Quitline Smoking Intervention : “TALK” Randomized Trial

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

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 Values Commitment Acceptance Defusion Self As Context Action Life-Embracing Behavior Change

11. 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) Enrollment Eligible (n=150) • Excluded (n= 29) • Did not confirm by phone (n=29) Randomized (n= 121) • 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) • 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) Allocation Lost to follow-up 3-months (n= 19) Lost to follow-up 6-months (n=16) Lost to follow-up 3-months (n= 22) Lost to follow-up 6-months (n= 24) Follow-Up Analysed for 3 months (n=59) Analysed for 6 months (n=59) Analysed for 3 months (n=62) Analysed for 6 months (n=62) Analysis

17. Aim 1: Baseline Demographics & Retention

18. Aim 1: Baseline Smoking & Social Env at Baseline & Retention

19. Calls Attempted & Completed

20. Aim 1: Treatment Competence

21. Aim 2: NRT Usage

22. Aim 2: Tx Satisfaction

23. Aim 3: 6M Quit (30D PP)

24. 6-Month Quit (30D PP) in Key Baseline Subgroups

25. Aim 3: Impact on Avoidance

26. Aim 3: ACT3M Avoidance6M Quit

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.edu