Cognitive Reappraisal, Emotional Regulation, Meditation
Conditions
Keywords
meditation, Inner Engineering, Shambhavi Mahamudra Kriya, EEG, Functional MRI, MRI, Cognition, Mindfulness, Mental Health, Adolescent
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALInner 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 "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.
Sponsors
Beth Israel Deaconess Medical Center
Tiny Blue Dot Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
15 Years to 18 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Emotional Wellbeing | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depression, Anxiety and Stress | 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. |
| Cognitive Flexibility | 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. |
| Cognitive Emotion Regulation | 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. |
| Personality Trait | 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. |
| Mindfulness | 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. |
| Sleep Quality | 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. |
Countries
United States
Contacts
CONTACTSepideh Hariri, PhD
CONTACTBalachundhar Subramaniam, MD, MPH
PRINCIPAL_INVESTIGATORSepideh Hariri, PhD
Beth Israel Deaconess Medical Centre, Boston, Massachusetts 02115
Outcome results
None listed