William R. Miller, Ph.D.

The University of New Mexico

The Eileen Pencer Memorial Lecture

Have you noticed:that in multisite clinical trials (like CTN)of treatments that are already evidence-basedeven under highly controlled, supervised,

manual guided delivery conditionsthe expected main effects are often quite small?and that efficacy often varies by therapist and by

site? This even happens with

pharmacotherapies In practice, EBTs are not homogeneous

entities

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Intake 4 Months 16 Months

CBI + PlaceboNaltrexone, No CBIPlacebo, No CBICBI + Naltrexone

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CBT MET TSF

Project MATCH COMBINE Study

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43.246.6

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Baseline 3 Months 12 MonthsMI SBNT

Percent Days Abstinent

MI = 3 Sessions vs. SBNT = 8 Sessions

TREATMENT TESTED

004 MET005 MI013 MET 021 MET009 Smoking cess.011 Tele calls015 Seeking Safety006 Incentives007 Incentives

PRIMARY OUTCOME

Drug use & retention days - nsdUse: nsd 5 vs. 4 sessions p<.05Retention nsd (pregnant users)Drug use & retention nsdCessation nsd by 13 weeksRetention nsd; PTSD symptoms & drug use nsd8.6 vs 5.2 sessions abstinent

p<.0015.5 vs 2.3 sessions abstinent p

<.001

The specific effect size for manual-guided EBT is typically small

Even small effects may be clinically meaningful

With large multisite samples, statistical significance can be found for small effects, but do clinicians care?

Miller, W. R., & Manuel, J. K. (2008). How large must a treatment effect be before it matters to practitioners? An estimation method and demonstration. Drug and Alcohol Review, 27, 524-528.

Clinically significant improvement= large enough to be interested in learning a new treatment method.

Approximately 10 pointincrease in % doing well ordoubling or halving ofcontinuous measures

Learning More from Clinical Trials

In practice, there is.In practice, there is.

In practice, evidence-based treatments are not homogeneous entities

Where are the bigger effects?

So

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Azrin 1973 Azrin 1976 Azrin 1982

Traditional

CRA

% DaysAbstinent

% DaysAbstinent

Psychologists tested patients in three different treatment programs

They identified patients with particularly high alcoholism recovery potential (HARP)

HARP vs. non-HARP patients did not differ from each other on prior treatment history or severity of alcoholism

More motivated for counseling More punctual in meeting

appointments Showing greater self-control Neater and more attractive in

appearance More cooperative Trying harder to stay sober Showing better recovery

Higher rates of abstinence Longer spans of abstinence Fewer slips More employment

“HARPs” had been selected at random.

Counselor expectations matter a lot.

Average 12-Month Drinking Outcomes for 8,389 Clients

Survival 98.5% Percent Continuous Abstinence

24.1% Percent Days Abstinent: 81.4% Average Reduction in Consumption 87.0%

Overall outcomes were fairly similar for treatment as usual (RAND, VAST, RREP), pharmacotherapy trials (lithium, disulfiram), and controlled trials of psychosocial treatments (MATCH)

Miller, W. R., Walters, S. T., & Bennett, M. E. (2001). How effective is alcoholism treatment? Journal of Studies on Alcohol, 62, 211-220.

Percent Days Abstinent

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Pre Months 1-3 Months 4-6

MATCH

Westerberg, V. S., Miller, W. R., & Tonigan, J. S. (2000). Comparison of outcomes for clients in randomized versus open trials of treatment for alcohol use disorders. Journal of Studies on Alcohol, 61, 720-727

Percent Days Abstinent

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MATCH

TAU

Westerberg, V. S., Miller, W. R., & Tonigan, J. S. (2000). Comparison of outcomes for clients in randomized versus open trials of treatment for alcohol use disorders. Journal of Studies on Alcohol, 61, 720-727

Luborsky, McLellan, Woody, O’Brien & Auerbach, 1985 Archives of General Psychiatry 42:602-611

Two drug treatment counselors resigned

Their 62 cases were assigned randomly to the four remaining counselors

There were dramatic differences in client outcomes.

McLellan et al., 1988 Journal of Nervous and Mental Disease, 176, 423-430.

