W(h)ither ESTs?

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W(h)ither ESTs?

• Kathleen M Carroll PhD
• Yale University School of Medicine

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Some considerations

• 140 ESTs and climbing
• Meta-analyses of meta-analyses suggest few cross
  treatment differences
• Few TAU/clinician choice comparisons
• Impact of individual clinicians unclear
• Many therapies/practices remain untested

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Overview

• Key issues regarding empirically validated
  therapies
• Efficacy Do empirically validated therapies
  stand up in the real world?
• Training What do we know, and what do we need
  to know about training?

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Concepts I find useful

• Efficacy versus clinical utility
• Evidence based technique versus evidence based
  practice
• Evidence based practice is the integration of
  best research evidence with clinical expertise
  and patient values (IOM, 2001)

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Stages of Behavioral Therapies Development

• Stage I Demonstrate feasibility, promise
• of novel approaches
• Stage II Evaluate efficacy
• Stage III Evaluate applicability,
• generalizability

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Stage model is iterative, not linear
Develop novel approaches Investigate
mechanisms Explore transportability Pilot high
risk/high yield approaches Understand
training
Efficacy trials Moderator/mediator
studies Sequencing studies Combining
approaches Dismantling
Effectiveness trials Dissemination
trials Training trials
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Stage Model Innovations

• Model for rapid and systematic development of
  promising treatments from good ideas to fully
  developed treatments ready for dissemination
• By supporting Stage I research, field opened to
  richer, more diverse range of new behavioral
  approaches
• Recognition that standard Stage II trials
  insufficient to demonstrate clinical utility

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Stage I challenges

• Proliferation versus consolidation
• Evaluating treatment mediators and mechanisms of
  action even at Stage I

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Stage II Moving beyond standard efficacy trials

• Mediators and moderators
• Dose-effect relationships
• Sequenced approaches,
• adaptive designs
• Combined treatments

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Research Practice
Bridging the Gap
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CTNs Mission
To improve substance abuse treatment Throughout
the US Using SCIENCE as the Vehicle
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CTN Centers
A research infrastructure of 17 RRTCs and 118
CTPs across 27 States, the District of Columbia,
and Puerto Rico
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Evidence-Based Treatments Questions for STAGE
III and the CTN

• Do ESTs work in the real world?
  Generalizability to different patients,
  practitioners, settings
• Can providers implement these treatments?
• How should they be
• trained to do so?
• Is the cost justified?
• Cost-effectiveness
• Sustainability will providers and
• clients use these treatments?

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Key CTN Tasks

• Evaluate Addiction Treatments in Real World
  Settings
• Foster collaboration between researchers and
  practitioners
• Conduct multi-site randomized clinical trials in
  real world community settings
• Translate Evidence Into Practice
• Develop evidence-based practice dissemination
  packages
• Involve clinicians, patients and third party
  payers

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CTN Research to date

• 26 Research Studies
• 23 multisite clinical trials
• 18 completed
• 70 Community Treatment Programs have enrolled
  over 7000 study participants
• Positive results for completed trials
• Coordinated dissemination

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Ongoing CTN trials

• Opioid dependence
• Buprenorphine/naloxone stabilization and taper
  schedules
• Buprenorphine detoxification for adolescents
• Nicotine dependence
• Smoking cessation in mmp
• HIV/HCV
• HIV risk reduction for men/women

• Women
• MET for pregnant women
• Seeking safety PTSD
• Families/adolescents
• Brief strategic family therapy
• Pharmaotherapy/ADHD
• Ethnic minorities
• MET for Spanish-speakers

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Drug Abuse Treatment Core Components and
Comprehensive Services
Treatment Plan
Self-Help (AA, NA) Meetings
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Outcomes Initial CTN trials

• Motivational Enhancement Therapy
• Motivational Incentives (contingency management)

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Rationale Evaluating MI in the CTN

• Attrition a major issue in substance abuse
  treatment
• Strategies to retain clients seen as very
  important by community treatment programs
• The bulk of attrition occurs very early in
  treatment
• Retention has been linked to better outcome in
  several studies

