Content uploaded by Paul Crits-Christoph
Author content
All content in this area was uploaded by Paul Crits-Christoph on Mar 28, 2018
Content may be subject to copyright.
Regular article
MET meets the real world: design issues and clinical strategies in the
Clinical Trials Network
Kathleen M. Carroll, Ph.D.
a,
*, Chris Farentinos, M.D.
b
, Samuel A. Ball, Ph.D.
a
,
Paul Crits-Christoph, Ph.D.
c
, Bryce Libby, L.C.S.W.
d
, Jon Morgenstern, Ph.D.
e
,
Jeanne L. Obert, M.S.
f
, Doug Polcin, Ed.D.
g
, George E. Woody, M.D.
c
for the Clinical Trials Network
a
Department of Psychiatry, Yale University School of Medicine, West Haven, CT 06516, USA
b
Changepoint, Inc., Portland, OR 97292, USA
c
University of Pennsylvania, Department of Psychiatry, Philadelphia, PA 19106, USA
d
Advanced Behavioral Health, Inc., Middletown, CT 06457, USA
e
Department of Psychiatry, Mount Sinai Medical Center, New York, NY 10029, USA
f
Matrix Institute, Los Angeles, CA 90025, USA
g
Haight-Ashbury Free Clinics, Inc., San Francisco, CA 94117, USA
Received 20 March 2002; received in revised form 15 May 2002; accepted 16 May 2002
Abstract
The Clinical Trials Network (CTN) represents a major initiative intended to bridge the gap between research and practice in substance
abuse treatment by implementing a range of studies evaluating behavioral, pharmacologic, and combined treatments in community-based
drug abuse treatment programs across the country. This article describes the development of CTN protocols evaluating the effectiveness of
Motivational Enhancement Therapy and Motivational Interviewing. Design, training, and implementation challenges associated with
conducting a clinical trial of brief behavioral treatments in community programs are discussed. Issues requiring attention included the
diversity in treatments offered across sites, heterogeneity in the study sample, and training of clinicians drawn from the staff of community
programs to deliver the study treatments. D2002 Elsevier Science Inc. All rights reserved.
Keywords: Substance abuse treatment; Randomized clinical trials; Behavioral therapies; Motivational interviewing
1. Introduction
A major challenge in the substance abuse treatment field
is the integration of practice and research. As described in
detail in a landmark report by the Institute of Medicine
(Institute of Medicine, 1998), there are a number of treat-
ments, both behavioral and pharmacologic, that have strong
empirical support from clinical trials that have not been
implemented in clinical practice (McLellan & McKay,
1998). To address in part the need to develop new treat-
ments, rigorously evaluate their efficacy, and then dissem-
inate scientifically validated treatments to the clinical
community, NIDA has articulated a Stage Model of Behav-
ioral Therapies Research (Onken, Blaine, & Battjes, 1997),
encompassing three progressive stages: Stage I consists of
initial development of and pilot/feasibility testing for new
and untested treatments; Stage II consists principally of
randomized controlled clinical trials to evaluate efficacy of
treatments that have shown promise or efficacy in initial
studies; and Stage III is intended to address issues of
transportability of treatments whose efficacy has been
demonstrated in at least two Stage II trials (Rounsaville,
Carroll, & Onken, 2001).
The Clinical Trials Network (CTN) was initiated by
NIDA in 1999 to bridge the gap between research and
practice by building a research infrastructure of partnerships
of researchers and community treatment programs (CTPs) to
conduct a wide range of Stage III research evaluating
behavioral, pharmacologic, and combined treatments in
0740-5472/02/$ – see front matter D2002 Elsevier Science Inc. All rights reserved.
PII: S 0740-5472(02)00255-6
* Corresponding author. Division of Substance Abuse, Yale University
School of Medicine, VA CT Healthcare Center (151D), West Haven, CT
06516, USA. Tel.: +1-203-937-3486; Fax: +1-203-937-3472.
E-mail address: kathleen.carroll@yale.edu (K.M. Carroll).
Journal of Substance Abuse Treatment 23 (2002) 73 – 80
community settings. Chief among the challenges faced by
the CTN in developing protocols is achieving appropriate
balance between internal validity (e.g., designs that empha-
size experimental control and ability to rule out alternate
explanations of findings) and external validity (e.g., designs
emphasizing generalizability of findings and the degree to
which research-supported treatments can be implemented in
community programs). That is, research focusing on internal
validity issues places a high value on experimental control
and, thus, requires design features such as random assign-
ment to experimental and control conditions, reduced vari-
ability in treatment delivery (e.g., through the use of
manuals), close monitoring of treatment delivery, and inde-
pendent evaluation of outcome (e.g., use of objective
measures such as urinalyses). In contrast, studies focusing
on external validity issues usually tolerate less control to
enhance the generalizability of findings.
This article will describe the development of one CTN
protocol evaluating a behavioral treatment, motivational
interviewing, and will focus on two principal issues: (1)
the challenges confronted in developing and implementing
the protocol and how these challenges shaped the protocol
design, and (2) the clinical issues involved in training and
supervision of the ‘‘real world’’ therapists who delivered the
study treatments.
2. Rationale for evaluating MET/MI in the CTN
Early dropout, partial treatment attendance, and early
relapse are common occurrences in most substance abuse
treatment programs. Given that the bulk of attrition occurs
very early in treatment, and retention in treatment has been
linked to better outcome in several studies (Ball & Ross,
1991; McLellan et al., 1994; Simpson, Joe, & Brown,
1997), identifying effective, practical means of enhancing
initial treatment engagement and outcome was seen as an
important target for the CTN.
Motivational Interviewing (MI) (Miller & Rollnick, 1991)
and Motivational Enhancement Therapy (MET) (Miller,
Zweben, DiClemente, & Rychtarik, 1992) have a high level
of empirical support as effective treatments with durable
effects for several substance use disorders (Babor, 1994;
Bien, Miller, & Tonigan, 1993; Project MATCH Research
Group, 1997; Wilk, Jensen, & Havighurst, 1997). Although
most trials evaluating these approaches have focused on
alcohol- and cigarette-dependent populations, a smaller num-
ber of recent studies suggest they may be effective among
drug abusing populations as well (MTP Research Group,
2001; Carroll, Libby, Sheehan, & Hyland, 2001; Martino,
Carroll, O’Malley, & Rounsaville, 2000; Saunders, Wilkin-
son, & Philips, 1995; Swanson, Pantalon, & Cohen, 1999).
Despite the strong empirical support for MI and MET, a
number of questions regarding their effectiveness in ‘‘real
world’’ settings remain. First, although MET and MI have
strong empirical support in efficacy trials involving alcohol
and smoking populations, their effectiveness in community-
based settings and with general populations of drug users
has received less attention. Second, it is not clear whether
MET and MI can be learned and implemented effectively by
clinicians working in CTPs, many of whom utilize a
primarily traditional, prescriptive (and sometimes confron-
tive) disease model approach that may not be compatible
with the empathic, nonjudgmental approach associated with
MI. Finally, MET and MI have been directly compared with
a number of other well-defined treatments in earlier trials
establishing their efficacy, but their effectiveness when
integrated into standard treatment in CTPs is not known.
Given the limited study of MI and MET in community
programs, a protocol evaluating these approaches was
appropriate for the CTN for a number of reasons: (1) MI
techniques were likely to be applicable to a broad range of
clinical populations as well as feasible across a broad range
of CTPs; (2) provision of training in MI was thought to be
attractive to many clinicians at the CTPs; (3) CTPs could
benefit from a training and supervision model designed to
be sustainable over time; (4) focus on brief treatments and
initial treatment engagement would facilitate comparatively
rapid completion of the protocols, offering the advantage of
rapid dissemination of findings to the academic and clinical
communities; and (5) lack of motivation to change was
frequently identified as a key factor associated with poor
treatment response and, thus, an approach targeting motiva-
tion was identified as highly relevant to the work of
community treatment providers. Moreover, as one of the
first CTN protocols, a trial evaluating MET or MI was
particularly attractive as it would allow evaluation of cli-
nician training strategies and could also generate important
data on the nature of ‘‘standard treatment’’ as delivered in
the participating programs, thus setting the stage for future
CTN protocols that will use ‘‘standard treatment’’ as a
comparison condition.
A design team composed of both researchers and
community providers from the participating CTN sites
developed the protocol collaboratively through regular
conference calls. This both enhanced the acceptance of
the protocol and insured that it would be feasible in
many diverse sites. The design team identified a number
of issues involved in evaluating MI and MET in the
CTN that highlight dynamic tensions inherent in devel-
oping Stage III protocols, that is, preserving scientific
integrity of the trial while fostering greater generalizabil-
ity of findings.
