Smoking CessationNCT06678243
Testing the mHealth App Intervention for Nondaily Smokers "SiS4"
A study testing Smiling instead of Smoking and QuitGuide in people with Smoking Cessation, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Smiling instead of Smoking and QuitGuide
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,600 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Dec 2024to 1 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Bettina B Hoeppner, 6176431988, BHOEPPNER@mgh.harvard.edu
About this study
Official title: Randomized Clinical Trial to Test the Efficacy of a Smartphone App for Smoking Cessation for Nondaily Smokers (SiS4)
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:
Read more
- 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.
Read the detailed description
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.
Aim 2: Examine mechanisms and moderators of change
- Using mediation modeling, the investigators will test if theorized mechanisms of change (i.e., self-efficacy, positive affect, or craving) account for observed effects on 30-day PPA six months post quit.
- (Exploratory aim:) Using moderated mediation models, the investigators will examine if socioeconomic status, race, and/or the presence of mental health conditions moderate the effectiveness of SiS or moderate the mediation effects outlined in aim 2a.
Exploratory Aim 3: Explore app usage patterns and their relationship to smoking cessation
- The investigators will identify patterns of overall app use, as identified by group-based trajectory modeling.
- The investigators will conduct a feature-level analysis of the apps (i.e., which features got used how often).
- The investigators will test if patterns of app use and/or feature use predict 30-day PPA six months post-quit.
If found to be efficacious, this study would provide the first evidence of an efficacious treatment (the SiS app) for people who smoke less than daily, for whom currently no treatment guidelines exist.
- Conditions
- Smoking Cessation
- Being tested
- Smiling instead of Smoking, QuitGuide
- Keywords
- smoking, smartphone app, smoking cessation, QuitGuide, Smiling instead of Smoking, positive psychology, mHealth, nondaily smoking
- Medical subject headings
- Smoking Cessation, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smiling instead of SmokingBehavioural
Also called SiS4
Participants 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.
QuitGuideBehavioural
Also called QG
Participants 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).
| Study group | Role | What they receive |
|---|---|---|
| Smiling instead of Smoking | Experimental | Participants will be onboarded to the smartphone app "Smiling instead of Smoking" (SiS4) and will be asked to use it for 7 weeks while they quit smoking. Receives: Behavioral: Smiling instead of Smoking |
| QuitGuide | Active comparator | Participants will be onboarded to the smartphone app "QuitGuide" (QG) which will be 're-branded', so that the name "Smiling instead of Smoking" will appear in the banner of the app instead of "QuitGuide", and will be asked to use it for 7 weeks while they quit smoking. Receives: Behavioral: QuitGuide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, 2, 6, 12, 24, and 52 weeks
Secondary outcomes (6)
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).
Measured: Baseline, 2, 6, 12, 24, and 52 weeks
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.
Measured: 2, 6, 12, 24, and 52 week after baseline
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.
Measured: Baseline, 2, 6, 12, 24, and 52 weeks
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).
Measured: Baseline, 2, 6, 12, 24, and 52 weeks
Negative affect
The investigators will measure negative 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 negative words are summed to yield a negative affect score, with higher scores indicating higher negative affect (negative outcome).
Measured: Baseline, week 2, 6, 12, 24, and 52
Mood and Physical Symptoms Scale (MPSS) (modified)
The Mood and Physical Symptoms Scale (MPSS) is a cigarette withdrawal scale. The measure focuses on mood and other symptoms of cigarette withdrawal. Items 1-7 list symptoms of withdrawal. Each item is on a scale from 1 ("not at all") to 5 ("extremely") and asked within the in the past 24 hours. The measure also captures the frequency (Item 8; 0, "Not at all" to 5, "All the time") and strength (Item 9; 0, "No urges" to 5, "Extremely strong") of the urge to smoke. The original scale included 12-items, but the investigators only included the first 9 items as being relevant to nondaily smokers. The investigators will use the total of all items (1-9) as a composite score of withdrawal symptoms and urge, where higher scores indicate greater withdrawal and smoking urge (negative outcome).
Measured: Baseline, 2, 6, 12, 24, and 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start6 Dec 2024
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- single-blind, remote, randomized clinical trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Bettina B. Hoeppner, Massachusetts General Hospital
- Investigators
- Bettina Hoeppner, Ph.D., M.S., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06678243
- Sponsor's protocol ID
- 24-501
- Other IDs
- 1R01CA282223
- Status last verified
- Oct 2026
- First submitted
- 5 Nov 2024
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators will provide de-identified IPD related to the aims, baseline demographics, and outcomes described in this study record to interested individuals one year following achievement of the aims of the project (i.e., publication of the main outcome papers). Data sharing will be contingent on meeting all institutional regulations for data use agreements and on receiving evidence of the recipient's institution's IRB approval for planned analyses of the data. The investigator team will be available to address queries.
