MET vs TAU in 4 large multisite RCTs found: 1) No main effect on retention or substance use for outpatient treatment. 2) One study found a small effect on early retention but not substance use. 3) Studies of pregnant drug users and Spanish speakers also found no main effects of MET vs TAU. The findings suggest MET may not produce meaningful improvements over TAU in typical substance abuse treatment settings based on these high quality trials.

1. Saint
•
Servolo

2. Spectacular Failures with MI
ICMI 2012
William R. Miller

3. But first:
some
spectacular
successes

4. What CTN Clinicians Think is Meaningful
How much better would a new treatment have to be?
80
70
Clinically significant
60
improvement =
50
40
large enough to be
30 interested in learning a
Pre new treatment method.
20
10 Significant
0
About 10 point increase in
% doing well or
doubling or halving of
continuous measures
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.

5. Allsop et al., 1997
Addiction, 92:61-74
• Design Randomized clinical trial
• Population Alcohol abuse
• Nation Scotland
• N 60 adult outpatients
• MI 8 session group MI + skills
• Comparison Group discussion TAU
• Follow-up 6 months

6. Allsop et al., 1997
200 189
150
107
100 MI+ RP
TAU
50 40
25 27
5
0
% Abstinent Days to First Days to Relapse
Drink
OR=8.0
p<.04 p<.03
p<.01

7. Monti et al., 1999
Journal of Consulting and Clinical Psychology, 67:989-994
• Design Randomized clinical trial
• Population Emergency room
• Nation US (Providence, RI)
• N 94 adolescents (18-19)
• MI 1 session (35-40 min)
• Comparison Standard care
• Follow-up 6 months

8. Monti et al., 1999
Outcomes Over 6 Months
90 85
80
70 62
60 50
Percent
50 MI
40
30 23 TAU
21
20
10 3
0
Drinking & Moving Violations Alcohol-Related
Driving Injury
OR=0.73 OR=0.13 OR=0.42
p<.05 p<.05 p<.01

9. Thevos et al, 2000
HMI Enhances the Adoption of Water Disinfection Practices in Zambia
health Promotion International, 15:207-214
• Design Comparison zones
• Population Water purification adoption
• Nation Zambia, Africa
• N 332 households
• MI Health visitor consults
• Comparison Health education
• Follow-up 6 months

10. Thevos et al., 2000
Bleach Sales: Bottles/Household/Month
1.4
1.2
1
0.8 MI
0.6 Educ
0.4
0.2
0
Months 1-2 Months 3-4 Months 5-6
OR=4.32 OR=3.69 OR=3.29
p<.001

11. Soria et al (2006)
A Randomized Controlled Trial of MI for Smoking Cessation
British Journal of General Practice, 65:768-774
• Design Randomized clinical trial
• Population Primary care
• Nation Spain
• N 200 smokers
• MI 3 GP sessions (20 min)
• Comparison Physician advice
• Follow up 12 months

12. Outcome: Soria et al. (2006)
OR = 5.2 (1.6-17.1)

13. Watkins et al. 2011
12-Month Effects of Early MI After Acute Stroke
Stroke 42: 1956-1961
• Design: Randomized controlled trial
• Nation: United Kingdom
• Sample: 411 adults after acute stroke
• Control: Usual stroke care
• Intervention: 4 individual MI sessions (30-60 min)
• Follow-up: 12 months
• Target: Decrease low mood/depression

14. Outcomes: Watkins et al 2011
60
54.3
50
42.6
40
30 Usual Care
MI
20
13.8
10 7.3
0
% Normal Mood % Dead
OR=1.66 (1.08-2.55) OR=2.15 (1.06-4.38)

15. Seal et al. 2012
A randomized controlled trial of telephone MI to enhance mental health
treatment engagement in Iraq and Afghanistan veterans
General Hospital Psychiatry, in press
• Design: Randomized controlled trial
• Nation: US (San Francisco)
• Sample: 73 Iraq & Afghanistan veterans
• Control: Referral + 4 phone check-ins
• Intervention: Referral + 4 phone MI
• Follow-up: 16 weeks
• Target: Engagement in MH treatment

