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Bill miller icmi 2012 plenary

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Bill miller icmi 2012 plenary

  1. 1. Saint• Servolo
  2. 2. Spectacular Failures with MI ICMI 2012William R. Miller
  3. 3. But first: somespectacular successes
  4. 4. What CTN Clinicians Think is Meaningful How much better would a new treatment have to be?8070 Clinically significant60 improvement =5040 large enough to be30 interested in learning a Pre new treatment method.2010 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. 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. 6. Allsop et al., 1997200 189150 107100 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. 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. 8. Monti et al., 1999 Outcomes Over 6 Months 90 85 80 70 62 60 50Percent 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. 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. 10. Thevos et al., 2000 Bleach Sales: Bottles/Household/Month1.41.2 10.8 MI0.6 Educ0.40.2 0 Months 1-2 Months 3-4 Months 5-6 OR=4.32 OR=3.69 OR=3.29 p<.001
  11. 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. 12. Outcome: Soria et al. (2006) OR = 5.2 (1.6-17.1)
  13. 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. 14. Outcomes: Watkins et al 201160 54.350 42.64030 Usual Care MI20 13.810 7.30 % Normal Mood % Dead OR=1.66 (1.08-2.55) OR=2.15 (1.06-4.38)
  15. 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. 16. Outcomes: Seal et al 201270 1.8 1.68 62 1.660 1.450 1.240 1 Control Control 0.830 26 MI MI 0.620 0.38 0.410 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. 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. 18. The news is not all good•
  19. 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. 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. 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. 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. 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. 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. 25. Broekhuisen et al., 2012 BMC Public Health, 12:348 doi:10.1186/1471-2458-12-348Training: 3-day MI training workshopFidelity 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 orlifestyle behaviors
  26. 26. Type P Power Failure• We had a relatively small sample and low power to detect a difference• There was no difference
  27. 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. 28. Bien et al., 1993 6-Month Drinking Outcomes140 131.4120100 91 8180 71 MI60 50 TAU 37.94020 0 Drinks per Month Peak BAC (mg%) % Days Abstinent No significant differences in outcomes at 6 months
  29. 29. Type C Comprehension Failure• We tried “MI” (which doesn’t sound much like MI)• It didn’t work
  30. 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. 31. Kuchipudi et al., 1990 Percent with Confirmed Abstinence 35 32 29 30 25Percent 20 MI 15 TAU 10 5 0 Confirmed Abstinence NS: Needed a 30% difference for statistical significance
  32. 32. What was the MI? Kuchipudi et al (1990)“Interviews with three different personsemphasizing the need for and benefits ofalcoholism therapy and . . the relationshipof the patient’s disease to continueddrinking. The person’s health and drinkingwere reviewed from the viewpoint and withthe authority of the director of the unit.”
  33. 33. Methodological Contributions to Negative Trials• Type Q: QA Monitoring Failure• Type F: Fidelity Failure• Type P: Power Failure• Type C: Comprehension Failure
  34. 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. 35. MIDAS StudyMiller 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. 36. MIDAS Study Outcome 0.80.75 0.70.65 0.60.55 TAU 0.50.45 0.40.35 0.3 Intake 3mo 6mo 9mo 12mo
  37. 37. MIDAS Study Outcome 0.80.75 0.70.65 0.60.55 TAU 0.5 TAU+MI0.45 0.40.35 0.3 Intake 3mo 6mo 9mo 12mo
  38. 38. Commitment Language in MI 21.5 10.5 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. 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. 40. NIDA Clinical Trials Network MI/MET vs. Treatment as Usual A priori comparisons on retention and drug useFour Multisite Randomized Clinical TrialsCarroll et al (2006) Outpatient treatment No treatment effect of MIBall et al (2007) Outpatient treatment No treatment effect of METWinhusen et al (2008) Pregnant drug users No treatment effect of METCarroll et al (2009) Spanish-speakers No treatment effect of MI
  41. 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. 42. Treatment Sessions Completed (in first 28 days; Carroll et al., 2006)MET>TAU p<.05 Cohen’s d = .24 (.56 for alcohol usersNo significant difference in substance use (p<.06 for alcohol)
  43. 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. 44. Ball et al., 2007 OutcomesMET = 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. 45. Days Drug Use Per Week (Ball et al., 2007)Treatment x Phase interaction: p<.001 favoring MET in weeks 5-16
  46. 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. 47. Treatment Sessions Attended Winhusen et al, 2008 No significant difference
  48. 48. % Drug-Positive Urine Samples Winhusen et al, 2008 Site by Treatment Interaction
  49. 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. 50. Days Retained in Treatment (All Drugs, Carroll et al., 2009)120 TAU MET100 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. 51. Days Retained in Treatment (Alcohol as Primary Drug, Carroll et al., 2009) Treatment: p<.02 favoring MET
  52. 52. Days Drinking Per Week(Alcohol as Primary Drug; Carroll et al., 2009) Treatment x Time: p<.02 favoring MET
  53. 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. 54. Heisler et al., 2012 Circulation (in press)Training• 3-day MI workshop• Biweekly booster training in webinarsQuality Assurance• “At six months an expert assessment of pharmacists’ MI techniques concluded that all pharmacists met or exceeded MI proficiency standards”
  55. 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, indifferent real-life clinical settings, programs found inefficacy trials to be effective before urging theirwidespread adoption in all settings”
  56. 56. What’s Going On? Some possibilities:1. TAU is tough to beat in top programs2. 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 CTN4. We’re not alone among multisite trials
  57. 57. Other Evidence-Based TreatmentsShowing No Effect in CTN Trials• Seeking Safety• Job Seekers Workshop• Telephone follow-up• Smoking cessation• Brief strategic family therapy
  58. 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. 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. 60. The woods are lovely, dark and deep
  61. 61. and miles to go before we sleep

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