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MeditationTHRIVENCT07173608

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

A study testing Inner Engineering Program in people with Meditation and Cognitive Reappraisal, run by Beth Israel Deaconess Medical Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 15 to 18 yearsHealthy volunteers can take part
What is being tested?
Inner Engineering Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
96 participants
Where
1 siteUnited States
Study dates
1 May 2026to Mar 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 12Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

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

United States1 site, 1 recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02445

    Recruiting

Other trials in United States

About this study

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.

Read the 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.

Being tested
Inner Engineering Program
Keywords
meditation, Inner Engineering, Shambhavi Mahamudra Kriya, EEG, Functional MRI, MRI, Cognition, Mindfulness, Mental Health, Adolescent
Medical subject headings
Emotional Regulation, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Inner Engineering ProgramBehavioural

    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.

Study groups in NCT07173608
Study groupRoleWhat they receive
InterventionExperimentalIntervention participants will take the Inner Engineering program and are asked to practice meditation daily for the duration of the study.
Receives: Behavioral: Inner Engineering Program
ControlNo interventionControl participants will be asked to continue their daily routine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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: Measured at Baseline, 6 weeks and 3 months

Secondary outcomes (6)

  1. 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.

    Measured: Measured at Baseline, 6 weeks and 3 months

  2. 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.

    Measured: Measured at Baseline, 6 weeks and 3 months

  3. 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.

    Measured: Measured at Baseline, 6 weeks and 3 months

  4. 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.

    Measured: Will be measured at Baseline, 6 weeks and 3 months

  5. Mindfulness

    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.

    Measured: Will be measured at Baseline, 6 weeks and 3 months

  6. Sleep Quality

    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.

    Measured: Will be measured at Baseline, 6 weeks and 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2025
  2. Study start1 May 2026
  3. Primary completionFeb 2028 (estimated)
  4. Study completionMar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
96 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07173608
Sponsor's protocol ID
2025P000560
Acronym
THRIVE
Status last verified
Apr 2026
First submitted
21 Aug 2025
Last updated
21 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Fox KC, Dixon ML, Nijeboer S, Girn M, Floman JL, Lifshitz M, Ellamil M, Sedlmeier P, Christoff K. Functional neuroanatomy of meditation: A review and meta-analysis of 78 functional neuroimaging investigations. Neurosci Biobehav Rev. 2016 Jun;65:208-28. doi: 10.1016/j.neubiorev.2016.03.021. Epub 2016 Mar 28.

    PubMed 27032724

  • Rodrigues E, Lima D, Barbosa P, Gonzaga K, Guerra RO, Pimentel M, Barbosa H, Maciel A. HRV Monitoring Using Commercial Wearable Devices as a Health Indicator for Older Persons during the Pandemic. Sensors (Basel). 2022 Mar 4;22(5):2001. doi: 10.3390/s22052001.

    PubMed 35271148

  • Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.

    PubMed 2748771

  • Cortazar N, Calvete E, Fernandez-Gonzalez L, Orue I. Development of a Short Form of the Five Facet Mindfulness Questionnaire-Adolescents for Children and Adolescents. J Pers Assess. 2020 Sep-Oct;102(5):641-652. doi: 10.1080/00223891.2019.1616206. Epub 2019 Jun 5.

    PubMed 31166802

  • Baer RA, Carmody J, Hunsinger M. Weekly change in mindfulness and perceived stress in a mindfulness-based stress reduction program. J Clin Psychol. 2012 Jul;68(7):755-65. doi: 10.1002/jclp.21865. Epub 2012 May 23.

    PubMed 22623334

  • Morizot J. Construct validity of adolescents' self-reported big five personality traits: importance of conceptual breadth and initial validation of a short measure. Assessment. 2014 Oct;21(5):580-606. doi: 10.1177/1073191114524015. Epub 2014 Mar 11.

    PubMed 24619971

  • Saetren SS, Hegelstad WTV, Tjora T, Hafstad GS, Augusti EM. Validation of the short version of Cognitive Emotion Regulation Questionnaire for adolescents in Norway. Scand J Public Health. 2025 Feb;53(1):32-40. doi: 10.1177/14034948231225616. Epub 2024 Feb 1.

    PubMed 38303505

  • Szabo M, Lovibond PF. Development and Psychometric Properties of the DASS-Youth (DASS-Y): An Extension of the Depression Anxiety Stress Scales (DASS) to Adolescents and Children. Front Psychol. 2022 Apr 14;13:766890. doi: 10.3389/fpsyg.2022.766890. eCollection 2022.

    PubMed 35496218

  • Fernandes I, Zanini DS, Peixoto EM. PERMA-Profiler for adolescents: validity evidence based on internal structure and related constructs. Front Psychol. 2024 Jul 12;15:1415084. doi: 10.3389/fpsyg.2024.1415084. eCollection 2024.

    PubMed 39070577

  • Bruining H, Hardstone R, Juarez-Martinez EL, Sprengers J, Avramiea AE, Simpraga S, Houtman SJ, Poil SS, Dallares E, Palva S, Oranje B, Matias Palva J, Mansvelder HD, Linkenkaer-Hansen K. Measurement of excitation-inhibition ratio in autism spectrum disorder using critical brain dynamics. Sci Rep. 2020 Jun 8;10(1):9195. doi: 10.1038/s41598-020-65500-4.

    PubMed 32513931

  • Orekhova EV, Stroganova TA, Schneiderman JF, Lundstrom S, Riaz B, Sarovic D, Sysoeva OV, Brant G, Gillberg C, Hadjikhani N. Neural gain control measured through cortical gamma oscillations is associated with sensory sensitivity. Hum Brain Mapp. 2019 Apr 1;40(5):1583-1593. doi: 10.1002/hbm.24469. Epub 2018 Dec 13.

    PubMed 30549144

  • Gao R, Peterson EJ, Voytek B. Inferring synaptic excitation/inhibition balance from field potentials. Neuroimage. 2017 Sep;158:70-78. doi: 10.1016/j.neuroimage.2017.06.078. Epub 2017 Jul 1.

    PubMed 28676297

  • Brandmeyer T, Delorme A. Closed-Loop Frontal Midlinetheta Neurofeedback: A Novel Approach for Training Focused-Attention Meditation. Front Hum Neurosci. 2020 Jun 30;14:246. doi: 10.3389/fnhum.2020.00246. eCollection 2020.

    PubMed 32714171

  • Brandmeyer T, Delorme A. Reduced mind wandering in experienced meditators and associated EEG correlates. Exp Brain Res. 2018 Sep;236(9):2519-2528. doi: 10.1007/s00221-016-4811-5. Epub 2016 Nov 4.

    PubMed 27815577

  • van Loon AWG, Creemers HE, Okorn A, Vogelaar S, Miers AC, Saab N, Westenberg PM, Asscher JJ. The effects of school-based interventions on physiological stress in adolescents: A meta-analysis. Stress Health. 2022 Apr;38(2):187-209. doi: 10.1002/smi.3081. Epub 2021 Jul 26.

    PubMed 34275188

Questions about this trial

What is this clinical trial studying?

A study testing Inner Engineering Program in people with Meditation and Cognitive Reappraisal, run by Beth Israel Deaconess Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sepideh Hariri, PhD (617-278-8082, sadhgurucenter_research@bidmc.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Emotional Wellbeing (time frame: Measured at Baseline, 6 weeks and 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07173608, which also lists 33 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.

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