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| Name | Class |
|---|---|
| Tiny Blue Dot Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Intervention participants will take the Inner Engineering program and are asked to practice meditation daily for the duration of the study. |
|
| Control | No Intervention | Control participants will be asked to continue their daily routine |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inner Engineering Program | Behavioral | 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 "engineer their inner climate the way they want it" to lead a joyful, fulfilling life. Previous research shows improved wellbeing, mindfulness, joy, sleep, relationships, psychological capital, and work engagement, compassion, and parent-child relationships. Evidence suggest it may promote enhanced Heart Rate Variability and Sympathovagal balance. |
| Measure | Description | Time Frame |
|---|---|---|
| Emotional Wellbeing | the PERMA profiler, (15 items) designed to measure Seligman's five pillars of wellbeing (PERMA is the acronym developed from the first letter of these five pillars): Positive emotions, Relationships, Engagement, Meaning, and Accomplishment. It shows good reliability among adolescents and good construct validity. The total PERMA-Profiler score is the average of all the factor scores, which can range from 0 to 10, with higher scores indicating greater mental wellbeing. | Measured at Baseline, 6 weeks and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Depression, Anxiety and Stress | The Depression Anxiety Stress Scales - Youth version (DASS-Y) (21-items) is designed to measure general psychological distress and negative emotional states. The scale shows good construct validity as it has strong associations with physiological hyperarousal and excessive worrying. The total score can range from 0 to 63, with higher scores indicating a greater presence of psychological distress and negative emotional states. |
| Measure | Description | Time Frame |
|---|---|---|
| Qualitative Assessment | Open ended phenomenological interviews (individual and focus group) will be conducted to understand the intervention group's lived experience of practicing the intervention, and its impact on Perception Box and wellbeing. All these interviews will be conducted virtually via zoom, after they have learnt the intervention and been practicing it for at least 4 weeks. The interviews will last for about 30-45 minutes each. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sepideh Hariri, PhD | Contact | 617-278-8082 | sadhgurucenter_research@bidmc.harvard.edu | |
| Balachundhar Subramaniam, MD, MPH | Contact | 617-667-2721 | sadhgurucenter_research@bidmc.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sepideh Hariri, PhD | Beth Israel Deaconess Medical Centre, Boston, Massachusetts 02115 | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27032724 | Background | 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. | |
| 35271148 | Background |
| Label | URL |
|---|---|
| Social and Emotional Learning Programs for Adolescents. Future of Children, | View source |
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This is a Randomized Controlled Trial with 48 intervention and 48 control adolescents (aged 15-18) to be followed up for 3 months. Subjects will be recruited from meditation-Naïve healthy individuals. The intervention group will complete the intervention training and learn a 21-minute meditation to practice daily. Various outcomes related to mental health and perception will be collected over a period of 3 months.
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| Measured at Baseline, 6 weeks and 3 months |
| Cognitive Flexibility | Cognitive Flexibility assessed via the Cognitive Flexibility Inventory (CFI) (20 items) to monitor how individuals challenge maladaptive thoughts. CFI has excellent internal consistency, and high 7-week test- retest reliability. The total score can range between 20 and 140, where higher scores indicate more cognitive flexibility. | Measured at Baseline, 6 weeks and 3 months |