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Rationale for MI in the first wave of CTN
protocols

• Applicable to a broad range of clients and
  Community Treatment Programs (CTPs)
• 2-condition design (MI versus standard treatment)
• Design allows preliminary evaluation of training
  strategies
• Design allows some evaluation of Treatment as
  Usual in CTPs (e.g., how much MI already in
  CTPs)
• Availability of MI expert trainers in all
  participating Nodes
• Availability of training materials
• Wide availability of MINT trainers for
  dissemination

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Design challenges Efficacy to effectiveness

• Brief 1-3 session MI insufficient for many drug
  users
• Solution Integrate in introductory phase of
  treatment
• Adapting MI to heterogeneous drug-using groups
• Solution Revision of manuals some
  assessments by design team members to be
  appropriate for all comers

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Design challenges Efficacy to effectiveness,
part 2

• Group treatment common in CTPs
• Two independent protocols, one developed for CTPs
  offering individual treatment, one developed
  specifically for CTPs offering group treatment
  only
• Training clinicians
• Randomize CTP clinician/volunteers to training
  condition (MI or standard treatment)
• CTP-centered training model aimed at sustaining
  expertise with training of supervisors model

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MI Study Design
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Primary/secondary aims

• Does integrating an MI style into the initial
  evaluation/assessment session of treatment
  enhance retention and outcome?
• Can community based clinicians be trained to
  implement MET/MI effectively?

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Recruitment and follow-up

• 4 of 5 sites successfully recruit full target
  sample (N100)
• Overall follow-up rates
• 77 at one month,
• 75 at 3 months (range 66-84)

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Who entered the trial?

• 635 screened (range 109-264)
• 431 eligible/provided informed consent (68 of
  those screened)
• 423 randomized
• (97 of consented)
• 377 complete protocol session
• (90 of randomized)

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Who did not enter the trial? Of the 204
(635-431) who were not eligible
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Participant characteristics

• Mean age 32
• 40 female
• 76 Caucasian
• 12 years of education
• 21 married or in stable relationship
• 32 mandated or referred by legal system
• Primary substance use problem
• Alcohol 48
• Marijuana21
• Cocaine 6
• Methamphetamine 18
• Opioids 5

indicates significant differences by site
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Can community clinicians learn and effectively
implement MI?

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LEVELS OF TRAINING

• MI Expert Trainer
• One per Node, MINT training
• Provides training, certification, ongoing
  supervision to CTP supervisor and MI clinicians
• CTP supervisor
• Drawn from CTP clinical leadership,
• Provides ongoing supervision and tape review
• MI Clinicians
• Drawn from staff, randomized to MI or standard
• 2 days training, plus successful completion of at
  least 3 MI cases for certification (low
  threshold)
• All sessions audiotaped, evaluated for criterion
  levels of competence in MI

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Adherence Competence Ratings

• 39 items rated on two 7-point Likert dimensions
• (frequency/extensiveness and skill level)

• MI-Consistent sample items
• Open-ended Qs
• Reflections
• Affirmations
• Pros/Cons
• Discrepancies
• MI Style

• MI-Inconsistent sample items
• Confrontation
• Skills Training
• Asserting Authority
• Psychodynamic
• Invoking Spirituality
• Total Abstinence

• General Counseling sample items
• Psychosocial Assessment
• Program Orientation
• Case Management
• Psychoeducation
• Assessing current substance use

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Can community clinicians learn and effectively
implement MI?Adherence ratings by condition
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Clinician skill ratings by treatment condition
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• Is integrating MI into a single early session
  effective in enhancing retention and reducing
  substance use?

