Inner Engineering Online (IEO) Intervention for a Specific Company Employee Program

Stress Clinical Trial

Official title:

Inner Engineering Online (IEO) Intervention for a Specific Company Employee Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04126564
• Other study ID #: 2019P000715
• Status: Completed
• Phase: N/A
• Start date: August 30, 2019
• Est. completion date: June 7, 2020

Study information

• Verified date: August 2020
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: June 7, 2020
• Est. primary completion date: June 7, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Burnout
• Burnout, Psychological
• Depression
• Depression, Anxiety
• Stress

Intervention

Behavioral:
• Inner Engineering Online
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.
• Reading a book/ journal
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.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Centre	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in Mindfulness	We assess for change in Mindfulness levels by using a validated scale for this purpose namely, Mindfulness Attention Awareness Scale (MAAS). The scale measures the individuals' ability for receptive awareness and attention to present. This aids in evaluating any change on the individual's awareness levels after the Inner engineering intervention. We compute the MAAS scores for each participant which is a mean score for 15 item questionnaires and compare the pre & post intervention results to look for change.	For Phase 1 analysis:Baseline to 4 weeks. For Phase 2 analysis: Baseline to 8 weeks
Other	Changes in Dispositional Positive Emotions Scale (DPES- Joy subscale)	We assess for change in the individuals' ability to feel joy and look for it in the mundane by using a validated scale for this purpose namely, Dispositional Positive Emotions Scale (DPES) particularly the Joy subscale. The Sub-scale measures the individuals' dispositional ability to feel joy in life. The aids in evaluating any change on the individual's joy predisposition levels after the Inner engineering intervention. We compute the DPES-JOY subscale scores for each participant which is a mean score for 6 item questionnaires and compare the pre & post intervention results to look for change.	For Phase 1 analysis:Baseline to 4 weeks. For Phase 2 analysis: Baseline to 8 weeks
Other	Changes in Depression (CES-D)	We assess for change in the individual feeling depressed using a validated scale for this purpose namely, Centre for Epidemiologic Studies, Depression scale. The scale comprises of 20 item questionnaires which measures the major facets of depression based on self-reported symptomatology. We compute the CES-D scale scores for each participant and compare the pre & post intervention results to look for change.	For Phase 1 analysis:Baseline to 4 weeks. For Phase 2 analysis: Baseline to 8 weeks
Other	Changes in Anxiety	We assess for change in the individual feeling anxious using a validated scale for this purpose namely, PROMIS emotional distress- Anxiety short form scale. The scale comprises of 7 item questionnaires which measures the major facets of anxiety based on self-reported symptomatology. We compute the PROMIS Anxiety short form scale scores for each participant and compare the pre & post intervention results to look for change.	For Phase 1 analysis:Baseline to 4 weeks. For Phase 2 analysis: Baseline to 8 weeks
Primary	Change in Burnout scores	The study aims to evaluate changes in burnout levels affected by the Inner Engineering Online intervention. We use a validated scale for this purpose named, Maslach Burnout Inventory (MBI). The scale measures different dimensions contributing to burnout in an individual. For this study we used the general services survey which is a 16 question survey and evaluates for Exhaustion, Cynicism & Professional Efficacy. We assess for change in burnout levels by analysing the MBI-GSS score for each participant and comparing it to pre & post intervention results.	For Phase 1 analysis:Baseline to 4 weeks. For Phase 2 analysis: Baseline to 8 weeks
Secondary	Change in Perceived Stress Levels	The study aims to evaluate changes in perceived levels of stress in survey participants and the effect Inner Engineering Online has over them. We use a validated scale for this purpose named, Perceived Stress Scale. The scale measures the degree to which situations in participant's life are appraised as stressful. This is the key secondary outcome for our study. We assess for change in perceived stress levels by analysing the PSS score for each participant and comparing it to pre & post intervention results.	For Phase 1 analysis:Baseline to 4 weeks. For Phase 2 analysis: Baseline to 8 weeks