Mindfulness-Based Intervention for Adolescents

NCT04711694 | Unknown

• 1 other identifier: 2018-017731
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anxiety; Adolescent Behavior; Stress

Keywords

Adolescent; Mindfulness; Anxiety; Stress; Teenager; MRI; Intervention

Outcome Measures

Primary Outcomes (4)

• Brain activity in stress-related networks at functional MRI

  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

  Change on gray matter volume in prefrontal areas

  At baseline, immediately after intervention, 18 months after intervention

• Brain connectivity at functional MRI

  Change in structural connectivity measures between prefrontal and limbic areas after intervention

  Before and after intervention

• Brain cortical thickness at structural MRI

  Cortical thickness in prefrontal areas

  At baseline, immediately after intervention, 18 months after intervention

Secondary Outcomes (8)

• Level of anxiety

  At baseline, immediately after intervention, 18 months after intervention

• Level of emotional awareness

  At baseline, immediately after intervention, 18 months after intervention

• 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

Study Arms (2)

Early Mindfulness Intervention

EXPERIMENTAL

The Early MBI group partake on the mindfulness intervention after first outcome assessment.

Behavioral: Minfulness-based Intervention

Late Mindfulness Intervention

PLACEBO COMPARATOR

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.

Behavioral: Minfulness-based Intervention

Interventions

Minfulness-based Intervention BEHAVIORAL

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.

Early Mindfulness Intervention; Late Mindfulness Intervention

Eligibility Criteria

• Age: 13 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Geneva, Switzerland: lead
• Leenards Foundation: collaborator
• University of Lausanne: collaborator
• Swiss National Centre Competence in Research - Synapsy: collaborator

Study Sites (1)

Geneva University

Geneva, 1205, Switzerland

RECRUITING

Related Publications (1)

• Piguet C, Celen Z, Meuleman B, Schilliger Z, Magnus Smith M, Mendola E, Pham E, Jouabli S, Ivanova V, Murray RJ, Klauser P, Merglen A. Impact of a Mindfulness-Based Intervention on Symptoms and Emotion Regulation Strategies in Young Adolescents From the General Population: A Randomized Controlled Trial. Depress Anxiety. 2025 Jun 10;2025:2679049. doi: 10.1155/da/2679049. eCollection 2025.

  PMID: 40529112 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Adolescent Behavior

Condition Hierarchy (Ancestors)

Mental Disorders; Behavior

Study Officials

• Camille Piguet, Physician

  Geneva University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Camille Piguet, Physician

CONTACT

+41 79 668 75 07; camille.piguet@unige.ch

Mariana M Smith, Physician

CONTACT

+41 22 372 5089; mariana.magnussmith@unige.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoc at centre Neurospin Paris

Study Record Dates

• First Submitted: May 16, 2019
• First Posted: January 15, 2021
• Study Start: February 12, 2019
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: January 15, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)