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Did MI retain significantly more participants in
treatment at the 1-month point?
YES
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Site differences in retention
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Did participants assigned to MI complete more
sessions than assigned to standard intervention?
YES
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Did MI retain significantly more participants
through the 84-day follow-up?
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Did MI reduce substance use more than the
standard intervention at 1 month?
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Did MI significantly affect rates of complete
abstinence among participants?
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Bottom Line Conclusions

• 1. Study successfully implemented
• Sites meet recruitment targets (2/week)
• Very good rates of follow up
• Diversity in participant and program
  characteristics seen across sites
• First CTN study to involve front line counselors
• MI successfully implemented at high level of
  fidelity and skill when provided with training,
  certification, and ongoing supervision

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Conclusions, retention

• Retention in treatment high across sites overall
• Integrating motivational interviewing into a
  single initial session has significant effect on
  early treatment retention, even after exposure to
  a diverse range of interventions

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Conclusions, substance use

• Overall substance use outcomes very good
• No significant effects of a single session of MI
  over standard treatment in reducing substance use

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Still to come

• Analyses of subgroups (gender, ethnicity,
  criminal justice)
• Analyses of cost of training
• Relationships of clinician skill and adherence
  levels to outcome
• MET (3 sessions individual) study analyses
  underway
• MET-Spanish (5 sites) completed October 05

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Contingency Management and the Need to address
Stage III issues early in Stage II

• Consistent findings, large effects for
  contingency management approaches based on
  principles of operant conditioning
• Limited utilization of contingency management in
  clinical practice
• Barriers include cost and acceptance among
  clinicians
• Nancy Petrys lower cost contingency management
• Variable ratio reinforcement, participants earn
  chances to win prizes of varying value
• Immediate reinforcer
• Average maximum cost is 250 (142) per
  participant

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N. Petry prize CM system Draws Escalate with
Stimulant-Free Test Results
5
4
Draws
3
2
1
Weeks Drug Free
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Petry et al., (2000), Give them prizes and they
will come Effects on retention in alcohol
dependent patients
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Percent positive for any illicit drug
Petry et al., 2000
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CTN Motivational Incentives study

• 13 sites, 6 outpatient drug free, 7 methadone
  maintenance
• Prize contingency management TAU vs Treatment
  as Usual
• Stimulant users only, incentives target
  stimulant-free urine specimens, with bonus draws
  for specimens free of all drugs

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CTN trial Outpatient sites, RETENTION
100
o
o
100
80
80
o
o
o
o
o
o
o
o
o
60
60
o
50
Percent Retained
o
o
Percent Submitting At Least One Sample
o
o
o
o
o
o
o
o
40
40
o
o
35
20
20
RH 1.6 CI 1.2 - 2.0
OR 1.6 CI 1.2 - 2.0
0
0
2
4
6
8
12
2
4
6
8
10
12
Study Week
10
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Outpatient sites PERCENT STIMULANT NEGATIVE
URINES
1
0
0
0
8
6
0
INCENTIVE
Percent of Submitted Urine Testing Negative
4
0
STANDARD
2
0
STUDY VISIT
0
5
1
7
1
9
2
1
2
3
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CTN METHADONE STUDY RETENTION
100
o
o
o
80
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
60
Percent Submitting At Least One Sample
Percent Retained
40
RH 1.1 CI 0.8 - 1.6
OR 1.3 CI 1.0 - 1.6
20
Study Week
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METHADONE PERCENT STIMULANT NEGATIVE URINES
1
0
0
Incentive
Standard
8
0
6
0
Percent of Submitted Urines Testing Negative
4
0
2
0
OR 1.96 CI 1.45 - 2.65
0
5
1
7
1
9
2
1
2
3
Study Visit
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CTN Contingency ManagementTrial Incentive Costs
Mean cost per patient 119 ( 67)
Mean cost/pt/day 1.42 (0.81)
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Bottom Line CTN CM studies

• A CM study was successfully completed within
  community treatment programs
• Abstinence incentives reduced during treatment
  stimulant use in methadone patients and improved
  retention in outpatient psychosocial treatment
• Costs were reasonable
• Several sites maintain CM systems

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What do clinicians need in order to implement
ESTs effectively?

