Smoking CessationNCT05220254
Stanford Tobacco Treatment Services - Virtual Reality Treatment for Smoking Cessation
A study testing MindCotine's VR app in people with Smoking Cessation and MindCotine Virtual Reality Mindful Exposure Therapy, run by Stanford University at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation, MindCotine Virtual Reality Mindful Exposure Therapy
- What is being tested?
- MindCotine's VR app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2021to 27 Oct 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- MindCotine's VR app
- Keywords
- Virtual Reality, Smoking Cessation
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MindCotine's VR appBehavioural
The MindCotine program would be a 6-week intervention to help users utilize mindfulness based skills, and involves virtual exposure therapy.
| Study group | Role | What they receive |
|---|---|---|
| MindCotine mobile app program | Experimental | Not described Receives: Behavioral: MindCotine's VR app |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 6 weeks
Secondary outcomes (7)
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
Measured: 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.
Measured: 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.
Measured: 6 weeks
Number of MindCotine App Journal Entries Completed
Journal Record refers to CBT-based self-reflections.
Measured: 6 weeks
Number of MindCotine App Coaching Engagements Completed
Coaching Engagement refers to communicating with a coach through the MindCotine mobile application.
Measured: 6 weeks
Average Change in Cigarette Use
Average change in cigarette use from baseline to end of treatment among patients using the MindCotine app.
Measured: baseline to end of treatment, up to 6 weeks
MindCotine Dropout
Number of patients who withdrew or were removed from the study.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start18 Oct 2021
- Primary completion27 Oct 2022
- Study completion27 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Judith Prochaska, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05220254
- Sponsor's protocol ID
- IRB-60253
- Other IDs
- P30CA124435
- Status last verified
- Nov 2023
- First submitted
- 13 Dec 2021
- Last updated
- 18 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jackson RW, Cao-Nasalga A, Chieng A, Pirkl A, Jagielo AD, Xu C, Goldenhersch E, Rosencovich N, Waitman C, Prochaska JJ. Adding Virtual Reality Mindful Exposure Therapy to a Cancer Center's Tobacco Treatment Offerings: Feasibility and Acceptability Single-Group Pilot Study. JMIR Form Res. 2024 Jul 23;8:e54817. doi: 10.2196/54817.
PubMed 39042439
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stanford Tobacco Treatment Services - Virtual Reality Treatment for Smoking Cessation
- ClinicalTrials.gov ID
- NCT05220254
- Acronym / sponsor ID
- IRB-60253
- Keywords
- Virtual Reality, Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 18 Oct 2021 (actual)
- Primary completion
- 27 Oct 2022 (actual)
- Study completion
- 27 Oct 2022 (actual)
- First posted
- 2 Feb 2022 (actual)
- Results
- Posted 18 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MindCotine mobile app program | Experimental | Behavioral: MindCotine's VR app |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- Ever had epilepsy
- Less than 10 cigarettes per week
- Not English or Spanish fluent
- No smartphone compatibility
- Unavailable to interact with the VR program,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MindCotine's VR appThe MindCotine program would be a 6-week intervention to help users utilize mindfulness based skills, and involves virtual exposure therapy. | Behavioural | MindCotine mobile app program |
Primary outcome
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.
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.
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.
7 secondary outcomes
Number of Patients Who Attempt to Quit Smoking by Using the Application
Time frame: 6 weeks prior to end of treatment survey
Number of Patients Using Cessation Medication by End of Treatment
Time frame: 6 weeks
Number of MindCotine App Program Activities Completed
Time frame: 6 weeks
Number of MindCotine App Journal Entries Completed
Time frame: 6 weeks
Number of MindCotine App Coaching Engagements Completed
Time frame: 6 weeks
Average Change in Cigarette Use
Time frame: baseline to end of treatment, up to 6 weeks
MindCotine Dropout
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39042439Jackson RW, Cao-Nasalga A, Chieng A, Pirkl A, Jagielo AD, Xu C, Goldenhersch E, Rosencovich N, Waitman C, Prochaska JJ. Adding Virtual Reality Mindful Exposure Therapy to a Cancer Center's Tobacco Treatment Offerings: Feasibility and Acceptability Single-Group Pilot Study. JMIR Form Res. 2024 Jul 23;8:e54817. doi: 10.2196/54817.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MindCotine's VR app in people with Smoking Cessation and MindCotine Virtual Reality Mindful Exposure Therapy, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients Who Registered With the MindCotine Application (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05220254, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2023.