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Assessing the Impact of Isha Kriya Meditation on Anxiety and Depression - a Pilot Study

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ClinicalTrials.gov Identifier: NCT05065476
Recruitment Status : Completed
First Posted : October 4, 2021
Last Update Posted : December 5, 2022
Sponsor:
Information provided by (Responsible Party):
Balachundhar Subramaniam, Beth Israel Deaconess Medical Center

Study Description
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Brief Summary:
This study aims to assess the impact of Isha Kriya, a freely available guided meditation, on mental health - specifically anxiety and depression.

Condition or disease
Anxiety Depression

Detailed Description:

In 2019, over 15% of the population experienced symptoms of anxiety. This was highest amongst 18-29-year-olds. Amongst these adults, 9.5% experienced mild, 3.4% experienced moderate, and 2.7% experienced severe symptoms of anxiety. About 1 in 6 adults is expected to suffer from depression at some point in their lives. Due to the pandemic, rates of anxiety and depression increased significantly. In December 2020, 42% of people surveyed by the US Census Bureau had symptoms associated with anxiety or depression. This is compared to 11% of adults having similar symptoms from Jan-June 2019. The rapidly diminishing mental health in the general population, especially since the COVID-19 pandemic, has raised the concern for an emerging new pandemic: the mental health pandemic. Mental health leaders and organizations are urging the federal and state authorities to make mental health a top priority and allocate resources to areas including early identification and prevention, establishing integrated health and mental health care to ensure "whole-person" well-being, assuring evidence-based standards of prevention, treatment and care.

Meditation has been shown to be effective in reducing symptoms associated with anxiety and depression. A recent study using a meditation called Isha Kriya showed improved perceived stress amongst operating room professionals in one sitting. Isha Kriya is a simple meditation practice (15minutes) that can be done by anyone over 12 years of age. It is offered free globally via in-person sessions, online webinars, and online videos. A meditation which is available electronically and freely could be an attractive option to include in prevention and treatment strategies for anxiety and depression. Furthermore, such intervention is easily scalable and accessible to everyone with access to the internet and if found effective, can be a valuable resource for addressing disparities in access to mental health resources in minority and underserved populations. This study aims to assess the effectiveness of this meditation on reducing symptoms associated with anxiety and depression over 6 weeks.

Study Design
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Study Type : Observational
Actual Enrollment : 267 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Assessing the Impact of Isha Kriya Meditation on Anxiety and Depression - a Pilot Study
Actual Study Start Date : May 1, 2021
Actual Primary Completion Date : November 30, 2021
Actual Study Completion Date : November 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Groups and Cohorts
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Group/Cohort
Study Group
Participants signed up for the webinar will be learning and practicing the "Isha Kriya" practice (meditation for beginners) taught by the Isha Foundation.


Outcome Measures
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Primary Outcome Measures :
  1. Compliance [ Time Frame: Changes from baseline to 6 weeks ]
    The weekly compliance questionnaire is a tool which helps the participants to keep a track of their activities each week. This enables the study team to measure compliance and protocol adherence by the participants by collecting information on their routine activity practiced and its frequency.


Secondary Outcome Measures :
  1. PROMIS - Anxiety Short Form [ Time Frame: Changes from baseline to 6 weeks ]
    PROMIS - Anxiety Short Form1 is an 8 item validated instrument that assesses 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.

  2. Center for Epidemiological Studies Depression Scale (CES-D-10) [ Time Frame: Changes from baseline to 6 weeks ]

    PROMIS - Anxiety Short Form is an 8 item validated instrument that assesses 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.



Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Participants will be recruited from a pool of healthy volunteers who sign up for a webinar where they learn the "Isha Kriya" practice. Isha Foundation has developed the Isha Kriya practice and conducts online Isha Kriya webinars (Meditation for Beginners). This webinar is routinely conducted by Isha Foundation.
Criteria

Inclusion Criteria:

  • Age 18-70 years
  • Interest in Isha Kriya

Exclusion Criteria:

  • Low English proficiency
  • Not currently residing in United States
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05065476


Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
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Principal Investigator: Sepideh Hariri, PhD Beth Israel Deaconess Medical Center
More Information
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Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Balachundhar Subramaniam, Professor of Anesthesia, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT05065476    
Other Study ID Numbers: 2021P000359
First Posted: October 4, 2021    Key Record Dates
Last Update Posted: December 5, 2022
Last Verified: December 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Balachundhar Subramaniam, Beth Israel Deaconess Medical Center:
meditation
anxiety
depression
Isha Kriya
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Anxiety Disorders
 Behavioral Symptoms
Mood Disorders
Mental Disorders