Clinical trial NCT04189146: Inner Engineering Yoga Program on Short and Long Term Health Effects (ISHA-Impact): A Longitudinal Study
Official title: Inner Engineering Yoga Program on Short and Long Term Health Effects (ISHA-Impact): A Longitudinal Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mediation
Mood
Stress
Habits
Nicotine
Alcohol Consumption
Pain Intensity
Sleep
Mindfulness
Emotions
Anxiety
Depression
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2019-12-06
Enrollment: 618
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Changes in Perceived Stress Levels
timeFrame: 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.
measure: Mood Changes
timeFrame: 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.
Secondary outcomes:
Other outcomes:
measure: Habits of daily living
timeFrame: 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.
measure: Nictoine Consumption
timeFrame: 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.
measure: Alcohol Consumption
timeFrame: 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.
measure: Pain Intensity
timeFrame: 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.
measure: Sleep patterns & behavior
timeFrame: 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.
measure: Mindfulness
timeFrame: 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.
measure: Emotional health
timeFrame: 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.
measure: Anxiety
timeFrame: 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.
measure: Depression
timeFrame: 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.
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Centre
state: Massachusetts
Study officials:
References:
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