ACT on Vaping: Digital Therapeutic for Young Adult Vaping Cessation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,178
- 试验地点
- 1
- 主要终点
- Cotinine-confirmed 30-day point prevalence abstinence from all nicotine and tobacco
研究概览
简要总结
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.
详细描述
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, 5.5, and 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The control app will also be called ACT on Vaping in participant-facing materials, for blinding purposes; Any outcome evaluator who has direct contact with participants will remain blinded to treatment group assignment.
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-30
- •Current weekly user of e-cigarette product(s) for the last 30 days
- •Has a smartphone; either an Android (running version 12 or higher) or iPhone (running iOS version 17 or higher, iPhone 11 or more recent)
- •Experience downloading and using one or more apps on their smartphone
- •Have a mobile data plan and/or access to WiFi to support the use of the ACT on Vaping app
- •Has access to text messaging
- •Has an email address
- •United States (US) resident, with a US mailing address
- •Willing to complete all study procedures
- •Comfortable reading and writing in English
排除标准
- •Currently using other tobacco cessation treatments at the time of screening, including pharmacotherapy or behavioral support (note: use of these treatment is allowable during trial participation)
- •Member of the same household as another research participant
- •Currently in prison
- •Google voice number as sole phone number, due to its association with fraudulent study entry attempts
- •Is ineligible per fraud prevention protocol
- •Employees/family of investigator or study center
研究组 & 干预措施
Arm I (ACT on Vaping app (Version A) + incentivized texts + intervention texts)
Participants receive access to the ACT on Vaping app utilizing Acceptance and Commitment Therapy. Participants also receive text message intervention content, as well as incentivized text message check-ins at 2 weeks, 2 months, and 4 months to assess changes in vaping on study.
干预措施: Smartphone app (Behavioral)
Arm I (ACT on Vaping app (Version A) + incentivized texts + intervention texts)
Participants receive access to the ACT on Vaping app utilizing Acceptance and Commitment Therapy. Participants also receive text message intervention content, as well as incentivized text message check-ins at 2 weeks, 2 months, and 4 months to assess changes in vaping on study.
干预措施: Survey Administration (Other)
Arm II (ACT on Vaping app (Version B) + incentivized texts)
Participants receive access to the ACT on Vaping app including health education content. Participants receive incentivized text message check-ins at 2 weeks, 2 months, and 4 months to assess changes in vaping on study.
干预措施: Smartphone app (Behavioral)
Arm II (ACT on Vaping app (Version B) + incentivized texts)
Participants receive access to the ACT on Vaping app including health education content. Participants receive incentivized text message check-ins at 2 weeks, 2 months, and 4 months to assess changes in vaping on study.
干预措施: Text Message (Other)
Arm I (ACT on Vaping app (Version A) + incentivized texts + intervention texts)
Participants receive access to the ACT on Vaping app utilizing Acceptance and Commitment Therapy. Participants also receive text message intervention content, as well as incentivized text message check-ins at 2 weeks, 2 months, and 4 months to assess changes in vaping on study.
干预措施: Text Message (Other)
Arm II (ACT on Vaping app (Version B) + incentivized texts)
Participants receive access to the ACT on Vaping app including health education content. Participants receive incentivized text message check-ins at 2 weeks, 2 months, and 4 months to assess changes in vaping on study.
干预措施: Survey Administration (Other)
结局指标
主要结局
Cotinine-confirmed 30-day point prevalence abstinence from all nicotine and tobacco
时间窗: At 6 months post-randomization
Biochemically confirmed 30-day abstinence from all nicotine and tobacco (excluding Food and Drug Administration \[FDA\]-approved pharmacotherapies). Will be assessed in each individual and summarized within each group as a proportion.
Cotinine-confirmed 7-day point prevalence abstinence from all nicotine and tobacco
时间窗: At 6 months post-randomization
Biochemically confirmed 7-day abstinence from all nicotine and tobacco (excluding FDA-approved pharmacotherapies).
次要结局
- Self-reported 30-day point prevalence abstinence from vaping(At 3 months post-randomization)
- Cotinine-confirmed 7-day point prevalence abstinence from all nicotine and tobacco(At 3 months post-randomization)
- Self-reported 7-day point prevalence abstinence from all nicotine and tobacco(At 3 months post-randomization)
- Cotinine-confirmed 7-day point prevalence abstinence from all nicotine and tobacco(3 At 3 months post-randomization)
- Self-reported 30-day point prevalence abstinence from vaping(At 6 months post-randomization)
- Self-reported 30-day point prevalence abstinence from all nicotine and tobacco(At 6 months post-randomization)
- Self-reported 7-day point prevalence abstinence from vaping(At 6 months post-randomization)
- Number of 24-hour quit attempts(Baseline to 3 months post-randomization)
- Prolonged self-reported abstinence from all nicotine and tobacco for 90 days(At 6 months post-randomization)
- Change in readiness to quit using electronic cigarettes (e-cigarettes) on the Contemplation Ladder(Baseline to 3 months post-randomization)
- Self-reported 7-day point prevalence abstinence from all nicotine and tobacco(At 6 months post-randomization)
- Self-reported 30-day point prevalence abstinence from all nicotine and tobacco(At 3 months post-randomization)
- Self-reported 7-day point prevalence abstinence from vaping(At 3 months post-randomization)