Publications
Hoeppner BB, Kelly JF, Urbanoski KA, Slaymaker V. Comparative utility of a single-item versus multiple-item measure of self-efficacy in predicting relapse among young adults. J Subst Abuse Treat. 2011 Oct;41(3):305-12. doi: 10.1016/j.jsat.2011.04.005. Epub 2011 Jun 22.
PubMed 21700411Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.
PubMed 3397865West R, Hajek P. Evaluation of the mood and physical symptoms scale (MPSS) to assess cigarette withdrawal. Psychopharmacology (Berl). 2004 Dec;177(1-2):195-9. doi: 10.1007/s00213-004-1923-6. Epub 2004 Jun 4.
PubMed 15179542
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial to Test the Efficacy of a Smartphone App for Smoking Cessation for Nondaily Smokers (SiS4)
- ClinicalTrials.gov ID
- NCT06678243
- Acronym / sponsor ID
- 24-501
- Conditions
- Smoking Cessation
- Keywords
- smoking, smartphone app, smoking cessation, QuitGuide, Smiling instead of Smoking, positive psychology, mHealth, nondaily smoking
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- 6 Dec 2024 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 7 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Aim 2: Examine mechanisms and moderators of change
- Using mediation modeling, the investigators will test if theorized mechanisms of change (i.e., self-efficacy, positive affect, or craving) account for observed effects on 30-day PPA six months post quit.
- (Exploratory aim:) Using moderated mediation models, the investigators will examine if socioeconomic status, race, and/or the presence of mental health conditions moderate the effectiveness of SiS or moderate the mediation effects outlined in aim 2a.
Exploratory Aim 3: Explore app usage patterns and their relationship to smoking cessation
- The investigators will identify patterns of overall app use, as identified by group-based trajectory modeling.
- The investigators will conduct a feature-level analysis of the apps (i.e., which features got used how often).
- The investigators will test if patterns of app use and/or feature use predict 30-day PPA six months post-quit.
If found to be efficacious, this study would provide the first evidence of an efficacious treatment (the SiS app) for people who smoke less than daily, for whom currently no treatment guidelines exist.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- single-blind, remote, randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Smiling instead of Smoking | Experimental | Behavioral: Smiling instead of SmokingParticipants will be onboarded to the smartphone app "Smiling instead of Smoking" (SiS4) and will be asked to use it for 7 weeks while they quit smoking. |
| QuitGuide | Active comparator | Behavioral: QuitGuideParticipants will be onboarded to the smartphone app "QuitGuide" (QG) which will be 're-branded', so that the name "Smiling instead of Smoking" will appear in the banner of the app instead of "QuitGuide", and will be asked to use it for 7 weeks while they quit smoking. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smiling instead of SmokingAlso: SiS4Participants 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. | Behavioural | Smiling instead of Smoking |
| QuitGuideAlso: QGParticipants 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). | Behavioural | QuitGuide |
Primary outcome
Self-reported 30-day point-prevalence abstinence (PPA) from smoking
Time frame: 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).
6 secondary outcomes
Self-reported 7-day point-prevalence abstinence (PPA) from smoking
Time frame: Baseline, 2, 6, 12, 24, and 52 weeks
Change in cigarettes smoked
Time frame: 2, 6, 12, 24, and 52 week after baseline
Smoking self-efficacy
Time frame: Baseline, 2, 6, 12, 24, and 52 weeks
Positive affect
Time frame: Baseline, 2, 6, 12, 24, and 52 weeks
Negative affect
Time frame: Baseline, week 2, 6, 12, 24, and 52
Mood and Physical Symptoms Scale (MPSS) (modified)
Time frame: Baseline, 2, 6, 12, 24, and 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Background: PubMed 21700411Hoeppner BB, Kelly JF, Urbanoski KA, Slaymaker V. Comparative utility of a single-item versus multiple-item measure of self-efficacy in predicting relapse among young adults. J Subst Abuse Treat. 2011 Oct;41(3):305-12. doi: 10.1016/j.jsat.2011.04.005. Epub 2011 Jun 22.
- Background: PubMed 3397865Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.
- Background: PubMed 15179542West R, Hajek P. Evaluation of the mood and physical symptoms scale (MPSS) to assess cigarette withdrawal. Psychopharmacology (Berl). 2004 Dec;177(1-2):195-9. doi: 10.1007/s00213-004-1923-6. Epub 2004 Jun 4.
- Individual participant dataSharing planned: Yes. The investigators will provide de-identified IPD related to the aims, baseline demographics, and outcomes described in this study record to interested individuals one year following achievement of the aims of the project (i.e., publication of the main outcome papers). Data sharing will be contingent on meeting all institutional regulations for data use agreements and on receiving evidence of the recipient's institution's IRB approval for planned analyses of the data. The investigator team will be available to address queries.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bettina Hoeppner, Ph.D., M.S. principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smiling instead of Smoking and QuitGuide in people with Smoking Cessation, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bettina Hoeppner, Ph.D., M.S. (617-643-1988, bhoeppner@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported 30-day point-prevalence abstinence (PPA) from smoking (time frame: Baseline, 2, 6, 12, 24, and 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06678243, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.