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 The
agency you work for has agreed to participate in a clinical trial
to study a behavioral intervention called Motivational Enhancement
Therapy (MET). This brochure provides an overview of this
intervention and answers to questions you might have about participating
as a clinician in this research project.
What is Motivational Enhancement Therapy?
During your career as a clinician you probably have run across clients
who report wanting to recover from their drug problems, but who seem
insufficiently motivated to make the changes that would help them
in their recovery. MET is a brief intervention designed to help clients
make changes in their behavior by using proven strategies that are
likely to increase their motivation to change. Unlike some interventions
regularly used in community treatment programs, MET is a manualized
intervention, which means that clinicians who deliver the intervention
follow a written set of guidelines (the intervention manual)
What will it be like to provide counseling using MET?
You will be providing a three session intervention that will involve
using assessment information collected on a personal feedback form
combined with motivational strategies to assist clients in engaging
in treatment.
Why is MET being tested?
MET has been shown to be an effective intervention for alcohol use
disorders and smoking. While researchers do not necessarily believe
that MET alone will give clients with severe drug problems all the
tools they need to change, it is hypothesized that the addition of
MET strategies will positively impact the utilization of other clinic
services.
If I volunteer to be a study clinician, will I automatically learn
MET?
One of the unique things about participating in a research study
is that in order to determine if an intervention is beneficial, it
must be compared to a standard intervention. In this study, all clinicians
who volunteer and are selected to be study clinicians will be assigned
at random to provide either Treatment As Usual (TAU), which will consist
of three individual treatment sessions in the beginning phase of a
client’s treatment, or the MET which will be delivered in place
of those first three sessions. Those who are assigned to be MET clinicians
will receive MET training before the study begins. Those who are assigned
to TAU will be offered MET training at the completion of the study.
Why will you randomly assign us?
In order to make sure that the characteristics of the clinicians
providing counseling to both groups are balanced, random assignment
is necessary. It is possible that more therapists of a certain gender,
race, or level of experience would choose to do a certain intervention.
In such a situation, when statisticians analyze the research results
it would be hard to tell whether differences between the MET and TAU
groups were due to the intervention or due the characteristics of
the clinicians. Random assignment will help to minimize the chances
of an imbalance related to clinician characteristics.
How will participating as a clinician on a research trial differ
from my current role and responsibilities?
Because a major goal of the Clinical Trials Network is to move interventions
that have been shown to be effective in tightly controlled research
settings into community treatment settings, it is hoped that your
activities as clinicians in the CTN trials will be similar to your
duties before you joined the study. However, there will be differences
such as those listed below:
Paperwork: If you volunteer for this study, you will be asked to fill
out some paperwork before the study begins that describes your eligibility
for the study and your characteristics as a clinician. Once the study
begins, you will need to fill out a checklist for each counseling
session in the study, and will fill out a questionnaire regarding
therapeutic alliance after each participant’s second session.
Training: Regardless of which intervention you are assigned
to, you will receive additional training. MET clinicians will receive
training in MET. The MET training will consist of three days of
a classroom seminar and role play exercises. Next you will complete
at least one practice/training case, which will give you an opportunity
to practice new skills and reach a level of mastery in MET. Once
the study is over, TAU clinicians will be offered the MET training
as well.
Treatment Manual Adherence: In many community clinics, therapists
tend to use whatever techniques seem to work with their clients.
As is typical of clinical therapy trials, the clinicians in this
study will need to deliver their counseling sessions according to
the therapy condition you are assigned to. For TAU clinicians, your
three study sessions will not differ from what you ordinarily do.
For MET clinicians, you will use the techniques learned in training
and you will follow the guidelines for each session as outlined
in the manual.
Supervision/Monitoring: All study counseling sessions –
both MET and TAU – will be audiotaped and rated by independent
experts to ensure that there is a discernable difference between
the MET sessions and the TAU sessions. For MET clinicians, audiotapes
of both the practice cases and the study cases will be rated by
MET supervisors to make sure that you are following the manual and
that you have an acceptable level of skill in MET. MET clinicians
will also have group supervision twice a month and individual supervision
as needed.
If I will have to do extra work, why should I participate as a clinician
in a research study?
There are many reasons to participate as a clinician in a clinical
trial. First, you will learn techniques and therapies that are not
yet commonly used in community treatment settings, but which have
been shown to help people stop or reduce their drug and/or alcohol
use. These techniques will be helpful in your work with clients for
years to come. You may be provided with additional training and supervision
that may help you with licensure or certification as well as adding
to your skills as a clinician. If you are considering returning to
school, experience in a research trial may enhance your application.
Additionally, you will be helping to develop the process of transferring
research-based treatments into clinical practice. Finally, as a clinician
in the Clinical Trials Network, you are in a unique position to contribute
to the knowledge of effective drug abuse treatment.
What should I tell clients about the Clinical Trials Network and
the study?
Two informational handouts are available for clients interested in
participating in clinical trials. You should familiarize yourself
with these brochures so that you can answer any questions and refer
potential participants to the right sources. What
Are Clinical Trials? is an excellent source for understanding
the benefits of participating in a research study. Motivational
Enhancement Therapy for Pregnant Substance Users – Should I Join?
is a brochure for clients that describes this study in general terms
that potential participants can easily understand. More specific information
about the study can be found in the Informed Consent form that the
research assistant will read with a client who is deciding whether
or not to participate. If you become a clinician for the study, you
will receive training on how to talk with the clients about the research
project. If you ever find yourself unable to answer a question about
the research, you should consult your supervisor, the research assistant,
or an investigator for more information.
For more information on the National Institute on Drug Abuse Clinical
Trials Network, visit the NIDA website at www.drugabuse.gov.
For information on other clinical trials, the National Institutes
of Health (NIH) has created
a website to help patients, family members, and the general public
obtain information about government sponsored clinical trials. You
may log on to www.Clinicaltrials.gov
to learn about ongoing or new trials for all types of health related
conditions. The descriptions for individual trials include eligibility
criteria, purpose of the trial, location, and how to apply if interested.
The website is maintained and updated regularly by the National Library
of Medicine.
National Institute on Drug Abuse
Center for the Clinical Trials Network
6001 Executive Boulevard
Room 4234, MSC 9557
Bethesda, Maryland 20892-9557
Telephone: (301) 443-6697
Fax: (301) 443-2317
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