching hospital whose
The uniform failure to recognize sanstaff had heard these findings but
doubted that such an error could occur
ity cannot be attributed to the quality
had he ever been sane.
staff as he might ordinarily. Because
there is uncommonly little to do on a
psychiatric ward, he attempted to enof the hospitals, for, although there
in their hospital. The staff was informed
gage others in conversation. When
were considerable variations amongthat at some time during the following
asked by staff how he was feeling, hethem, several are considered excellent.3 months, one or more pseudopatients
indicated that he was fine, that he no Nor can it be alleged that there was
would attempt to be admitted into the
longer experienced symptoms. He re- simply not enough time to observe the psychiatric hospital. Each staff member
sponded to instructions from attendants,
pseudopatients. Length of hospitaliza- was asked to rate each patient who preto calls for medication (which was not tion ranged from 7 to 52 days, with an sented himself at admissions or on the
swallowed), and to dining-hall instruc-average of 19 days. The pseudopatients ward according to the likelihood that
tions. Beyond such activities as were
were not, in fact, carefully observed,
the patient was a pseudopatient. A 10available to him on the admissions
but this failure clearly speaks more to point scale was used, with a 1 and 2
ward, he spent his time writing traditions
down
within psychiatric hospitals reflecting high confidence that the pahis observations about the ward, its
than to lack of opportunity.
tient was a pseudopatient.
patients, and the staff. Initially these Finally, it cannot be said that the
Judgments were obtained on 193 panotes were written “secretly,” but as itfailure to recognize the pseudopatients’ tients who were admitted for psychi-
soon became clear that no one much
sanity was due to the fact that they atric treatment. All staff who had had
cared, they were subsequently written
were not behaving sanely. While there sustained contact with or primary reon standard tablets of paper in such
was clearly some tension present in all sponsibility for the patient-attendants,
public places as the dayroom. No secret
of them, their daily visitors could detect nurses, psychiatrists, physicians, and
was made of these activities.
no serious behavioral consequencespsychologists-were asked to make
The pseudopatient, very much asnor,
a indeed, could other patients. It was judgments. Forty-one patients were altrue psychiatric patient, entered a hosquite common for the patients to “de- leged, with high confidence, to be
pital with no foreknowledge of when
tect” the pseudopatients’ sanity. During pseudopatients by at least one member
he would be discharged. Each was told
the first three hospitalizations, when of the staff. Twenty-three were considthat he would have to get out by his
accurate counts were kept, 35 of a total ered suspect by at least one psychiatrist.
own devices, essentially by convincing
of 118 patients on the admissions ward Nineteen were suspected by one psychithe staff that he was sane. The psychovoiced their suspicions, some vigorously. atrist and one other staff member.
logical stresses associated with hospital”You’re not crazy. You’re a journalist, Actually, no genuine pseudopatient (at
ization were considerable, and all but
or a professor [referring to the con- least from my group) presented himself
one of the pseudopatients desired to be tinual note-taking]. You’re checking up during this period.
discharged almost immediately after
on the hospital.” While most of the
The experiment is instructive. It indibeing admitted. They were, therefore, patients were reassured by the pseudo- cates that the tendency to designate
motivated not only to behave sanely,
patient’s insistence that he had been
sane people as insane can be reversed
but to be paragons of cooperation. That sick before he came in but was fine
when the stakes (in this case, prestige
their behavior was in no way disruptive now, some continued to believe that
and diagnostic acumen) are high. But
is confirmed by nursing reports, which the pseudopatient was sane throughout
what can be said of the 19 people who
have been obtained on most of the
his hospitalization (11). The fact that
were suspected of being “sane” by one
patients. These reports uniformly
theindipatients often recognized normality
psychiatrist and another staff member?
cate that the patients were “friendly,”
when staff did not raises important
Were these people truly “sane,” or was
it rather the case that in the course of
“cooperative,” and “exhibited no abquestions.
normal indications.”
Failure to detect sanity during the
avoiding the type 2 error the staff
tended to make more errors of the first
course of hospitalization may be due
to the fact that physicians operate with sort-calling the crazy “sane”? There is
The Normal Are Not Detectably Sane
a strong bias toward what statisticians no way of knowing. But one thing is
call the type 2 error (5). This is to
certain: any diagnostic process that
Despite their public “show” of sanity,
say that physicians are more inclined
lends itself so readily to massive errors
the pseudopatients were never detected.
to call a healthy person sick (a false
of this sort cannot be a very reliable
one.
Admitted, except in one case, with
a
positive,
type 2) than a sick person
diagnosis of schizophrenia (10), each
healthy (a false negative, type 1). The
was discharged with a diagnosis of
reasons for this are not hard to find:
The Stickiness of
schizophrenia “in remission.” The label it is clearly more dangerous to mis”in remission” should in no way be
diagnose illness than health. Better to
Psychodiagnostic Labels
dismissed as a formality, for at no timeerr on the side of caution, to suspect
during any hospitalization had any illness even among the healthy.
Beyond the tendency to call the
question been raised about any pseudo- But what holds for medicine does
healthy sick-a tendency that accounts
patient’s simulation. Nor are there any not hold equally well for psychiatry.
better for diagnostic behavior on admission are
than it does for such behavior after
indications in the hospital records thatMedical illnesses, while unfortunate,
the pseudopatient’s status was suspect. not commonly pejorative. Psychiatric
a lengthy period of exposure-the data
Rather, the evidence is strong that, oncediagnoses, on the contrary, carryspeak
withto the massive role of labeling in
252
SCIENCE, VOL. 179
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psychiatric assessment. Having once
been labeled schizophrenic, there is
nothing the pseudopatient can do to
overcome the tag. The tag profoundly
colors others’ perceptions of him and
his behavior.
ences, with no markedly deleterious
ment on one of the pseudopatients who
was never questioned about his writing.
such a history was translated in the Given that the patient is in the hospital,
psychopathological context, this from
he must be psychologically disturbed.
the case summary prepared after the And given that he is disturbed, continupatient was discharged.
ous writing must be a behavioral maniconsequences. Observe, however, how
From one viewpoint, these data are
This white 39-year-old male . . . manihardly surprising, for it has long beenfests a long history of considerable ambivknown that elements are given meaningalence in close relationships, which begins
by the context in which they occur.in early childhood. A warm relationship
Gestalt psychology made this point with his mother cools during his adolescence. A distant relationship to his father
festation of that disturbance, perhaps a
subset of the compulsive behaviors that
are sometimes correlated with schizo-
phrenia.
One tacit characteristic of psychiatric
vigorously, and Asch (13) demondiagnosis is that it locates the sources
is described as becoming very intense.
strated that there are “central” personAffective stability is absent. His attempts of aberration within the individual and
to control emotionality with his wife and only rarely within the complex of stimality traits (such as “warm” versus
“cold”) which are so powerful that they children are punctuated by angry outbursts and, in the case of the children,
uli that surrounds him. Consequently,
markedly color the meaning of other spankings. And while he says that he has behaviors that are stimulated by the
information in forming an impression several good friends, one senses consider- environment are commonly misattrib-
of a given personality (14). “Insane,” able ambivalence embedded in those relauted to the patient’s disorder. For ex”schizophrenic,” “manic-depressive,” tionships also ….
ample, one kindly nurse found a
The facts of the case were unintenand “crazy” are probably among the
pseudopatient pacing the long hospital
most powerful of such central traits. tionally distorted by the staff to achieve
corridors. “Nervous, Mr. X?” she asked.
Once a person is designated abnormal, consistency with a popular theory of
“No, bored,” he said.
all of his other behaviors and characterthe dynamics of a schizophrenic reac- The notes kept by pseudopatients are
istics are colored by that label. Indeed,
that label is so powerful that many of
tion (15). Nothing of an ambivalent
full of patient behaviors that were misinterpreted by well-intentioned staff.
the pseudopatients’ normal behaviors with parents, spouse, or friends. To the
Often enough, a patient would go “berwere overlooked entirely or profoundly extent that ambivalence could be inserk” because he had, wittingly or unmisinterpreted. Some examples may ferred, it was probably not greater than
wittingly, been mistreated by, say, an
is found in all human relationships. It
clarify this issue.
attendant. A nurse coming upon the
Earlier I indicated that there were
is true the pseudopatient’s relationships
scene would rarely inquire even cursorwith his parents changed over time, but
no changes in the pseudopatient’s perily into the environmental stimuli of
in the ordinary context that wouldthe patient’s behavior. Rather, she assonal history and current status beyond
those of name, employment, and, where
hardly be remarkable-indeed, it might
sumed that his upset derived from his
very well be expected. Clearly, the
necessary, vocation. Otherwise, a veridipathology, not from his present intermeaning ascribed to his verbalizations
cal description of personal history and
actions with other staff members. Occircumstances was offered. Those cir(that is, ambivalence, affective instabilcasionally, the staff might assume that
cumstances were not psychotic. How ity) was determined by the diagnosis:the patient’s family (especially when
nature had been described in relations
were they made consonant with theschizophrenia. An entirely different
they had recently visited) or other padiagnosis of psychosis? Or were thosemeaning would have been ascribed if
tients had stimulated the outburst. But
diagnoses modified in such a way as to it were known that the man was
never were the staff found to assume
bring them into accord with the cir-“normal.”
that one of themselves or the structure
cumstances of the pseudopatient’s life, All pseudopatients took extensive of the hospital had anything to do with
as described by him?
notes publicly. Under ordinary circuma patient’s behavior. One psychiatrist
As far as I can determine, diagnoses stances, such behavior would have
pointed to a group of patients who were
were in no way affected by the relativeraised questions in the minds of obsitting outside the cafeteria entrance
health of the circumstances of a pseudo-servers, as, in fact, it did among pa- half an hour before lunchtime. To a
patient’s life. Rather, the reverse oc-tients. Indeed, it seemed so certain that group of young residents he indicated
curred: the perception of his cirthe notes would elicit suspicion that that such behavior was characteristic
cumstances was shaped entirely by the elaborate precautions were taken to re- of the oral-acquisitive nature of the
diagnosis. A clear example of such
move them from the ward each day. syndrome. It seemed not to occur to
translation is found in the case of a
But the precautions proved needless. him that there were very few things to
pseudopatient who had had a close
reThe
closest any staff member came to anticipate in a psychiatric hospital belationship with his mother but questioning
was
these notes occurred when sides eating.
rather remote from his father during
one pseudopatient asked his physician A psychiatric label has a life and an
what kind of medication he was receivhis early childhool. During adolescence
influence of its own. Once the impresand beyond, however, his fathering
beand began to write down the resion has been formed that the patient is
came a close friend, while his relationsponse. “You needn’t write it,” he was
schizophrenic, the expectation is that
ship with his mother cooled. His present
told gently. “If you have trouble re- he will continue to be schizophrenic.
relationship with his wife was characmembering, just ask me again.”
When a sufficient amount of time has
teristically close and warm. Ap…
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