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NIDA-CTN-0005
(Enrollment Closed)
Motivational Interviewing (MI) to Improve Treatment
Engagement and Outcome in Subjects Seeking Treatment for Substance
Abuse
Primary aims: The specific aims of these studies are:
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To evaluate the efficacy of MET (or MI), relative to standard
(intake/orientation/evaluation) procedures at the participating
CTPs, in enhancing treatment engagement and retention as well
as in reducing substance use.
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To evaluate the durability of MET (or MI) relative to standard
treatment at the CTPs through a 3-month follow-up.
Secondary aims include the following:
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To explore patient characteristics associated with outcome,
as a preliminary step toward understanding the types of patients
particularly suited for MET/MI versus those for whom standard
treatment is sufficient.
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To evaluate the ability of clinicians at the CTPs to learn
and effectively implement MET/MI techniques.
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To conduct process analyses which will seek to :(1) assess
the discriminability and specificity of each of the treatment
approaches, (2) evaluate process (e.g., therapeutic alliance,
therapist adherence, therapist skill) and outcome (e.g., patient
satisfaction level, patient motivation) measures that relate
to successful treatment engagement, retention, and outcome,
and (3) to characterize the nature of standard treatment provided
at the participating CTPs.
Study Design
Participants seeking treatment at the participating CTPs will be
randomly assigned to either ‘standard’ or "MET/MI" treatment,
with a 1- and 3-month follow-up. Primary outcome measures will include
(1) treatment retention (e.g., number of sessions/weeks completed,
the rate of patients completing 3 or more subsequent sessions, and
(2) substance use (e.g., urinalyses, days of opioid, cocaine, marijuana,
alcohol use, rates of abstinence). Secondary outcomes will include
motivation, psychosocial functioning, HIV risk behaviors, treatment
utilization, and patient satisfaction. Process assessments will include
measures of the working alliance as well as therapist adherence/competence
ratings which will evaluate how effectively MET/MI was implemented
Participating CTPs will implement one of two independent protocols,
depending on which is the best suited or feasible for the intake procedures
at their clinic. Thus, following an invitation to participate, explanation
of the study, and provision of informed consent, patients would complete
a brief assessment battery followed by either:
1. Random assignment to 3 individual sessions of standard treatment
(treatment as usual) at the program versus 3 individual sessions
of MET.
2. Random assignment to 1 individual standard assessment/evaluation
session.
Participants:
Each participating CTP would recruit and randomize approximately
100 patients in one year (e.g., about 2 per week would go through
the protocol, roughly 5-7 patients would be receiving treatment in
the protocol at any one time)
Individuals will be eligible for the protocol who:
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Are seeking outpatient treatment for any substance use disorder.
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Are willing to participate in the protocol (e.g., to be randomized
to treatment, be contacted for follow-up assessment, to have
their sessions audiotaped).
Individuals will be excluded who:
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Are not sufficiently medically or psychiatrically stable to
participate in outpatient treatment (e.g., ASAM Level 1 or 2).
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Are not seeking detoxification only, methadone maintenance,
or residential inpatient treatment.
Therapists
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Clinicians will be individuals currently employed at participating
CTPs who are interested in participating in the research protocol,
and:
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Willing to learn a manualized version of MET and follow manual
guidelines for the duration of the protocol.
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Willing to be randomly assigned to either the MET or Standard
conditions and participate in any initial and ‘refresher’
training sessions.
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Willing to have their sessions be audiotaped for review by clinical
supervisor and adherence/ competence raters, attend regular supervision
sessions, complete process ratings (e.g., ratings of the therapeutic
alliance and techniques used during sessions). Clinicians delivering
the ‘standard’ treatment would also have their sessions
audiotaped.
-
Approved by the CTPs administrative/supervisory staff as appropriate
for the study (e.g., sufficiently reliable, performs CTP duties
competently, is likely to work at the clinic for the duration
of the study).
Clinicians who have received credentialing as a MET trainer, have
received formal MET training within the 3 months prior to protocol
training, or who have served as MET therapists in a prior clinical
trial can serve as on-site MET supervisors for this study, but cannot
serve as a therapist in either condition. Clinicians who have received
a less formalized or recent exposure to MET or motivational interviewing
can participate as therapists. There is a minimum of 2 therapists
per condition (4 therapists total per CTP), but ideally more because
of practical issues such as therapist turnover and vacations, as well
as the importance of understanding therapist effects.
Training
We are anticipating a Node-based training model, where a key Node
MET/MI trainer would be responsible for training of a CTP MET/MI
supervisor and the participating clinicians. Therapist training
would involve participation in a didactic seminar, led by the Node
MET trainer, followed by completion of closely-supervised training
cases, which would be audiotaped and reviewed by the Node MET supervisor
and the CTP MET supervisor, who would also provide detailed feedback
based on adherence/competence ratings.
Once a therapist was determined to have met minimal performance
criteria, s/he would be eligible to participate in the randomized
phase of the trial and would receive ongoing supervision, which
would include review of session audiotapes, for quality control
purposes. In addition, the session tapes would be rated independently
for adherence and competence, by raters who are unaware of the participants
treatment assignment, to evaluate issues such as (1) to what degree
MET/MI overlapped with standard treatment, (2) to what degree there
was a great deal of variation in how MET/MI was delivered across
Nodes and CTPs, and so on.
Assessments:
A brief battery (less than 1-2 hours for MET protocol, less for
MI protocol) would be completed by participants prior to random
assignment. The battery will assess domains such as basic demographic
data, reasons for seeking treatment (e.g., was the patient mandated)
type and severity of drug use, level of motivation, and nature and
severity of psychosocial problems. Participants would also complete
a brief battery following treatment completion and at follow-ups
conducted 1 and 3 months later.
The assessment battery will be drawn from the ‘CTN Encyclopedia
of Assessments’ that will be selected by the Assessment subcommittee
at its upcoming meeting.
**Wherever possible, duplication of information between the CTPs
standard assessment/intake battery and the protocols will be minimized.
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