16. Outcomes: Seal et al 2012
70 1.8 1.68
62 1.6
60
1.4
50 1.2
40 1
Control Control
0.8
30 26 MI
MI 0.6
20 0.38
0.4
10 0.2
0 0
% Engaged Visits (Mean)
OR=2.41 (1.33-4.37) OR=4.36 (1.96-9.368
Effect size = .74

17. Some addiction treatment trials with
>2:1 abstinence advantage for MI
Alcohol: Allsop et al (1997)
Brown & Miller (1993)
Amphetamine: Baker et al (2001)
Marijuana: Babor et al (2004)
Barrowclough et al (1998)
Stephens et al (2000)
Tobacco: Colby et al (1998)
Soria et al (2006)

18. The news is not all
good
•

19. Type Q
Quality Assurance Failure
• We gave practitioners a little training
• We didn’t measure fidelity (well)
• They tried MI
• It didn’t work

20. Robling et al., 2012
British Medical Journal, 344 doi: 10.1136/bmj.e2359
• Design Cluster randomized clinical trial
• Population Pediatric diabetes services
• Nation UK
• N 693 children (4-15 yr) with Type
1 diabetes. and their caregivers
• MI Agenda setting and guiding
• Comparison Clinical teams delivering TAU
• Follow-up 1 year HbA1c

21. Robling et al., 2012
British Medical Journal, 344 doi: 10.1136/bmj.e2359
Training
• On-line training + two 4-hour workshops with
MINT members
• Home-made global rating scale used for QA
• Guiding & agenda setting skill increased
significantly in the intervention group clinicians
• Skill ratings maintained over 1 year follow-up
• Absolute skill level unclear – was it MI?

22. Robling et al., 2012
British Medical Journal, 344 doi: 10.1136/bmj.e2359
Outcome
• No treatment effect (between groups)
• HbA1c values increased (worse) in both groups

23. Type F
Fidelity Failure
• We gave practitioners a fair amount of
training and measured fidelity (QA)
• MI fidelity was poor
• They tried MI
• It didn’t work

24. Broekhuisen et al., 2012
BMC Public Health, 12:348 doi:10.1186/1471-2458-12-348
• Design Randomized clinical trial
• Population Familial hypercholesterolemia
• Nation The Netherlands
• N 340 adults screened+ for FH
• MI Computer advice, Lifestyle coach
session + 4 phone boosters
• Comparison No-intervention control
• Follow-up 12 months

25. Broekhuisen et al., 2012
BMC Public Health, 12:348 doi:10.1186/1471-2458-12-348
Training: 3-day MI training workshop
Fidelity monitoring: MITI
“None of the analysed face-to-face counseling sessions
met the MITI thresholds. . . Skills required for effective
MI may take longer to develop than the 3-day MI
workshop in our project.”
Outcome: No significant effect on LDL or
lifestyle behaviors

26. Type P
Power Failure
• We had a relatively small sample and
low power to detect a difference
• There was no difference

27. Bien et al., 1993
Behavioural & Cognitive Psychotherapy, 21:347-356
• Design Randomized clinical trial
• Population Outpatient alcohol (VA)
• Nation US (Albuquerque, NM)
• N 32 adults
• MI 1 session MET (+ TAU)
• Comparison TAU
• Follow-up 3 + 6 months post discharge

28. Bien et al., 1993
6-Month Drinking Outcomes
140 131.4
120
100 91
81
80 71 MI
60 50 TAU
37.9
40
20
0
Drinks per Month Peak BAC (mg%) % Days Abstinent
No significant differences in outcomes at 6 months

29. Type C
Comprehension Failure
• We tried “MI” (which doesn’t
sound much like MI)
• It didn’t work

30. Kuchipudi et al., 1990
Journal of Studies on Alcohol, 51:356-360
• Design Randomized clinical trial
• Population Pancreatitis, ulcer or cirrhosis;
non-responders to prior advice
• Nation US (Hines, IL)
• N 114 alcohol-related admissions
• MI 3 sessions with 3 practitioners
• Comparison TAU
• Follow-up 16 weeks
• Outcome Drinking or not

