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Inner Engineering Yoga Program on Short and Long Term Health Effects (ISHA-Impact): A Longitudinal Study (ISHA-Impact)

Primary Purpose

Mediation, Mood, Stress

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Inner Engineering Intervention
Sponsored by
Beth Israel Deaconess Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Mediation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Participants who have registered to take the Inner Engineer Online Course.
  • Participants who have registered to take the Inner Engineer Completion Course.
  • Participants must be able to read and understand English.

Exclusion Criteria:

  • Participants who report living outside the United States at the time of enrollment.
  • Participants < 18 years of age.

Sites / Locations

  • Beth Israel Deaconess Medical CentreRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Inner Engineering Intervention

Arm Description

The intervention investigators propose for the study includes an Online Course with 7 modules, or a 10 hours long course, and a 1-2 day In-Person Course, in which participants will learn a simple 21 minute practice called Shambhavi Mahamudra Kriya, also known as Shambhavi Kriya.

Outcomes

Primary Outcome Measures

Changes in Perceived Stress Levels
The study aims to evaluate changes in perceived levels of stress in survey participants and the effect Inner Engineering has over them in long term. The investigators use a validated scale for this purpose named, Perceived Stress Scale (PSS). The scale measures the degree to which situations in participant's life are appraised as stressful. This is defined to be the key secondary outcome for the study. Higher scores are suggestive of more stress. Logistic regression analysis is performed on the outcome measures collected over the specified time-frame.
Mood Changes
The study aims to evaluate changes in mood profiles affected by the Inner Engineering Online (IEO) over time. For evaluation of mood profiles the investigators use a validated scale named, Profile of Mood States (POMS). The scale measures different dimensions of mood swings over a period of time and calculates Total Mood Disturbances by performing a sub-scale analysis. The subscales defined include Tension, Depression, Anger, Fatigue, Confusion & Vigor. Higher scores are suggestive of poorer outcome. Logistic regression analysis is performed on the outcome measures collected over the specified time-frame.

Secondary Outcome Measures

Full Information

First Posted
October 11, 2019
Last Updated
January 17, 2023
Sponsor
Beth Israel Deaconess Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04189146
Brief Title
Inner Engineering Yoga Program on Short and Long Term Health Effects (ISHA-Impact): A Longitudinal Study
Acronym
ISHA-Impact
Official Title
Inner Engineering Yoga Program on Short and Long Term Health Effects (ISHA-Impact): A Longitudinal Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 12, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

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
This study will include any participant who registered, and plans to attend the Inner Engineering In-Person Completion Course. In 2019, this course was offered in: Los Angeles in March, Philadelphia in April and Toronto & Dallas in November. This study has been involved in every IECO Course since 2019 and is still active today. Beginning in August 2021, investigators will recruit for the August Inner Engineering In-Person Completion Course. Investigators anticipate that this study can include up to 5,000 study participants. Participants would attend this course and complete the pre-modules regardless of whether or not they participate in this study.
Detailed Description
This study aims to enroll participants who have registered for the Inner Engineering in-person course. Briefly, this course is a 1-2 day in-person course, in which participants will learn a simple 21 minute practice called Shambhavi Mahamudra Kriya, also known as Shambhavi Kriya. Shambhavi Kriya is a powerful and purifying energy technique which incorporates the breath. This practice is said to align the body systems so that the body, mind and emotions function in harmony. More information about the course can be found on the ISHA foundation website: https://www.innerengineering.com/ieo-new/completion/. Registrants for IECO are asked to complete a series of seven (7) online modules (IEO) prior to the start of the in-person course. The online series provides the participants with an opportunity to intellectually explore the basics of life using methods that are distilled from the essence of yogic sciences. The course imparts wisdom to manage the body, mind, emotions, and the fundamental life energy within. Importantly, the course modules (IEO) and the in-person meeting (IECO) and subsequent meditation and yoga practices would occur regardless of whether or not a person decided to participate in the study. The only study procedure imparted includes requesting the participants to complete a series of surveys over a one-year period. This study only involves administration of electronic surveys at six different time points. These time points include: at the time of consent; after completing the Inner Engineering Online modules but before the in-person course begins; after the completion of the in-person (IECO) course; at 6 weeks; at 6 months and at 12 months. These surveys can take up to 15 minutes to complete. Electronic reminders will be sent to participants who have not completed these surveys within a week. Additionally, participants must complete a two-minute compliance survey at the end of each week for 6 weeks after IECO completion. After these 6 weeks, this same two-minute compliance survey will be sent monthly until the end of the year. This survey is an important component of our data analysis, because it collects information on the frequency and duration of their routine practice. Participants can choose to either complete their baseline & post-IEO surveys only, or continue and complete Post IECO- 1 year follow up period. A break was incorporated because IEO & IECO are 2 separate events, and participants who chose to complete IEO may not necessarily complete IECO. This break ensures maximum participation. This study will include participants who are registered and plan to attend any Inner Engineering Online & Inner Engineering Online Completion Course. This course is offered several times throughout the year and each course has several hundred participants. We anticipate we can collect data from up to 5,000 study participants and create a significant database of Inner Engineering practitioners.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mediation, Mood, Stress, Habits, Nicotine, Alcohol Consumption, Pain Intensity, Sleep, Mindfulness, Emotions, Anxiety, Depression

