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Clinical Trials/NCT07173608
NCT07173608RecruitingNot Applicable

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

Beth Israel Deaconess Medical Center1 site in 1 country96 target enrollmentStarted: May 1, 2026Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
96
Locations
1
Primary Endpoint
Emotional Wellbeing

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
15 Years to 18 Years (Child, Adult)
Sex
All
Accepts 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)

Arms & Interventions

Control

No Intervention

Control participants will be asked to continue their daily routine

Intervention

Experimental

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

Intervention: Inner Engineering Program (Behavioral)

Outcomes

Primary Outcomes

Emotional Wellbeing

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.

Secondary Outcomes

  • 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)
  • Sleep Quality(Will be measured at Baseline, 6 weeks and 3 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sepideh Hariri

Instructor in Anesthesia at Harvard Medical School, Program Manager at Department of Anesthesia, Beth Israel Deaconess Medical Center

Beth Israel Deaconess Medical Center

Study Sites (1)

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