1. Quitline Smoking Intervention: “TALK” Randomized Trial Jonathan B. Bricker, PhD Fred Hutchinson Cancer Research Center University of Washington

2. Scientific Collaborators & Project Partners Jan Blalock, PhD, Psychologist, Univ of Texas/MD Anderson Terry Bush, PhD, Psychologist, Alere, Seattle Jaimee Heffner, PhD, Psychologist, FHCRC Julie Kientz, PhD, Computer Scientist, UW Jennifer McClure, PhD, Psychologist, Group Health Roger Vilardaga, PhD, Psychologist, FHCRC/UW 2 Morrow Inc., Mobile Health, Seattle Blink UX, Web Design, Seattle Collaborative Data Services, Data ops, FHCRC Harvard University Health Communications, Boston Moby, Web Programming, Seattle Nutrition Assessment Shared Resource, Data ops, FHCRC

3. Funding Sources  National Cancer Institute  R01-CA-166646 (PI: Bricker)  R01-CA-151251 (PI: Bricker)  R01-CA-120153 (PI: Blalock)  National Institute on Drug Abuse  R21-DA-030646 (PI: Bricker)  K23-DA-0265517 (PI: Heffner)  K99-DA-0037276 (PI: Vilardaga)  Hartwell Innovation Fund (PI: Bricker)  Fred Hutchinson Cancer Research Center (PI: Bricker)

4. Today’s Tobacco Consequences  The leading cause of preventable death, killing 480K US (Surgeon General, 2014) & 6 million worldwide (WHO, 2013).  Causes lung and multiple cancers, hypertension, CHD, and stroke (Surgeon General, 2014).  $289 Billion in US medical and lost productivity costs (Surgeon General, 2014).

5. Reach & Efficacy of Smoking Intervention Modalities Reach (# of million using modality annually) 1m 2m 3m 4m Efficacy (% Quit at 12 months) 30% 20% 10% Individual Web Telephone Group

6. Acceptance & Commitment Therapy (ACT) is a Potential Solution to the Problem of Low Quit Rates

7. Acceptance of our “baggage” Committed Action in valued direction

8. Pathways to Acceptance  Mindfulness: Present-moment focused attention in the face of challenging circumstances  Defusion: Stepping back and watching the process of thinking  Self-as-Context: The “part” of us that is aware of what we think, feel, and sense

9. Pathways to Commitment  Values: What deeply matters; want you want your life to be about  Action: Doing what it takes, guided by what deeply matters

10. Acceptance & Commitment Lead to Life-Embracing Behavior Change Mindfulness Defusion Self As Context Acceptance Values Commitment Action Life-Embracing Behavior Change

11. DomainACTStandard SC Treatment Theoretical basisRelational frame theory Information processing theories Approach for handling smoking cues AcceptanceAvoidance Approach for increasing motivation ValuesReasons to change Methods for skill training Metaphorical, experiential Literal and logical, explanatory ACT vs. Standard Treatment

12. ACT Research Program: “The Wheel”

13. Telephone-Delivered ACT for Smoking Cessation

14. Quitlines: Address Barriers to Reach  Accessible: In US, 95% have a telephone. (Pew Internet & American Life Project, 2009)  Available: All 50 States have a quitline as do most of Europe and Latin America  Cost-effective: Covered by insurance, Medicaid, or the state. Costs less than group and with only 25% lower fraction of effectiveness.  Relatively brief: about 90 minutes total (3 to 9 sessions)  Many demographics make use: Men, minorities, poor

15. Phase II Trial of Telephone-Delivered ACT vs. CBT for Smoking Cessation (R21DA030646; PI: Bricker)  Primary Aim 1: Compare ACT with CBT on implementation outcomes  Primary Aim 2: Demonstrate that ACT, as compared to CBT, has trend toward cessation. Primary outcome: 30 pp at 6 month post tx  Primary Aim 3: Determine mediation by acceptance of smoking cues and commitment to quitting