Rather than seeing internal and external validity as
mutually exclusive, the design team adopted a hybrid
model that sought to maximize the scientific yield of the
study by retaining key design features associated with
efficacy research such as random assignment of patients
to treatments, independence of treatment delivery and
data collection, use of objective outcomes (e.g., urine
toxicology screens), definition, and monitoring of treat-
ments delivered (through manuals for behavioral treat-
K.M. Carroll et al. / Journal of Substance Abuse Treatment 23 (2002) 73–8074
ments, specialized training of providers in delivering
study treatments, and evaluation of the integrity of study
treatments) (Carroll & Rounsaville, in press). However, as
shown in Table 1, in order to also address issues of
interest to clinicians, policy makers, and payors, addi-
tional components associated with effectiveness research
were added. These included a multisite format to enhance
diversity in patients and settings where treatments are
delivered, delivery of study treatments by ‘‘real world’’
clinicians, evaluation of patient and provider satisfaction,
and comparison of novel treatments to standard
approaches (Carroll & Rounsaville, in press). In the
following sections, we will summarize how these issues
influenced our decisions regarding protocol design and
therapist training and supervision.
3. Development of the MET/MI protocol: design
challenges and strategies
Design challenges included whether MET or MI
should be evaluated as a stand-alone or initial compo-
nents of treatment, how they could be integrated into a
treatment system organized around the provision of
group therapy, variations across sites in the nature of
standard treatment to which MET and MI would be
compared, and issues associated with broadening inclu-
sion and exclusion criteria and managing a diverse
subject sample.
3.1. Stand alone vs. initial component of treatment
Among alcohol-using populations, MET and MI have
been evaluated primarily as brief interventions consisting
of between one and four sessions in their entirety. How-
ever, given the comparatively high severity, morbidity, and
co-occurring problems seen among treatment-seeking
drug-dependent individuals, it was unclear whether only
a few sessions of treatment would be sufficient. Thus, a
design was developed in which MET or MI was integrated
as early as possible into the orientation/entry/evaluation
phase of treatment as a strategy to enhance initial reten-
tion and outcome. This had the advantage of greater
compatibility with clinical practice and also allowed
comparison with a standard treatment control group (i.e.,
treatment as usual).
3.2. Individual vs. group delivery of treatment
While group treatment is pervasive in the substance
abuse treatment system, MET and MI were developed and
have been evaluated as solely individual treatments. With
emphasis on providing personalized, objective feedback on
the consequences of substance use and the development of
highly individualized change plans, many aspects of MET
would be difficult to implement in a group setting. More-
over, no data on the effectiveness of MET or MI in a group
format or treatment manuals were available.
Thus, while it was fairly straightforward to develop a
protocol evaluating MET or MI in those community treat-
ment settings where individual treatment was customary, a
new strategy was needed for those settings where solely
group treatments were offered, given that another goal of the
protocol team was to place minimal constraints and avoid
changing standard treatments at the sites to accommodate
the protocol. This led to the development of two independ-
ent protocols to accommodate these features of the treatment
delivery system and participating sites. Therefore, for com-
munity programs that offered individual treatment, a pro-
tocol was developed that randomized patients to either three
individual sessions of MET or three individual sessions of
standard treatment, provided during the first month of
treatment. The study design is summarized in Fig. 1.
For those settings that offered group treatments only, a
second protocol was developed and is summarized in
Fig. 2. Capitalizing on the programs’ convention of
offering a single individual evaluation/assessment session
prior to the patient’s being assigned to group treatment,
this protocol will compare retention and outcome for
individuals assigned to a standard evaluation/assessment
session vs. one where techniques of MI are integrated.
This resulted in two independent protocols addressing
different, but related questions.
