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

NCT07173608 | Not Yet Recruiting

• 1 other identifier: 2025P000560
• Study Type: interventional
• Target: 96
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Meditation; Cognitive Reappraisal; Emotional Regulation

Keywords

meditation; Inner Engineering; Shambhavi Mahamudra Kriya; EEG; Functional MRI; MRI; Cognition; Mindfulness; Mental Health; Adolescent

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Depression, Anxiety and Stress

  Measured at Baseline, 6 weeks and 3 months

• Cognitive Flexibility

  Measured at Baseline, 6 weeks and 3 months

• Cognitive Emotion Regulation

  Measured at Baseline, 6 weeks and 3 months

• Personality Trait

  Will be measured at Baseline, 6 weeks and 3 months

• Mindfulness

  Will be measured at Baseline, 6 weeks and 3 months

Other Outcomes (8)

• Qualitative Assessment

  Will be measured at 6 weeks

• Resting Heart Rate

  Will be measured at Baseline, 6 weeks and 3 months

• Heart Rate Variability

  Will be measured at Baseline, 6 weeks and 3 months

Study Arms (2)

Intervention

EXPERIMENTAL

Intervention participants will take the Inner Engineering program and are asked to practice meditation daily for the duration of the study.

Behavioral: Inner Engineering Program

Control

NO INTERVENTION

Control participants will be asked to continue their daily routine

Interventions

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.

Intervention

Eligibility Criteria

• Age: 15 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Tiny Blue Dot Foundation: collaborator

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  BACKGROUND

Related Links

• Social and Emotional Learning Programs for Adolescents. Future of Children,
• The descriptive phenomenological method in psychology: A modified Husserlian approach

MeSH Terms

Conditions

Emotional Regulation; Psychological Well-Being

Condition Hierarchy (Ancestors)

Self-Control; Social Behavior; Behavior; Personal Satisfaction

Study Officials

• Sepideh Hariri, PhD

  Beth Israel Deaconess Medical Centre, Boston, Massachusetts 02115

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor in Anesthesia at Harvard Medical School, Program Manager at Department of Anesthesia, Beth Israel Deaconess Medical Center

Model Details: 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.

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: September 15, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: April 23, 2026

Record last verified: 2026-04