- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05797155
A Mobile App Based Cognitive Dissonance Intervention for Smoking Cessation (Support2Quit)
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Oregon
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Springfield, Oregon, United States, 97477-2019
- Oregon Research Behavioral Intervention Strategies, Inc.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: 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.
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App containing daily tips for smoking cessation
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Experimental: 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
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Behavioral: 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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants With Cigarette Abstinence
Time Frame: 1-month and 3-month follow-up
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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.
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1-month and 3-month follow-up
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Fagerstrom Tobacco Dependence Scale
Time Frame: Baseline, 1-month follow-up, 3-month follow-up
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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.
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Baseline, 1-month follow-up, 3-month follow-up
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Number of Participants With Reduction in Number of Cigarettes Smoked Per Day
Time Frame: 1-month and 3-month follow-up
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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.
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1-month and 3-month follow-up
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Number of Participants With Reduction in the Number of Cigarettes Smoked Per Day and Reduced to 0-5 Cigarettes
Time Frame: 1-month and 3-month follow-up
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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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1-month and 3-month follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Program Engagement
Time Frame: 1-month, 3-month
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This measure will assess usage of CoQuit app.
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1-month, 3-month
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Consumer Satisfaction and Program Evaluation
Time Frame: 3-month
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The measure will assess the perceived ease of using the app and perceived benefit of the app.
Some items will use a 7 point Likert scale to assess satisfaction with the mobile app and usability function of the app.
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3-month
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Collaborators and Investigators
Investigators
- Principal Investigator: Dana Smith, PhD, Oregon Research Behavioral Intervention Strategies, Inc.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DP006495-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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