NCT04126564

Brief Summary

In this randomized controlled trial; differences in overall stress, burnout and wellbeing will be assessed for employees of a company participating in Inner Engineering Online, an online mind-body course that incorporates both meditation and yoga. The study will be conducted in two phases, where in participants will be advised to practice meditation or read books.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
71

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 30, 2019

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

September 26, 2019

Completed
19 days until next milestone

First Posted

Study publicly available on registry

October 15, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 7, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 7, 2020

Completed
4.3 years until next milestone

Results Posted

Study results publicly available

September 23, 2024

Completed
Last Updated

September 23, 2024

Status Verified

August 1, 2024

Enrollment Period

9 months

First QC Date

September 26, 2019

Results QC Date

September 1, 2022

Last Update Submit

August 28, 2024

Conditions

Keywords

BurnoutStressAnxietyDepressionMeditationInner Engineering Online

Outcome Measures

Primary Outcomes (1)

  • Maslach Burnout Inventory Scale General Survey

    The study aims to evaluate changes in burnout levels affected by intervention using the Maslach Burnout Inventory scale General Survey (MBI\_GS). This survey consists of 16 questions and designed for use with occupational groups other than human services and education, including those working in jobs such as customer service, maintenance, manufacturing, management, and most other professions.Sum of 16 items is reported for each study period. With possible range of total score between 0-80, a higher score indicates more burnout or worse score addressing their experience of burnout.

    For Phase 1 analysis:Baseline to 4 weeks. For Phase 2 analysis: Baseline to 8 weeks

Secondary Outcomes (1)

  • Perceived Stress Score Levels

    For Phase 1 analysis:Baseline to 4 weeks. For Phase 2 analysis: Baseline to 8 weeks

Other Outcomes (4)

  • Mindfulness Level

    For Phase 1 analysis:Baseline to 4 weeks. For Phase 2 analysis: Baseline to 8 weeks

  • Dispositional Positive Emotions Scale (DPES- Joy Subscale)

    For Phase 1 analysis:Baseline to 4 weeks. For Phase 2 analysis: Baseline to 8 weeks

  • Centre for Epidemiologic Studies, Depression Scale

    For Phase 1 analysis:Baseline to 4 weeks. For Phase 2 analysis: Baseline to 8 weeks

  • +1 more other outcomes

Study Arms (2)

IEO Intervention Group

EXPERIMENTAL

The Group 1 is the active study group which receives the online mindfulness intervention first.

Behavioral: Inner Engineering Online

Control Group

ACTIVE COMPARATOR

Group 2 will be asked to read a book or journal of their choice for first 30 days, and then recieve online mindfulness intervention (IEO).

Behavioral: Inner Engineering OnlineBehavioral: Reading a book/ journal

Interventions

Inner Engineering Online (IEO) is a web based intervention administered by the Isha Foundation, a not-for-profit, global, volunteer-based organization.The Inner engineering online program is a holistic tool for promoting well-being that teaches individuals how to mindfully and effectively respond to daily stressors using yogic sciences. The program offers guided meditation and yoga practices to promote harmonizing mind-body-emotion, and energy of the individual while simultaneously promoting mindfulness, joy, and vitality. It includes seven modules of 90 minutes each, discussing meditations \& yoga.

Control GroupIEO Intervention Group

Reading a book regularly promotes knowledge enhancement, reduces stress and enhances memory among other benefits. For the purpose of this study, we advocate reading any book/ journal of participants choice routinely.

Control Group

Eligibility Criteria

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

You may qualify if:

  • Age\>=18 years
  • Interest in Inner Engineering Online Program

You may not qualify if:

  • Low English Proficiency
  • Not currently residing in United States

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Centre

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

  • Upadhyay P, Chang TFH, Hariri S, Rallabandi S, Yathavakilla S, Novack V, Subramaniam B. The Effect of Inner Engineering Online (IEO) Program on Reducing Stress for Information Technology Professionals: A Randomized Control Study. Evid Based Complement Alternat Med. 2022 Jan 4;2022:9001828. doi: 10.1155/2022/9001828. eCollection 2022.

MeSH Terms

Conditions

Burnout, PsychologicalDepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehaviorMental Disorders

Limitations and Caveats

Although our study has a rigorous experimental design by utilizing random assignment and active control, the study is limited by its small sample size. Future study may re-examine the effectiveness of IEO in promoting occupational health by using a larger and diverse sample.

Results Point of Contact

Title
Dr. Balachundar Subramaniam
Organization
Sadhguru Center for a Conscious Planet, BIDMC

Study Officials

  • Balachundhar Subramaniam, MD, MPH

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: A cross over model ensures that both experimental and control group participants get to experience the effects of a proposed intervention. For our study, we are providing Inner Engineering Online as an intervention and both experimental and control group participants get to experience the benefits of meditation.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

September 26, 2019

First Posted

October 15, 2019

Study Start

August 30, 2019

Primary Completion

June 7, 2020

Study Completion

June 7, 2020

Last Updated

September 23, 2024

Results First Posted

September 23, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations