quitline smoking intervention: “talk” randomized trial jonathan b. bricker, phd fred hutchinson...
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Quitline Smoking Intervention: “TALK” Randomized Trial
Jonathan B. Bricker, PhDFred Hutchinson Cancer Research Center
University of Washington
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
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)
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).
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
Acceptance & Commitment Therapy (ACT) is a Potential
Solution to the Problem of Low Quit Rates
Acceptance of our
“baggage”
Committed Action in valued
direction
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
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
Acceptance & Commitment Lead to Life-Embracing Behavior
Change
Mindfulness
Defusion
Self As Context
Acceptance
Values
Commitment
Action
Life-Embracing Behavior Change
Domain ACT Standard SC Treatment
Theoretical basis Relational frame theory
Information processing theories
Approach for handling smoking cues
Acceptance Avoidance
Approach for increasing motivation
Values Reasons to change
Methods for skill training
Metaphorical, experiential
Literal and logical, explanatory
ACT vs. Standard ACT vs. Standard TreatmentTreatment
ACT Research Program: “The Wheel”
Telephone-Delivered ACT for Smoking Cessation
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
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
TALK Consort Diagra
m
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)
Aim 1: Baseline Demographics & Retention
Demographic
Overall(N= 121)
CBT(n=62)
ACT(n=59)
Baselinep=value
Outcomep=value
Age, mean 39.1 38.6 39.6 0.55 0.89
Female 69% 73% 66% 0.40 0.09
Caucasian 73% 69% 76% 0.39 0.16
Married 28% 29% 27% 0.82 0.51
Working 37% 31% 44% 0.13 0.80
HS or less 55% 53% 56% 0.77 0.20
Aim 1: Baseline Smoking & Social Env at Baseline & Retention
Demographic
Overall(N = 121)
CBT(n=62)
ACT(n=59
)Baselinep=value
Outcomep=value
Smoking Behavior
At least-a-pack/day
36% 29% 42% 0.13 0.63
Smoked x>10 years
75% 76% 75% 0.88 0.86
Health Behaviors
Depression score, mean
6.3 6.4 6.2 0.78 0.12
Heavy drinker 11% 7% 16% 0.11 1Weight, mean lbs.
187.5 190.7 184.3 0.46 0.68
Env. Smoking
Close friends smoke, mean
3.1 3.0 3.1 0.78 0.45
Partner smokes
37% 34% 41% 0.44 0.39
Calls Attempted & Completed
CBTMean (SD)
ACTMean (SD)
p-value
Total Call Attempts 17.9 (6.7) 12.2 (5.2) 0.0001
Number of Calls Completed 1.69 (1.3) 3.25 (1.94) 0.001
Completed All 5 Calls 3 (4.8%) 28 (47.5%) 0.001
Aim 1: Treatment Competence
CBT ACTp-value
Agreement 90.9% 98.7% 0.10
Mean (SD) 4.58 (0.64)4.92
(0.34)0.10
Aim 2: NRT Usage
CBT ACT p-value
NRT Usage 73% 67% 0.59
Aim 2: Tx Satisfaction
CBT ACT p-value
Satisfied overall 85% 97% 0.10
Recommend to friend 83% 97% 0.06
Program’s skills useful to quit 87% 100% 0.03
Aim 3: 6M Quit (30D PP)
CBT ACTOR
(95% CI)
22% 31%1.5
(0.7, 3.4)
6-Month Quit (30D PP) in Key Baseline Subgroups
Baseline Subgroup CBT ACTOR
(95% CI)
Pack-A-Day or More 17% 36%2.8 (0.6, 12.4)
Screened Depressed 13% 33%1.2
(1.0-1.6)
Avoidant of Cravings 10% 37%5.3 (1.3, 22.0)
Aim 3: Impact on Avoidance
CBTmean (SD)
ACTmean (SD) p-value
Avoidance of Cravings 2.13 (0.42) 2.41 (0.67) 0.04
Aim 3: ACT3M Avoidance6M Quit
Beta (SE) p-Value
ACT (vs. CBT)3M Avoidance
0.29 (0.14) 0.04
3M Avoidance6M Quit Rate
2.69 (0.71) 0.001
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
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!
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