Nicotine addiction Mental and Behavioural Disorders
Conditions
Interventions
The design of the study follows the recommendations for clinical trials in health using virtual reality, in particular Tier VR 2, focusing on acceptability, feasibility, tolerability, and initial clin
Sponsors
Universidad de Flores
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 24 to 65 years 2. Minimum consumption of 5 cigarettes per day 3. Score of 4-9 on the Contemplation Scale (CL) 4. Residents in the City of Buenos Aires 5. Own an Android mobile phone with gyroscope 6. Have data plan or Wi-Fi access 7. Expressed an interest in using VR as a method to quit smoking
Exclusion criteria
Exclusion criteria: 1. Diagnosed with a current psychiatric disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Self-reported abstinence at 1 day after the end of the program. The question used for assessment was "Did you smoke tobacco in the last 24 hours?" | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Sustained abstinence, i.e. self-reported abstinence at 90 days after the end of the program in the TG. The question used for assessment was "Did you smoke tobacco in the last 90 days?" 2. Adherence assessed using log file data collected using the platform Amplitude, which measured total use of the app of each participant. Full adherence was defined as the participant completing the treatment in the suggested time (i.e. 21 days without any breaks). Regular adherence was defined as participants completing all daily activities in up to 60 days; and depth of adherence as the total number of mindfulness training minutes. 3. Cigarette consumption reported by participants as the number of cigarettes they smoked each day during treatment, as part of their daily self-reports. The daily number of cigarettes was averaged every week to generate an average number for that period. 4. Craving was assessed using the Questionnaire for Smoking Urges (QSU), which consists of a 7-point Likert scale. This data was collected through an online survey at baseline, at the end of days 7 and 14, and on 1-day follow-up, as well as on 90-day follow-up. The internal consistency for the overall scale was adequate (? = .87). 5. Mindfulness was assessed using the Five Facets Mindfulness Questionnaire (FFMQ). The five dimensions are: observing, describing, acting with awareness, not judging internal experience, and not reacting to internal experience. This data was collected through an online survey at baseline and at 1-day follow-up, as well as on day 90-day follow-up. 6. Readiness to quit was assessed using the Contemplation Ladder, which consists of 11 rungs and 5 anchor statements reflecting the stages of change, designed to measure readiness to quit smoking. It was assessed through an online survey at baseline and at 1-day follow up. 7. Nicotine dependence was assessed using the Fagerström Test (R | — |
Countries
Argentina
Outcome results
None listed