NCT05797155

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
437

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

April 4, 2023

Completed
8 months until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2025

Completed
8 months until next milestone

Results Posted

Study results publicly available

November 24, 2025

Completed
Last Updated

November 24, 2025

Status Verified

November 1, 2025

Enrollment Period

1.3 years

First QC Date

March 9, 2023

Results QC Date

September 16, 2025

Last Update Submit

November 11, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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.

    1-month and 3-month follow-up

Study Arms (2)

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

Behavioral: Support2Quit App - Cognitive Dissonance Based Smoking Cessation + Smoking Cessation Tips

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.

Behavioral: Tips for Smoking Cessation App

Interventions

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

Support2Quit App - Cognitive Dissonance Based Smoking Cessation

App containing daily tips for smoking cessation

Comparison App - Smoking Cessation Support without Cognitive Dissonance Activities

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Currently participating in a tobacco cessation program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Research Behavioral Intervention Strategies, Inc.

Springfield, Oregon, 97477-2019, United States

Location

MeSH Terms

Conditions

Tobacco Use

Interventions

Portasystemic Shunt, Transjugular Intrahepatic

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Portasystemic Shunt, SurgicalAnastomosis, SurgicalSurgical Procedures, OperativeVascular GraftingVascular Surgical ProceduresCardiovascular Surgical Procedures

Results Point of Contact

Title
Dr. Dana Smith
Organization
Oregon Research Behavioral Intervention Strategies Inc.

Study Officials

  • Dana Smith, PhD

    Oregon Research Behavioral Intervention Strategies, Inc.

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2023

First Posted

April 4, 2023

Study Start

December 1, 2023

Primary Completion

March 15, 2025

Study Completion

March 15, 2025

Last Updated

November 24, 2025

Results First Posted

November 24, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations