Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02445, United States
Location status: Recruiting
NCT Number: NCT07173608
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.
Interested in participating?
Request Info15 year–18 year
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02445, United States
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Measured at Baseline, 6 weeks and 3 months
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.
Time frame: Measured at Baseline, 6 weeks and 3 months
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.
Time frame: Measured at Baseline, 6 weeks and 3 months
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.
Time frame: Measured at Baseline, 6 weeks and 3 months
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.
Time frame: Will be measured at Baseline, 6 weeks and 3 months
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.
Time frame: Will be measured at Baseline, 6 weeks and 3 months
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.
Time frame: Will be measured at Baseline, 6 weeks and 3 months
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.
Time frame: Will be measured at 6 weeks
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.
Time frame: Will be measured at Baseline, 6 weeks and 3 months
Fitbit Wearable Smart Watches will be worn for 7 consecutive days use to assess resting heart rate.
Time frame: Will be measured at Baseline, 6 weeks and 3 months
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.
Time frame: Measured at Baseline and 3 months
SOMAScan Proteomics technology will be used to assess 11,000 proteins in blood plasma to observe any differences between the intervention and control groups.
Time frame: Measured at Baseline and 3 months
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
Time frame: Measured at Baseline and 3 months
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.
Time frame: Measured at Baseline and 3 months
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.
Time frame: Measured at Baseline and 3 months
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.
Contact information is provided by the study sponsor or research team.
Balachundhar Subramaniam, MD, MPH
CONTACT
Sepideh Hariri, PhD
CONTACT
Beth Israel Deaconess Medical Center
Other
Acronym: THRIVE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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