16. TALK Consort Diagram Screened (n=237) Excluded (n= 87)  Declined Eligibility Survey (n=46)  Ineligible (n=36)  Did not take Baseline Survey (n=5) Analysed for 3 months (n=59) Analysed for 6 months (n=59) Lost to follow-up 3-months (n= 19) Lost to follow-up 6-months (n=16) Allocated to intervention (n=59)  Received 5 calls (n=28)  Received 4 calls (n=4)  Received 3 calls (n=5)  Received 2 calls (n=7)  Received 1 calls (n=7)  Received 0 calls (n= 8) Lost to follow-up 3-months (n= 22) Lost to follow-up 6-months (n= 24) Allocated to CBT (n=62)  Received 5 calls (n=3)  Received 4 calls (n=6)  Received 3 calls (n=21)  Received 2 calls (n=10)  Received 1 calls (n=16)  Received 0 calls (n=6) Analysed for 3 months (n=62) Analysed for 6 months (n=62) Allocation Analysis Follow-Up Randomized (n= 121) Enrollment Eligible (n=150) Excluded (n= 29)  Did not confirm by phone (n=29)

17. Aim 1: Baseline Demographics & Retention Demographic Overall (N= 121) CBT (n=62) ACT (n=59) Baseline p=value Outcome p=value Age, mean39.138.639.60.550.89 Female69%73%66%0.400.09 Caucasian73%69%76%0.390.16 Married28%29%27%0.820.51 Working37%31%44%0.130.80 HS or less55%53%56%0.770.20

18. Aim 1: Baseline Smoking & Social Env at Baseline & Retention Demographic Overall (N = 121) CBT (n=62) ACT (n=59) Baseline p=value Outcome p=value Smoking Behavior At least-a- pack/day 36%29%42%0.130.63 Smoked x>10 years 75%76%75%0.880.86 Health Behaviors Depression score, mean 6.36.46.20.780.12 Heavy drinker 11%7%16%0.111 Weight, mean lbs. 187.5190.7184.30.460.68 Env. Smoking Close friends smoke, mean 3.13.03.10.780.45 Partner smokes 37%34%41%0.440.39

19. Calls Attempted & Completed CBT Mean (SD) ACT Mean (SD)p-value Total Call Attempts17.9 (6.7)12.2 (5.2)0.0001 Number of Calls Completed1.69 (1.3)3.25 (1.94)0.001 Completed All 5 Calls3 (4.8%)28 (47.5%)0.001

20. Aim 1: Treatment Competence CBTACT p-value Agreement90.9%98.7%0.10 Mean (SD)4.58 (0.64)4.92 (0.34)0.10

21. Aim 2: NRT Usage CBTACTp-value NRT Usage73%67%0.59

22. Aim 2: Tx Satisfaction CBTACTp-value Satisfied overall85%97%0.10 Recommend to friend83%97%0.06 Program’s skills useful to quit87%100%0.03

23. Aim 3: 6M Quit (30D PP) CBTACT OR (95% CI) 22%31% 1.5 (0.7, 3.4)

24. 6-Month Quit (30D PP) in Key Baseline Subgroups Baseline Subgroup CBTACT OR (95% CI) Pack-A-Day or More17%36% 2.8 (0.6, 12.4) Screened Depressed13%33% 1.2 (1.0-1.6) Avoidant of Cravings10%37% 5.3 (1.3, 22.0)

25. Aim 3: Impact on Avoidance CBT mean (SD) ACT mean (SD)p-value Avoidance of Cravings2.13 (0.42)2.41 (0.67)0.04

26. Aim 3: ACT  3M Avoidance  6M Quit Beta (SE)p-Value ACT (vs. CBT)  3M Avoidance0.29 (0.14)0.04 3M Avoidance  6M Quit Rate2.69 (0.71)0.001

27. Conclusions: Telephone ACT is…  Feasible to deliver  Acceptable to quitline callers  Showing promising quit rates compared to CBT  Operating according to its theoretical model  Ready for a fully-powered RCT

28. Next Grant…  Results stimulated an NIDA research grant application for $3 million  Fully-powered RCT of 1100 participants with one year follow-up  June 2014: Perfect Score in Study Section!

29. Many Thanks! Contact: Dr. Jonathan Bricker Email: jbricker@uw.edujbricker@uw.edu