Aren2002-Ethics Comparison Group

Ethics & Behavior
ISSN: 1050-8422 (Print) 1532-7019 (Online) Journal homepage: http://www.tandfonline.com/loi/hebh20
Ethical Considerations in Psychotherapy

Effectiveness Research: Choosing the Comparison
Group
Patricia A. Aren & Jennifer Alvidrez
To cite this article: Patricia A. Aren & Jennifer Alvidrez (2002) Ethical Considerations in
Psychotherapy Effectiveness Research: Choosing the Comparison Group, Ethics & Behavior,
12:1, 63-73, DOI: 10.1207/S15327019EB1201_4
To link to this article: http://dx.doi.org/10.1207/S15327019EB1201_4
Published online: 08 Jan 2010.
Submit your article to this journal
Article views: 41
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Citing articles: 5 View citing articles
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Download by: [Florida Atlantic University] Date: 06 November 2015, At: 04:11
ETHICS & BEHAVIOR, 12(1), 6373
Copyright 2002, Lawrence Erlbaum Associates, Inc.
Ethical Considerations in
Psychotherapy Effectiveness Research:
Choosing the Comparison Group
Downloaded by [Florida Atlantic University] at 04:11 06 November 2015
Patricia A. Aren and Jennifer Alvidrez

Department of Psychiatry
University of California, San Francisco
The primary purpose behind effectiveness research is to determine whether a

treatment with demonstrated efficacy has utility when administered to the general
population. The main questions these studies are meant to answer are these: Can the
typical patient respond to treatment? Is the treatment acceptable to the typical
patient? Can the treatment be administered safely and in its entirety in the typical
treatment setting? Is the treatment under study significantly better than the
community standard of care both from a cost and outcome perspective? Answering
these questions is meant to provide sufficient information to providers and policy-
makers so that effective interventions can be adopted and become the new commu-
nity standard.
For this research to make a meaningful impact on a provider and policymakers
decision to change the status quo, study interventions should be compared to the ex-
isting community standard of treatment, often referred to as treatment as usual (TAU).
From an ethical perspective, this decision may not always be the safest choice. In some
populations, TAU may mean no treatment at all, and in others TAU may be worse than
withholding treatment. The effectiveness researcher is then caught between the pull to
do no harm and the need for research to have an impact on change. The purpose of this
article is to highlight certain conditions when TAU is ethically acceptable and to dis-
cuss alternatives when TAU may be an unethical treatment condition. For purposes of
precision, we focus exclusively on psychotherapy effectiveness research rather than
system-intervention research or medication-intervention research.
Key words: treatment as usual, control groups, ethics, psychotherapy effectiveness
Requests for reprints should be sent to Patricia A. Aren, Department of Psychiatry, 401 Parnassus
Avenue, Box F-0984, San Francisco, CA 94143-0984. E-mail: pata@lppi.ucsf.edu
64 AREN AND ALVIDREZ
Does state-of-the-art psychotherapy work as well in the real world as it does in

the laboratory? Is it any better than or different from what psychotherapists
already do? These questions have been debated for the last 20 years in the
psychotherapy literature (Jacobsen & Christensen, 1996). Many providers
believe the psychotherapies that have been empirically evaluated in research are
not effective when applied to the general population. They point out that samples
used in psychotherapy studies are not representative of the typical patient seek-
ing mental health care. Many researchers, on the other hand, believe that
providers have poor success because they are improperly trained to use the inter-
ventions (Persons & Silberschatz, 1998). This debate has led the field to shift
away from the traditional clinical trial and to begin conducting psychotherapy
effectiveness studies.
Considerable discussion and debate has ensued regarding how to conduct
psychotherapy effectiveness research that is both scientifically sound and useful
in answering policy-related questions (Hollon, 1996). Very few people have
considered the ethical ramifications of this type of research, particularly regard-
ing the use of comparison conditions. Because effectiveness research is generally
concerned with the effectiveness of new interventions compared to existing treat-
ment, the typical comparison condition in this research is usual care, sometimes
called treatment as usual (TAU). As a comparison condition, TAU provides a
powerful means of demonstrating the effectiveness of interventions. People who
make decisions about how mental health problems should be treated are more
likely to implement policy changes if the data from research show a new inter-
vention to be more effective and less costly than care that is currently being
provided. However, in some situations, TAU is equivalent to substandard treat-
ment, or no treatment. The effectiveness researcher is pulled between making an
impact on policy (justice) and minimizing harm to the research participant
(beneficence).
The purpose of this article is to highlight how effectiveness researchers have
faced this dilemma and to discuss the pros and cons of using TAU versus other
comparisons. We start by discussing the importance of conducting effectiveness
research, how it differs from traditional clinical trials, and why TAU is generally
considered to be the best comparison intervention. We then discuss under what
circumstances TAU is necessary and offer suggestions for those instances when
TAU may not be an ethical alternative. We begin with the caveat that our discus-
sion is specific to psychotherapy effectiveness research. In addition, our sugges-
tions are not meant to be the final word on how to best tackle the ethical dilemmas
in effectiveness research. They are offered as a starting point to encourage re-
searchers to think about the ethical ramifications of choosing different compari-
son conditions in their research.
ETHICS IN PSYCHOTHERAPY EFFECTIVENESS RESEARCH 65
WHY EFFECTIVENESS RESEARCH IS NECESSARY
A majority of psychotherapy studies have followed the traditional, randomized

