NCT07868783

Brief Summary

The goal of this study is to learn if a meditation intervention called Transcendental Meditation or TM can be used in a small department at Weill Cornell Medicine to help reduce employees' levels of burnout, anxiety, insomnia, and depression as well as to determine the feasibility and acceptability of the meditation practice by Weill Cornell employees. The main question the study aims to answer is whether: • Levels of burnout, anxiety, insomnia, and depression will be decreased, and overall mental well-being will improve over a 3.5-month period before and after TM intervention. Participants will attend 9 sessions total (8 group sessions and 1 individual session) with a certified TM instructor from The David Lynch Foundation Institute for Mental Health and Resilience where they will gain experience in proper TM techniques. Also, participants will conduct 2 of their own TM sessions at home daily during the course of this study.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable anxiety

Timeline
13mo left

Started Nov 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 9, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

November 15, 2026

Expected
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2027

9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2027

Last Updated

October 9, 2026

Status Verified

October 1, 2026

Enrollment Period

4 months

First QC Date

October 5, 2026

Last Update Submit

October 5, 2026

Conditions

Keywords

Transcendental MeditationTMburnout

Outcome Measures

Primary Outcomes (11)

  • Adherence to home practice of TM (1 month from baseline)

    Adherence to home TM practice will be assessed at 1 month post TM instruction, using a self-report form. Adherence to home TM practice will be the number of participants who responded that they did at least one home TM practice session per day on average out of all study participants. The self report survey asks participants over the past week and month how often they have done TM at home with three choices: 1) Twice a day, 2) Once a Day, and 3) Rarely or not at all. "Adherence" to home TM practice will be defined as at least one home TM practice session per day on average on this survey.

    1 month

  • Adherence to home practice of TM (3 months from baseline)

    Adherence to home TM practice will be assessed at 3 month post TM instruction, using a self-report form. Adherence to home TM practice will be the number of participants who responded that they did at least one home TM practice session per day on average out of all study participants. The self report survey asks participants over the past week and month how often they have done TM at home with three choices: 1) Twice a day, 2) Once a Day, and 3) Rarely or not at all. "Adherence" to home TM practice will be defined as at least one home TM practice session per day on average on this survey.

    3 month

  • Percentage of participants who attend 6 of the 8 training sessions over the course of the 3-month study

    Attendance at TM training sessions (feasibility) will be quantified as a binary outcome (either yes or no) based on whether at least 80% of the participants attend 6 of the 8 training sessions over the course of the 3 month study.

    3 months

  • Change in Level of Anxiety from Baseline to 1 month

    Anxiety symptoms will be evaluated between baseline and 1 month with the Generalized Anxiety Disorder-7 (GAD-7) which is a brief 7-item anxiety questionnaire. The survey has 7 question prompts evaluating anxiety symptoms over the past 2 weeks and ranges from the lowest score of 0 to highest total score of 21. The highest score indicates severe anxiety while the lowest score indicates minimal anxiety.

    baseline, 1 month

  • Change in Level of Anxiety from Baseline to 3 months

    Anxiety symptoms will be evaluated between baseline and 3 months with the Generalized Anxiety Disorder-7 (GAD-7) which is a brief 7-item anxiety questionnaire . The survey has 7 question prompts evaluating anxiety symptoms over the past 2 weeks and ranges from the lowest score of 0 to highest total score of 21. The highest score indicates severe anxiety while the lowest score indicates minimal anxiety.

    baseline, 3 months

  • Change in Depression Score from Baseline to 1 Month

    The depression score will be measured by the NIH Promis Emotional Distress-Depression Short Form 6a. The survey has 6 questions prompts evaluating depression levels over the past week. The survey ranges from a lowest score of 0 indicating minimal to no depression and a highest score of 30 indicating severe depression. These surveys will evaluate change in depression from baseline to 1 month.

    baseline, 1 month

  • Change in Depression Score from Baseline to 3 Months

    The depression score will be measured by the NIH Promis Emotional Distress-Depression Short Form 6a. The survey has 6 questions prompts evaluating depression levels over the past week. The survey ranges from a lowest score of 0 indicating minimal to no depression and a highest score of 30 indicating severe depression. These surveys will evaluate change in depression from baseline to 3 months.

    Baseline, 3 months

  • Change in Burnout Score from Baseline to 1 Month

    Changes in feelings of burnout will be measured by the Maslach Burnout Inventory for Medical Personnel and will be assessed between baseline and 1 month. This survey has 22 question prompts related to how the employee feels from work related stress over the course of year. Respondents rate items on a frequency scale from 0 (Never) to 6 (Every day). The scores for the following three categories are added up independently: * Emotional Exhaustion (EE): 9 items summed to a range of 0 to 54. Higher scores mean greater emotional depletion while lower score indicate less emotional exhaustion * Depersonalization / Cynicism (DP): 5 items summed to a range of 0 to 30. Higher scores mean greater detachment and cynicism while lower scores indicate less detachment or cynicism * Personal Accomplishment (PA): 8 items summed to a range of 0 to 48. Lower scores indicate reduced professional efficacy and a higher risk of burnout while higher scores indicate less burnout risk and more accomplishment.

