Tobacco Use
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALSupport2Quit 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
BEHAVIORALTips for Smoking Cessation App
App containing daily tips for smoking cessation
Sponsors
Oregon Research Behavioral Intervention Strategies, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age 18 or older * Self-reported daily smoking * Having a valid home mailing address in the United States * English-speaking * Access to a smart phone with video capability for the duration of the project * Expressed desire to quit smoking
Exclusion criteria
• Currently participating in a tobacco cessation program
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Cigarette Abstinence | 1-month and 3-month follow-up | 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. |
| Fagerstrom Tobacco Dependence Scale | Baseline, 1-month follow-up, 3-month follow-up | 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. |
| Number of Participants With Reduction in Number of Cigarettes Smoked Per Day | 1-month and 3-month follow-up | 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. |
| Number of Participants With Reduction in the Number of Cigarettes Smoked Per Day and Reduced to 0-5 Cigarettes | 1-month and 3-month follow-up | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 292 |
| 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 | 145 |
| Total | 437 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 33 | 12 |
Baseline characteristics
| Characteristic | Total | Support2Quit App - Cognitive Dissonance Based Smoking Cessation | Comparison App - Smoking Cessation Support Without Cognitive Dissonance Activities |
|---|---|---|---|
| Age, Continuous | 49.08 years STANDARD_DEVIATION 11.82 | 49.21 years STANDARD_DEVIATION 12 | 48.84 years STANDARD_DEVIATION 11.5 |
| Annual household income $10,000 - $19,999 | 50 Participants | 35 Participants | 15 Participants |
| Annual household income $20,000 - $29,999 | 63 Participants | 40 Participants | 23 Participants |
| Annual household income $30,000 - $39,999 | 31 Participants | 19 Participants | 12 Participants |
| Annual household income $40,000 - $49,999 | 35 Participants | 25 Participants | 10 Participants |
| Annual household income $50,000 - $59,999 | 44 Participants | 30 Participants | 14 Participants |
| Annual household income $60,000 - $69,999 | 20 Participants | 8 Participants | 12 Participants |
| Annual household income $70,000 - $79,999 | 29 Participants | 19 Participants | 10 Participants |
| Annual household income $80,000 - $89,999 | 21 Participants | 15 Participants | 6 Participants |
| Annual household income Decline to answer | 72 Participants | 53 Participants | 19 Participants |
| Annual household income Over $90,000 | 44 Participants | 28 Participants | 16 Participants |
| Annual household income Under $10,000 | 28 Participants | 20 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 29 Participants | 17 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 408 Participants | 275 Participants | 133 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Highest level of education Bachelor's degree | 86 Participants | 52 Participants | 34 Participants |
| Highest level of education Declined to answer | 1 Participants | 1 Participants | 0 Participants |
| Highest level of education Did not graduate high school | 13 Participants | 12 Participants | 1 Participants |
| Highest level of education Doctorate | 5 Participants | 4 Participants | 1 Participants |
| Highest level of education High school graduate | 86 Participants | 63 Participants | 23 Participants |
| Highest level of education Master's degree | 23 Participants | 17 Participants | 6 Participants |
| Highest level of education Some college, no degree | 135 Participants | 91 Participants | 44 Participants |
| Highest level of education Technical school or associate degree | 88 Participants | 52 Participants | 36 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 9 Participants | 6 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 5 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 45 Participants | 32 Participants | 13 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 33 Participants | 24 Participants | 9 Participants |
| Race (NIH/OMB) White | 343 Participants | 224 Participants | 119 Participants |
| Region of Enrollment United States | 437 participants | 292 participants | 145 participants |
| Sex/Gender, Customized Female | 319 Participants | 215 Participants | 104 Participants |
| Sex/Gender, Customized Male | 114 Participants | 76 Participants | 38 Participants |
| Sex/Gender, Customized Non-binary | 2 Participants | 0 Participants | 2 Participants |
| Sex/Gender, Customized Transgender | 2 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 292 | 0 / 145 |
| other Total, other adverse events | 0 / 292 | 0 / 145 |
| serious Total, serious adverse events | 0 / 292 | 0 / 145 |
Outcome results
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.