3.3. Setting diversity issues
Unlike efficacy studies where control or comparison
conditions are selected to address very focused research
questions (e.g., does Treatment X improve outcome com-
pared with a minimal discussion control?), the MET/MI
protocols and other CTN studies will be evaluating whether
outcomes are improved when experimental treatments are
added to or compared to standard treatments in community
Table 1
Design elements supporting internal and external validity used in MET and MI protocols
Elements supporting internal validity Elements supporting external validity
Random assignment to treatments Comparison condition = treatment as usual
Manual guided treatments Few restrictions on patient participation
Objective outcome measures, including urinalyses Clinicians are volunteers from community programs
Training and ongoing supervision of therapists Study conducted at 11 community treatment programs
Monitoring of treatment delivery,
fidelity via independent evaluation of session tapes
Brief assessment battery (approximately 45 minutes for MI,
90 minutes for MET)
K.M. Carroll et al. / Journal of Substance Abuse Treatment 23 (2002) 73–80 75
programs. Thus, the MET/MI protocols employed an
‘‘active treatment’’ comparison condition, which is usually
associated with a smaller effect size than studies using no-
treatment or less active discussion control conditions
(Basham, 1986), and hence these protocols will provide a
challenging test of MET and MI. Moreover, what constitutes
‘‘standard treatment’’ at the participating sites is not yet
well-understood and is likely to vary widely across the
participating programs. The programs themselves may
espouse a particular orientation (disease model, CBT), but
background and training differences across clinicians may
also vary widely within a given program.
This had several implications for the design of the MET
and MI protocols. First, given that the protocols are being
conducted in 11 different CTPs across the country (six will
implement the 3-session MET protocol, and five will
implement the 1-session MI protocol), 11 different types
of ‘‘standard treatment’’ may be offered as comparison
conditions (although treatment modality and number of
sessions would be constrained). One strategy used to
anticipate this was to provide adequate statistical power
through a comparatively large sample size. Thus, if mean-
ingful site-by-treatment interactions occur, within-site ana-
lyses will be possible that might help pinpoint why MET or
MI was more effective than standard treatment in some sites
and not in others. Second, all study sessions (MET/MI and
standard treatment) will be audio taped; process ratings will
be done to determine whether there was any overlap of
MET/MI techniques in standard treatment. Tape ratings will
also characterize in detail the specific techniques used in
standard treatment (disease model, cognitive behavioral,
psychodynamic, other) at each of the participating sites.
3.4. Patient diversity issues: broadening
inclusion/exclusion criteria
An important goal of the CTN is to evaluate the effective-
ness of empirically validated treatments among more diverse
samples of substance users than may be typical of efficacy
trials (which have been criticized as being unrepresentative
of patients seen in standard treatment) (Carroll, Nich,
McLellan, McKay, & Rounsaville, 1999). Thus, the protocol
sought to attract a highly heterogeneous sample by minimiz-
ing possible barriers to treatment entry and broadening study
inclusion/exclusion criteria as much as possible. Therefore,
inclusion criteria require only that prospective study partic-
Fig. 1. MET protocol design.
K.M. Carroll et al. / Journal of Substance Abuse Treatment 23 (2002) 73–8076
ipants be 18 years or older and current substance users
seeking outpatient treatment. Excluded individuals are those
who are seeking detoxification and methadone maintenance
only or who are currently so psychiatrically or medically
unstable that outpatient treatment is not feasible. Thus, these
protocols are open to a wide variety of substance users (e.g.
marijuana, cocaine, opioids, alcohol, and polysubstance
users) with a wide variety of co-occurring psychiatric, legal,
medical, employment, and social problems.
While the potential generalizability of such a study is
exciting, higher levels of heterogeneity in the sample raised a
variety of practical problems in developing a clinical
research protocol that could meet the needs of ‘‘all comers.’’
For example, available treatment manuals for MET and MI
were generally written targeting specific types of substance
users (alcohol users, smokers, etc.). Thus, it was necessary to
adapt existing MET and MI manuals (e.g., Ball, 1996; Miller
et al., 1992; Miller & Rollnick, 1991; Obert, Rawson &
Miotto, 1997) to be appropriate for a more diverse sample.
Other adaptations involved adding a wider variety of exer-
cises and strategies to address different levels of readiness to
change, broadening the manual to anticipate working with
participants with a variety of different mandates to treatment,
and using flexible language to allow clinicians to adapt the
interventions to a wide variety of individuals.
In addition, assessment instruments had to be selected or
modified to anticipate a wide variety of types of substance
use and related problems in the study sample while remain-
ing quite brief (45 minutes total for the MI protocol, 90
minutes for the MET protocol). For example, the Short
Inventory of Problems (SIP-R) was modified from the
Drinker Inventory of Consequences (DrINC) (Miller, Toni-
gan, & Longabaugh, 1995) for use with drug users. The
SIP-R was used in the assessment battery to allow for
feedback on consequences of substance use to the partici-
pant and the development of discrepancies.