| Cognitive Emotion Regulation | Regulation strategies assessed via Cognitive Emotion Regulation questionnaire -short 18-item version (CERQ-short) with nine subscales (Self-blame, Other-blame, Rumination, Catastrophizing, Positive refocusing, Planning, Positive reappraisal, Putting into perspective and Acceptance). The reliability of the scales was found to be acceptably high among adolescents. The total possible score can range between 18 and 90, with higher scores indicating a greater use of cognitive emotion regulation strategies. | Measured at Baseline, 6 weeks and 3 months |
| Personality Trait | Openness assessed via The Big Five Personality Trait Short Questionnaire (BFPTSQ) (10 item) assessing Openness, Extraversion, Agreeableness, Conscientiousness, and Emotional Stability. It has good reliability and convergent validity. Each personality type will get a score range of 1 to 7, with higher scores indicating the presence of that personality type. | Will be measured at Baseline, 6 weeks and 3 months |
| Mindfulness | Mindful awareness is assessed via the Five Facet Mindfulness Questionnaire (FFMQ) with 5 subscales: Observing, Describing, Acting with Awareness, Nonjudgement and Non-reactivity. FFMQ-A-SF consists of 25 items (5 per facet) especially developed for adolescents. It shows good internal consistency and high construct validity. The total FFMQ score ranges from 39 to 195, with higher scores indicating greater mindfulness. | Will be measured at Baseline, 6 weeks and 3 months |
| Sleep Quality | Pittsburg Sleep Quality Index (PSQI) is a widely used, validated self-report questionnaire that assesses sleep quality and disturbances over a 1-month interval. It consists of 19 items that generate seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. These components are summed to produce a global score ranging from 0 to 21, with higher scores indicating poorer sleep quality. | Will be measured at Baseline, 6 weeks and 3 months |
| Will be measured at 6 weeks |
| Resting Heart Rate | Fitbit Wearable Smart Watches will be worn for 7 consecutive days use to assess resting heart rate. | Will be measured at Baseline, 6 weeks and 3 months |
| Heart Rate Variability | Fitbit Wearable Smart Watches will be worn for 7 consecutive days to assess changes in heart rate, called heart rate variability. a higher value of heart rate variability indicates better cardiovascular health. | Will be measured at Baseline, 6 weeks and 3 months |
| Blood Proteins | SOMAScan Proteomics technology will be used to assess 11,000 proteins in blood plasma to observe any differences between the intervention and control groups. | Measured at Baseline and 3 months |
| Change in Frontal Midline Theta Power | Frontal Midline Theta Power is obtained from an average of electrodes around the midline in a standard EEG cap and has been proposed as a correlate of meditation success in previous studies. Increased value suggests increased control over the brain's default mode network, suggesting more successful meditation experience. Time Frame: Measured at Baseline and 6 months | Measured at Baseline and 3 months |
| Change in Gamma Slope Index (GSI) | GSI is an indicator of the Excitation-Inhibition (E-I) balance in the brain and is computed from the power spectral density slope of oscillatory activity in the brain, taking the low-gamma (40-60Hz) band slope of the Power Spectral Density, and is steeper (more negative) when the E-I balance is tipped towards more inhibition. A higher negative value suggests shift of the brain's excitation/inhibition balance toward more inhibition, indicating a calmer brain. | Measured at Baseline and 3 months |
| Changes in Brain Regional Volume | Brain regional volume (mm^3) will be assessed using MRI. Brain regional volume is the volume of brain matter. Group-wise comparisons will be made between the intervention group and control. A positive difference between the intervention and control groups indicates greater brain volume. | Measured at Baseline and 3 months |
| Change in Brain Connectivity | fMRI is an indirect measure of brain activity based on blood oxygen level dependent (BOLD) signals. Based on BOLD signals, functional connectivity will be assessed. Functional connectivity between two regions will be assessed for both the intervention and control group. A t-statistics value will be calculated based on the differences in signal intensities between the two groups. A more positive t-statistic indicates greater brain connectivity. | Measured at Baseline and 3 months |
| 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. |
| 2748771 | Background | 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. |
| 31166802 | Background | 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. |
| 22623334 | Background | 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. |
| 24619971 | Background | 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. |
| 38303505 | Background | 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. |
| 35496218 | Background | 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. |
| 39070577 | Background | Fernandes I, Zanini DS, Peixoto EM. PERMA-Profiler for adolescents: validity evidence based on internal structure and related constructs. Front Psychol. 2024 Jul 12;15:1415084. doi: 10.3389/fpsyg.2024.1415084. eCollection 2024. |
| 32513931 | Background | Bruining H, Hardstone R, Juarez-Martinez EL, Sprengers J, Avramiea AE, Simpraga S, Houtman SJ, Poil SS, Dallares E, Palva S, Oranje B, Matias Palva J, Mansvelder HD, Linkenkaer-Hansen K. Measurement of excitation-inhibition ratio in autism spectrum disorder using critical brain dynamics. Sci Rep. 2020 Jun 8;10(1):9195. doi: 10.1038/s41598-020-65500-4. |
| 30549144 | Background | Orekhova EV, Stroganova TA, Schneiderman JF, Lundstrom S, Riaz B, Sarovic D, Sysoeva OV, Brant G, Gillberg C, Hadjikhani N. Neural gain control measured through cortical gamma oscillations is associated with sensory sensitivity. Hum Brain Mapp. 2019 Apr 1;40(5):1583-1593. doi: 10.1002/hbm.24469. Epub 2018 Dec 13. |
| 28676297 | Background | Gao R, Peterson EJ, Voytek B. Inferring synaptic excitation/inhibition balance from field potentials. Neuroimage. 2017 Sep;158:70-78. doi: 10.1016/j.neuroimage.2017.06.078. Epub 2017 Jul 1. |
| 32714171 | Background | Brandmeyer T, Delorme A. Closed-Loop Frontal Midlinetheta Neurofeedback: A Novel Approach for Training Focused-Attention Meditation. Front Hum Neurosci. 2020 Jun 30;14:246. doi: 10.3389/fnhum.2020.00246. eCollection 2020. |
| 27815577 | Background | Brandmeyer T, Delorme A. Reduced mind wandering in experienced meditators and associated EEG correlates. Exp Brain Res. 2018 Sep;236(9):2519-2528. doi: 10.1007/s00221-016-4811-5. Epub 2016 Nov 4. |
| 34275188 | Background | van Loon AWG, Creemers HE, Okorn A, Vogelaar S, Miers AC, Saab N, Westenberg PM, Asscher JJ. The effects of school-based interventions on physiological stress in adolescents: A meta-analysis. Stress Health. 2022 Apr;38(2):187-209. doi: 10.1002/smi.3081. Epub 2021 Jul 26. |
| 28863392 | Background | Pascoe MC, Thompson DR, Jenkins ZM, Ski CF. Mindfulness mediates the physiological markers of stress: Systematic review and meta-analysis. J Psychiatr Res. 2017 Dec;95:156-178. doi: 10.1016/j.jpsychires.2017.08.004. Epub 2017 Aug 23. |
| 37178829 | Background | Chen W, Zhong Q, Chen H, Chen S. Heart rate variability in children and adolescents with major depressive disorder: A systematic review and meta-analysis. J Affect Disord. 2023 Aug 15;335:204-215. doi: 10.1016/j.jad.2023.05.022. Epub 2023 May 11. |
| 37437729 | Background | Baumeister-Lingens L, Rothe R, Wolff L, Gerlach AL, Koenig J, Sigrist C. Vagally-mediated heart rate variability and depression in children and adolescents - A meta-analytic update. J Affect Disord. 2023 Oct 15;339:237-255. doi: 10.1016/j.jad.2023.07.027. Epub 2023 Jul 10. |
| 27347478 | Background | Sharma A, Newberg AB. Mind-Body Practices and the Adolescent Brain: Clinical Neuroimaging Studies. Adolesc Psychiatry (Hilversum). 2015;5(2):116-124. doi: 10.2174/2210676605666150311223728. |
| 30934877 | Background | Young KS, Sandman CF, Craske MG. Positive and Negative Emotion Regulation in Adolescence: Links to Anxiety and Depression. Brain Sci. 2019 Mar 29;9(4):76. doi: 10.3390/brainsci9040076. |
| 27461914 | Background | Lichenstein SD, Verstynen T, Forbes EE. Adolescent brain development and depression: A case for the importance of connectivity of the anterior cingulate cortex. Neurosci Biobehav Rev. 2016 Nov;70:271-287. doi: 10.1016/j.neubiorev.2016.07.024. Epub 2016 Jul 25. |
| 22820409 | Background | Creswell JD, Irwin MR, Burklund LJ, Lieberman MD, Arevalo JM, Ma J, Breen EC, Cole SW. Mindfulness-Based Stress Reduction training reduces loneliness and pro-inflammatory gene expression in older adults: a small randomized controlled trial. Brain Behav Immun. 2012 Oct;26(7):1095-101. doi: 10.1016/j.bbi.2012.07.006. Epub 2012 Jul 20. |
| 35818436 | Background | Alvarez-Lopez MJ, Conklin QA, Cosin-Tomas M, Shields GS, King BG, Zanesco AP, Kaliman P, Saron CD. Changes in the expression of inflammatory and epigenetic-modulatory genes after an intensive meditation retreat. Compr Psychoneuroendocrinol. 2022 Jun 23;11:100152. doi: 10.1016/j.cpnec.2022.100152. eCollection 2022 Aug. |
| 28577879 | Background | Kuhlman KR, Chiang JJ, Horn S, Bower JE. Developmental psychoneuroendocrine and psychoneuroimmune pathways from childhood adversity to disease. Neurosci Biobehav Rev. 2017 Sep;80:166-184. doi: 10.1016/j.neubiorev.2017.05.020. Epub 2017 May 31. |
| 20157309 | Background | Danese A, Caspi A, Williams B, Ambler A, Sugden K, Mika J, Werts H, Freeman J, Pariante CM, Moffitt TE, Arseneault L. Biological embedding of stress through inflammation processes in childhood. Mol Psychiatry. 2011 Mar;16(3):244-6. doi: 10.1038/mp.2010.5. Epub 2010 Feb 16. No abstract available. |
| 24571182 | Background | Gard T, Holzel BK, Lazar SW. The potential effects of meditation on age-related cognitive decline: a systematic review. Ann N Y Acad Sci. 2014 Jan;1307:89-103. doi: 10.1111/nyas.12348. |
| 23142788 | Background | Chiesa A, Serretti A, Jakobsen JC. Mindfulness: top-down or bottom-up emotion regulation strategy? Clin Psychol Rev. 2013 Feb;33(1):82-96. doi: 10.1016/j.cpr.2012.10.006. Epub 2012 Oct 23. |
| 39764085 | Background | Jafari N, Manvelian A, Mohamed E, Rayapuraju A, Orui H, Alkuhaimi S, Reed PU, Subramaniam B. Inner engineering is associated with perceived improvements in relationship quality, interpersonal connections, and interpersonal compassion. Front Psychol. 2024 Dec 23;15:1454293. doi: 10.3389/fpsyg.2024.1454293. eCollection 2024. |
| 37265958 | Background | Hagen I, Skjelstad S, Nayar US. Promoting mental health and wellbeing in schools: the impact of yoga on young people's relaxation and stress levels. Front Psychol. 2023 May 17;14:1083028. doi: 10.3389/fpsyg.2023.1083028. eCollection 2023. |
| 22707866 | Background | Muralikrishnan K, Balakrishnan B, Balasubramanian K, Visnegarawla F. Measurement of the effect of Isha Yoga on cardiac autonomic nervous system using short-term heart rate variability. J Ayurveda Integr Med. 2012 Apr;3(2):91-6. doi: 10.4103/0975-9476.96528. |
| 29228793 | Background | Peterson CT, Bauer SM, Chopra D, Mills PJ, Maturi RK. Effects of Shambhavi Mahamudra Kriya, a Multicomponent Breath-Based Yogic Practice ( Pranayama), on Perceived Stress and General Well-Being. J Evid Based Complementary Altern Med. 2017 Oct;22(4):788-797. doi: 10.1177/2156587217730934. Epub 2017 Sep 22. |
| 35100026 | Background | Chang TFH, Ramburn TT, Pundir S, Purandare P, Subramaniam B. The Effect of the Inner Engineering Online Program as a Positive Intervention on Subjective Well-Being and Positive Work Outcomes. J Integr Complement Med. 2022 Mar;28(3):278-282. doi: 10.1089/jicm.2021.0180. Epub 2022 Jan 31. |
| Background | Immordino-Yang, M. H., Darling-Hammond, L., & Krone, C. R. (2019). Nurturing Nature: How Brain Development Is Inherently Social and Emotional, and What This Means for Education. Educational Psychologist, 54(3), 185-204. https://doi.org/10.1080/00461520.2019.1633924 |
| The descriptive phenomenological method in psychology: A modified Husserlian approach | View source |
| ID | Term |
|---|---|
| D000080103 | Emotional Regulation |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D000068356 | Self-Control |
| D012919 | Social Behavior |
| D001519 | Behavior |
| D010549 | Personal Satisfaction |
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