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This research study aims to develop a cognitive dissonance-based mobile app for smoking cessation (Support2Quit) and test the efficacy of the app with 500 adult smokers who express a desire to quit smoking.
This research project will evaluate the Support2Quit mobile app for smoking cessation by having 500 daily adult smokers recruited through social media and randomized to either the Support2Quit app or an app that has similar content but no tasks for inducing cognitive dissonance among participants. Outcomes will be measured at 1- and 3-months post-baseline and will include quit attempts, number of days without smoking (smoke free days), and changes in smoking attitudes and behavior, and smoking abstinence. Usability data, system log data on program use, and participant satisfaction data will also be analyzed.
The researchers hypothesize that individuals using the cognitive dissonance intervention (CDI) will show greater increases in quit attempts, smoke free days, quit rates, and positive smoking attitudes and behaviors than individuals in the active comparison condition. The researchers will test whether gender, smoking dependence, readiness to quit, previous quit attempts, age of smoking initiation, and socio-economic status moderate intervention effects on smoking outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Support2Quit App - Cognitive Dissonance Based Smoking Cessation | Experimental | This group will receive daily smoking cessation tips and will be asked to complete activities within the app that are designed to induce cognitive dissonance, create and share videos related to the activities with an online group, and provide support to other group members |
|
| Comparison App - Smoking Cessation Support without Cognitive Dissonance Activities | Active Comparator | This group will use an app that consists of tips for quitting cigarettes but does not include the cognitive dissonance component. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Support2Quit App - Cognitive Dissonance Based Smoking Cessation + Smoking Cessation Tips | Behavioral | Support2Quit App (Cognitive Dissonance Based Smoking Cessation) Use of the Support2Quit app, completion of cognitive dissonance activities, sharing of videos with online group, and providing support to other group members |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Cigarette Abstinence | Based on 1-item that asked "In the past 7 days, have you smoked any cigarettes?". The variable is coded 1 if they the participants indicated they did not smoke any cigarettes otherwise coded 0. A value of 1 = abstinence and 0 = not abstinent. | 1-month and 3-month follow-up |
| Fagerstrom Tobacco Dependence Scale | This is a 6 item measure of tobacco dependence and response options are a mix of ordered categorical and dichotomous items. Item 1 "How many cigarettes per day to you smoke?" (0 = less than 10 cigarettes a day, 3 = 31 or more cigarettes a day). Item 2 "How soon after you wake do you smoke your first cigarette (0 = after 60 minutes, 3 = within 5 minutes). Item 3 "Is it hard to keep from smoking in places where it is prohibited (1 = yes, 0 = no). Item 4 "Which cigarette would you hate to give up most (1 = the first in the morning, 0 = any other). Item 5 "Do you smoke more cigarettes during the first 2 hours of the day compared to the rest of the day (1 = yes, 0 = no). Item 6 "Do you smoke when you are so ill you are in bed?" (1 = yes, 0 = no). A total sum score is computed and can range from 0 to 10 points with higher scores indicating higher levels of tobacco dependence. | Baseline, 1-month follow-up, 3-month follow-up |
| Number of Participants With Reduction in Number of Cigarettes Smoked Per Day | Represents whether or not (1 = yes, 0 = no) a reduction of cigarettes smoked per day is reported from the baseline assessment. A higher score indicates a reduction in cigarettes smoked. | 1-month and 3-month follow-up |
| Number of Participants With Reduction in the Number of Cigarettes Smoked Per Day and Reduced to 0-5 Cigarettes | Represents whether or not (1 = yes, 0 = no) a reduction of cigarettes smoked per day is reported from the baseline assessment and is the number of daily cigarettes in 0-5 per day. A higher score indicates a reduction in cigarettes smoked per day and the number smoked is 5 or less. |
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Inclusion Criteria:
Exclusion criteria:
• Currently participating in a tobacco cessation program
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| Name | Affiliation | Role |
|---|---|---|
| Dana Smith, PhD | Oregon Research Behavioral Intervention Strategies, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Research Behavioral Intervention Strategies, Inc. | Springfield | Oregon | 97477-2019 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Support2Quit App - Cognitive Dissonance Based Smoking Cessation | This group will receive daily smoking cessation tips and will be asked to complete activities within the app that are designed to induce cognitive dissonance, create and share videos related to the activities with an online group, and provide support to other group members Support2Quit App - Cognitive Dissonance Based Smoking Cessation + Smoking Cessation Tips: Support2Quit App (Cognitive Dissonance Based Smoking Cessation) Use of the Support2Quit app, completion of cognitive dissonance activities, sharing of videos with online group, and providing support to other group members |
| FG001 | Comparison App - Smoking Cessation Support without Cognitive Dissonance Activities | This group will use an app that consists of tips for quitting cigarettes but does not include the cognitive dissonance component. Tips for Smoking Cessation App: App containing daily tips for smoking cessation |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Support2Quit App - Cognitive Dissonance Based Smoking Cessation | This group will receive daily smoking cessation tips and will be asked to complete activities within the app that are designed to induce cognitive dissonance, create and share videos related to the activities with an online group, and provide support to other group members Support2Quit App - Cognitive Dissonance Based Smoking Cessation + Smoking Cessation Tips: Support2Quit App (Cognitive Dissonance Based Smoking Cessation) Use of the Support2Quit app, completion of cognitive dissonance activities, sharing of videos with online group, and providing support to other group members |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 With Cigarette Abstinence | Based on 1-item that asked "In the past 7 days, have you smoked any cigarettes?". The variable is coded 1 if they the participants indicated they did not smoke any cigarettes otherwise coded 0. A value of 1 = abstinence and 0 = not abstinent. | Posted | Count of Participants | Participants | 1-month and 3-month follow-up |
|
Data was collected from the baseline assessment to the 3 month post-baseline follow up assessment.