4. Training and supervisory challenges and strategies
Although methods and standards for training therapists to
deliver manual-guided treatments in efficacy trials have been
established for many years, the MET and MI protocol design
team faced the additional challenge of developing a clinician
training plan that would be feasible and effective for ‘‘real
world’’ clinicians. This involved anticipating a high level of
therapist diversity and adapting training and supervision
procedures to meet the needs of this therapist group.
4.1. Therapist diversity issues
In many efficacy trials of behavioral treatments, thera-
pists delivering the treatments are highly selected and
experienced experts who have substantial commitment to
the approach. Use of highly experienced and committed
therapists is thought to simplify training, reduce variability
in treatment delivery, and foster a high level of treatment
fidelity (Carroll, Kadden, Donovan, Zweben, & Rounsa-
ville, 1994; Crits-Christoph et al., 1998; Rounsaville, Chev-
ron, Weissman, Prusoff, & Frank, 1986; Rounsaville,
O’Malley, Foley, & Weissman, 1988).
However, a major question facing this protocol was
whether MET/MI was effective when delivered by ‘‘real
world’’ clinicians drawn from the staff of the participating
CTPs. Thus, it would be necessary to recruit clinicians from
the community programs who were willing to participate in
the research project, undergo training in MET/MI, and
agree to be supervised and have their clinical work taped
for the duration of the study for process assessment of
treatment fidelity.
An important threat to study validity might arise if the
experimental treatment (MET/MI) was delivered by ‘‘eager
volunteers’’ willing to participate in clinical research, while
the standard treatment was delivered by clinicians who did
not volunteer nor were interested in learning new ap-
proaches (as the two clinician groups might also differ with
respect to other variables, such as general therapeutic skill,
experience, ability to engage with clients, and so on). The
solution adopted in this trial was to recruit a large number of
volunteer clinicians from the staff of each participating site
(at least six per site) and then randomize the clinicians
themselves to deliver either MET/MI or standard treatment
in the protocol. Clinicians assigned to the MET/MI con-
Fig. 2. MI protocol design.
K.M. Carroll et al. / Journal of Substance Abuse Treatment 23 (2002) 73–80 77
dition would go through didactic training and supervised
practice prior to being certified to deliver MET or MI in the
protocol. Clinicians assigned to deliver standard treatment
will be offered the opportunity to be trained in MET/MI
after the protocol was completed.
Thus, unlike many efficacy trials of behavioral treat-
ments, minimal training and educational requirements were
made of the clinician/volunteers. The protocol required only
that they be willing to learn MET/MI, participate in training
and supervision sessions, and agree to have their sessions
taped and monitored. This was intended to lead to a highly
diverse group of clinicians, with wide variations in experi-
ence, education, and training backgrounds, knowledge of
MET/MI or manual-guided treatments, and commitment to
a wide variety of clinical approaches, but would also lead to
particular challenges in training and supervising such a
group of therapists.
Other important considerations in developing the ther-
apist training/monitoring plans for this trial were its cred-
ibility and durability. That is, if MET/MI training and
monitoring was highly centralized (e.g., provided through
a single training center, as is common in many multisite
efficacy studies to achieve a high degree of standardization
across sites), it might be more difficult to recognize and
respond to the unique issues involved in delivering MET/MI
in each of the sites. Trainers in geographically distant
locations might also be less well-equipped to work with
the diversity of clinicians participating in the protocol.
Moreover, a highly centralized approach would not broaden
the availability in training resources across the sites.
Thus, the training protocol involved a decentralized
system where an ‘‘MET/MI Expert Trainer’’ was identified
at each site who was already skilled in and certified to
provide MET/MI training. This group of expert trainers then
participated in a specialized ‘‘training of trainers’’ program
with Drs. William Miller and Theresa Moyers from the
University of New Mexico. The training of the MET/MI
expert trainers was intended to foster a consistent approach
to training across the sites and to anticipate the challenges in
training a highly diverse group of clinicians in MET/MI.
The expert trainers then returned to their sites where they
provided didactic training in MET/MI to the participating
clinicians and one clinical supervisor in each site.
Training involved a 2-day didactic training seminar
(including review of the MET or MI manuals, and training
tapes plus several role plays) plus an ongoing certification/
monitoring process that involved ongoing review of session
tapes and evaluation of clinicians’ adherence and compe-
tence in delivering MET/MI throughout the trial. In addi-
tion, the expert trainers also trained one clinical supervisor
at each site in MET/MI and in supervising clinicians to
perform MET/MI. This was intended to provide additional
supervisory support to clinicians, foster closer integration of
the protocol in the clinics, as well as to provide durable,
continuing MET/MI training resources at each of the par-
ticipating programs.
