Number of Quit Attempts
Conditions
Keywords
Quitting Smoking, Phone Application
Brief summary
Background: Quitting smoking is hard. It is easy to relapse. Smokers may think of temptation to smoke as a threat if they think it suggests that they are unable to meet the challenges of stopping. When people feel such a threat to their sense of self-identity, they may get defensive. They may want to downplay the importance of quitting. This could make them try to quit less. Self-affirmation is a process of focusing on strengths and values. This can offset threats to the self and promote healthier behavior. Objective: To explore people s values, smoking attitudes, and smoking behavior. Eligibility: People ages 18 and older who smoke Design: The study takes place entirely on a mobile device. Participants will give their age, gender, data about their smoking habits, and desired quit date. Then they will get different texts about quitting. Participants will answer follow-up surveys 1 and 3 months later. ...
Detailed description
Quitting smoking is challenging and relapse is likely. Smokers may perceive temptation to smoke as threatening if they think it suggests that they are unable to meet the challenges of cessation. When individuals experience such a threat to their sense of self-identity (e.g., to their sense that they have integrity and/ or competence), they often respond defensively. Individuals have a tendency to react defensively to information that informs them that their behavior increases risk for a particular disease or negative health consequences. Self-affirmation a process through which individuals focus on their strengths and values can offset threats to the self and promote healthier behaviors, including smoking cessation. To the extent that relapse or difficulty quitting is perceived as a threat to self-identity, when individuals are presented with the opportunity to self-affirm they may perceive failure as less threatening, mitigating the motivation to downplay the importance of quitting. Preliminary evidence suggests that self-affirmation can be feasibly incorporated into an existing smoking cessation text message-based intervention, and may bolster cessation rates among users motivated to quit smoking. Here, we propose to extend that research by examining whether the addition of self-affirmation text messages to a smoking cessation app (Smoke Free United Kingdom (UK) promotes smoking cessation, compared to standard of care (i.e., existing app content only). Importantly, self-affirmation material will be incorporated into the current app and will not change the goals or nature of the original texting program. We predict that the individuals in the self-affirmation condition will be more likely to report being smoke-free at the 1-month and 3-month follow-ups.
Interventions
BEHAVIORALSelf-affirmation induction
Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.
Sponsors
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* INCLUSION/EXCLUSION: * Because the app is designed to assist with smoking cessation, all smokers are eligible to participate. * Subjects are eligible if they are 18+ years of age.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting a Quit Attempt Within the Past Week at 1 Month and 3 Months | 1 month and 3 months | Participants were asked to report the number of times they attempted to quit smoking at 1 month and 3 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Days Participants Remained Smoke-free at the 1 and 3 Month Follow-up | 1 month and 3 months follow-up | Participants were asked the number of days they have remained smoke-free at the 1 and 3 month follow-up. |
| Type of Tobacco Products | 1 month and 3 months follow-up | Participants will be asked the type of tobacco products they use at the 1 and 3 month follow-up. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Baseline Affirmation and Affirmation Texts Participants will be given a Baseline Affirmation Quiz at the beginning of the study and will receive affirmation text messages throughout the study
Self-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message. | 2,027 |
| Baseline Affirmation and No Affirmation Texts Participants will be given a Baseline Affirmation Quiz at the beginning of the study but will not receive affirmation text messages throughout the study
Self-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message. | 1,984 |
| No Baseline Affirmation and Affirmation Texts Participants will not be given a Baseline Affirmation Quiz but will receive affirmation text messages throughout the study
Self-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message. | 1,903 |
| No Baseline Affirmation and No Affirmation Texts Participants will experience the Smoke Free United Kingdom (UK) app without any affirmation content Smoke Free UK app (no baseline affirmation quiz and no affirmation text messages)
Self-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message. | 1,985 |
| Total | 7,899 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Opting out of the app | 1,869 | 1,819 | 1,743 | 1,821 |
Baseline characteristics
| Characteristic | Baseline Affirmation and Affirmation Texts | Baseline Affirmation and No Affirmation Texts | No Baseline Affirmation and Affirmation Texts | No Baseline Affirmation and No Affirmation Texts | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2027 Participants | 1984 Participants | 1903 Participants | 1985 Participants | 7899 Participants |
| Age, Continuous | 30.6 years STANDARD_DEVIATION 8.6 | 30.5 years STANDARD_DEVIATION 8.6 | 30.5 years STANDARD_DEVIATION 8.8 | 30.5 years STANDARD_DEVIATION 8.7 | 30.5 years STANDARD_DEVIATION 8.7 |
| Desire to Smoke | 3.2 units on a scale STANDARD_DEVIATION 1.3 | 3.1 units on a scale STANDARD_DEVIATION 1.4 | 3.2 units on a scale STANDARD_DEVIATION 1.3 | 3.1 units on a scale STANDARD_DEVIATION 1.4 | 3.2 units on a scale STANDARD_DEVIATION 1.3 |
| Number of Participants Currently Using Cessation Aid No | 1581 Participants | 1583 Participants | 1469 Participants | 1545 Participants | 6178 Participants |
| Number of Participants Currently Using Cessation Aid Yes | 446 Participants | 401 Participants | 434 Participants | 440 Participants | 1721 Participants |
| Quit Attempts in Past Year | 7.2 Attempts STANDARD_DEVIATION 22.8 | 6.5 Attempts STANDARD_DEVIATION 20.7 | 6.6 Attempts STANDARD_DEVIATION 19.6 | 7.9 Attempts STANDARD_DEVIATION 27.5 | 7.9 Attempts STANDARD_DEVIATION 27.5 |
| Race and Ethnicity Not Collected | — | — | — | — | 0 Participants |
| Region of Enrollment United States | 2027 participants | 1984 participants | 1903 participants | 1985 participants | 7899 participants |
| Sex: Female, Male Female | 799 Participants | 759 Participants | 765 Participants | 786 Participants | 3109 Participants |
| Sex: Female, Male Male | 1228 Participants | 1225 Participants | 1138 Participants | 1199 Participants | 4790 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 2,027 | 0 / 1,984 | 0 / 1,903 | 0 / 1,985 |
| other Total, other adverse events | 0 / 2,027 | 0 / 1,984 | 0 / 1,903 | 0 / 1,985 |
| serious Total, serious adverse events | 0 / 2,027 | 0 / 1,984 | 0 / 1,903 | 0 / 1,985 |
Outcome results
Primary
Number of Participants Reporting a Quit Attempt Within the Past Week at 1 Month and 3 Months
Participants were asked to report the number of times they attempted to quit smoking at 1 month and 3 months.
Time frame: 1 month and 3 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Baseline Affirmation and Affirmation Texts | Number of Participants Reporting a Quit Attempt Within the Past Week at 1 Month and 3 Months | Past Week Cessation at 1 Month | 142 Participants |
| Baseline Affirmation and Affirmation Texts | Number of Participants Reporting a Quit Attempt Within the Past Week at 1 Month and 3 Months | Past Month Cessation at 1 Month | 114 Participants |
| Baseline Affirmation and Affirmation Texts | Number of Participants Reporting a Quit Attempt Within the Past Week at 1 Month and 3 Months | Past Week Cessation at 3 Months | 54 Participants |
| Baseline Affirmation and Affirmation Texts | Number of Participants Reporting a Quit Attempt Within the Past Week at 1 Month and 3 Months | Past Month Cessation at 3 Months | 46 Participants |
| Baseline Affirmation and No Affirmation Texts | Number of Participants Reporting a Quit Attempt Within the Past Week at 1 Month and 3 Months | Past Month Cessation at 1 Month | 128 Participants |
| Baseline Affirmation and No Affirmation Texts | Number of Participants Reporting a Quit Attempt Within the Past Week at 1 Month and 3 Months | Past Week Cessation at 3 Months | 58 Participants |
| Baseline Affirmation and No Affirmation Texts | Number of Participants Reporting a Quit Attempt Within the Past Week at 1 Month and 3 Months | Past Month Cessation at 3 Months | 49 Participants |
| Baseline Affirmation and No Affirmation Texts | Number of Participants Reporting a Quit Attempt Within the Past Week at 1 Month and 3 Months | Past Week Cessation at 1 Month | 143 Participants |
| No Baseline Affirmation and Affirmation Texts | Number of Participants Reporting a Quit Attempt Within the Past Week at 1 Month and 3 Months | Past Week Cessation at 3 Months | 55 Participants |
| No Baseline Affirmation and Affirmation Texts | Number of Participants Reporting a Quit Attempt Within the Past Week at 1 Month and 3 Months | Past Month Cessation at 1 Month | 128 Participants |
| No Baseline Affirmation and Affirmation Texts | Number of Participants Reporting a Quit Attempt Within the Past Week at 1 Month and 3 Months | Past Month Cessation at 3 Months | 48 Participants |
| No Baseline Affirmation and Affirmation Texts | Number of Participants Reporting a Quit Attempt Within the Past Week at 1 Month and 3 Months | Past Week Cessation at 1 Month | 139 Participants |
| No Baseline Affirmation and No Affirmation Texts | Number of Participants Reporting a Quit Attempt Within the Past Week at 1 Month and 3 Months | Past Month Cessation at 3 Months | 38 Participants |
| No Baseline Affirmation and No Affirmation Texts | Number of Participants Reporting a Quit Attempt Within the Past Week at 1 Month and 3 Months | Past Month Cessation at 1 Month | 133 Participants |
| No Baseline Affirmation and No Affirmation Texts | Number of Participants Reporting a Quit Attempt Within the Past Week at 1 Month and 3 Months | Past Week Cessation at 1 Month | 145 Participants |
| No Baseline Affirmation and No Affirmation Texts | Number of Participants Reporting a Quit Attempt Within the Past Week at 1 Month and 3 Months | Past Week Cessation at 3 Months | 48 Participants |
Secondary
Number of Days Participants Remained Smoke-free at the 1 and 3 Month Follow-up
Participants were asked the number of days they have remained smoke-free at the 1 and 3 month follow-up.
Time frame: 1 month and 3 months follow-up
Population: This outcome measure was not done because there was too little variability, and the data could not be analyzed due to high levels of attrition. The former Principal Investigator left the institute and no data are available or will ever become available for this Outcome.
Secondary
Type of Tobacco Products
Participants will be asked the type of tobacco products they use at the 1 and 3 month follow-up.
Time frame: 1 month and 3 months follow-up
Population: This outcome measure was not done because type of tobacco products were not collected from participants at 1 month and 3 months follow-up.