Early Mindfulness-based Intrevention for Anxious Adolescents: a fMRI Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Brain activity in stress-related networks at functional MRI
研究概览
简要总结
The Mindfulteen Study is a 3-year long longitudinal cohort study with a nested randomized controlled trial, integrating neuroimaging, biological and clinical outcomes, and designed to evaluate the impact of a mindfulness-based intervention (MBI) on young adolescents.
Young adolescents between 13 and 15 years with no history of current mental health disorder (with the exception for anxiety symptoms) or of psychotherapy are included and randomized to either early or late intervention (i.e. waiting list or control group), after being stratified between low or high anxiety group based on State and Trait Anxiety Inventory (STAI-T) score. Participants on the control group participate on MBI after completing the second assessment. The intervention is an 8-week long MBI adapted to adolescents. Primary outcomes are based on neuroimaging (structural and functional MRI) and secondary outcomes are clinical (self-reported questionnaires covering mostly emotion and stress reactivity and trait mindfulness) and biological (cortisol, inflammation markers and redox markers). Assessments are performed at baseline, immediately after intervention or waiting time and after 18 months of intervention.
详细描述
Promotion of mental health is a major concern worldwide, particularly among young population as major psychiatric diseases can have their onset during adolescence and young adulthood. During adolescence, there is growing evidence that "at-risk" states for mental disorders, as high stress reactivity for example, can be identified prior to clinical symptoms, and that early interventions can have a major impact preventing the further development of full-blown mental illness.
In the last two decades, given a growing interest for non-pharmacological approaches to improve mental and physical health, mindfulness-based interventions (MBI) have received serious attention. After the initial applications on chronic pain, stress reduction and prevention of depressive relapses, MBIs are now widely implemented among clinical and non-clinical populations.
Therefore, investigators aim to better understand the modifications of brain circuits involved in the emergence of stress related disorders and the impact of a MBI on those circuits. Hence, a translational project was designed, integrating neuroimaging, biological and clinical outcomes of stress reactivity to evaluate the impact of a MBI on adolescents.
The Mindfulteen Study is a 3-year longitudinal cohort study with a nested randomized controlled trial. The randomized controlled trial part of the study was designed to assess the clinical effect of MBI on adolescents, comparing to a control group. Therefore, after inclusion participants are electronically randomized between either early intervention group or late intervention group (i.e., waiting list or control group). Participants allocated in the late intervention group engage in MBI after the waiting period, providing data also for the longitudinal cohort part of the study and therefore increasing the data available for before and after comparison. The long-term effect of MBI will be assessed after 18 months of intervention.
Before randomization, participants are stratified according to their score on the trait questionnaire of the State Trait Anxiety Inventory (STAI) as low anxiety group (≤ 31) or high anxiety group (>31).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Participants cannot be blinded to MBI time (early vs late). Outcome assessors are blind to intervention group. One of the two mindfulness instructors is not blind, as she works as clinical research coordinator. However, MBI are always held by both instructors together and the groups are mixed between early and late intervention allocated participants, diminishing the impact of the lack of blinding of one instructor.
入排标准
- 年龄范围
- 13 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 13 to 15 year-old
- •Interest in participating in a mindfulness based intervention
- •Francophone
- •Have access to internet and a to a compatible device (smartphone or tablet) every day to run the study's application
- •Availability for the study duration
- •Consent documented by signature and support from the legal representatives as documented by a signature
- •Informed Consent as documented by a signature
排除标准
- •History of chronic somatic disease or clinically significant medical condition (e.g., asthma, diabetes, renal failure, hepatic dysfunction, etc.)
- •History of neurologic or major psychiatric disease (except for an anxious disorder without comorbidity and a history of major depressive episode resolved for at least 6 months).
- •History of psychotherapy in the past 6 months
- •History of regular meditation practice
- •Women who are pregnant or breast feeding
- •Known or suspected non-compliance, drug or alcohol abuse,
- •Inability to participate in group sessions,
- •Previous enrolment into the current study
- •Inability to undergo study's procedures (IRM and blood sample collection)
研究组 & 干预措施
Early Mindfulness Intervention
The Early MBI group partake on the mindfulness intervention after first outcome assessment.
干预措施: Minfulness-based Intervention (Behavioral)
Late Mindfulness Intervention
The Late MBI group partake on the mindfulness intervention after the second outcome assessment.
This groups is the control group for the Early MBI group.
After the second assessment, this group engage on the same intervention as the early group.
干预措施: Minfulness-based Intervention (Behavioral)
结局指标
主要结局
Brain activity in stress-related networks at functional MRI
时间窗: At baseline, immediately after intervention, 18 months after intervention
Change of the fronto-limbic circuit recovery after a social laboratory stress using the Montreal Imaging Stress Task (MIST)
Brain connectivity at functional MRI
时间窗: Before and after intervention
Change in structural connectivity measures between prefrontal and limbic areas after intervention
Brain cortical thickness at structural MRI
时间窗: At baseline, immediately after intervention, 18 months after intervention
Cortical thickness in prefrontal areas
Brain gray matter at structural MRI
时间窗: At baseline, immediately after intervention, 18 months after intervention
Change on gray matter volume in prefrontal areas
次要结局
- Level of emotional regulation(At baseline, immediately after intervention, 18 months after intervention)
- Level of inflammation(At baseline, immediately after intervention, 18 months after intervention)
- Level redox system activity(At baseline, immediately after intervention, 18 months after intervention)
- Level of redox system activity(At baseline, immediately after intervention, 18 months after intervention)
- Level of anxiety(At baseline, immediately after intervention, 18 months after intervention)
- Heart rate variability(At baseline, immediately after intervention, 18 months after intervention)
- Level of emotional awareness(At baseline, immediately after intervention, 18 months after intervention)
- Hair cortisol level(At baseline, immediately after intervention, 18 months after intervention)
研究者
Camille Nemitz Piguet
Postdoc at centre Neurospin Paris
University of Geneva, Switzerland