% Positive Urines Methadone Dose

% Employed % Arrested

McLellan et al. (1988). Journal of Nervous and Mental Disease, 176, 423-430.

Mean PDA Week 68Mean PDA Week 52Mean PDA Week 26Mean PDA Week 4Mean PDA Baseline

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All Clients got “the same” manual-guided treatmentin the NIAAA COMBINE Study

Much emphasis is given to “common factors” as an alternative to EBTs

So-called “common factors” may or may not be all that common in practice

If they do exert a large effect, they should not be hard to observe

“Nonspecific” just means that they have not yet been adequately specified and tested

So why not both . . and?

Miller, Benefield & Tonigan (1993) JCCP 61: 455-461

Confront (r = .65)

Miller, Benefield & Tonigan (1993) JCCP 61: 455-461

42%

Accurate empathy is a well-specified, learnable, reliably measurable therapist skill – the ability to understand and reflect clients’ meaning

Originally defined and studied by Carl Rogers

It is not identification with your client

Were delivering the same manual-guided behavior therapy (self-control training)

Were trained both in behavior therapy and accurate empathy

Had sessions independently observed and rated by three supervisors, including the Truax & Carkhuff scale for accurate empathy

Were then rank-ordered (1-9) for empathic skill while delivering behavior therapy

And when we examined 6-month client outcomes . . . .

Miller, Taylor & West (1980) JCCP 48:590-601

60

6 months 12 months 24 months

r = .82 r = .71 r = .51

Miller & Baca (1983) Behavior Therapy 14: 441-448

67% 52% 26%

Patients in treatment for alcoholism were randomly assigned to counselors with:

LOW levels of empathy and related skillsMEDIUM levels of empathy and related

skillsor HIGH levels of empathy and related skills

What percentage of patients relapsed?

Valle (1981) J Studies on Alcohol 42: 783-790

Invalidated Resist Withdraw

Not respected Arguing DisengagedNot understood Discounting DislikingNot heard Defensive InattentiveAngry Oppositional PassiveAshamed Denying Avoid/leaveUncomfortable Delaying Not returnUnable to changeJustifying

Affirmed AcceptApproach

Understood Open Talk moreAccepted Undefensive LikingRespected Interested EngagedHeard Cooperative ActivatedComfortable/safe Listening Come backEmpoweredHopeful/Able to change

OpenCooperativeArguingEngagedActiveEmpoweredHopefulLiking

DefensiveOppositionalListeningDisengagedPassivePowerlessUnable to

changeDisliking

Bien et al 1993

Brown & Miller 1993

Aubrey 1998

20 minutes in ER One handwritten letter

One telephone call Systematic

Encouragement

Hire Empathic Therapists!

It is an evidence-based practice to hire staff based on and to train staff in

the skill of accurate empathy

Percentage of variance in 12-month drinking

outcome determined by therapist factors (random assignment designs)

There’s some beef!

Miller, Taylor & West 1980 Valle 1981 Miller et al., 1993

52% 42%

Empathy Empathy+ Confronting (-)

65%

OR THE OR THE BOARDSBOARDS

and some of them are influenced by the therapist

Motivation for change Self-efficacy Hope/optimism Attendance/adherence

Involving a spouse in treatment significantly improves client substance use outcomes

And again it matters what you do

There are some specific treatment effects generally supported by clinical trials

They are often relatively small compared to Therapist effects Client effects and social context Overall impact of treatment And perhaps for these reasons they vary across

sites These larger “nonspecifics” (e.g.,

empathy) need to be specified, tested, and trained as EBTs

Treatment-as-usual is a high standard to beat

Re-training staff in EBTs can be challenging and expensive

Specific treatment effect size often shrinks with dissemination into clinical practice

Therapist belief/enthusiasm / style matters Testable question: Is it cost effective to re-

train staff in an EBT? In any event, it makes sense to train the

next generation of addiction professionals in EBTs from the very beginning!

What is it about the therapists who are delivering the treatment that affects outcome?

What is it about the treatment that really matters?

Understanding the underlying mechanisms of efficacy of treatments and therapists will help us to know: Whom to hire What is essential in training What to focus on in fidelity monitoring What can be changed in adaptations