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Mindfulness-Based Intervention for Adolescents (Mindfulteen)

14 de enero de 2021 actualizado por: 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.

Descripción general del estudio

Estado

Desconocido

Descripción detallada

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).

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

120

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

      • Geneva, Suiza, 1205
        • Reclutamiento
        • Geneva University
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

13 años a 15 años (Niño)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Descripción

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)

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación cruzada
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.

Comparador de placebos: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Brain activity in stress-related networks at functional MRI
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: At baseline, immediately after intervention, 18 months after intervention
Cortical thickness in prefrontal areas
At baseline, immediately after intervention, 18 months after intervention

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Level of anxiety
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Camille Piguet, Physician, Geneva University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

12 de febrero de 2019

Finalización primaria (Anticipado)

30 de noviembre de 2022

Finalización del estudio (Anticipado)

30 de noviembre de 2022

Fechas de registro del estudio

Enviado por primera vez

16 de mayo de 2019

Primero enviado que cumplió con los criterios de control de calidad

14 de enero de 2021

Publicado por primera vez (Actual)

15 de enero de 2021

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

15 de enero de 2021

Última actualización enviada que cumplió con los criterios de control de calidad

14 de enero de 2021

Última verificación

1 de enero de 2021

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 2018-017731

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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