    baseline, 1 month

  • Change in Burnout Score from Baseline to 3 Months

    Changes in feelings of burnout will be measured by the Maslach Burnout Inventory for Medical Personnel and will be assessed between baseline and 1 month. This survey has 22 question prompts related to how the employee feels from work related stress over the course of year. Respondents rate items on a frequency scale from 0 (Never) to 6 (Every day). The scores for the following three categories are added up independently: * Emotional Exhaustion (EE): 9 items summed to a range of 0 to 54. Higher scores mean greater emotional depletion while lower score indicate less emotional exhaustion * Depersonalization / Cynicism (DP): 5 items summed to a range of 0 to 30. Higher scores mean greater detachment and cynicism while lower scores indicate less detachment or cynicism * Personal Accomplishment (PA): 8 items summed to a range of 0 to 48. Lower scores indicate reduced professional efficacy and a higher risk of burnout while higher scores indicate less burnout risk and greater accomplishment

    Baseline, 3 months

  • Change in Sleep Disturbance from Baseline to 1 Month

    Change in sleep disturbance between 1 month and baseline will be evaluated with the Insomnia Severity Index which has 7 question prompts. The survey ranges from a low score of 0 indicating no sleep disturbance to a maximum score of 28 indicating severe clinical insomnia.

    baseline, 1 month

  • Change in Sleep Disturbance from Baseline to 3 Month

    Change in sleep disturbance between 3 month and baseline will be evaluated with the Insomnia Severity Index which has 7 question prompts. The survey ranges from a low score of 0 indicating no sleep disturbance to a maximum score of 28 indicating severe clinical insomnia.

    Baseline, 3 Months

Secondary Outcomes (4)

  • Change Mental Well-Being from Baseline to 1 month

    baseline, 1 month

  • Change in Mental Well Being from Baseline to 3 Months

    baseline, 3 month

  • Change in Resilience Score from Baseline to 1 Month

    baseline, 1 month

  • Change in Resilience Score from Baseline to 3 Months

    Baseline, 3 Months

Study Arms (1)

Transcendental Meditation

EXPERIMENTAL

Participants will undergo a TM training program of nine sessions and practice the TM technique twice daily for approximately 20 minutes

Behavioral: Transcendental Meditation

Interventions

Participants will undergo a TM training program of nine sessions and practice the TM technique twice daily for approximately 20 minutes.The TM training program will include a total of 9 sessions conducted by experienced certified TM instructors: an introductory session (Session 0, described above), core instruction consisting of 4 sessions taught on 4 consecutive days (Sessions 1-4, 60-75 minutes each), followed by 4 follow-up sessions offered at intervals over the following 3 months (Sessions 5-8, 45 minutes each). All 9 sessions will be completed within 3.5 months from the time of the first session.

Also known as: TM
Transcendental Meditation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Be 18 years of age or older
  • Be a full-time employee at Weill Cornell Medicine or NewYork-Presbyterian Hospital.
  • Agree to complete the entire TM training program of eight sessions and practice the TM technique twice daily for approximately 20 minutes.
  • Agree to complete a battery of self-report baseline and post-test surveys online (1-month and 3-months post baseline).
  • If being treated with psychoactive medications, have maintained a stable regimen for at least two months prior to enrollment.
  • Can commit to remaining in the New York area for 3 ½ consecutive months (with the exception of brief trips, e.g., weekend trips) for the duration of the study period (baseline measures through 3-month post-testing).

You may not qualify if:

  • Are younger than 18 years of age.
  • Are already instructed in the Transcendental Meditation technique.
  • Are not a full-time employee at Weill Cornell Medical College or NewYork-Presbyterian Hospital.
  • Are unwilling to complete the entire TM training program of eight sessions and practice the TM technique twice daily for approximately 20 minutes.
  • Are unwilling to complete a battery of self-report surveys online at baseline, at one month, and at three months post-baseline.
  • Have an unstable regimen of psychoactive medications in the past two months or psychiatric hospitalization in the last six months, per self-report.
  • Are unable to commit to remaining in the New York area for 3 ½ consecutive months (with the exception of brief trips, e.g., weekend trips) for the duration of the study period (baseline measures through 3-month post-testing).
  • This study will not include Adults unable to consent, Individuals who are not yet adults (infants, children, teenagers), and prisoners. The study may include pregnant women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weill Cornell Medicine, Starr Facility

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Anxiety DisordersBurnout, PsychologicalSleep Initiation and Maintenance Disorders

Interventions

Meditation

Condition Hierarchy (Ancestors)

Mental DisordersStress, PsychologicalBehavioral SymptomsBehaviorSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesRelaxation TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Joseph Osborne, MD, PhD

    Weill Cornell Medicine Department of Nuclear Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joseph Osborne, MD, PhD

CONTACT

Valentina Marulanda-Corzo, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2026

First Posted

October 9, 2026

Study Start (Estimated)

November 15, 2026

Primary Completion (Estimated)

March 15, 2027

Study Completion (Estimated)

November 27, 2027

Last Updated

October 9, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will not share

Locations