Stanford Tobacco Treatment Services - Virtual Reality Treatment for Smoking Cessation

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

Study Overview

• Status: Completed
• Conditions: Smoking Cessation; MindCotine Virtual Reality Mindful Exposure Therapy
• Intervention / Treatment: Behavioral: MindCotine's VR app

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94305
      • Stanford University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MindCotine mobile app program	Behavioral: MindCotine's VR app; The MindCotine program would be a 6-week intervention to help users utilize mindfulness based skills, and involves virtual exposure therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients Who Registered With the MindCotine Application	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.	6 weeks
Number of Patients With Interest in the MindCotine Application	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.	6 weeks
Number of Patients Who Would Recommend the MindCotine Application as a Measure of Feasibility Among Patients Who Smoke.	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.	6 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2021
• Primary Completion (Actual): October 27, 2022
• Study Completion (Actual): October 27, 2022

Study Registration Dates

• First Submitted: December 13, 2021
• First Submitted That Met QC Criteria: January 20, 2022
• First Posted (Actual): February 2, 2022

Study Record Updates

• Last Update Posted (Estimated): December 18, 2023
• Last Update Submitted That Met QC Criteria: November 30, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Virtual Reality; Smoking Cessation
• Other Study ID Numbers: IRB-60253; P30CA124435 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No