This trial investigates the benefits of different resources that may help cigarette smokers quit smoking, including a new mobile application for smoking cessation called Goal2Quit and nicotine replacement therapy via primary care. Goal2Quit is a depression-specific smoking cessation mobile application. Goal2Quit paired with nicotine replacement therapy and primary care may help depressed smokers to quit smoking.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03837379.
PRIMARY OBJECTIVES:
I. Develop Goal2Quit consistent with the behavioral activation (BA) for smoking cessation manual and will complete usability testing of the application (app) with depressed smokers (N=10) engaged with primary care.
II. Refine the app and preliminarily test the integrated intervention via a single-arm feasibility test (N=10) followed by individual interviews to address potential pitfalls.
III. Conduct an randomized controlled trial (RCT) (N=150, followed for 12 weeks) of Goal2Quit + nicotine replacement therapy (NRT) sampling as compared to treatment as usual (TAU) among primary care engaged adults with primary objective to provide effect size estimates for a larger RCT.
OUTLINE:
USABILITY TESTING: Patients are audio and video recorded while using Goal2Quit.
FEASIBILITY TESTING: Patients receive a code to download Goal2Quit, use the app for over 10 minutes, and ask questions about its functionality. Patients also receive a 2-week starter kit sample of NRT (patch and lozenge), educational materials suggesting that Goal2Quit be used daily to quit smoking, a handout for detailing assessments and payment schedules for assessments, and a National Cancer Institute (NCI) ''Clearing the Air'' booklet which includes information on quitting smoking.
SMALL-SCALE RCT: Patients are randomized to 1 of 2 arms.
ARM I (GOAL2QUIT + NRT): Patents receive their intervention in the same manner as feasibility testing
participants.
ARM II (TAU): Patients receive treatment as usual, consisting of a NCI ''Clearing the Air'' booklet which includes information on quitting smoking, and information on study participation.
After initiation of study, patients are followed up weekly for 8 weeks, and at 12 weeks.
Trial PhaseNo phase specified
Trial Typeprevention
Lead OrganizationMedical University of South Carolina
Principal InvestigatorJennifer Dahne