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This study only involves administration of electronic surveys at six different time points. These time points include: at the time of consent; after completing the Inner Engineering Online modules but before the in-person course begins; after the completion of the in-person (IECO) course; at 6 weeks; at 6 months and at 12 months. These surveys can take up to 15 minutes to complete. Electronic reminders will be sent to participants who have not completed these surveys within a week. Additionally, participants must complete a two-minute compliance survey at the end of each week for 6 weeks after IECO completion. After these 6 weeks, this same two-minute compliance survey will be sent monthly until the end of the year. This survey is an important component of our data analysis, because it collects information on the frequency and duration of their routine practice.
Masking
None (Open Label)
Allocation
N/A
Enrollment
5000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Inner Engineering Intervention
Arm Type
Other
Arm Description
The intervention investigators propose for the study includes an Online Course with 7 modules, or a 10 hours long course, and a 1-2 day In-Person Course, in which participants will learn a simple 21 minute practice called Shambhavi Mahamudra Kriya, also known as Shambhavi Kriya.
Intervention Type
Behavioral
Intervention Name(s)
Inner Engineering Intervention
Intervention Description
The intervention investigators propose for the study includes an Online Course with 7 modules, or a 10 hours long course, and a 1-2 day In-Person Course, in which participants will learn a simple 21 minute practice called Shambhavi Mahamudra Kriya, also known as Shambhavi Kriya. Shambhavi Kriya is a powerful and purifying energy technique incorporating the breath. This practice is said to align the participants system such that their body, mind and emotions function in harmony.
Primary Outcome Measure Information:
Title
Changes in Perceived Stress Levels
Description
The study aims to evaluate changes in perceived levels of stress in survey participants and the effect Inner Engineering has over them in long term. The investigators use a validated scale for this purpose named, Perceived Stress Scale (PSS). The scale measures the degree to which situations in participant's life are appraised as stressful. This is defined to be the key secondary outcome for the study. Higher scores are suggestive of more stress. Logistic regression analysis is performed on the outcome measures collected over the specified time-frame.
Time Frame
The investigators collect these scores at the 6 pre-specified time points; i.e., at the time of consent; after completing the IEO modules but before conference; post conference completion; at 6 weeks; at 6 months and at 12 months.
Title
Mood Changes
Description
The study aims to evaluate changes in mood profiles affected by the Inner Engineering Online (IEO) over time. For evaluation of mood profiles the investigators use a validated scale named, Profile of Mood States (POMS). The scale measures different dimensions of mood swings over a period of time and calculates Total Mood Disturbances by performing a sub-scale analysis. The subscales defined include Tension, Depression, Anger, Fatigue, Confusion & Vigor. Higher scores are suggestive of poorer outcome. Logistic regression analysis is performed on the outcome measures collected over the specified time-frame.
Time Frame
The investigators collect these scores at the 6 pre-specified time points; i.e., at the time of consent; after completing the IEO modules but before conference; post conference completion; at 6 weeks; at 6 months and at 12 months.
Other Pre-specified Outcome Measures:
Title
Habits of daily living
Description
The investigators use a validated scale for this purpose named, NHANES III. The scale measures the habits of daily living of an individual. This is a qualitative scale, and scoring is not done. Logistic regression analysis is performed on the outcome measures collected over the specified time-frame.
Time Frame
The investigators collect these scores at the 6 pre-specified time points; i.e., at the time of consent; after completing the IEO modules but before conference; post conference completion; at 6 weeks; at 6 months and at 12 months.
Title
Nictoine Consumption
Description
The investigators use several validated scale for this purpose namely, NHANES III, Nicotine dependence, Negative Health Expectancies and Emotional Expectancies among others. The scales measure the nicotine dependence and aids in quantifying dependence which in turn aids in evaluating any change on the individual's perception after the Inner Engineering intervention. Higher scores suggest greater nicotine dependence. Logistic regression analysis is performed on the outcome measures collected over the specified time-frame.
Time Frame
The investigators collect these scores at the 6 pre-specified time points; i.e., at the time of consent; after completing the IEO modules but before conference; post conference completion; at 6 weeks; at 6 months and at 12 months.
Title
Alcohol Consumption
Description
