Clinical trial NCT04126564: Inner Engineering Online (IEO) Intervention for a Specific Company Employee Program
Official title: Inner Engineering Online (IEO) Intervention for a Specific Company Employee Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burnout
Stress
Depression, Anxiety
Keywords: Burnout
Stress
Anxiety
Depression
Meditation
Inner Engineering Online
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2019-10-15
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: OTHER

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.

Detailed description: The benign behavioral intervention involved is Inner Engineering Online (IEO), a mind-body course that incorporates meditation and yoga, as well as reading a book or journal of their choice.The subjects will be randomized into two groups after they agree to the participate in the study. The study will be conducted in 2 phases.

Phase 1: If they are in group 1, they will participate in IEO which includes practice of meditation \& yoga daily for a minimum of 30 minutes and complete a IEO activity log for 30 days.They will be asked to complete a set of questionnaires at baseline and after 30 days.If they are in group 2, they are asked to read a book or journal of their choice for 30 minutes each day for the first 30 days and complete a reading log.

Phase 2: After they complete reading for 30 days, group 2 participants will now participate in IEO which includes practice of meditation \& yoga daily for a minimum of 30 minutes and complete an IEO activity log for the next 30 days. They are asked to complete a set of questionnaires at baseline, 30 days, and at 60 days.

These questionnaires aim to assess for burnout, stress, and well-being. These include:

* Maslach Burnout Inventory - Human Services Survey - 16 item questionnaire measuring burnout
* Perceived Stress Scale - 10 item questionnaire measuring stress
* Center for Epidemiology Studies depression Scale (CES-D) - 20 item questionnaire measuring depression
* Emotional Distress and Anxiety Short Form - 7 item questionnaire measuring anxiety
* Joy subscale of the Dispositional Positive Emotion Scale - 6 item questionnaire measuring happiness
* Mindful Attention Awareness Scale - 15 item questionnaire measuring mindfulness

Finally, participants of both the groups will be subjected to a 30 day follow-up surveys after a month of IEO completion. They will receive a set of previously administered questionnaire and a compliance survey at this point. Group 1 participants receive this survey at the 60 day time point while Group 2 participants receive it at 90 days.

Eligibility criteria: Inclusion Criteria:

1. Age\>=18 years
2. Interest in Inner Engineering Online Program

Exclusion Criteria:

1. Low English Proficiency
2. Not currently residing in United States

Primary outcomes:
measure: Maslach Burnout Inventory Scale General Survey
timeFrame: For Phase 1 analysis:Baseline to 4 weeks. For Phase 2 analysis: Baseline to 8 weeks
Secondary outcomes:
measure: Perceived Stress Score Levels
timeFrame: For Phase 1 analysis:Baseline to 4 weeks. For Phase 2 analysis: Baseline to 8 weeks
Other outcomes:
measure: Mindfulness Level
timeFrame: For Phase 1 analysis:Baseline to 4 weeks. For Phase 2 analysis: Baseline to 8 weeks
measure: Dispositional Positive Emotions Scale (DPES- Joy Subscale)
timeFrame: For Phase 1 analysis:Baseline to 4 weeks. For Phase 2 analysis: Baseline to 8 weeks
measure: Centre for Epidemiologic Studies, Depression Scale
timeFrame: For Phase 1 analysis:Baseline to 4 weeks. For Phase 2 analysis: Baseline to 8 weeks
measure: Patient-Reported Outcomes Measurement Information System Emotional Distress- Anxiety Short Form Scale.
timeFrame: For Phase 1 analysis:Baseline to 4 weeks. For Phase 2 analysis: Baseline to 8 weeks
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Centre
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Balachundhar Subramaniam, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.