Transforming Adolescent Perception and Mental Health Through Meditation and Cognitive Reappraisal A Mixed Method Study

Обзор

This study will evaluate how a comprehensive meditation-based program, Inner Engineering, supports teens ages 15-18 in becoming more joyful, focused, resilient, and better equipped to manage stress and thrive. Through this study, researchers will examine whether practices like meditation, yoga, and cognitive reframing can help adolescents view and respond to challenges with greater clarity and balance. The study will assess mental and physical impacts through self-report, physiological, and neuroimaging methods.

Подробное описание

Adolescence is a critical developmental period marked by heightened vulnerability to mental health challenges and increased neuroplasticity, making it an ideal window for preventive interventions. This mixed-method randomized controlled trial (RCT) evaluates the efficacy of a secular, multimodal contemplative program-Inner Engineering-in enhancing psychological wellbeing, cognitive flexibility, and physiological balance among adolescents aged 15-18. Participants (N=96) will be randomized to either the intervention or a meditation-naïve control group.

The intervention training integrates cognitive reappraisal, breath-based meditation, and yoga-based postures, followed by daily practice. Assessments will occur at baseline, 6 weeks, and 12 weeks, and will include self-report questionnaires, behavioral tasks, EEG, fMRI, wearable physiological monitoring (including heartrate, sleep, respiration), and blood-based biomarkers of inflammation and neuroplasticity. Qualitative interviews will provide additional insight into the lived experiences of intervention participants.

The intervention aims to enabling more adaptive, inclusive, and empowered ways of perceiving external situations and internal states.

This is the first comprehensive RCT to investigate the multidimensional impact of an integrated contemplative program on the developing adolescent mental health, physiological and neural outcomes and perception . Findings may support scalable, evidence-based contemplative education tools to promote clarity, resilience, and expanded perception in youth.

Вмешательства

• Поведенческое Inner Engineering Program
  The intervention is a comprehensive secular training called Inner Engineering (IE), offered by the international non-profit Isha Foundation. This program combines cognitive reappraisal and emotion regulation strategies, breath-based meditation and simple yoga practices. The training provides precise, step by step and easy to follow instructions on how to perform the practices. No previous experience of yoga and meditation is required. By fostering health, exuberance and awareness, one can "engin

Первичные конечные точки

• Emotional Wellbeing [Срок оценки: Measured at Baseline, 6 weeks and 3 months]

Вторичные конечные точки (6)

• Depression, Anxiety and Stress [Срок оценки: Measured at Baseline, 6 weeks and 3 months]
• Cognitive Flexibility [Срок оценки: Measured at Baseline, 6 weeks and 3 months]
• Cognitive Emotion Regulation [Срок оценки: Measured at Baseline, 6 weeks and 3 months]
• Personality Trait [Срок оценки: Will be measured at Baseline, 6 weeks and 3 months]
• Mindfulness [Срок оценки: Will be measured at Baseline, 6 weeks and 3 months]
• Sleep Quality [Срок оценки: Will be measured at Baseline, 6 weeks and 3 months]

Критерии участия

Критерии включения

• Individuals between15-18 years of age
• Ability to understand study instructions and provide informed consent/assent. (parental consent for minors)
• Access to internet and a device to complete online study activities
• Currently residing in the United States
• Willing and able to travel to the hospital location in Boston for study procedures.

Критерии исключения

• Non-English speaking (Justification: the intervention and assessment instruments are not validated in a sufficient range of languages, and the research team lacks polylingual capabilities or the financial resources to hire interpreters for the duration of all proposed assessments.)
• Practicing meditation regularly in the past 6 months (4 or more times per week for 4 weeks or more in the past 6 months)
• History of psychiatric illness such as severe anxiety, severe depression, posttraumatic stress disorder (PTSD), Schizophrenia or bipolar disorder
• Current use of cognition enhancing drugs
• Current management for chronic pain
• History (within past 5 years) of seizure, brain surgery or any condition causing cognitive decline.
• Active history (within the last 5 years) of alcohol or drug abuse.
• Current pregnancy or planning to become pregnant in the next 6 months
• Currently enrolled in another interventional study that could impact the primary outcome, as determined by the PI
• Significant visual impairment
• Subject has previously learned the intervention.
• Subject has contraindications for MRI (Detailed in the eligibility screening questions)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Организация здравоохранения

Центры проведения

США · 1 центр

• Beth Israel Deaconess Medical Center — Boston

Публикации

• Fox KC, Dixon ML, Nijeboer S, Girn M, Floman JL, Lifshitz M, Ellamil M, Sedlmeier P, Christoff K. Functional neuroanatomy of meditation: A review and meta-analysis of 78 functional neuroimaging investigations. Neurosci Biobehav Rev. 2016 Jun;65:208-28. doi: 10.1016/j.neubiorev.2016.03.021. Epub 2016 Mar 28. PMID 27032724
• Rodrigues E, Lima D, Barbosa P, Gonzaga K, Guerra RO, Pimentel M, Barbosa H, Maciel A. HRV Monitoring Using Commercial Wearable Devices as a Health Indicator for Older Persons during the Pandemic. Sensors (Basel). 2022 Mar 4;22(5):2001. doi: 10.3390/s22052001. PMID 35271148
• Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4. PMID 2748771
• Cortazar N, Calvete E, Fernandez-Gonzalez L, Orue I. Development of a Short Form of the Five Facet Mindfulness Questionnaire-Adolescents for Children and Adolescents. J Pers Assess. 2020 Sep-Oct;102(5):641-652. doi: 10.1080/00223891.2019.1616206. Epub 2019 Jun 5. PMID 31166802
• Baer RA, Carmody J, Hunsinger M. Weekly change in mindfulness and perceived stress in a mindfulness-based stress reduction program. J Clin Psychol. 2012 Jul;68(7):755-65. doi: 10.1002/jclp.21865. Epub 2012 May 23. PMID 22623334
• Morizot J. Construct validity of adolescents' self-reported big five personality traits: importance of conceptual breadth and initial validation of a short measure. Assessment. 2014 Oct;21(5):580-606. doi: 10.1177/1073191114524015. Epub 2014 Mar 11. PMID 24619971
• Saetren SS, Hegelstad WTV, Tjora T, Hafstad GS, Augusti EM. Validation of the short version of Cognitive Emotion Regulation Questionnaire for adolescents in Norway. Scand J Public Health. 2025 Feb;53(1):32-40. doi: 10.1177/14034948231225616. Epub 2024 Feb 1. PMID 38303505
• Szabo M, Lovibond PF. Development and Psychometric Properties of the DASS-Youth (DASS-Y): An Extension of the Depression Anxiety Stress Scales (DASS) to Adolescents and Children. Front Psychol. 2022 Apr 14;13:766890. doi: 10.3389/fpsyg.2022.766890. eCollection 2022. PMID 35496218

Идентификаторы

NCT: NCT07173608 · 2025P000560

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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