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Mindfulness-Based Intervention for Adolescents (Mindfulteen)

2021년 1월 14일 업데이트: Camille Nemitz Piguet, University of Geneva, Switzerland

Early Mindfulness-based Intrevention for Anxious Adolescents: a fMRI Randomized Controlled Trial

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.

연구 개요

상태

알려지지 않은

상세 설명

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).

Assessments are performed before intervention, immediately after intervention or waiting period and in 18 months. For the late intervention group, an additional assessment is performed immediately after the intervention.

The overall objective of the Mindfulteen Study is to assess the immediate and long-term effect of an MBI on reactivity to stress and anxiety, in a non-clinical sample of young adolescents from the general population. Underlying psychological and biological changes are assessed using a multimodal brain MRI protocol, blood and hair sampling, as well as physiological measurements of stress.

The primary aim is to characterize brain functional modifications in cortico-limbic and cortico-striatal-thalamic circuits (functional MRI data) and their underlying neuroanatomical changes (analysis of structural, spectroscopy and diffusion MRI data) in adolescents exposed to MBI, comparing adolescents with high anxiety and low anxiety levels.

Secondary aims include the effects of MBI on self-reported levels of anxiety, emotion regulation strategies (clinical scores) and physiological markers of hypothalamic-pituitary-adrenal axis (hair cortisol), as well as biological markers of oxidative stress and inflammation (blood sampling).

연구 유형

중재적

등록 (예상)

120

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

13년 (어린이)

건강한 자원 봉사자를 받아들입니다

연구 대상 성별

모두

설명

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위
  • 중재 모델: 크로스오버 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Early Mindfulness Intervention
The Early MBI group partake on the mindfulness intervention after first outcome assessment.

The proposed MBI is an adaptation from the Mindfulness Based Stress Reduction (MBSR) and Mindfulness based Cognitive Therapy (MBCT) programs to youth. This MBI consists of a total of twelve 90 minutes long sessions, the first 8 being the intervention per se and the last 4 a proposition to the transition to regular practice and a chance to better integrate mindfulness in daily life.

A theme regarding mindfulness is addressed in each session, through meditation practices and exercises. Between sessions, participants are invited to practice at home, using an application designed for this study (the MindApp), where participants can find the recorded practices. Investigators have access to participants' use of the meditation recordings and expect that these data will provide a more objective measure of the amount of home practice.

위약 비교기: 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.

The proposed MBI is an adaptation from the Mindfulness Based Stress Reduction (MBSR) and Mindfulness based Cognitive Therapy (MBCT) programs to youth. This MBI consists of a total of twelve 90 minutes long sessions, the first 8 being the intervention per se and the last 4 a proposition to the transition to regular practice and a chance to better integrate mindfulness in daily life.

A theme regarding mindfulness is addressed in each session, through meditation practices and exercises. Between sessions, participants are invited to practice at home, using an application designed for this study (the MindApp), where participants can find the recorded practices. Investigators have access to participants' use of the meditation recordings and expect that these data will provide a more objective measure of the amount of home practice.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Brain activity in stress-related networks at functional MRI
기간: 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)
At baseline, immediately after intervention, 18 months after intervention
Brain gray matter at structural MRI
기간: At baseline, immediately after intervention, 18 months after intervention
Change on gray matter volume in prefrontal areas
At baseline, immediately after intervention, 18 months after intervention
Brain connectivity at functional MRI
기간: Before and after intervention
Change in structural connectivity measures between prefrontal and limbic areas after intervention
Before and after intervention
Brain cortical thickness at structural MRI
기간: At baseline, immediately after intervention, 18 months after intervention
Cortical thickness in prefrontal areas
At baseline, immediately after intervention, 18 months after intervention

2차 결과 측정

결과 측정
측정값 설명
기간
Level of anxiety
기간: At baseline, immediately after intervention, 18 months after intervention
Change of the level of anxiety measured by the State and Trait Anxiety Inventory. Minimum score 20, maximum score 60. Higher score means a worse outcome (higher anxiety).
At baseline, immediately after intervention, 18 months after intervention
Level of emotional awareness
기간: At baseline, immediately after intervention, 18 months after intervention
Change on the baseline Emotion Awareness Questionnaire score after intervention. Minimum score 0, maximum score 40. Higher score means a better outcome.
At baseline, immediately after intervention, 18 months after intervention
Level of emotional regulation
기간: At baseline, immediately after intervention, 18 months after intervention
Change on the baseline Emotion Regulation Questionnaire score after intervention. Minimum score 6, maximum score 30. Higher score means a better outcome.
At baseline, immediately after intervention, 18 months after intervention
Level of inflammation
기간: At baseline, immediately after intervention, 18 months after intervention
Change on baseline innate immunity-related proteins after intervetion, measured in pg/ml.
At baseline, immediately after intervention, 18 months after intervention
Level redox system activity
기간: At baseline, immediately after intervention, 18 months after intervention
Change on the baseline activity of plasma glutathion and metabolites after intervention, measured in mMol/L-
At baseline, immediately after intervention, 18 months after intervention
Hair cortisol level
기간: At baseline, immediately after intervention, 18 months after intervention
Change on the baseline hair cortisol measure after intervention, measured in pg/mg.
At baseline, immediately after intervention, 18 months after intervention
Heart rate variability
기간: At baseline, immediately after intervention, 18 months after intervention
Change on baseline herat rate variability after intervetion.
At baseline, immediately after intervention, 18 months after intervention
Level of redox system activity
기간: At baseline, immediately after intervention, 18 months after intervention
Change on baseline activity of enzimes involved in glutathion metabolism after intervention, measured in U/gHb
At baseline, immediately after intervention, 18 months after intervention

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Camille Piguet, Physician, Geneva University

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2019년 2월 12일

기본 완료 (예상)

2022년 11월 30일

연구 완료 (예상)

2022년 11월 30일

연구 등록 날짜

최초 제출

2019년 5월 16일

QC 기준을 충족하는 최초 제출

2021년 1월 14일

처음 게시됨 (실제)

2021년 1월 15일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2021년 1월 15일

QC 기준을 충족하는 마지막 업데이트 제출

2021년 1월 14일

마지막으로 확인됨

2021년 1월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • 2018-017731

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

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아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

스트레스에 대한 임상 시험

Minfulness-based Intervention에 대한 임상 시험

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