31. Kuchipudi et al., 1990
Percent with Confirmed Abstinence
35 32
29
30
25
Percent
20
MI
15 TAU
10
5
0
Confirmed Abstinence
NS: Needed a 30% difference for statistical significance

32. What was the MI?
Kuchipudi et al (1990)
“Interviews with three different persons
emphasizing the need for and benefits of
alcoholism therapy and . . the relationship
of the patient’s disease to continued
drinking. The person’s health and drinking
were reviewed from the viewpoint and with
the authority of the director of the unit.”

33. Methodological Contributions
to Negative Trials
• Type Q: QA Monitoring Failure
• Type F: Fidelity Failure
• Type P: Power Failure
• Type C: Comprehension Failure

34. Type M
Method Failure
• C:
MI was well understood
• Q:
Intervention quality was monitored
• F:
Fidelity was good
• P:
Sample was large enough to detect a
clinically meaningful effect
• And yet no effect was observed

35. MIDAS Study
Miller et al (2003); Journal of Consulting & Clinical Psychology 71:754-763
• Design Randomized clinical trial
• Population Treatment for drug use disorder
• Nation US (Albuquerque)
• N 114 alcohol-related admissions
• MI 1 MET session, up to 90 minutes
• Comparison TAU
• Follow-up 12 months
• Outcome Drug use

36. MIDAS Study Outcome
0.8
0.75
0.7
0.65
0.6
0.55
TAU
0.5
0.45
0.4
0.35
0.3
Intake 3mo 6mo 9mo 12mo

37. MIDAS Study Outcome
0.8
0.75
0.7
0.65
0.6
0.55 TAU
0.5 TAU+MI
0.45
0.4
0.35
0.3
Intake 3mo 6mo 9mo 12mo

38. Commitment Language in MI
2
1.5
1
0.5
0
-0.5
-1
Successful
-1.5
Unsuccessful
-2
1 2 3 4 5 6 7 8 9 10
Time in MI Session (deciles)

39. Type S: Spectacular Failure
• C: MI was well understood
• Q: Intervention quality was monitored
• F: Fidelity and training were good
• P: Large sample for power
• Multisite replication
• No main effect observed

40. NIDA Clinical Trials Network
MI/MET vs. Treatment as Usual
A priori comparisons on retention and drug use
Four Multisite Randomized Clinical Trials
Carroll et al (2006) Outpatient treatment
No treatment effect of MI
Ball et al (2007) Outpatient treatment
No treatment effect of MET
Winhusen et al (2008) Pregnant drug users
No treatment effect of MET
Carroll et al (2009) Spanish-speakers
No treatment effect of MI

41. Carroll et al., 2006
Drug & Alcohol Dependence, 81:301-312
• Design Multisite randomized clinical trial
• Population Substance abuse treatment entry
• Nation US (NIDA Clinical Trials Network)
• N 423 outpatients at 5 sites
• MI 2h evaluation in MI style
• Comparison 2h TAU evaluation/assessment
• Follow-up 12 weeks
• Outcome Retention and substance use

42. Treatment Sessions Completed
(in first 28 days; Carroll et al., 2006)
MET>TAU p<.05 Cohen’s d = .24 (.56 for alcohol users
No significant difference in substance use (p<.06 for alcohol)

43. Ball et al., 2007
Journal of Consulting and Clinical Psychology, 75(4), 556-567
• Design Multisite randomized clinical trial
• Population Substance abuse treatment entry
• Nation US (NIDA Clinical Trials Network)
• N 461 outpatients at 5 sites
• MI 3 individual MET sessions
• Comparison TAU
• Follow-up 16 weeks
• Outcome Retention and substance use

