Integrating Use of Self-Affirmation Content Into a Mobile App to Promote Quit Attempts With Text-Based Smoking Cessation Intervention Messaging

Study Overview
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Brief Summary
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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. ...

Detailed Description
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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.

Official Title
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Integrating Use of Self-Affirmation Content Into a Mobile App to Promote Quit Attempts With Text-Based Smoking Cessation Intervention Messaging

Conditions
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Number of Quit Attempts

Intervention / Treatment
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* Behavioral: Self-affirmation induction


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Baseline Affirmation and Affirmation Texts<br>Participants will be given a Baseline Affirmation Quiz at the beginning of the study and will receive affirmation text messages throughout the study | Behavioral: Self-affirmation induction<br>* 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.<br>|
| Active Comparator: Baseline Affirmation and No Affirmation Texts<br>Participants will be given a Baseline Affirmation Quiz at the beginning of the study but will not receive affirmation text messages throughout the study | Behavioral: Self-affirmation induction<br>* 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.<br>|
| Active Comparator: No Baseline Affirmation and Affirmation Texts<br>Participants will not be given a Baseline Affirmation Quiz but will receive affirmation text messages throughout the study | Behavioral: Self-affirmation induction<br>* 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.<br>|
| Placebo Comparator: No Baseline Affirmation and No Affirmation Texts<br>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) | Behavioral: Self-affirmation induction<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quitting Smoking, Phone Application