An interventional study of MindCotine Virtual reality in Tobacco Use Cessation, sponsored by Cedars-Sinai Medical Center. Not yet recruiting. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-26.
Sponsored by Cedars-Sinai Medical Center · Not applicable, Interventional, and Other
Lung cancer is the second most common cancer and the leading cause of cancer related deaths in the United States (US . Tobacco use is the leading cause of lung cancer and tobacco control continues to be the primary method of lung cancer prevention. Smoking cessation interventions (SCIs) are strongly recommended by screening guidelines and have a class A recommendation by the United States Preventive Services Task Force. Currently, a variety of smoking cessation interventions exist, and evidence suggests that pharmacotherapy, such as nicotine replacement therapy, in combination with behavioral interventions is more effective than either intervention alone. Many individuals, however, prefer not to use or are unable to use pharmacotherapy. A variety of behavioral interventions exist to aid in smoking cession. Recently, virtual reality (VR) has emerged as a possible tool to conduct behavior interventions. Previous research has demonstrated that use of VR can improve patient engagement in a variety of chronic disease interventions. Little is known however about the feasibility and adoption of VR in smoking cessation, especially among individuals at high risk for lung cancers. VR based platforms utilize 'cue exposure therapy'. Given that cravings are often triggered by external factors, or cues, cue exposure therapy exposes individuals to repeated drug-related cues and provides them with tools to eliminate cue-induced cravings. Given the inability for all individuals to use pharmacotherapy there remains a critical need to improve adherence to and efficacy of behavioral interventions for smoking cessation. To address this unmet need, the investigators propose, as pilot study, to enroll patients undergoing routine lung cancer screening and who are not interested in or cannot take pharmacologic therapies for smoking cession, to participate in VR based smoking cessation therapy.
The purpose of this study is to assess the adoption rate of VR smoking cessation intervention (MindCotine app) in those who are at risk for lung cancer and are participating in a lung cancer screening program.
The investigators will enroll 20 individuals. 10 of whom elect to participate in the VR program and 10 of whom are using standard of care smoking cessation methods.
The study duration is 90 days after completion of the MindCotine VR program. The MindCotine program consists of a 8-week training stage, and includes audiovisual content, cognitive behavioral therapy based self-reflective questions, setting a quit date, and notifications. The audio-visual content includes formal mindfulness exercises involving breathing techniques, body awareness, thought recognition, emotions, and smoking impulses. VR therapy exercises include the following topics: The Act of Smoking; RAIN meditation; Stress at work; Bodily sensations; Deep emotions; Nicotine anonymous; Alcohol as a trigger. Each content consists of a 2 minute animated environment to induce meditative states of mind, 6 minutes of exposure with real people, and 2 more minutes of an animated environment to induce a meditative mindset.
Participants will be surveyed at baseline, 1 day after the completion of the 8 week VR program and again 90 days after the completion of the VR program.
Cedars-Sinai Medical Center is the lead sponsor of 441 studies on the registry; 108 are open to participants now.
Of its 62 completed or terminated interventional studies of FDA-regulated products, 47 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants electing to participate in the virtual reality based smoking cessation platform
Device: MindCotine Virtual reality
Those utilizing standard of care smoking cessation therapies
Virtual reality platform
Feasibility of recruitment
Ability to recruit our target number of participants during the study period
Time frame: 1 year
Adoptability
Adoption rate will be assess as those who complete at least 75% of the VR content compared to the total persons enrolled in the study
Time frame: 1 year
efficacy of smoking cessation
percentage of persons who stopped smoking during the course of the study in the VR group compared to controls
Time frame: 1year
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Cedars-Sinai Medical Center