44. Ball et al., 2007 Outcomes
MET = TAU (no significant difference) on
MET TAU
Days enrolled in treatment 72 69
% still enrolled at 4 months 43% 41%
No main effect of MET vs. TAU on
% positive urine samples 21% 28%
% drug use days

45. Days Drug Use Per Week
(Ball et al., 2007)
Treatment x Phase interaction: p<.001 favoring MET in weeks 5-16

46. Winhusen et al., 2008
Journal of Substance Abuse Treatment, 35(2), 161-173
• Design Multisite randomized clinical trial
• Population Pregnant drug users
• Nation US (NIDA Clinical Trials Network)
• N 400 women at 4 sites
• MI 3 individual MET sessions
• Comparison TAU
• Follow-up 16 weeks
• Outcome Drinking or not

47. Treatment Sessions Attended
Winhusen et al, 2008
No significant difference

48. % Drug-Positive Urine Samples
Winhusen et al, 2008
Site by Treatment Interaction

49. Carroll et al., 2009
Journal of Consulting and Clinical Psychology, 77(5), 993-999
• Design Multisite randomized clinical trial
• Population Substance abuse treatment entry
• Nation US (NIDA Clinical Trials Network)
• N 405 Spanish-speaking clients
• MI 3 individual MET sessions
• Comparison TAU
• Follow-up 16 weeks
• Outcome Retention and substance use

50. Days Retained in Treatment
(All Drugs, Carroll et al., 2009)
120
TAU MET
100
80
60
40
20
0
Site 1 Site 2 Site 3 Site 4 Site 5 Total
No significant difference in retention or drug use

51. Days Retained in Treatment
(Alcohol as Primary Drug, Carroll et al., 2009)
Treatment: p<.02 favoring MET

52. Days Drinking Per Week
(Alcohol as Primary Drug; Carroll et al., 2009)
Treatment x Time: p<.02 favoring MET

53. Heisler et al., 2012
Circulation (in press)
• Design Cluster randomized pragmatic trial
• Setting 2 high-performing health systems
• Nation US (VA & Kaiser Permanente)
• N 4100 diabetes with uncontrolled BP
• MI Script-guided pharmacist encounters
(phone or in person) during 14 months
• Comparison Usual care
• Follow-up 6 months (after 14 months)
• Outcome Systolic BP from med care records

54. Heisler et al., 2012
Circulation (in press)
Training
• 3-day MI workshop
• Biweekly booster training in webinars
Quality Assurance
• “At six months an expert assessment of pharmacists’
MI techniques concluded that all pharmacists met or
exceeded MI proficiency standards”

55. Reduction in Systolic BP
Heisler et al, 2012
9.7 TAU MI
9 8.9
7.2
3 months 6 months
p < .001
“These findings show the importance of evaluating, in
different real-life clinical settings, programs found in
efficacy trials to be effective before urging their
widespread adoption in all settings”

56. What’s Going On?
Some possibilities:
1. TAU is tough to beat in top programs
2. MI losing its efficacy? (method failure)
“Use the new treatments while they still work”
Becoming diffuse with diffusion?
MI penetration into TAU?
3. Therapists were randomly assigned in CTN
4. We’re not alone among multisite trials

57. Other Evidence-Based Treatments
Showing No Effect in CTN Trials
• Seeking Safety
• Job Seekers Workshop
• Telephone follow-up
• Smoking cessation
• Brief strategic family therapy

58. We don’t yet know:
• What components of MI fidelity are most
important in determining outcomes?
• What factors (besides fidelity and empathy)
influence therapist effectiveness with MI?
• Why does MI work at some sites and not
others?
• Are there client populations/attributes for
whom MI is ineffective, and why?
• What is “treatment as usual” (when that is
the comparison)?

59. What we do know so far:
• Efficacy of MI has been reported across nations,
populations, and change targets
• The effect size of MI varies widely across:
– Studies
– Sites within studies
– Therapists within sites
• Expect small or no effect comparing MI to TAU
• Empathy matters (often not measured)
• Counselor fidelity matters
• Client change talk matters

60. The woods are lovely, dark and deep

61. and miles to go before we sleep