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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05797155
Other study ID # DP006495-02
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 1, 2023
Est. completion date September 29, 2024

Study information

Verified date January 2024
Source Oregon Research Behavioral Intervention Strategies, Inc.
Contact Erika James, BA
Phone 541-484-2123
Email erika.james@influentsin.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This research study aims to develop a cognitive dissonance-based mobile app for smoking cessation (CoQuit) and test the efficacy of the app with 500 adult smokers who express a desire to quit smoking.


Description:

This research project will evaluate the CoQuit mobile app for smoking cessation by having 500 daily adult smokers recruited through social media and randomized to either the CoQuit 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 (smokefree 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date September 29, 2024
Est. primary completion date May 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 smartphone with video capability for the duration of the project - Expressed desire to quit smoking Exclusion criteria: • Currently participating in a tobacco cessation program

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
CoQuit App - Cognitive Dissonance Based Smoking Cessation + Smoking Cessation Tips
CoQuit App (Cognitive Dissonance Based Smoking Cessation) Use of the CoQuit app, completion of cognitive dissonance activities, sharing of videos with online group, and providing support to other group members
Tips for Smoking Cessation App
App containing daily tips for smoking cessation

Locations

Country Name City State
United States Oregon Research Behavioral Intervention Strategies, Inc. Springfield Oregon

Sponsors (1)

Lead Sponsor Collaborator
Oregon Research Behavioral Intervention Strategies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Tobacco Use Questionnaire Change frequency of tobacco use from baseline to 3 months. Baseline, 1-month, 3-month
Primary Fagerstrom Tobacco Dependence Scale Change in nicotine dependence from baseline to 3 months. This is a 6 item measure. Total scores range from 0 to 10 points with higher scores indicating higher levels of dependence. Baseline, 1-month, 3-month
Primary Contemplation Ladder Change in motivation to quit smoking. This measure is a single ten point scale arranged as a ladder with descriptions of readiness to quit for 5 levels; higher scores indicate higher readiness to quit. Baseline, 1-month, 3-month
Primary Cognitive Dissonance Thermometer Change in cognitive dissonance will be assessed using the Dissonance Thermometer, which measures participants' experience of 14 different feelings (e.g., embarrassed, optimistic) related to particular stimuli. Higher scores indicate higher levels of cognitive dissonance. Baseline, 1-month, 3-month
Secondary Program Engagement This measure will assess usage of CoQuit app. 1-month, 3-month
Secondary Consumer Satisfaction and Program Evaluation 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. 3-month
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