MindCotine Virtual Reality Mindful Exposure Therapy, Smoking Cessation
Conditions
Keywords
Virtual Reality, Smoking Cessation
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
Interventions
BEHAVIORALMindCotine's VR app
The MindCotine program would be a 6-week intervention to help users utilize mindfulness based skills, and involves virtual exposure therapy.
Sponsors
National Cancer Institute (NCI)
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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
| Measure | Time frame | Description |
|---|---|---|
| Number of MindCotine App Journal Entries Completed | 6 weeks | Journal Record refers to CBT-based self-reflections. |
| Number of MindCotine App Coaching Engagements Completed | 6 weeks | Coaching Engagement refers to communicating with a coach through the MindCotine mobile application. |
| 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 |
| MindCotine Dropout | 6 weeks | Number of patients who withdrew or were removed from the study. |
| 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 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 Program Activities Completed | 6 weeks | Program activities include VR-MET exercises and guided mindfulness-based two-dimensional video, audio, and reflection exercises. |
Countries
United States
Participant flow
Recruitment details
Participants use the app for 6 weeks and complete a final end of treatment survey.
Pre-assignment details
105 participants were screened for eligibility.
Participants by arm
| Arm | Count |
|---|---|
| MindCotine Mobile App Program MindCotine VR app program, a 6-week intervention to help users utilize mindfulness based skills involving virtual exposure therapy. | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 7 |
| Overall Study | Removed due to ineligibility | 1 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | MindCotine Mobile App Program |
|---|---|
| Age, Continuous | 52 years STANDARD_DEVIATION 13 |
| Cigarette use - patients who smoke every day | 14.7 cigarettes per day STANDARD_DEVIATION 7.2 |
| Cigarette use - patients who smoke some days | 25 cigarettes per week STANDARD_DEVIATION 7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 15 Participants |
| Region of Enrollment United States | 20 Participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 9 Participants |
| Smoking habit Smokes daily | 18 Participants |
| Smoking habit Smokes some days | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 4 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
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.
Time frame: 6 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MindCotine Mobile App Program | Number of Patients Who Registered With the MindCotine Application | 9 Participants |
Primary
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.
Time frame: 6 weeks
Population: Participants who completed the end of treatment survey.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MindCotine Mobile App Program | Number of Patients Who Would Recommend the MindCotine Application as a Measure of Feasibility Among Patients Who Smoke. | 7 Participants |
Primary
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.
Time frame: 6 weeks
Population: Participants who were screened for eligibility
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MindCotine Mobile App Program | Number of Patients With Interest in the MindCotine Application | 27 Participants |
Secondary
Average Change in Cigarette Use
Average change in cigarette use from baseline to end of treatment among patients using the MindCotine app.
Time frame: baseline to end of treatment, up to 6 weeks
Population: patients who used the app
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MindCotine Mobile App Program | Average Change in Cigarette Use | -4.1 cigarettes | Standard Deviation 8 |
Secondary
MindCotine Dropout
Number of patients who withdrew or were removed from the study.
Time frame: 6 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MindCotine Mobile App Program | MindCotine Dropout | 5 Participants |
Secondary
Number of MindCotine App Coaching Engagements Completed
Coaching Engagement refers to communicating with a coach through the MindCotine mobile application.
Time frame: 6 weeks
Population: Participants who used the app
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MindCotine Mobile App Program | Number of MindCotine App Coaching Engagements Completed | 11 Coaching engagements | Standard Deviation 12.3 |
Secondary
Number of MindCotine App Journal Entries Completed
Journal Record refers to CBT-based self-reflections.
Time frame: 6 weeks
Population: Participants who used the app
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MindCotine Mobile App Program | Number of MindCotine App Journal Entries Completed | 19 Journal entries | Standard Deviation 26 |
Secondary
Number of MindCotine App Program Activities Completed
Program activities include VR-MET exercises and guided mindfulness-based two-dimensional video, audio, and reflection exercises.
Time frame: 6 weeks
Population: Participants who used the app
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MindCotine Mobile App Program | Number of MindCotine App Program Activities Completed | 13 activities | Standard Deviation 20.2 |
Secondary
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.
Time frame: 6 weeks
Population: Participants who completed the end of treatment survey.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MindCotine Mobile App Program | Number of Patients Using Cessation Medication by End of Treatment | 5 Participants |
Secondary
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
Time frame: 6 weeks prior to end of treatment survey
Population: Participants who completed the end of treatment survey.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MindCotine Mobile App Program | Number of Patients Who Attempt to Quit Smoking by Using the Application | 4 Participants |