clinical trial design focusing on internal validity; that is, controlling all potentially
confounding variables that could interfere with the true effect that treatment has
on a designated disorder. These studies have been useful in identifying psycho-
therapies that are efficacious in treating major mental disorders. The precision that
results from internal validity often compromises external validity, or how repre-
sentative study patients, therapists, and settings are of their counterparts in the
community. Although efficacy studies are useful in explaining why treatments

work by identifying mechanisms of action and isolating effective components of
therapy, the need for internal validity has limited the impact that psychotherapy
research has had on provider practice and policy decisions. Psychotherapists often
complain that research participants do not represent the universe of patients seek-
ing mental health treatment and that manuals used in research are too simplistic to
address the constellation of problems and mental health comorbidities people
have (Persons & Silberschatz, 1998). Policymakers tend not to see psychotherapy
as a first-line treatment because there are insufficient data to suggest that psy-
chotherapy is transportable and as effective as any other intervention. As demon-
strated in new research initiatives to treat depression (i.e., the National Institute of
Mental Healths Sequenced Treatment Alternatives to Relieve Depression and
Prevention of Suicide in Primary Care Elderly programs), psychotherapy is gen-
erally thought of as a second-line treatment, only to be considered once pharma-
cological treatments have failed.
Because providers and policymakers are aware of the limitations of random-
ized controlled trials with regard to generalization, psychotherapy effectiveness
studies have become important avenues of psychotherapy research.
WHAT IS AN EFFECTIVENESS STUDY?
Effectiveness studies are the equivalent of Phase 3 studies in medication research

(Hohmann & Parron, 1996). Once a psychotherapy is found to be safe and effica-
cious, its utility in the broader community of consumers is then evaluated. One
main difference between Phase 3 medication trials and effectiveness research is
that effectiveness studies are as influenced by public policy concerns as they are
by scientific rigor (Hohmann & Parron, 1996). The main questions these studies
are meant to answer are these: Can the typical patient respond to treatment? Is the
treatment acceptable to the typical patient? Can the treatment be administered
safely and in its entirety in the typical treatment setting? Is the treatment under
study significantly better than the community standard of care from both a cost
and outcome perspective? As highlighted in the controversies surrounding the

Consumer Reports Survey (Jacobsen & Christensen, 1996; Seligman, 1995), con-
trol comparisons are as important in effectiveness research as they are in
controlled trials. However, because the intent of this research is to inform policy
and practice regarding the provision of mental health services, the comparison
groups used in effectiveness studies tend not to be placebos, waiting lists,
dismantled versions of the intervention, or other psychotherapies that are not in
use in the community. With a few exceptions, the main comparison condition in
psychotherapy effectiveness research is whatever treatment is already being
delivered, or TAU.
WHY TAU IS THE BEST COMPARISON IN

