Inner Engineering Online (IEO) Intervention for a Specific Company Employee Program
Primary Purpose
Burnout, Stress, Depression, Anxiety
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Inner Engineering Online
Reading a book/ journal
Sponsored by
About this trial
This is an interventional other trial for Burnout focused on measuring Burnout, Stress, Anxiety, Depression, Meditation, Inner Engineering Online
Eligibility Criteria
Inclusion Criteria:
- Age>=18 years
- Interest in Inner Engineering Online Program
Exclusion Criteria:
- Low English Proficiency
- Not currently residing in United States
Sites / Locations
- Beth Israel Deaconess Medical Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
IEO Intervention Group
Control Group
Arm Description
The Group 1 is the active study group which receives the online mindfulness intervention first.
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).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT04126564
First Posted
September 26, 2019
Last Updated
August 3, 2020
Sponsor
Beth Israel Deaconess Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04126564
Brief Title
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
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
August 30, 2019 (Actual)
Primary Completion Date
June 7, 2020 (Actual)
Study Completion Date
June 7, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burnout, Stress, Depression, Anxiety
Keywords
Burnout, Stress, Anxiety, Depression, Meditation, Inner Engineering Online
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Allocation
Randomized
Enrollment
71 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IEO Intervention Group
Arm Type
Experimental
Arm Description
The Group 1 is the active study group which receives the online mindfulness intervention first.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Inner Engineering Online
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Reading a book/ journal
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Burnout scores
Description
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.
Time Frame
For Phase 1 analysis:Baseline to 4 weeks. For Phase 2 analysis: Baseline to 8 weeks
Secondary Outcome Measure Information:
Title
Change in Perceived Stress Levels
Description
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.
Time Frame
For Phase 1 analysis:Baseline to 4 weeks. For Phase 2 analysis: Baseline to 8 weeks
Other Pre-specified Outcome Measures:
Title
Changes in Mindfulness
Description
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.
Time Frame
For Phase 1 analysis:Baseline to 4 weeks. For Phase 2 analysis: Baseline to 8 weeks
Title
Changes in Dispositional Positive Emotions Scale (DPES- Joy subscale)
Description
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.
Time Frame
For Phase 1 analysis:Baseline to 4 weeks. For Phase 2 analysis: Baseline to 8 weeks
Title
Changes in Depression (CES-D)
Description
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.
Time Frame
For Phase 1 analysis:Baseline to 4 weeks. For Phase 2 analysis: Baseline to 8 weeks
Title
Changes in Anxiety
Description
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.
Time Frame
For Phase 1 analysis:Baseline to 4 weeks. For Phase 2 analysis: Baseline to 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age>=18 years
Interest in Inner Engineering Online Program
Exclusion Criteria:
Low English Proficiency
Not currently residing in United States
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Balachundhar Subramaniam, MD, MPH
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Centre
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35027938
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.
Results Reference
derived
Learn more about this trial
Inner Engineering Online (IEO) Intervention for a Specific Company Employee Program
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