The investigators use a validated scale for this purpose namely, AUDIT. The scale measures the individual's dependence on alcohol and objectively quantifies dependence which in turn aids in evaluating any change on the individual's perception after the Inner Engineering intervention. A score of 8 or more is considered to be hazardous use of alcohol. Logistic regression analysis is performed on the outcome measures collected over the specified time-frame.
Time Frame
The investigators collect these scores at the 6 pre-specified time points; i.e., at the time of consent; after completing the IEO modules but before conference; post conference completion; at 6 weeks; at 6 months and at 12 months.
Title
Pain Intensity
Description
The investigators use a validated scale for this purpose namely, Pain intensity & Pain interference scales. The scales measure the individuals' pain perception, and quantify the effects of the individuals' pain which in turn aids in evaluating any change on the individual's perception after the Inner Engineering intervention. higher scores suggestive of increased pain perception. Logistic regression analysis is performed on the outcome measures collected over the specified time-frame.
Time Frame
The investigators collect these scores at the 6 pre-specified time points; i.e., at the time of consent; after completing the IEO modules but before conference; post conference completion; at 6 weeks; at 6 months and at 12 months.
Title
Sleep patterns & behavior
Description
The investigators use a validated scale for this purpose namely, Pittsburgh Sleep Quality Index (PSQI). The scale measure the individuals' sleep patterns & behavior and quantifies sleep quality which in turn aids in evaluating any change on the individual's sleep quality after the Inner Engineering intervention. Scores higher than 5 are suggestive of poor sleep quality. Logistic regression analysis is performed on the outcome measures collected over the specified time-frame.
Time Frame
The investigators collect these scores at the 6 pre-specified time points; i.e., at the time of consent; after completing the IEO modules but before conference; post conference completion; at 6 weeks; at 6 months and at 12 months.
Title
Mindfulness
Description
The investigators use 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. Higher scores are suggestive of increased mindfulness and awareness. Logistic regression analysis is performed on the outcome measures collected over the specified time-frame.
Time Frame
The investigators collect these scores at the 6 pre-specified time points; i.e., at the time of consent; after completing the IEO modules but before conference; post conference completion; at 6 weeks; at 6 months and at 12 months.
Title
Emotional health
Description
The investigators use a validated scale for this purpose namely, PERMA profiler. The scale measures the 5 pillars of well-being (Positive emotions, engagement, relationship, meaning, accomplishment) along with negative emotions and health in the individual. Higher scores are suggestive of better outcomes. This aids in evaluating any change on the individual's awareness levels after the Inner Engineering intervention. Logistic regression analysis is performed on the outcome measures collected over the specified time-frame.
Time Frame
The investigators collect these scores at the 6 pre-specified time points; i.e., at the time of consent; after completing the IEO modules but before conference; post conference completion; at 6 weeks; at 6 months and at 12 months.
Title
Anxiety
Description
The investigators used the PROMIS (Anxiety-8) an 8-item validated instrument that assesses the severity of anxiety. Participants are asked on a scale of 1 (Never) to 5 (Always) on the frequency of occurrence of each negative experience. Overall score is computed based on sum from individual responses. A higher sum indicates greater anxiety.
Time Frame
The investigators collect these scores at the 6 pre-specified time points; i.e., at the time of consent; after completing the IEO modules but before conference; post conference completion; at 6 weeks; at 6 months and at 12 months.
Title
Depression
Description
The investigators used the CES-D 20-item scale to assess depression. Each item is coded 1 "rarely or none of the time (less than 1 day)" to 4 "most or all of the time (5-7 days)." Scores range from 0 to 60, with high scores indicating greater depressive symptoms.
Time Frame
The investigators collect these scores at the 6 pre-specified time points; i.e., at the time of consent; after completing the IEO modules but before conference; post conference completion; at 6 weeks; at 6 months and at 12 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Participants who have registered to take the Inner Engineer Online Course. Participants who have registered to take the Inner Engineer Completion Course. Participants must be able to read and understand English. Exclusion Criteria: Participants who report living outside the United States at the time of enrollment. Participants < 18 years of age.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Balachundhar Subramaniam, MD, MPH
Phone
617-667-2721
Email
bsubrama@bidmc.harvard.edu
Facility Information:
Facility Name
Beth Israel Deaconess Medical Centre
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Balachundhar Subramaniam, MD, MPH
Phone
617-667-2721
Email
bsubrama@bidmc.harvard.edu
First Name & Middle Initial & Last Name & Degree
Balachundhar Subramaniam, MD, MPH

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28991114
Citation
Hyman SA, Shotwell MS, Michaels DR, Han X, Card EB, Morse JL, Weinger MB. A Survey Evaluating Burnout, Health Status, Depression, Reported Alcohol and Substance Use, and Social Support of Anesthesiologists. Anesth Analg. 2017 Dec;125(6):2009-2018. doi: 10.1213/ANE.0000000000002298.
Results Reference
background
PubMed Identifier
23720542
Citation
Kato T. Development of the Sleep Quality Questionnaire in healthy adults. J Health Psychol. 2014 Aug;19(8):977-86. doi: 10.1177/1359105313482168. Epub 2013 May 29.
Results Reference
background
Citation
Shioata, M.N., D. Keltner, and O.P. John, Positive Emotion Dispositions Differntially Associatd with Big Five Personality and Attachement Style. The Journal of Positive Psychology, 2006. 1(2): p. 61-71.
Results Reference
background
PubMed Identifier
9327588
Citation
Ryan RM, Frederick C. On energy, personality, and health: subjective vitality as a dynamic reflection of well-being. J Pers. 1997 Sep;65(3):529-65. doi: 10.1111/j.1467-6494.1997.tb00326.x.
Results Reference
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PubMed Identifier
11148302
Citation
Ryan RM, Deci EL. On happiness and human potentials: a review of research on hedonic and eudaimonic well-being. Annu Rev Psychol. 2001;52:141-66. doi: 10.1146/annurev.psych.52.1.141.
Results Reference
background
PubMed Identifier
29228793
Citation
Peterson CT, Bauer SM, Chopra D, Mills PJ, Maturi RK. Effects of Shambhavi Mahamudra Kriya, a Multicomponent Breath-Based Yogic Practice ( Pranayama), on Perceived Stress and General Well-Being. J Evid Based Complementary Altern Med. 2017 Oct;22(4):788-797. doi: 10.1177/2156587217730934. Epub 2017 Sep 22.
Results Reference
background
PubMed Identifier
22707866
Citation
Muralikrishnan K, Balakrishnan B, Balasubramanian K, Visnegarawla F. Measurement of the effect of Isha Yoga on cardiac autonomic nervous system using short-term heart rate variability. J Ayurveda Integr Med. 2012 Apr;3(2):91-6. doi: 10.4103/0975-9476.96528.
Results Reference
background
Citation
Selvaraj, N., et al., Heart Rate Dynamics during Shambhavi Mahamudra - A Practice of Isha Yoga. Journal of Complementary and Inegrative Medicine, 2008. 5(1): p. 1-22.
Results Reference
background
PubMed Identifier
35572309
Citation
Upadhyay P, Joshi A, Mishra I, Kelly L, Novack L, Hariri S, Kveraga K, Subramaniam B. Short Term Effects of Inner Engineering Completion Online Program on Stress and Well-Being Measures. Front Psychol. 2022 Apr 27;13:814224. doi: 10.3389/fpsyg.2022.814224. eCollection 2022.
Results Reference
derived
Links:
URL
https://www.innerengineering.com/ieo-new/completion/
Description
ISHA Foundation Website

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Inner Engineering Yoga Program on Short and Long Term Health Effects (ISHA-Impact): A Longitudinal Study

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