4.2. MET/MI vs. standard approaches to treatment
A key challenge facing the trainers was the wide dispar-
ity between MET and MI and standard approaches to
treatment at the programs. MET and MI were developed
from observations that individuals seeking to change their
behavior were often found to cycle through stages of
readiness: precontemplation, contemplation, determination
(or preparation), action, and maintenance. MET/MI applies
a counseling style and specific techniques to mobilize
inherent resources within the client for positive change.
MET and MI are based on the premise that sustained
positive change is most effectively achieved if the client is
following a course that he/she has personally identified as
being the ‘‘best,’’ rather than a course of treatment that has
been imposed from an outside source.
The style in which these sessions are delivered is as
important, if not more important than the content of the
material. The client-centered, empathetic but directive inter-
action of MET/MI is designed to explore and reduce the
inherent ambivalence in clients presenting for substance
abuse treatment. This approach requires that the clinician
relates to the client in a nonjudgmental, collaborative
manner, which is a philosophical stance requiring both skill
and patience. Working in the METstyle, the clinician acts as
a coach or consultant rather than an authority figure. While
certain techniques may be useful in understanding how to
deliver the interventions, the hallmark of MET therapy is the
collaborative, empathic and respectful interactions. This
nonjudgmental style may contrast with approaches used
by many drug counselors. This led to a number of special
considerations in training the clinicians for the protocol.
4.3. Experiences in didactic training
The experience of delivering a standardized training
designed to teach the style and strategies of MET and MI
proved to be both interesting and rewarding. The diversity
of backgrounds and levels of previous knowledge of MI
amongst recipients was quite apparent. The ‘‘real world’’
clinicians came from very different educational and practical
backgrounds. Some entered the field from their own experi-
ence of recovery while others came from a range of
education that varied from a 2-year community college
experience to a doctoral degree. Many brought with them
a long history of a confrontational-style practice or of being
the authority who dictates to the client what to do.
In general, as in other recent trials of this type (Morgen-
stern, Morgan, McCrady, Keller, & Carroll, 2001), the
clinicians were eager to learn a novel approach and found
the MET/MI techniques persuasive and intuitive. Many
clinicians expressed to the trainers their sense that they
‘‘already do this,’’ that the MET/MI style and strategies
were quite familiar, although these observations contrasted
sharply with those of the trainers. During the seminars, the
clinicians were able to recognize and adopt the empathic
K.M. Carroll et al. / Journal of Substance Abuse Treatment 23 (2002) 73–8078
style of MET/MI with greater ease than some of the more
subtle strategies associated with encouraging participants to
change their behavior.
4.4. Experiences in supervision
After the didactic training, each clinician was assigned a
number of ‘‘training cases,’’ in which they had an opportunity
to practice MET or MI, depending on which of the two
protocols their site implemented. All sessions were audio-
taped and reviewed by the expert trainers who provided
detailed feedback and supervision regarding the degree to
which the clinician adhered to the manual and the skill in
which they delivered the interventions. Thus, the trainers
were faced with the challenge of reviewing session tapes from
clinicians who were not accustomed to having their work
scrutinized or assessed for fidelity to a treatment manual.
Moreover, despite many therapists’ sense that they were
‘‘already doing’’ MET or MI, the trainees lack of familiarity
with the style and the complexity of delivering the treatment
was heightened during the training cases. Many of the
clinicians had been trained to offer advice, to tell clients
what they think, and to confront denial by teaching the
‘‘facts’’ about drug dependence and recovery. Thus, the
supervision process required that the trainers consistently
challenge the clinicians to work very differently with their
clients and think differently about their work.
Another issue encountered during the supervisory ses-
sions was facilitating the clinicians’ adherence to the
manual. Following a treatment manual was a novel concept
for many of the clinicians (see Ball et al., 2001) who
typically have a great deal of latitude in the way they
deliver counseling. Thus, an important part of the super-
vision process became frequent review and reference to the
MET or MI manuals. One of the most difficult concepts for
some clinicians was the integration and utilization of
available pretreatment assessment data as a basis for pro-
viding feedback to clients and developing discrepancy
between stated goals and actual behavior, because it is not
common practice in the real world to integrate structured
feedback from objective assessments into the first few
sessions with clients.