EFFECTIVENESS RESEARCH
Policymakers often disregard the traditional research studies, not only due to
external validity issues but also because comparison conditions like placebo
controls or dismantled treatments often have little meaning for individuals not
immersed in the research world. For example, from the perspective of the medical
director of a health maintenance organization (HMO), placebos do not exist in
their formulary and therapists do not intentionally omit critical components of
psychotherapy when treating a patient. Even though waiting lists do exist in the
community, policymakers and providers rarely consider these to be active forms
of treatment. To the medical directors mind, patients are given pharmacologic or
psychosocial treatments in their entirety, and any change in how care is delivered
will only occur if research can show that a new intervention is any better (or more
cost-effective) than the care that patients currently receive. Demonstrating that an
intervention is better than no treatment does not answer the policymakers or
providers ultimate question: Is this intervention any better or cheaper than what
my organization already provides?
TAU varies from system to system. In the generic sense, TAU is whatever care
patients already have access to. For instance, in effectiveness studies on the
improvement of depression treatment in primary care medicine, TAU is typically
primary care provider treatment of depression with medication (Schulberg et al.,
1997). In psychotherapy studies, TAU may be whatever intervention providers in
a community already offer. If a researcher wants to document the effectiveness of
interpersonal therapy in treating depression, the appropriate TAU comparison may
be medication management, supportive therapy, or any treatment that the patient
would normally receive if the research study were not in place.
It is important to note that the research should do little to control TAU. Al-
though researchers can define what constitutes TAU in the research study, they
should not manipulate its components. TAU must be ecologically valid. Because
of shifting mental health policies and changes in patient benefits, TAU may
change a number of times during the course of a study. Therefore, continued doc-
umentation of treatment as it occurs naturally is very important. Because of the
shifting nature of mental health policy, in some populations (Alvidrez & Aren,
this issue) TAU may mean substandard or no treatment, or access to care may be
very difficult (Degenholtz, Parker, & Reynolds, this issue). Under these circum-
stances, researchers must be very careful to define what TAU is for their particu-
lar study to ensure that their participants are being treated ethically. If existing
treatment falls below a standard set by either the national or local community,
then other comparisons are necessary.
WHEN TAU IS AN EFFECTIVE TREATMENT
Because the purpose of effectiveness research is to demonstrate the utility of an in-

tervention compared to existing treatment, the default comparison condition for ef-
fectiveness researchers tends to be TAU. Under many circumstances, effectiveness
researchers feel that to do research that does not include TAU is technically uneth-
ical because the results of research that does not include TAU are unlikely to impact
policy, and therefore the research is a waste of participant time. TAU has the best
ecological validity of all control conditions and therefore provides a more mean-
ingful test of the intervention under study (Clarke, 1995). However, before decid-
ing whether or not TAU is an ethical treatment alternative in a psychotherapy ef-
fectiveness study, scientists still need to answer the following questions: Is there
any treatment that the mental health community from which I will sample consid-
ers to be the minimum level of effective treatment? How does the mental health
community from which I will sample manage the target problem? Can the
population being sampled readily access TAU? All of these questions should be an-
swered before deciding to use comparison conditions other than TAU. What
follows is a discussion of each question for psychotherapy effectiveness research.
Is There a Minimum Level of Effective Treatment?
This first question is concerned with whether or not best-practice guidelines exist
for a target condition at the national level. The most common and least time-
consuming way to answer this question is to look to existing guidelines produced
by national organizations, such as the National Institutes of Health, the American
Psychological Association, the American Psychiatric Association, and the
National Association of Social Workers (NASW). The information obtained from
these sources helps to determine whether or not any existing intervention is felt to
be effective in treating the disorder.
In the case of major depression, several guidelines exist. Although they differ as
to the relative importance of psychotherapy or medication, they all indicate that ei-
ther treatment is preferred over no treatment, and hence TAU that offers neither
psychotherapy nor medication would be considered unethical. For an effectiveness
trial to be ethical, research participants should have access to one of these inter-
ventions. In the case of adjustment disorder, however, no standard guidelines exist,
and thus a TAU that did not offer any particular type of treatment would not neces-
sarily violate an individuals right to treatment. Participants would receive care as
they would normally under the best circumstances, and there is no guarantee that
any intervention will be significantly more successful than no treatment. For a