Time frame: Baseline, 1-month follow-up, 3-month follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Support2Quit App - Cognitive Dissonance Based Smoking Cessation | Fagerstrom Tobacco Dependence Scale | Baseline | 5.7 units on a scale | Standard Deviation 2 |
| Support2Quit App - Cognitive Dissonance Based Smoking Cessation | Fagerstrom Tobacco Dependence Scale | 1-Month Follow-Up | 4.1 units on a scale | Standard Deviation 2.4 |
| Support2Quit App - Cognitive Dissonance Based Smoking Cessation | Fagerstrom Tobacco Dependence Scale | 3-Month Follow-Up | 4.0 units on a scale | Standard Deviation 2.1 |
| Comparison App - Smoking Cessation Support without Cognitive Dissonance Activities | Fagerstrom Tobacco Dependence Scale | Baseline | 5.4 units on a scale | Standard Deviation 1.9 |
| Comparison App - Smoking Cessation Support without Cognitive Dissonance Activities | Fagerstrom Tobacco Dependence Scale | 1-Month Follow-Up | 4.4 units on a scale | Standard Deviation 2.2 |
| Comparison App - Smoking Cessation Support without Cognitive Dissonance Activities | Fagerstrom Tobacco Dependence Scale | 3-Month Follow-Up | 4.2 units on a scale | Standard Deviation 2.4 |
Comparison: This is a longitudinal analysis from baseline to 3-month follow-upp-value: 0.437t-test, 2 sided
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.
Time frame: 1-month and 3-month follow-up
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Support2Quit App - Cognitive Dissonance Based Smoking Cessation | Number of Participants With Cigarette Abstinence | 1-Month Follow-Up | 102 Participants |
| Support2Quit App - Cognitive Dissonance Based Smoking Cessation | Number of Participants With Cigarette Abstinence | 3-Month Follow-Up | 112 Participants |
| Comparison App - Smoking Cessation Support without Cognitive Dissonance Activities | Number of Participants With Cigarette Abstinence | 1-Month Follow-Up | 38 Participants |
| Comparison App - Smoking Cessation Support without Cognitive Dissonance Activities | Number of Participants With Cigarette Abstinence | 3-Month Follow-Up | 54 Participants |
Comparison: This is a cross sectional analysis at 1-month.p-value: 0.03695% CI: [1.04, 2.67]Regression, Logistic
Comparison: This is a cross sectional analysis at 3-monthsp-value: 0.63295% CI: [0.72, 1.72]Regression, Logistic
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.
Time frame: 1-month and 3-month follow-up
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Support2Quit App - Cognitive Dissonance Based Smoking Cessation | Number of Participants With Reduction in Number of Cigarettes Smoked Per Day | 1-Month Follow-Up | 191 Participants |
| Support2Quit App - Cognitive Dissonance Based Smoking Cessation | Number of Participants With Reduction in Number of Cigarettes Smoked Per Day | 3-Month Follow-Up | 218 Participants |
| Comparison App - Smoking Cessation Support without Cognitive Dissonance Activities | Number of Participants With Reduction in Number of Cigarettes Smoked Per Day | 1-Month Follow-Up | 91 Participants |
| Comparison App - Smoking Cessation Support without Cognitive Dissonance Activities | Number of Participants With Reduction in Number of Cigarettes Smoked Per Day | 3-Month Follow-Up | 110 Participants |
Comparison: This is a cross sectional analysis at 1-monthp-value: 0.08895% CI: [0.94, 2.42]Regression, Logistic
Comparison: This is a cross sectional analysis at 3-monthsp-value: 0.64695% CI: [0.64, 2.07]Regression, Logistic
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.
Time frame: 1-month and 3-month follow-up
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Support2Quit App - Cognitive Dissonance Based Smoking Cessation | Number of Participants With Reduction in the Number of Cigarettes Smoked Per Day and Reduced to 0-5 Cigarettes | 1-Month Follow-Up | 144 Participants |
| Support2Quit App - Cognitive Dissonance Based Smoking Cessation | Number of Participants With Reduction in the Number of Cigarettes Smoked Per Day and Reduced to 0-5 Cigarettes | 3-Month Follow-Up | 165 Participants |
| Comparison App - Smoking Cessation Support without Cognitive Dissonance Activities | Number of Participants With Reduction in the Number of Cigarettes Smoked Per Day and Reduced to 0-5 Cigarettes | 1-Month Follow-Up | 56 Participants |
| Comparison App - Smoking Cessation Support without Cognitive Dissonance Activities | Number of Participants With Reduction in the Number of Cigarettes Smoked Per Day and Reduced to 0-5 Cigarettes | 3-Month Follow-Up | 74 Participants |
Comparison: This is a cross sectional analysis at 1-monthp-value: 0.0195% CI: [1.15, 2.72]Regression, Logistic
Comparison: This is a cross sectional analysis at 3-monthsp-value: 0.15895% CI: [0.89, 2.11]Regression, Logistic