Stanford Tobacco Treatment Services - Virtual Reality Treatment for Smoking Cessation

Not Applicable

Completed

• Conditions: MindCotine Virtual Reality Mindful Exposure Therapy; Smoking Cessation
• Interventions: Behavioral: MindCotine's VR app

• Registration Number: NCT05220254
• Lead Sponsor: Stanford University

Brief Summary

This study aims to see how feasible a mobile app based virtual reality program for smoking cessation (MindCotine) would be among Stanford cancer center patients

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-10-18
• Study First Submitted: 2021-12-13
• Study First Submitted QC: 2022-01-20
• Study First Posted: 2022-02-02
• Primary Completion: 2022-10-27
• Study Completion: 2022-10-27
• Results First Submitted: 2023-10-30
• Status Verified: 2023-11
• Results First Submitted QC: 2023-11-30
• Last Update Submitted: 2023-11-30
• Results First Posted: 2023-12-18
• Last Update Posted: 2023-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Daily cigarette smoker or some day smoker (>9 cigarettes per week)
• Age 18+
• English or Spanish fluent
• Smartphone compatibility
• Available to interact with a smartphone app for 6-weeks
• Available to complete the EOT assessment at end of 6-weeks
• Ability to understand and the willingness to personally sign the written IRB-approved informed consent document.
• Confirm phone, email, address during consent

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Exclusion Criteria

• Ever had epilepsy
• Less than 10 cigarettes per week
• Not English or Spanish fluent
• No smartphone compatibility
• Unavailable to interact with the VR program,
• Unavailable to answer questions about the intervention post-treatment

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MindCotine mobile app program	MindCotine's VR app	-

Primary Outcome Measures

Name	Time	Method
Number of Patients With Interest in the MindCotine Application	6 weeks	Total number of patients who expressed interest in the app, out of total number of participants who were screened for enrollment. This measure is to assess whether MindCotine is a feasible smoking cessation option among patients who smoke cigarettes.
Number of Patients Who Registered With the MindCotine Application	6 weeks	Total number of patients who registered with the app, out of total number of participants who were enrolled (eligible and willing to accept help with quitting). This measure is to assess whether MindCotine is a feasible smoking cessation option among patients who smoke cigarettes.
Number of Patients Who Would Recommend the MindCotine Application as a Measure of Feasibility Among Patients Who Smoke.	6 weeks	Learning whether MindCotine is a feasible smoking cessation option among patients who smoke cigarettes.; Interest in using the app will be calculated as total number of patients who recommend the app to others.

Secondary Outcome Measures

Name	Time	Method
Average Change in Cigarette Use	baseline to end of treatment, up to 6 weeks	Average change in cigarette use from baseline to end of treatment among patients using the MindCotine app.
Number of Patients Who Attempt to Quit Smoking by Using the Application	6 weeks prior to end of treatment survey	Measured as the number of participants who had a 24-hour quit attempt in the past 6-weeks prior to end of treatment survey
Number of MindCotine App Coaching Engagements Completed	6 weeks	Coaching Engagement refers to communicating with a coach through the MindCotine mobile application.
Number of MindCotine App Program Activities Completed	6 weeks	Program activities include VR-MET exercises and guided mindfulness-based two-dimensional video, audio, and reflection exercises.
MindCotine Dropout	6 weeks	Number of patients who withdrew or were removed from the study.
Number of Patients Using Cessation Medication by End of Treatment	6 weeks	Number of participants using cessation medications among those who completed the end of treatment survey.
Number of MindCotine App Journal Entries Completed	6 weeks	Journal Record refers to CBT-based self-reflections.

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Palo Alto, California, United States