Single Blind, Parallel Group Trial of Novel, On-Demand Virtual Reality to Amplify Practice Efficacy (NO VAPE) Added to Cognitive Behavioral Therapy for Nicotine Vaping Cessation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 主要终点
- Difference in CBT sessions attended
研究概览
简要总结
3. General Description of Study Design
The proposed study will evaluate the effect of adding a VR app with CBT-embedded content to a 12-session individual CBT treatment program. Investigators propose a prospective, randomized, single-blind, trial with 90 individuals aged 16 years and over who vape nicotine at least weekly for three months, and wish to quit vaping within the next month. Subjects will be randomly assigned to either the experimental (NO VAPE + CBT) or control group (sham NO VAPE + CBT) for 12 weeks. The study will use a double blind design where both subjects and investigators and outcome assessors will be masked to subjects' group assignments. The experimental group will receive the following over a 12-week period: NO VAPE (VR app) combined with the MGH 12-session remote behavioral vaping cessation support program for vaping cessation. The control group will receive a sham NO VAPE (VR app) combined with the MGH 12-session remote behavioral vaping cessation support program. The VR app will be used at home by participants in between CBT session visits. Participants will also briefly report their CBT skills practice using the MyCap smartphone app. Participants will be assigned randomly to the experimental or control group in a 1:1 ratio, with randomization blocks of 6, stratified by no/mild nicotine dependence (Electronic Cigarette Dependence Index [ECDI] score 0-8) or moderate/high nicotine dependence (ECDI score 9 or higher) in a prospective trial in people age 16 and over, who use vaped nicotine regularly and wish to quit vaping.
The primary outcome is self-reported time spent in CBT skills practice per week. Groups will be compared on mean number of days and duration of self-reported CBT skill practice per week over the 12-week treatment period.
Secondary outcomes are: tolerability and feasibility of the NO VAPE virtual reality (VR) vaping cessation tool, which will be assessed by the following self-reported ratings in both groups: a) average CBT session attendance weekly, b) satisfaction ratings, c) adverse events; and by the following self-reported ratings d) self-ratings of the virtual reality application usability, e) engagement, f) presence, and g) simulator cyber sickness.
Exploratory outcomes are: 1) biochemically verified 7-day point prevalence vaping abstinence at week 12, and 2) 4-week biochemically verified continuous abstinence from weeks 9-12.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 16 years or older
- •Report of nicotine vaping at least weekly for the prior ≥ 3 months
- •Self-report of not smoking tobacco regularly at enrollment (tobacco smoking on <8 of the past 30 days)
- •Report motivation to quit vaping in the next 30 days
- •Own or are willing to use a Meta Quest VR headset
- •Vision corrected to within 20/50 bilaterally
- •Access to a mobile device to complete daily survey assessments
- •If age is greater than or equal to 18 years: Competent and willing to provide written informed consent
- •If age is less than 18 years: Competent and willing to provide written informed assent AND have a parent/legal guardian who is competent and willing to provide written informed consent
排除标准
- •Individuals at greater risk of harm from virtual reality side effects, such as a history of motion sickness, history of migraines or severe headaches, history of vertigo, epilepsy or neurological conditions where visual stimuli may trigger seizures or other issues (excludes history of febrile seizures), or self-report of pregnancy, recent concussion, or other conditions that increase risks of dizziness, nausea, or headaches
- •Evidence of active problem substance use severe enough, in the investigator's opinion, to compromise ability to safely participate
- •Unwilling to provide saliva or urine samples
- •Any condition or situation that would, in the investigator's opinion, make it unlikely that the participant could adhere safely to the study protocol
- •Individuals who are under the legal protection of the government or state (Wards of the State)
- •Inability to understand study procedures, read, and write in English
结局指标
主要结局
Difference in CBT sessions attended
时间窗: 12 Weeks
We will evaluate the number of CBT sessions attended across the 12 weeks
Time spent practicing CBT skills
时间窗: Weeks 1-12
We time spent practicing CBT between sessions in minutes. The app collects data automatically on how much time is spent using it, and how much time is spent within each environment.
次要结局
- Change in craving(Weeks 1-12)
- Change in withdrawal symptoms(Weeks 1-12)
- Change in severity of tobacco use disorder (TUD)(Week 12)