Trainers were careful to maintain a highly individualized,
supportive stance with the clinicians, praising successful
efforts to implement MET/MI, and pointing out specific
instances where they had fallen back on a more traditional
approach. Trainers found the most effective ways of spend-
ing supervision time was in the reviewing of actual session
tapes, stopping the tape several times, and carefully analyz-
ing specific interventions or missed opportunities for MET/
MI techniques. Other useful methods of supervision were
frequent role-plays and providing detailed feedback on
adherence/competence rating forms. Supervisors found that
merely asking the clinicians where they feel they need help
without appropriately structuring the supervision time did
not yield positive results.
Despite these challenges, the observation of the trainers
was that the clinicians learned and implemented MET and
MI quite well. Across the sites, the supervisors found that
most of counselors were able to meet criteria for certifica-
tion after the prescribed minimum number of training cases
(one case for the MET protocol and three cases for the MI
protocol) but approximately one-third of the clinicians
required additional training cases to achieve minimal levels
of proficiency.
5. Summary
The MET and MI protocols are large, multisite, random-
ized trials of brief behavioral interventions evaluating the
effectiveness of manualized treatments in ‘‘real world’’
clinical settings. As one of the first CTN protocols, these
trials will provide important data on the effectiveness and
durability of these approaches across a wide range of
patients and settings, on the capacity of clinicians to learn
and implement these approaches effectively, and on the
nature of standard treatments in these settings.
Acknowledgments
Support was provided by NIDA grants U10 DA13038,
DA DA13045, and K05-DA00457.
References
Babor, T. F. (1994). Avoiding the horrid and beastly sin of drunkenness:
does dissuasion make a difference? Journal of Consulting and Clinical
Psychology,62, 1127 – 1140.
Ball, J. C., & Ross, A. (1991). The effectiveness of methadone maintenance
treatment. New York: Springer-Verlag.
Ball, S. A. (1996). Brief motivational intervention for heavy drinking.
Unpublished treatment manual.
Ball, S. A., Bachrach, K., DeCarlo, J., Farentinos, C., Keen, M.,
McSherry, T., Polcin, D., Snead, N., Sockriter, R., Wrigley, P., Zam-
marelli, L., & Carroll, K. M. (2001). Characteristics of community
clinicians trained to provide manual-guided therapy for substance
abusers. Under review.
Basham, R. B. (1986). Scientific and practical advantages of comparative
design in psychotherapy outcome research. Journal of Consulting and
Clinical Psychology,34, 88 – 94.
Bien, T. H., Miller, W. R., & Tonigan, J. S. (1993). Brief interventions for
alcohol problems: a review. Addiction,88, 315 – 335.
Carroll, K. M., Kadden, R., Donovan, D., Zweben, A., & Rounsaville, B. J.
(1994). Implementing treatment and protecting the validity of the in-
dependent variable in treatment matching studies. Journal of Studies on
Alcohol, (Suppl. 12), 149 – 155.
Carroll, K. M., Libby, B., Sheehan, J., & Hyland, N. (2001). Motivational
interviewing to enhance treatment initiation in substance abusers: an
effectiveness study. American Journal on Addictions,10, 335 – 339.
Carroll, K. M., Nich, C., McLellan, A. T., McKay, J. R., & Rounsaville, B.
J. (1999). ‘‘Research’’ versus ‘‘real world’’ patients: representativeness
of subjects participating in clinical trials of treatments for cocaine de-
pendence. Drug and Alcohol Dependence,54, 171 – 177.
K.M. Carroll et al. / Journal of Substance Abuse Treatment 23 (2002) 73–80 79
Carroll, K. M., & Rounsaville, B. J. (In press). Bridging the gap between
research and practice in substance abuse treatment: a hybrid model
linking efficacy and effectiveness research. Psychiatric Services.
Crits-Christoph, P., Siqueland, L., Chittams, J., Barber, J. P., Beck, A. T.,
Frank, A., Liese, B., Luborsky, L., Mark, D., Mercer, D., Onken, L. S.,
Najavits, L. M., Thase, M. E., & Woody, G. (1998). Training in
cognitive, supportive-expressive, and drug counseling therapies for
cocaine dependence. Journal of Consulting and Clinical Psychology,
66, 484 – 492.
Institute of Medicine. (1998). Bridging the gap between practice and re-
search: forging partnerships with community-based drug and alcohol
treatment. Washington, DC: National Academy Press.
Martino, S., Carroll, K. M., O’Malley, S. S., & Rounsaville, B. J. (2000).
