NCT04968795

Brief Summary

The purpose of this study is to evaluate the effect of a 4-week heart-based meditation practice wellness workshop on burnout and emotional wellness in corporate employees. Corporate employees can be defined as individuals who work in large institutions with greater than 300 employees. The specific aim of this study is to assess changes in scores measuring symptoms of emotional exhaustion, depersonalization, and personal accomplishment using the Maslach Burnout Index. We hypothesize that the meditation wellness practice will be associated with reduction in burnout for those who take part in the meditation program in comparison to the participants who did not meditate and participate in the wellness program.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

May 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 20, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

October 8, 2021

Status Verified

September 1, 2021

Enrollment Period

12 months

First QC Date

July 9, 2021

Last Update Submit

September 30, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Differences in Burnout Scores

    Assess the difference in burnout scores between both groups at week 0 and week 4.

    Week 0 & Week 4

Secondary Outcomes (1)

  • Changes in in scores measuring symptoms of emotional exhaustion, depersonalization, and personal accomplishment, using the Maslach Burnout Inventory.

    Week 0 & Week 4

Study Arms (2)

Control

Participate in filling the questionnaire but NOT the meditation/wellness session (control).

Wellness Group

Participate in filling the questionnaire and the meditation/wellness session

Other: Heartfulness Meditation

Interventions

A four-week Heartfulness Wellness seminar, where people are exposed to Heartfulness Meditation and its meditation tools. Participants experience: Heartfulness Guided Relaxation, Heartfulness Meditation and Heartfulness Unwinding/Rejuvenation Technique.

Wellness Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study population is reflective of the general population, who work in large corporations and have self-identified as having moderate to high levels of stress.

You may qualify if:

  • Adults above 18 years of age willing to participate in the study.

You may not qualify if:

  • Individuals less than 18 years of age, active suicidal ideation, current or past diagnoses of serious psychotic disorders- schizophrenia, personality disorders and post-traumatic stress disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Resolution Blue Labs Inc

Toronto, Ontario, M1T1P2, Canada

RECRUITING

MeSH Terms

Conditions

Burnout, Psychological

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Andy Kumar, MD/PhD Candidate

    Resolution Blue Labs Inc

    PRINCIPAL INVESTIGATOR
  • Aravindhan Ravindhran, MD

    Resolution Blue Labs Inc

    PRINCIPAL INVESTIGATOR
  • Arth Patel, MD Candidate

    Resolution Blue Labs Inc

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2021

First Posted

July 20, 2021

Study Start

May 1, 2021

Primary Completion

April 30, 2022

Study Completion

July 1, 2022

Last Updated

October 8, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations