About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Inner Engineering Program
BehavioralThe 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
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.
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.
Other outcomes
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.
Resting Heart Rate
Fitbit Wearable Smart Watches will be worn for 7 consecutive days use to assess resting heart rate.
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.
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.
Sponsors and contacts
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Beth Israel Deaconess Medical Center
Lead sponsor
Tiny Blue Dot Foundation
Collaborator