Hippocampal Network Changes Following Mindfulness Training in Tobacco Vaping Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Change in Brain Connectivity Network
研究概览
简要总结
The purpose of this translational bench-to-bedside study is to examine the neurobiological effects of an evidence-based technology-delivered mindfulness training (MT) program on vaping-related rsFC alterations in hippocampal networks and testing whether changes in rsFC ((Delta)rsFC) in these networks predict reduction in tobacco vaping behaviors in adolescents. The study also aims to test the accessibility and feasibility of using this mindfulness-based stress reduction (MBSR) platform as an implementation for widespread MT in adolescents.
详细描述
Study Description:
This protocol will use functional magnetic resonance imaging (fMRI) and in-person and technology-delivered mindfulness-based stress reduction (MBSR) training to elucidate neurobehavioral correlates of regular nicotine vaping in adolescents compared to non-vaping adolescents, and changes in these correlates after MBSR training. Our central hypothesis is that nicotine vaping in adolescents will be associated with impaired hippocampal connectivity with large-scale brain networks (e.g., Executive Control network (ECN), Default Mode Network (DMN), Salience Network (SN)) involved in cognitive control and emotion regulation and decreased state transitions (measured via dynamic resting state functional connectivity (rsFC)); and that MBSR training will increase hippocampal connectivity to ECN and alter time in state and state transitions in frequent vaping adolescents, with these rsFC changes predicting changes in vaping behavior.
Objectives:
Primary Objectives:
- To characterize static and dynamic rsFC of hippocampal networks in frequent nicotine vaping adolescents compared to non-vaping adolescents.
- To characterize rsFC changes in hippocampal networks following an in-person and technology-delivered MBSR training program in frequent nicotine vaping adolescents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •INCLUSION CRITERIA:
- •In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- •Non-Vaping group:
- •For adolescents aged 17 and under, parental/guardian informed consent to participate in the study
- •English language fluency
- •Males and females; Age 13-18 enrolled in grades 9-12, or the summer after graduation.
- •No MRI contraindications
- •No evidence of current psychosis, mania, or significant suicidality
- •If on medication for depression, anxiety or ADHD, dose has been stable for 3 months
- •No DSM-5 diagnosis of moderate or severe substance use disorder (SUD) related to a psychoactive substance, including tobacco, in the past year
- •Access to necessary resources for participating in a technology-based intervention, which includes smartphone ownership for this study
- •No use of nicotine more than five (5) times in their life, and none at all in the last 30 days prior to enrollment.
- •Vaping group:
- •For adolescents aged 17 and under, parental/guardian informed consent to participate in the study
- •English language fluency
- •Males and females; Age 13-18 enrolled in grades 9-12, or the summer after graduation.
- •No MRI contraindications
- •No evidence of current psychosis, mania, or significant suicidality
- •If on medication for depression, anxiety or attention deficit hyperactivity disorder (ADHD), dose has been stable for 3 months
- •No Diagnostic and Statistical Manual-5 (DSM-5) diagnosis of moderate or severe SUD related to another psychoactive substance (other than tobacco) in the past year
- •Vape a nicotine containing product at least 10 days in the past 30 days
- •Access to necessary resources for participating in a technology-based intervention, which includes smartphone ownership for this study
排除标准
- •An individual who meets any of the following criteria will be excluded from participation in this study based on self and or parent-report unless otherwise noted:
- •Vaping or Non-Vaping Group:
- •Chronic medical conditions associated with cerebral blood flow abnormalities per PI/MAI determination after review of the medical history.
- •Neurological conditions that may interfere with MRI data quality per PI/MAI determination after review of the medical history.
- •Neurodevelopmental disorders that are likely to significantly affect data in the judgment of the MAI/PI
- •Non-penetrating traumatic brain injury with loss of consciousness > 30 minutes or significant sequelae persisting longer than two weeks or any penetrating traumatic brain injury.
- •Changing dose of psychotropic medication in past three months
- •Current regular meditation or yoga practice averaging >10 min/day for >2 days per week
- •Pregnancy, self-report upon protocol entry, but by urine test prior to MRI scan.
研究组 & 干预措施
Baseline group: Vapers
Adolescents ages 13-18 years old with history of nicotine vaping, who vape 4-7 days per week, complete structural and resting fMRI of the brain and some questionnaires.
干预措施: functional magnetic resonance imaging (fMRI) (Other)
Baseline group: Non-vapers
Adolescents ages 13-18 years old with no history of nicotine vaping complete structural and resting fMRI of the brain and some questionnaires.
干预措施: functional magnetic resonance imaging (fMRI) (Other)
Intervention: Mindfulness-based stress reduction (MBSR) training
Adolescents ages 13-18 years old with history of nicotine vaping, from the baseline assessment group complete a 9-week intervention once per week in-person or remote mindfulness-based stress reduction (MBSR) training followed by a post-intervention assessment and a second fMRI brain scan.
干预措施: Mindfulness-based Stress Reduction (MBSR) Program (Behavioral)
Intervention: Mindfulness-based stress reduction (MBSR) training
Adolescents ages 13-18 years old with history of nicotine vaping, from the baseline assessment group complete a 9-week intervention once per week in-person or remote mindfulness-based stress reduction (MBSR) training followed by a post-intervention assessment and a second fMRI brain scan.
干预措施: functional magnetic resonance imaging (fMRI) (Other)
结局指标
主要结局
Change in Brain Connectivity Network
时间窗: Baseline (pre MBSR training) and post-MBSR training (1-6 weeks after MBSR training)
The change in brain connectivity network from baseline (pre mindfulness-based stress reduction (MBSR) training) to post MBSR functional magnetic resonance imaging (fMRI) brain scan. Analysis will be done as change in brain network connectivity based on pre and post MBSR fMRI scan. Change = post-pre values
次要结局
- Participant Self-report Change in Vaping Behaviors(Baseline (0-3 months pre-MBSR training) & post MBSR training (up to six weeks after MBSR training))
- Participant Self-report Engagement With Mindfulness-based Stress Reduction (MBSR) Training(Up to 9 weeks during the MBSR training)
- Participant Self-report Engagement With the Craving-to-Quit App(Up to 4 months following the MBSR training)