Testing the mHealth App Intervention for Nondaily Smokers "SiS4"
ConditionSmoking Cessation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital
About this trial
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:
1. Use a smartphone app every day for 7 weeks 2. 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Smiling instead of Smoking
BehavioralParticipants randomized to the treatment condition will use the "Smiling instead of Smoking" (SiS) smartphone app. This app delivers and guides participants through two types of content to help them during their quit attempt: (1) positive psychology content (i.e., happiness habit-building exercises, happiness boost activity, and science-based information on the relevance of positive psychology activities) designed to help nondaily smokers maintain positive affect while they go through the process of smoking cessation; and (2) traditional behavioral smoking cessation content to guide their quit process based on US Clinical Practice Guidelines.
QuitGuide
BehavioralParticipants randomized to the control condition will use the National Cancer Institute (NCI)'s "QuitGuide" (QG) smartphone app. The QuitGuide app follows the US Clinical Practice Guidelines. The app is freely available on NCI's Smokefree.gov website, which is a recommended resource for treating smokers in the healthcare setting. The QuitGuide app is frequently used as a comparison app in smartphone app smoking cessation studies. It asks participants to set a quit day, track their mood and cravings, and log their cigarettes. It provides app users with guidance on quitting (i.e., "Learn to Quit" information), offers strategies to counter smoking triggers, and allows users to set reminders to stay smoke free (time and location based).
Treatment groups
1,600 Participants
are divided into 2 treatment groupsGroup A: Smiling instead of SmokingExperimental treatment 1 intervention
Group B: QuitGuideActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Self-reported 30-day point-prevalence abstinence (PPA) from smoking
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).
Time frame
Baseline, 2, 6, 12, 24, and 52 weeksSecondary outcomes
1
Self-reported 7-day point-prevalence abstinence (PPA) from smoking
The investigators will measure 7-day PPA (smoking abstinence) using the same smoking status self-report form described above for 30-day PPA. In each online survey, participants will be asked: "what is your current smoking status?" with the following options: "I smoke daily", "I smoke non-daily (and have smoked in the past 7 days)" , "I smoke non-daily (but have NOT smoked in the past 7 days)" , "I do not smoke at all". If participants have indicated that they do not smoke, they will be asked whether they have been abstinent during the past 7 days (yes/no).
Time frame
Baseline, 2, 6, 12, 24, and 52 weeks2
Change in cigarettes smoked
In each online survey after the baseline, participants will be asked: "what is your current smoking status?" If a participant does not report abstinence, they will be asked to indicate how many cigarettes they smoked over the past 7 days. The investigators will calculate change in cigarettes smoked by subtracting the total number of cigarettes smoked in the week before baseline from the total number of cigarettes smoked in the past week. Negative change numbers indicate better progress towards smoking cessation.
Time frame
2, 6, 12, 24, and 52 week after baseline3
Smoking self-efficacy
A single-item measure that assess a person's confidence in their ability to quit smoking / stay quit will be included. Participants will be asked to rate their answer to the question "How confident are you that you will be able to quit smoking/stay quit?" on a 1-100 slider scale (i.e., 1=not at all confident, 100=absolutely confident). Higher scores indicate greater self-efficacy to abstain from smoking.
Time frame
Baseline, 2, 6, 12, 24, and 52 weeks4
Positive affect
The investigators will measure positive affect using the Positive and Negative Affect Schedule (PANAS). The PANAS is a 20-item measure assessing intensity with which individuals experience various emotional states in the preceding two weeks, 10 of which assess positive emotional states (e.g., proud) and 10 of which assess negative emotional states (e.g., afraid), on a 1-5 scale (i.e., 1=very slightly or not at all; 5=extremely). Scores for the positive words are summed to yield a positive affect score, with higher scores indicating higher positive affect (positive outcome).
Time frame
Baseline, 2, 6, 12, 24, and 52 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Massachusetts General Hospital
Lead sponsor
National Institutes of Health (NIH)
Collaborator
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov