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| ID | Type | Description | Link |
|---|---|---|---|
| 17-C-N039 |
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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.
...
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Baseline Affirmation and Affirmation Texts | Experimental | Participants will be given a "Baseline Affirmation" Quiz at the beginning of the study and will receive affirmation text messages throughout the study |
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| Baseline Affirmation and No Affirmation Texts | Active Comparator | Participants will be given a "Baseline Affirmation" Quiz at the beginning of the study but will not receive affirmation text messages throughout the study |
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| No Baseline Affirmation and Affirmation Texts | Active Comparator | Participants will not be given a "Baseline Affirmation Quiz" but will receive affirmation text messages throughout the study |
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| No Baseline Affirmation and No Affirmation Texts | Placebo Comparator | 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) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-affirmation induction | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 month and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 month and 3 months follow-up |
| Type of Tobacco Products |
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| Name | Affiliation | Role |
|---|---|---|
| William M Klein, Ph.D. | National Cancer Institute (NCI) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Institute (NCI) | Bethesda | Maryland | 20892 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18298234 | Background | Armitage CJ, Harris PR, Hepton G, Napper L. Self-affirmation increases acceptance of health-risk information among UK adult smokers with low socioeconomic status. Psychol Addict Behav. 2008 Mar;22(1):88-95. doi: 10.1037/0893-164X.22.1.88. | |
| 25720333 | Background | Spohr SA, Nandy R, Gandhiraj D, Vemulapalli A, Anne S, Walters ST. Efficacy of SMS Text Message Interventions for Smoking Cessation: A Meta-Analysis. J Subst Abuse Treat. 2015 Sep;56:1-10. doi: 10.1016/j.jsat.2015.01.011. Epub 2015 Feb 2. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 6, 2017 |
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Participants will be asked the type of tobacco products they use at the 1 and 3 month follow-up.
| 1 month and 3 months follow-up |
| 19372432 | Background | Cohen GL, Garcia J, Purdie-Vaughns V, Apfel N, Brzustoski P. Recursive processes in self-affirmation: intervening to close the minority achievement gap. Science. 2009 Apr 17;324(5925):400-3. doi: 10.1126/science.1170769. |
| 33666561 | Result | Seaman EL, Robinson CD, Crane D, Taber JM, Ferrer RA, Harris PR, Klein WMP. Association of Spontaneous and Induced Self-Affirmation With Smoking Cessation in Users of a Mobile App: Randomized Controlled Trial. J Med Internet Res. 2021 Mar 5;23(3):e18433. doi: 10.2196/18433. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Number of Participants Currently Using Cessation Aid | Count of Participants | Participants |
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| Desire to Smoke | Desire to smoke: 1 = not at all; 5 = a lot. | Mean | Standard Deviation | units on a scale |
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| Quit Attempts in Past Year | Past year cessation attempts were assessed as a write-in question; all values from 0 to 365 were considered valid cases. All responses outside of this range were excluded from analysis of past year cessation attempts but were included in all subsequent analyses. | Mean | Standard Deviation | Attempts |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | 1 month and 3 months |
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| 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. | 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. | Posted | 1 month and 3 months follow-up |
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| Secondary | Type of Tobacco Products | Participants will be asked the type of tobacco products they use at the 1 and 3 month follow-up. | This outcome measure was not done because type of tobacco products were not collected from participants at 1 month and 3 months follow-up. | Posted | 1 month and 3 months follow-up |
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Study start to study completion date, approximately 17 months and 26 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 2,027 | 0 | 2,027 | 0 | 2,027 |
| EG001 | 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. | 0 | 1,984 | 0 | 1,984 | 0 | 1,984 |
| EG002 | 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. | 0 | 1,903 | 0 | 1,903 | 0 | 1,903 |
| EG003 | 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. | 0 | 1,985 | 0 | 1,985 | 0 | 1,985 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William Klein | National Cancer Institute | 2402766972 | kleinwm@mail.nih.gov |
| Jun 22, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
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| D015438 | Health Behavior |
| D001519 | Behavior |
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| No |
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| Past Month Cessation at 1 Month |
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| Past Week Cessation at 3 Months |
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| Past Month Cessation at 3 Months |
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| OG002 | 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. |
| OG003 | 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. |
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| OG002 | 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. |
| OG003 | 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. |
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