Brain Mechanisms of Reducing Polysubstance Use Following a Novel Body-mind Intervention 2
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Intervention effects on brain grey matter using fMRI
研究概览
简要总结
The proposed study will test whether neurofeedback (NF) could optimize integrative body-mind training (IBMT) practice.
详细描述
The proposed study will test whether real-time NF could optimize IBMT practice and improve effects in reducing polysubstance use through targeting self-control networks in the brain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least 18 years old
- •Free of any psychiatric diagnoses or medication (besides a substance use disorder (SUD) to alcohol, tobacco, or cannabis)
- •In the past month, at least 4 episodes of heavy episodic drinking; at least 3 occasions of cannabis use; and daily cigarette use for at least the past month
- •Normal or corrected-to-normal vision
- •Written informed consent
- •No previous meditation or NF experiences
排除标准
- •Any psychiatric diagnoses other than an SUD
- •Medical disorder(s) that may affect the central nervous system; medications that affect the central and autonomic nervous system; or a positive pregnancy test result (females)
- •Excluding cannabis, evidence of recent (past month) illicit drug use
研究组 & 干预措施
IBMT
An evidence-based preventive intervention - integrative body-mind training (IBMT) has shown positive effects in reducing stress and improving self-control and brain plasticity. It has bodifulness and mindfulness components.
干预措施: IBMT (Behavioral)
NF
An evidence-based intervention - NF can not only provide real-time feedback for practice but also target the self-control networks, suggesting the possibility of augmenting IBMT effects via NF.
干预措施: NF (Behavioral)
IBMT + NF
The combined IBMT and NF also show positive effects in reducing substance use.
干预措施: IBMT (Behavioral)
IBMT + NF
The combined IBMT and NF also show positive effects in reducing substance use.
干预措施: NF (Behavioral)
Sham NF
Sham NF has the same settings as the active NF but does not have correct parameters of stimulation.
干预措施: NF (Behavioral)
结局指标
主要结局
Intervention effects on brain grey matter using fMRI
时间窗: The outcome measures are assessed in-person at baseline, 2-4 weeks and 3 months
Brain volume changes such as anterior and posterior cingulate cortex measured by fMRI structural imaging
Intervention effects on brain white matter using fMRI
时间窗: The outcome measures are assessed in-person at baseline, 2-4 weeks and 3 months
Brain white matter changes such as anterior and posterior cingulate cortex measured by fMRI diffusion tensor imaging
Intervention effects on brain function using Functional Magnetic Resonance Imaging (fMRI)
时间窗: The outcome measures are assessed in-person at baseline, 2-4 weeks and 3 months
Brain connectivity changes such as anterior and posterior cingulate cortex measured by fMRI resting state imaging
次要结局
- Intervention effects on addiction behavior using substance use questionnaires in PhenX Toolkit(The outcome measures are assessed in-person at baseline, 2-4 weeks and 3 months)