study of this nature, there is no ethical obligation to include TAUthe obligation
is to provide careful monitoring of research participants so that quality care can be
offered if the condition worsens.
Often novice effectiveness researchers are confused by the variety of opin-
ions as to which practices are best and which opinion they should listen to in
making a decision as to what constitutes ethical care. The important point here
is that the decision the researcher has to make is one of ethics, not philosophi-
cal opinion. This is particularly relevant in disorders like major depression,
where there is disagreement as to whether or not psychotherapy can be consid-
ered a first-line treatment or which psychotherapy is truly the best to treat de-
pression. Even though national leaders disagree about which treatment should
be offered first, these leaders generally agree that offering either treatment first
is better than no treatment, or untested treatments, like homeopathic remedies.
Therefore, although leaders in the field may feel that treatment would be best
delivered in a particular order, very few would argue that breaking the order of
treatment is unethical.
The case is less clear for psychotherapy as usual. Organizations primarily
concerned with the quality of psychotherapy (e.g., the American Psychological
Association and NASW) have yet to develop guidelines regarding best practices
for psychotherapy of any disorder. To complicate matters, empirically validated
psychotherapeutic interventions for major depression are cognitivebehavioral
and interpersonal therapies, yet 70% of psychologists report being trained in and
utilizing psychodynamic therapy, an intervention with little empirical support
(Norcross, Prochaska, & Farber, 1993). The researcher is then faced with making
a decision between what is proven to be efficacious by science and what is
considered to be efficacious by the clinical community. For effectiveness studies,
the decision should be that either intervention, be it empirically valid or consid-
ered standard by the treatment community on a national level, can be considered
ethical TAU. It is not up to the effectiveness researcher to hold TAU therapists to a
particular type of therapy. It is up to the effectiveness researcher to make sure that
in the TAU arm, one or more of these interventions is available to the research
participants randomized to this condition.
How Does the Target Community Manage the Target Problem?
The second question is concerned with whether or not the mental health com-
munity the scientist is sampling from offers the minimal level of effective treat-
ment for the target condition. In other words, is there a match between national
standards of minimumor ethicalcare and what is provided in the target
community? For instance, if a researcher were to conduct a psychotherapy
effectiveness study in a group-model HMO, the researcher would need to ob-
tain the HMOs policy on the treatment of the target condition. In situations
where no single policy exists (e.g., community providers who are paid by a va-
riety of sources), the researcher will have to document the typical care given by
providers in the community. As an example, the researcher may have to inter-
view or survey providers in the target community about the extent and type of
care they provide for patients with the target condition. In the case of schizo-
phrenia, the minimum national standard is medication combined with case
management. If a psychotherapy researcher wishes to study the effectiveness
of cognitivebehavioral intervention in controlling negative symptoms of
schizophrenia, the TAU condition must contain medication and case manage-
ment. The scientist cannot assume that patients in the study are receiving this
care. It is imperative that the scientist defines TAU for the population being
sampled and to make sure that the community treatment meets the minimum
requirements of care.
There is not always a match between national opinion as to minimally standard
psychotherapy and what is provided in different settings. For instance, many
psychotherapists feel that 10 sessions of treatment (the usual number of outpatient
psychotherapy sessions approved by HMOs) is insufficient to treat some disor-
ders. However, there is considerable disagreement as to what is an adequate
number of sessions, as the answer to that question often varies depending on the
type of treatment offered and the condition being treated. In this case, the
researcher must take into consideration the purpose of the study and what could
be done to ensure that participants are not harmed by participating in the study.
If a researcher wishes to demonstrate that a manualized, 20-session cognitive
behavioral therapy is superior to TAU in an HMO (usually 10 initially approved
sessions with an option to request more), then the 10-session limit, with proper
participant monitoring, is ethical.
What should researchers do in the unusual event that TAU is above the national
or community standard? Should the researchers use this setting for their studies?
As mentioned before, the purpose of effectiveness research is to measure the gen-
eralizability of an intervention to the larger community and to affect change in
policy. If a clinic or institution offers unusually good caremore than is expected
in the communitythen this is not likely to provide a meaningful comparison
unless the researchers purpose is to improve services primarily within this setting.
The researcher, before embarking on a study, should have in mind the community
to which the results should generalize. Defining the population or setting the
researcher wishes to impact on will help the decision as to whether or not the TAU
in a particular setting will provide a meaningful comparison.
Can the Population Being Sampled Readily Access TAU?
The third question is a modification of the second: If TAU is an active interven-