• Mastery of 140 interventions impractical
• Most clinicians not in specialty clinics/
  practices where the large number of EVTs might be
  manageable
• Clinicians work rarely
• directly monitored
• Not enough evidence this is
• reasonable

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Options for training programs

• Lumping
• Major categories (e.g., CBT, interpersonal,
  motivational, psychodynamic)
• Focus on few change principles
• Master specific EVTs by interest or specialty
• This has resulted in few practitioners who
  actually practice EVTs
• Splitting
• Require mastery of 3-4 EVTs?

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Options for treatment programs

• For specialty programs with experienced
  therapists, training in 3-4 change processes
  associated with ESTs may be practical
• Key questions What kind of training, for what
  therapist, in what setting
• Turnover issues

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Do ESTs remain effective when practiced
imprecisely?

• CM programs highly sensitive to relatively small
  changes in reinforcement magnitude or schedules
• Large difference in actual techniques when used
  by different groups (e.g. CBT for depression
  versus substance use)
• Other therapies may be more robust. Which?
• Does tailoring effect efficacy?

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What we (think) we know about training clinicians
for efficacy trials

• Efficacy study models appear to be effective
  model of training selected therapists to use
  manualized therapies in clinical trials
• The model appears associated with relatively
  little variability in outcome across therapists,
  highly discriminable treatments implemented with
  good fidelity to manual guidelines
• BUT Many elements accepted at face value and
  have not been systematically evaluated

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We dont train in vain

• What kind of training, for what type of
  clinician, is needed to effectively implement
  EVTs?

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Design CBT Dissemination trial
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Clinician characteristicsN78

• Mean age 45
• 54 female
• 27 African American, 8 Hispanic, 61 Caucasian
• 49 masters, 28 bachelors, 22 high school or
  equivalent
• Mean years experience9
• 47 self-identify as having had a substance
  abuse problem

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The clinical context

• Mean weekly caseload21 clients (range 6-70)
• 62 receive 1 hour of supervision per week 31
  receive none
• 91 report using mixed or eclectic approach

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Outcomes Dissemination trial

• Demonstration of ability to implement key CBT
  skills (independent evaluation of adherence and
  skill via videotaped role play with trained
  actors)
• CBT knowledge pre/posttraining
• Self-reports of implementation of CBT in practice
• NOT evaluating patient outcomes

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Percent trained to criterion (scores of 3.5 or
more on 2 of 3 role plays)
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but.

• Training is time consuming and expensive
• Individualization and standardization
• Scheduling
• Turnover

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One small step for manuals

• Computer assisted training in TSF

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Twelve Step Facilitation training study

• Multimedia, interactive CD-Rom program
• Role plays, multiple choice questions, practice
  exercises
• Frequently asked questions
• Vignettes of TSF supervision and illustrative
  sessions

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TSF Adherence scores by training condition
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TSF CD Rom Skill scores by training condition
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Challenges for Stage III

• Not how effective is this treatment but
• How much does it cost?
• We only do groups
• Can I do it in 5 minutes?

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Stage III Leads Back to Stage I
Manualized Treatment (CBT)
Delivered through clinician
Low dose of CBT
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Computer-based delivery of CBT as adjunct
Clinician delivers Support, Monitoring, feedback
Flexibility Opportunities for
repetition Interactive individualized Special
features of multimedia format allow pts to
SEE practice effective coping
Patient receives larger dose of CBT, little added
cost
Computer based CBT as adjunct to treatment
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CBT 4 CBTComputer Based Therapy/CBT

• 6 modules, 1 hour each, high flexibility
• Video examples of characters struggling
• Multimedia presentation of skills
• Repeat movie with character using skills to
  change ending
• Interactive exercises, quizzes
• Multiple examples of extra-session practice

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W(h)ither ESTs Key questions

• Efficacy
• First line versus 2nd or 3rd choice
• Adaptive designs?
• Is EVT more effective than clinicians choice?
• Training
• Who to train?
• How much and what kind?
• How sustainable
• Role of supervision
• Costs and benefits?

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