This study will evaluate the comparative effectiveness of three smoking cessation therapies: mobile health (mHealth) application iCanQuit, mHealth application iCanQuit + Motiv8, and the Florida quit line.
The research team will recruit 1,332 adult patients who smoke from primary care clinics in North Central Florida, focusing on: (a) the relative effectiveness of the 3 treatments in adult patients who smoke cigarettes, in underserved urban and rural primary care settings. The team will assign patients by chance to one of the 3 treatments. Smoking cessation will be confirmed with a breath test (measured at 2, 6, and 12 months). The study will measure the effects of these treatments in based on gender, race, ethnicity, rurality, and social vulnerability; (b) their effects on patients' quality of life, self-confidence in quitting, and satisfaction with the treatments; and (c) their impact on patients' reported levels of motivation, commitment to values, and acceptance of triggers for smoking.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
1,332
iCanQuit is a smoking cessation smart phone application that uses acceptance and commitment therapy (ACT) approach, a cognitive behavioral treatment
iCanQuit + Motiv8 is a integrated version of iCanQuit (Cognitive Behavioral Therapy smoking cessation therapy application) with Motiv8 (a contingency management program that rewards decreased smoking determined by measuring CO levels of participant)
An evidence-based, existing smoking cessation healthcare option recommended by the U.S. clinical practice that connects active smokers to trained quit coaches via referral by their providers.
University of Florida
Gainesville, Florida, United States
RECRUITINGSmoking Point-Prevalence Abstinence (PPA)
negative CO breath sample ≤ 5 ppm using an iCO monitor, and self-reported abstinence from smoking in the last 7 days
Time frame: Month 6
Smoking Point-Prevalence Abstinence (PPA)
negative CO breath sample ≤ 5 ppm using an iCO monitor, and self-reported abstinence from smoking in the last 7 days
Time frame: Months 2 and 12
Treatment Satisfaction
5-item scale measuring treatment by interest, usefulness, concern with privacy, how easy to understand, and satisfaction. Items will be measured on a 0-10 point scale, with higher scores corresponding to greater acceptability.
Time frame: Month 12
Quality of Life and Well-Being
World Health Organization Quality of Life-BREF (WHOQOL-BREF): 26-item scale that measures quality of life. Items are rated on a 5-point Likert scale (low score of 1 to high score of 5), with a higher score indicating a higher quality of life.
Time frame: Baseline, and month 6
Self Efficacy
Self-Efficacy Questionnaire (SEQ-12): 12-item scale. Items are rated on a 5-point Likert scale (low score of 1 to high score of 5), with higher scores indicating greater self-efficacy.
Time frame: Baseline, and month 6
Acceptance
9-item physical sensations subscale of the Avoidance and Inflexibility Scale. Items are rated on a 5-point Likert scale (low score of 1 to high score of 5), with higher scores reflecting more inflexibility/avoidance in the presence of difficult smoking-related thoughts, feelings, and sensations.
Time frame: Months 2 and 6
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Values
Valuing Questionnaire (VQ): 10-item measure assessing the extent to which one lives consistently with their values, including Progress and Obstruction subscales. Both subscales total scores range from 0 to 30. A psychologically healthier score is indicated by a higher score on the Progress scale along with a lower score on the Obstructions scale.
Time frame: Months 2 and 6
Motivation
Motivational Engagement Questionnaire: 5-item measure. Items are rated on a 7-point Likert scale (low score of 1 to high score of 7), with higher scores indicating more motivation to quit smoking.
Time frame: Months 2 and 6
Smoking Prolonged Abstinence
Self-reported abstinence from the date of the last time a cigarette was smoked.
Time frame: Months 6 and 12