tion, can people with the target condition access this care? In some populations,
such as elderly and minority individuals, minimally effective care for mood
disorders exists in the community, but these populations rarely have access to
treatment (Alvidrez & Aren, this issue; Degenholtz et al., this issue). How TAU
is managed very much depends on the research question. If the purpose of the
study is to improve African Americans use of mental health services and utiliza-
tion is the main outcome, then TAU is the only viable alternative. No policymaker
will invest funds in a program to increase service use if the new intervention is not
compared to the utilization rates that would exist under the usual circumstances.
However, if the intent of the study is to demonstrate the effectiveness of
cognitivebehavioral treatment of panic disorder in African Americans, then TAU
should include some methods for assuring that the participants have access to ex-
isting care. In this last case, the comparison condition is not technically TAU but
an augmented version of it.
ALTERNATIVES TO TAU
TAU is an ethically acceptable comparison condition in psychotherapy research if

the scientist can demonstrate that existing treatment meets the minimum standard
of care for the target condition and the target population has access to that care.
When TAU does not meet these standards, other options should be considered. In
choosing an alternative, researchers need to evaluate which comparison will be
most meaningful to providers and policymakers. Scientists may have to discuss al-
ternative comparisons with representative policymakers and providers before ulti-
mately deciding on the comparison condition.
The most common alternatives to TAU are TAU augmented with some serv-
ice, historical controls, and minimal interventions. An augmented version of
TAU is often the best choice when appropriate care exists in the community but
the target population does not have easy access to it. As illustrated by Degen-
holtz et al. (this issue), some high-risk populations, like suicidal elderly people,
would normally have access to usual care, but either because of provider biases
about the effectiveness of treatment or patient-level barriers to care, these
patients do not usually access usual care. Under those circumstances, the more
ethical alternative is to augment the mental health services in such a way that
the chances of getting TAU are greater than usual. The augmentation has to be
rather minimal so that the augmented version of TAU is not too different from
actual TAU. Examples of augmentations could be some minimal patient educa-
tion to enhance treatment acceptance or provider education to increase the like-
lihood that the treatment will be offered (Brown, Schulberg, Madonia, Shear, &
Houk, 1996).
A variation of augmented TAU is minimal intervention. In the event that TAU
in the community is less than what is considered to be standard care, the scientist
may have to create a comparison arm that consists of a minimal level of accept-
able treatment. For instance, in some rural areas, certain counties may not have
any mental health services. For a psychotherapy study, this may mean having to
hire people to provide the minimally acceptable service. The risk here is that the
new intervention is being compared to another intervention that does not exist in
the community. Policymakers for that community may not find the outcomes
supporting the new therapy very compelling if the comparison condition is not an
intervention that they feel has merit. Scientists should have input from the com-
munity and policymakers to make sure that the comparison intervention is a
meaningful one.
Another alternative to TAU is to use a historical control. Historical controls
are particularly useful for studies in which the outcome is already being moni-
tored. This method involves comparing the outcomes of TAU prior to initiating
the new intervention with the outcomes after the new intervention is initiated. A
scientist interested in the impact that psychotherapy has on independent func-
tioning could compare hospitalization rates, medication adherence, employment,
and emergency room use to those after the program is initiated. However, to say
that the psychotherapy intervention was responsible for any change in function-
ing, the scientist would have to make sure that there were not fluctuations in the
financing of severe mental illness or the introduction of new medications during
the assessment period. Historical controls are also limited in that other outcomes,
such as self-report measures, cannot be collected in the comparison group unless
those measures were administered as part of the ongoing service prior to the
study period. No psychotherapy effectiveness studies have used this comparison
method to date.
SUMMARY AND CONCLUSIONS
In summary, the intent of our discussion was to explore the ethical ramifications
of using TAU as a comparison condition in psychotherapy studies. To that end,
our discussion may be less relevant to scientists who wish to study practice
reorganization or system-level interventions. These studies have their own

