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Trial Outcomes & Findings for Stanford Tobacco Treatment Services - Virtual Reality Treatment for Smoking Cessation (NCT NCT05220254)

NCT ID: NCT05220254

Last Updated: 2023-12-18

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

6 weeks

Results posted on

2023-12-18

Participant Flow

Participants use the app for 6 weeks and complete a final end of treatment survey.

105 participants were screened for eligibility.

Participant milestones

Participant milestones
Measure
MindCotine Mobile App Program
MindCotine VR app program, a 6-week intervention to help users utilize mindfulness based skills involving virtual exposure therapy.
Overall Study
STARTED
20
Overall Study
Used the MindCotine Intervention
9
Overall Study
Completed End of Treatment Survey
8
Overall Study
COMPLETED
8
Overall Study
NOT COMPLETED
12

Reasons for withdrawal

Reasons for withdrawal
Measure
MindCotine Mobile App Program
MindCotine VR app program, a 6-week intervention to help users utilize mindfulness based skills involving virtual exposure therapy.
Overall Study
Withdrawal by Subject
4
Overall Study
Removed due to ineligibility
1
Overall Study
Lost to Follow-up
7

Baseline Characteristics

Patients who smoke every day

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
MindCotine Mobile App Program
n=20 Participants
MindCotine VR app program, a 6-week intervention to help users utilize mindfulness based skills involving virtual exposure therapy.
Age, Continuous
52 years
STANDARD_DEVIATION 13 • n=20 Participants
Sex: Female, Male
Female
11 Participants
n=20 Participants
Sex: Female, Male
Male
9 Participants
n=20 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=20 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
20 Participants
n=20 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=20 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=20 Participants
Race (NIH/OMB)
Asian
2 Participants
n=20 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=20 Participants
Race (NIH/OMB)
Black or African American
1 Participants
n=20 Participants
Race (NIH/OMB)
White
15 Participants
n=20 Participants
Race (NIH/OMB)
More than one race
1 Participants
n=20 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=20 Participants
Region of Enrollment
United States
20 Participants
n=20 Participants
Smoking habit
Smokes daily
18 Participants
n=20 Participants
Smoking habit
Smokes some days
2 Participants
n=20 Participants
Cigarette use - patients who smoke every day
14.7 cigarettes per day
STANDARD_DEVIATION 7.2 • n=18 Participants • Patients who smoke every day
Cigarette use - patients who smoke some days
25 cigarettes per week
STANDARD_DEVIATION 7 • n=2 Participants • Patients who smoke some days

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
MindCotine Mobile App Program
n=20 Participants
MindCotine VR app program, a 6-week intervention to help users utilize mindfulness based skills involving virtual exposure therapy.
Number of Patients Who Registered With the MindCotine Application
9 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: Participants who were screened for eligibility

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.

Outcome measures

Outcome measures
Measure
MindCotine Mobile App Program
n=105 Participants
MindCotine VR app program, a 6-week intervention to help users utilize mindfulness based skills involving virtual exposure therapy.
Number of Patients With Interest in the MindCotine Application
27 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: Participants who completed the end of treatment survey.

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.

Outcome measures

Outcome measures
Measure
MindCotine Mobile App Program
n=8 Participants
MindCotine VR app program, a 6-week intervention to help users utilize mindfulness based skills involving virtual exposure therapy.
Number of Patients Who Would Recommend the MindCotine Application as a Measure of Feasibility Among Patients Who Smoke.
7 Participants

SECONDARY outcome

Timeframe: 6 weeks prior to end of treatment survey

Population: Participants who completed the 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

Outcome measures

Outcome measures
Measure
MindCotine Mobile App Program
n=8 Participants
MindCotine VR app program, a 6-week intervention to help users utilize mindfulness based skills involving virtual exposure therapy.
Number of Patients Who Attempt to Quit Smoking by Using the Application
4 Participants

SECONDARY outcome

Timeframe: 6 weeks

Population: Participants who completed the end of treatment survey.

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

Outcome measures

Outcome measures
Measure
MindCotine Mobile App Program
n=8 Participants
MindCotine VR app program, a 6-week intervention to help users utilize mindfulness based skills involving virtual exposure therapy.
Number of Patients Using Cessation Medication by End of Treatment
5 Participants

SECONDARY outcome

Timeframe: 6 weeks

Population: Participants who used the app

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

Outcome measures

Outcome measures
Measure
MindCotine Mobile App Program
n=9 Participants
MindCotine VR app program, a 6-week intervention to help users utilize mindfulness based skills involving virtual exposure therapy.
Number of MindCotine App Program Activities Completed
13 activities
Standard Deviation 20.2

SECONDARY outcome

Timeframe: 6 weeks

Population: Participants who used the app

Journal Record refers to CBT-based self-reflections.

Outcome measures

Outcome measures
Measure
MindCotine Mobile App Program
n=9 Participants
MindCotine VR app program, a 6-week intervention to help users utilize mindfulness based skills involving virtual exposure therapy.
Number of MindCotine App Journal Entries Completed
19 Journal entries
Standard Deviation 26

SECONDARY outcome

Timeframe: 6 weeks

Population: Participants who used the app

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

Outcome measures

Outcome measures
Measure
MindCotine Mobile App Program
n=9 Participants
MindCotine VR app program, a 6-week intervention to help users utilize mindfulness based skills involving virtual exposure therapy.
Number of MindCotine App Coaching Engagements Completed
11 Coaching engagements
Standard Deviation 12.3

SECONDARY outcome

Timeframe: baseline to end of treatment, up to 6 weeks

Population: patients who used the app

Average change in cigarette use from baseline to end of treatment among patients using the MindCotine app.

Outcome measures

Outcome measures
Measure
MindCotine Mobile App Program
n=9 Participants
MindCotine VR app program, a 6-week intervention to help users utilize mindfulness based skills involving virtual exposure therapy.
Average Change in Cigarette Use
-4.1 cigarettes
Standard Deviation 8

SECONDARY outcome

Timeframe: 6 weeks

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

Outcome measures

Outcome measures
Measure
MindCotine Mobile App Program
n=20 Participants
MindCotine VR app program, a 6-week intervention to help users utilize mindfulness based skills involving virtual exposure therapy.
MindCotine Dropout
5 Participants

Adverse Events

MindCotine Mobile App Program

Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
MindCotine Mobile App Program
n=20 participants at risk
MindCotine VR app program, a 6-week intervention to help users utilize mindfulness based skills involving virtual exposure therapy.
Nervous system disorders
Disorientation
5.0%
1/20 • 9 weeks
Nervous system disorders
Dizziness
20.0%
4/20 • 9 weeks
Nervous system disorders
Double vision
5.0%
1/20 • 9 weeks
Nervous system disorders
Headache
5.0%
1/20 • 9 weeks
Nervous system disorders
Lighheadedness
5.0%
1/20 • 9 weeks
Gastrointestinal disorders
Nausea
10.0%
2/20 • 9 weeks

Additional Information

Judith Prochaska

Stanford University

Phone: (650) 724-3608

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place