quitline smoking intervention : “talk” randomized trial

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!

Many Thanks!

Contact: Dr. Jonathan Bricker

Email: jbricker@uw.edu