Neural Mechanisms of Meditation Training in Healthy and Depressed Adolescents: An MRI Connectome Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in Putamen Node Strength
研究概览
简要总结
The primary objective will be to study changes in putamen structural connectivity in healthy teens with meditation training. Hypothesis: Putamen structural node strength will increase in the training group compared to controls.
R61 Go/No-Go Criteria. Detect an effect size (a threshold of Cohen's d > 0.20) in changes of the primary mechanistic outcome (Putamen structural node strength) by the described meditation training in 100 healthy adolescents that are 14-18 years old and retain at least 80% of randomized participants for primary outcome measurement at the end of the study regardless of adherence to the intervention.
The secondary objective will be to study changes in emotional problems in healthy teens with meditation training. Hypothesis: There will be a significant decrease in emotional problems measured with the Strengths and Difficulties Questionnaire (SDQ) in the training group compared to controls.
Design and Outcomes: The current research study design will utilize an individually randomized group treatment, open-label, waitlist-controlled clinical trial to test the efficacy and safety of the investigator's innovative mindfulness meditation intervention (Training for Awareness Resilience and Action [TARA]) on the primary outcome (Putamen structural node strength) and secondary outcome (emotional problems measured with the Strengths and Difficulties Questionnaire [SDQ]) in healthy adolescents between the ages of 14 to 18 years old.
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
- Single (Participant)
入排标准
- 年龄范围
- 14 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy female and male adolescents, 14-18 years old
- •Fluency in English
排除标准
- •Subjects younger or older than 14-18 years old.
- •Subjects who are not healthy. Subjects who are taking any psychotropic medication.
- •MRI contraindications (ferromagnetic objects on or inside the body, e.g., braces) and pregnancy.
- •Not allowable: Current mindfulness training (e.g. MBSR, MBCT, DBT) and/or practice with a typically sitting meditation or yoga of 20 or more minutes two or more times per week within 60 days prior to study entry.
- •Potential adolescent subjects with current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to the study requirements will be excluded and not allowed to enter the study.
- •Potential subjects with an inability or unwillingness to give written informed assent or whose legal guardian/representative are unable or unwilling to give written informed consent will be excluded and not allowed to enter the study.
结局指标
主要结局
Change in Putamen Node Strength
时间窗: Baseline/randomization and 12 weeks after baseline/randomization
Change in the Putamen node strength assessed using diffusion MRI. Node strengths are calculated as the sum of connection weights between the brain region of interest and all other nodes in the network. Higher values of node strength in general indicate stronger white matter connectivity between a specific brain region and the other regions, often caused by higher myelination. Higher values of change in node strength, similarly, indicate a higher level of structural network change occurred within the tissue.
次要结局
- Change in Emotional Problems(Baseline/randomization and 12 weeks after baseline/randomization)