Participants completed questionnaires at baseline, 1 month post-baseline and 3 months post-baseline.
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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 | Support2Quit App - Cognitive Dissonance Based Smoking Cessation | This group will receive daily smoking cessation tips and will be asked to complete activities within the app that are designed to induce cognitive dissonance, create and share videos related to the activities with an online group, and provide support to other group members Support2Quit App - Cognitive Dissonance Based Smoking Cessation + Smoking Cessation Tips: Support2Quit App (Cognitive Dissonance Based Smoking Cessation) Use of the Support2Quit app, completion of cognitive dissonance activities, sharing of videos with online group, and providing support to other group members |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Dana Smith | Oregon Research Behavioral Intervention Strategies Inc. | 541-484-2123 | danas@ori.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 9, 2022 | Sep 15, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 15, 2025 | Sep 15, 2025 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 6, 2024 | Sep 15, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D064424 | Tobacco Use |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D019168 | Portasystemic Shunt, Transjugular Intrahepatic |
| ID | Term |
|---|---|
| D011170 | Portasystemic Shunt, Surgical |
| D000714 | Anastomosis, Surgical |
| D013514 | Surgical Procedures, Operative |
| D058017 | Vascular Grafting |
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This study will recruit 500 daily adult smokers through social media to test the Support2Quit app for smoking cessation. Participants will be randomly assigned to either the Support2Quit app or an app that has similar content but no tasks for inducing cognitive dissonance among participants.
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|
| Tips for Smoking Cessation App | Behavioral | App containing daily tips for smoking cessation |
|
| 1-month and 3-month follow-up |
| BG001 | Comparison App - Smoking Cessation Support Without Cognitive Dissonance Activities | This group will use an app that consists of tips for quitting cigarettes but does not include the cognitive dissonance component. Tips for Smoking Cessation App: App containing daily tips for smoking cessation |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Highest level of education | Count of Participants | Participants |
|
| Annual household income | Count of Participants | Participants |
|
| OG001 | Comparison App - Smoking Cessation Support without Cognitive Dissonance Activities | This group will use an app that consists of tips for quitting cigarettes but does not include the cognitive dissonance component. Tips for Smoking Cessation App: App containing daily tips for smoking cessation |
|
|
|
| Primary | Fagerstrom Tobacco Dependence Scale | This is a 6 item measure of tobacco dependence and response options are a mix of ordered categorical and dichotomous items. Item 1 "How many cigarettes per day to you smoke?" (0 = less than 10 cigarettes a day, 3 = 31 or more cigarettes a day). Item 2 "How soon after you wake do you smoke your first cigarette (0 = after 60 minutes, 3 = within 5 minutes). Item 3 "Is it hard to keep from smoking in places where it is prohibited (1 = yes, 0 = no). Item 4 "Which cigarette would you hate to give up most (1 = the first in the morning, 0 = any other). Item 5 "Do you smoke more cigarettes during the first 2 hours of the day compared to the rest of the day (1 = yes, 0 = no). Item 6 "Do you smoke when you are so ill you are in bed?" (1 = yes, 0 = no). A total sum score is computed and can range from 0 to 10 points with higher scores indicating higher levels of tobacco dependence. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 1-month follow-up, 3-month follow-up |
|
|
|
|
| Primary | Number of Participants With Reduction in Number of Cigarettes Smoked Per Day | Represents whether or not (1 = yes, 0 = no) a reduction of cigarettes smoked per day is reported from the baseline assessment. A higher score indicates a reduction in cigarettes smoked. | Posted | Count of Participants | Participants | 1-month and 3-month follow-up |
|
|
|
|
| Primary | Number of Participants With Reduction in the Number of Cigarettes Smoked Per Day and Reduced to 0-5 Cigarettes | Represents whether or not (1 = yes, 0 = no) a reduction of cigarettes smoked per day is reported from the baseline assessment and is the number of daily cigarettes in 0-5 per day. A higher score indicates a reduction in cigarettes smoked per day and the number smoked is 5 or less. | Posted | Count of Participants | Participants | 1-month and 3-month follow-up |
|
|
|
|
| 0 |
| 292 |
| 0 |
| 292 |
| 0 |
| 292 |
| EG001 | Comparison App - Smoking Cessation App without Cognitive Dissonance Activities | This group will use an app that consists of tips for quitting cigarettes but does not include the cognitive dissonance component. Tips for Smoking Cessation App: App containing daily tips for smoking cessation | 0 | 145 | 0 | 145 | 0 | 145 |
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| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| 3-Month Follow-Up |
|
This is a cross sectional analysis at 3-months
| Regression, Logistic |
| .646 |
| Odds Ratio (OR) |
| 1.15 |
| 2-Sided |
| 95 |
| 0.64 |
| 2.07 |
The Support2Quit group was scored 1 and the Comparison group was scored 0 (reference group for the odds ratio). |
| Superiority |
This is a cross sectional analysis at 3-months
| Regression, Logistic |
| .158 |
| Odds Ratio (OR) |
| 1.36 |
| 2-Sided |
| 95 |
| 0.89 |
| 2.11 |
The Support2Quit group was scored 1 and the Comparison group was scored 0 (reference group for the odds ratio). |
| Superiority |