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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Burnout, Stress, Depression, Anxiety

Intervention / Treatment
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* Behavioral: Inner Engineering Online
* Behavioral: Reading a book/ journal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age>=18 years Interest in Inner Engineering Online Program Exclusion Criteria: Low English Proficiency Not currently residing in United States

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IEO Intervention Group<br>The Group 1 is the active study group which receives the online mindfulness intervention first. | Behavioral: Inner Engineering Online<br>* 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.<br>|
| Active Comparator: Control Group<br>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 Online<br>* 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.<br>Behavioral: Reading a book/ journal<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Burnout, Stress, Anxiety, Depression, Meditation, Inner Engineering Online