This clinical trial evaluates a smartphone application (app) called Acceptance and Commitment Therapy (ACT) on Vaping for helping young adults quit using electronic cigarettes (e-cigarettes). E-cigarettes pose numerous risks, particularly to youth and young adults. Addressing the high prevalence of e-cigarette use by young adults requires effective and accessible treatments to support current users to quit. Research shows this group prefers and benefits from newer methods of treatment delivery such as digital interventions. ACT on Vaping is a digital therapeutic intended to deliver behavioral therapy to young adults who vape to motivate and support abstinence from all nicotine and tobacco products. The app contains sessions that promote awareness of cues that trigger tobacco use and teach skills for responding to these triggers in a way that is tailored for the participant's readiness to quit. Receiving access to the ACT on Vaping app may be effective in helping young adults quit vaping.
OUTLINE: Participants are randomized to 1 of 2 arms. ARM I: Participants use the ACT on Vaping app (Version A) and receive a text messaging program to motivate and support quitting. Participants also receive incentivized text message check-ins at 2 weeks, 2 months, and 4 months to assess their vaping status. ARM II: Participants use the ACT on Vaping app (Version B) and receive incentivized text message check-ins at 2 weeks, 2 months, and 4 months to assess their vaping status. After completion of study intervention, participants are followed up at 3 and 6 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
1,372
Receive access to the ACT on Vaping app
Receive access to the ACT on Vaping app
Receive incentivized text messages to access vaping status
Receive intervention text messages
Ancillary studies
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Cotinine-confirmed 7-day point prevalence abstinence from all nicotine and tobacco
Biochemically confirmed 7-day abstinence from all nicotine and tobacco (excluding FDA-approved pharmacotherapies).
Time frame: At 6 months post-randomization
Self-reported 7-day point prevalence abstinence from all nicotine and tobacco
Proportion of participants self-reporting 7-day abstinence from all nicotine and tobacco (excluding FDA-approved pharmacotherapies).
Time frame: At 6 months post-randomization
Self-reported 7-day point prevalence abstinence from all nicotine and tobacco
Proportion of participants self-reporting 7-day abstinence from all nicotine and tobacco (excluding FDA-approved pharmacotherapies).
Time frame: At 3 months post-randomization
Cotinine-confirmed 7-day point prevalence abstinence from all nicotine and tobacco
Biochemically-confirmed 7-day abstinence from all nicotine and tobacco (excluding FDA-approved pharmacotherapies).
Time frame: 3 At 3 months post-randomization
Self-reported 30-day point prevalence abstinence from all nicotine and tobacco
Proportion of participants self-reporting 30-day abstinence from all nicotine and tobacco (including FDA-approved pharmacotherapies).
Time frame: At 3 months post-randomization
Self-reported 30-day point prevalence abstinence from all nicotine and tobacco
Proportion of participants self-reporting 30-day abstinence from all nicotine and tobacco (including FDA-approved pharmacotherapies).
Time frame: At 6 months post-randomization
Self-reported 7-day point prevalence abstinence from vaping
Proportion of participants self-reporting 7-day abstinence from vaping.
Time frame: At 3 months post-randomization
Self-reported 30-day point prevalence abstinence from vaping
Proportion of participants self-reporting 30-day abstinence from vaping.
Time frame: At 3 months post-randomization
Self-reported 7-day point prevalence abstinence from vaping
Proportion of participants self-reporting 7-day abstinence from vaping.
Time frame: At 6 months post-randomization
Self-reported 30-day point prevalence abstinence from vaping
Proportion of participants self-reporting 30-day abstinence from vaping.
Time frame: At 6 months post-randomization
Number of 24-hour quit attempts
Number of times between baseline and 3-month follow-up that participant stopped using all nicotine and tobacco (excluding FDA-approved pharmacotherapies) for 24 hours or longer.
Time frame: Baseline to 3 months post-randomization
Prolonged self-reported abstinence from all nicotine and tobacco for 90 days
Proportion of participants self-reporting no nicotine or tobacco use (excluding FDA-approved pharmacotherapies) for 90 days prior to 6-month follow-up.
Time frame: At 6 months post-randomization
Change in readiness to quit using electronic cigarettes (e-cigarettes) on the Contemplation Ladder
Self-reported motivation to quit smoking e-cigarettes (Contemplation Ladder), rated 1-10. Higher scores indicate greater motivation to quit \[i.e., high (\>5) vs. low (5 or less)\].
Time frame: Baseline to 3 months post-randomization
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