Randomized Clinical Trial to Test the Efficacy of a Smartphone App for Smoking Cessation for Nondaily Smokers (SiS4)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,600
- 试验地点
- 2
- 主要终点
- Self-reported 30-day point-prevalence abstinence (PPA) from smoking
研究概览
简要总结
The goal of this project is to test if a new behavioral treatment for people who smoke nondaily and wish to quit works. The new treatment is a smartphone app that engages users in positive psychology exercises and gives them tested tools for quitting smoking. The positive psychology exercises help users maintain their positive emotions while they quit smoking. This app has been developed with and for people who smoke nondaily through several steps of development.
The main questions it aims to answer are:
- Does the smoking cessation app (SiS4) help people who smoke nondaily quit smoking?
- How do people's attitudes towards smoking, their smoking urges, and their mental well-being shift when using the SiS4 app?
Researchers will compare the new app to an existing app that was developed for people who smoke daily to see if the new app works better to help people who smoke nondaily quit smoking.
Participants will:
- Use a smartphone app every day for 7 weeks
- Complete online surveys about their smoking, attitudes about smoking, withdrawal symptoms and smoking urges, app use, and mental well-being at enrollment as well as 2 weeks, 6 weeks, 3 months, 6 months and 12 months after the initially chosen quit date.
If the SiS4 app works well, it would be the first evidence-based quit-smoking treatment for people who smoke nondaily.
详细描述
The present study is a large-scale (n=1,600) single-blind, remote, parallel, randomized clinical trial (RCT) comparing our app, the SiS app, to the NCI's smartphone app "QuitGuide". The RCT will be conducted entirely remotely, because the app is intended to be accessible to smokers nationally without need for in person contact. All participants will set a targeted smoking cessation quit date and will be instructed to use the provided app for 7 weeks, 1 week prior to and 6 weeks post-quit. Online surveys will be conducted at enrollment and follow-up occurring 2 weeks, 6 weeks, 3 months, 6 months and 12 months after the initially chosen quit date. The primary outcome measure will be 30-day point-prevalence abstinence (PPA) at 6 months post-quit. The investigator team developed the app, "Smiling instead of Smoking (SiS)," specifically for and in collaboration with people who smoke less than daily. This app uses a positive psychology approach, in line with their preference to focus on positive self-identity and wellness.
The investigators have rigorously and iteratively developed and tested this app in a series of small scale prior studies. Study 1 (2017P001106) demonstrated feasibility and acceptability when smokers were onboarded in person. Study 2 (2018P002699) demonstrated feasibility and acceptability when smokers were onboarded remotely, nationwide. Study 3 (NCT04672239) demonstrated the app's ability to engage nondaily smokers and showed proof-of-concept efficacy in a small, randomized trial, where participants using the SiS app had significantly higher self-efficacy, lower craving, and higher positive affect at the end of treatment, compared to controls.
In this large-scale efficacy trial, the primary outcome measure will be 30-day point-prevalence abstinence (PPA) at 6-month post quit. The aims of the study are:
Aim 1: Test the effectiveness of the SiS app to improve smoking cessation outcomes
- H1: 30-day PPA six months post quit will be higher for SiS compared to QuitGuide participants.
- H2: SiS participants will have higher 30-day PPA at end of treatment and 12 months post quit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Sufficiently fluent in English to read and comprehend intervention and assessment materials
- •Owns a smartphone (Android or iOS only)
- •Currently smokes less than daily but at least weekly
- •Has smoked 100+ cigarettes lifetime
- •Has current intention to quit smoking
- •Currently resides in the US
- •Can use online survey technology to complete surveys
- •Can download, install and use a smartphone app
排除标准
- 未提供
结局指标
主要结局
Self-reported 30-day point-prevalence abstinence (PPA) from smoking
时间窗: Baseline, 2, 6, 12, 24, and 52 weeks
The 30-day point prevalence abstinence (PPA) is a self-reported measure recorded at 6 months post-quit. In each online survey participant will be asked to report, "During the past 30 days, on how many days did you smoke". If a participant does not report abstinence, they will be asked to indicate how many cigarettes they smoked per day on the days they smoked and whether they are seriously thinking of quitting smoking. The investigators will also include the question, "have you been abstinent during the past 30 days?" (yes/no). In order to get to this question, participants will answer have to answer prior questions as, " I do not smoke at all", and "yes", they have been abstinent during the past 7 days. The investigators will code a binary indicator for self-reported 30-day point prevalence abstinence (yes/ no).
次要结局
- Self-reported 7-day point-prevalence abstinence (PPA) from smoking(Baseline, 2, 6, 12, 24, and 52 weeks)
- Change in cigarettes smoked(2, 6, 12, 24, and 52 week after baseline)
- Smoking self-efficacy(Baseline, 2, 6, 12, 24, and 52 weeks)
- Positive affect(Baseline, 2, 6, 12, 24, and 52 weeks)
- Negative affect(Baseline, week 2, 6, 12, 24, and 52)
- Mood and Physical Symptoms Scale (MPSS) (modified)(Baseline, 2, 6, 12, 24, and 52 weeks)
研究者
Bettina B. Hoeppner
Associate Professor
Massachusetts General Hospital