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Completed

NCT Number: NCT05220254

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

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Key information

Conditions

Smoking Cessation Behavior Health Behavior MindCotine Virtual Reality Mindful Exposure Therapy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Palo Alto, California, 94305, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MindCotine's VR app

Behavioral

The MindCotine program would be a 6-week intervention to help users utilize mindfulness based skills, and involves virtual exposure therapy.

Primary outcomes

  1. Number of Patients Who Registered With the MindCotine Application

    Time frame: 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.

  2. Number of Patients With Interest in the MindCotine Application

    Time frame: 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.

  3. Number of Patients Who Would Recommend the MindCotine Application as a Measure of Feasibility Among Patients Who Smoke.

    Time frame: 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 outcomes

  1. Number of Patients Who Attempt to Quit Smoking by Using the Application

    Time frame: 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

  2. Number of Patients Using Cessation Medication by End of Treatment

    Time frame: 6 weeks

    Number of participants using cessation medications among those who completed the end of treatment survey.

  3. Number of MindCotine App Program Activities Completed

    Time frame: 6 weeks

    Program activities include VR-MET exercises and guided mindfulness-based two-dimensional video, audio, and reflection exercises.

  4. Number of MindCotine App Journal Entries Completed

    Time frame: 6 weeks

    Journal Record refers to CBT-based self-reflections.

  5. Number of MindCotine App Coaching Engagements Completed

    Time frame: 6 weeks

    Coaching Engagement refers to communicating with a coach through the MindCotine mobile application.

  6. Average Change in Cigarette Use

    Time frame: 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.

  7. MindCotine Dropout

    Time frame: 6 weeks

    Number of patients who withdrew or were removed from the study.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 2, 2022
Registry last updated
Dec 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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