Motivational interviewing with psychiatrically ill substance abusing
patients. American Journal on Addictions,9, 88 – 91.
McLellan, A. T., Alterman, A. I., Metzger, D. S., Grissom, G. R., Woody,
G. E., Luborsky, L., & O’Brien, C. P. (1994). Similarity of outcome
predictors across opiate, cocaine, and alcohol treatments: role of treat-
ment services. Journal of Consulting and Clinical Psychology,62,
1141– 1158.
McLellan, A. T., & McKay, J. R. (1998). The treatment of addiction: what
can research offer practice? In: S. Lamb, M. R. Greenlick, & D.
McCarty (Eds.), Bridging the gap between practice and research: forg-
ing partnerships with community based drug and alcohol treatment
( pp. 147 – 185). Washington, DC: National Academy Press.
Miller, W. R., & Rollnick, S. (1991). Motivational interviewing: preparing
people to change addictive behavior. New York: Guilford.
Miller,W.R.,Tonigan,J.S.,&Longabaugh,R.(1995).The Drinker
Inventory of Consequences (DrInc): an instrument for assessing ad-
verse consequences of alcohol abuse. Test manual. (NIAAA Project
MATCH Monograph Series Volume 4. Rockville, MD).
Miller, W. R., Zweben, A., DiClemente, C. C., & Rychtarik, R. G. (1992).
Motivational enhancement therapy manual: a clinical research guide
for therapists treating individuals with alcohol abuse and dependence.
Unpublished manuscript, Rockville, MD.
Morgenstern, J., Morgan, T. J., McCrady, B. S., Keller, D. S., & Carroll, K.
M. (2001). Manual-guided cognitive behavioral therapy training: a
promising method for disseminating empirically supported substance
abuse treatments to the practice community. Psychology of Addictive
Behaviors,15, 83 – 88.
MTP Research Group. (2001). Treating cannabis dependence: findings
from a multisite study. Under review.
Obert, J. L., Rawson, R. A., & Miotto, K. (1997). Substance abuse treat-
ment for ‘‘hazardous users’’: an early intervention. Journal of Psycho-
active Drugs,29, 291 – 298.
Onken, L. S., Blaine, J. D., & Battjes, R. (1997). Behavioral therapy re-
search: a conceptualization of a process. In: S. W. Hennegler, & R.
Amentos (Eds.), Innovative approaches for difficult to treat populations
( pp. 477 – 485). Washington, DC: American Psychiatric Press.
Project MATCH Research Group. (1997). Matching Alcohol Treatments to
Client Heterogeneity: Project MATCH posttreatment drinking out-
comes. Journal of Studies on Alcohol,58, 7 – 29.
Rounsaville, B. J., Carroll, K. M., & Onken, L. S. (2001). NIDA’s stage
model of behavioral therapies research: getting started and moving
on from Stage I. Clinical Psychology: Science and Practice,8,
133 – 142.
Rounsaville, B. J., Chevron, E., Weissman, M. M., Prusoff, B. A., & Frank,
E. (1986). Training therapists to perform interpersonal psychotherapy in
clinical trials. Comprehensive Psychiatry,27, 364 – 371.
Rounsaville, B. J., O’Malley, S. S., Foley, S., & Weissman, M. M. (1988).
Role of manual-guided training in the conduct and efficacy of inter-
personal psychotherapy for depression. Journal of Consulting and Clin-
ical Psychology,56, 681 – 688.
Saunders, B., Wilkinson, C., & Philips, M. (1995). The impact of a brief
motivational intervention with opiate users attending a methadone pro-
gramme. Addiction,90, 415 – 424.
Simpson, D. D., Joe, G. W., & Brown, B. S. (1997). Treatment retention
and follow-up outcomes in the Drug Abuse Treatment Outcome Study
(DATOS). Psychology of Addictive Behaviors,11, 294 – 307.
Swanson, A. J., Pantalon, M. V., & Cohen, K. R. (1999). Motivational
interviewing and treatment adherence among psychiatric and dually
diagnosed patients. Journal of Nervous and Mental Disease,187,
630 – 635.
Wilk, A. I., Jensen, N. M., & Havighurst, T. C. (1997). Meta-analysis of
randomized controlled trials addressing brief interventions in heavy
alcohol drinkers. Journal of General Internal Medicine,12, 274 – 283.
K.M. Carroll et al. / Journal of Substance Abuse Treatment 23 (2002) 73–8080