unique features that influence which comparison conditions are used. Our dis-
cussion is meant to help the psychotherapy researcher understand why TAU is
an important comparison and to offer alternatives when TAU is not an ethical
choice. In addition, we note that the alternatives presented here are not exhaus-
tive. Each study has its own unique features and questions, and therefore it is the
researchers knowledge of the populations and settings with which they work, as
well as the goals of the research, that should ultimately drive the selection of the
comparison condition.
Effectiveness research is an important avenue of study that informs how

providers treat their patients and how policymakers organize mental health care.
Psychotherapy research is just beginning to embark on the realm of effectiveness
research. In evaluating the effectiveness of psychotherapy, the most ecologically
valid comparison intervention is TAU. This comparison offers policymakers and
providers information that can help them decide if treatment as currently deliv-
ered should be changed to improve the quality of mental health services offered in
the community. The decision to use TAU as the comparison should not stop with
the intent to inform policy, however. Existing care should be critically evaluated to
make sure that the target populations actually have access to minimally acceptable
care. In the event that potential study participants would be randomized to sub-
standard care, scientists must consider other comparison interventions, such as fa-
cilitating access to existing care or creating an intervention that mimics the men-
tal health community standard. To be sure that the study remains meaningful to
policymakers and providers, the scientists should confer with the target audience
to determine if any comparison other than TAU would be a meaningful one. Only
then can alternatives to TAU be useful in uncovering the impact that psychother-
apy has in the real world.
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Brown, C., Schulberg, H. C., Madonia, M. J., Shear, M. K., & Houk, P. R. (1996). Treatment outcomes
for primary care patients with major depression and lifetime anxiety disorders. American Journal
of Psychiatry, 153, 12931300.
Clarke, G. (1995). Improving the transition from basic efficacy research to effectiveness studies:
Methodological issues and procedures. Journal of Consulting and Clinical Psychology, 63,
718725.
Hohmann, A. A., & Parron, D. L. (1996). How the new NIH guidelines on inclusion of women and
minorities apply: Efficacy trials, effectiveness trials and validity. Journal of Consulting and Clini-
cal Psychology, 64, 851855.
Hollon, S. (1996). The efficacy and effectiveness of psychotherapy relative to medications. American
Psychologist, 51, 10251030.
Jacobson, N. S., & Christensen, A. (1996). Studying the effectiveness of psychotherapy: How well can
clinical trials do the job? American Psychologist, 51, 10311039.
Norcross, J. C., Prochaska, J. O., & Farber, J. A. (1993). Psychologists conducting psychotherapy: New
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Ethics & Behavior

ISSN: 1050-8422 (Print) 1532-7019 (Online) Journal homepage: http://www.tandfonline.com/loi/hebh20

Ethical Considerations in Psychotherapy

Patricia A. Aren & Jennifer Alvidrez

To link to this article: http://dx.doi.org/10.1207/S15327019EB1201_4

Published online: 08 Jan 2010.

Submit your article to this journal

View related articles

Citing articles: 5 View citing articles

Full Terms & Conditions of access and use can be found at

Patricia A. Aren and Jennifer Alvidrez

The primary purpose behind effectiveness research is to determine whether a

Key words: treatment as usual, control groups, ethics, psychotherapy effectiveness

Does state-of-the-art psychotherapy work as well in the real world as it does in

WHY EFFECTIVENESS RESEARCH IS NECESSARY

A majority of psychotherapy studies have followed the traditional, randomized

community. Although efficacy studies are useful in explaining why treatments

WHAT IS AN EFFECTIVENESS STUDY?

Effectiveness studies are the equivalent of Phase 3 studies in medication research

and outcome perspective? As highlighted in the controversies surrounding the

WHY TAU IS THE BEST COMPARISON IN

then other comparisons are necessary.

WHEN TAU IS AN EFFECTIVE TREATMENT

Because the purpose of effectiveness research is to demonstrate the utility of an in-

Is There a Minimum Level of Effective Treatment?

any intervention will be significantly more successful than no treatment. For a

How Does the Target Community Manage the Target Problem?

Can the Population Being Sampled Readily Access TAU?

The third question is a modification of the second: If TAU is an active interven-

TAU is an ethically acceptable comparison condition in psychotherapy research if

SUMMARY AND CONCLUSIONS

reorganization or system-level interventions. These studies have their own

Effectiveness research is an important avenue of study that informs how

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