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

Sponsor
Beth Israel Deaconess Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05065476
Collaborator
(none)
150
1
32
4.7

Study Details

Study Description

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 Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Anticipated Enrollment :
    150 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
    Anticipated Primary Completion Date :
    Dec 31, 2023
    Anticipated Study Completion Date :
    Dec 31, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Primary Outcome Measures

    1. Compliance [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 [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) [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

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Age 18-70 years

    • Interest in Isha Kriya

    Exclusion Criteria:
    • Low English proficiency

    • Not currently residing in United States

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215

    Sponsors and Collaborators

    • Beth Israel Deaconess Medical Center

    Investigators

    • Principal Investigator: Sepideh Hariri, PhD, Beth Israel Deaconess Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Balachundhar Subramaniam, Professor of Anesthesia, Beth Israel Deaconess Medical Center
    ClinicalTrials.gov Identifier:
    NCT05065476
    Other Study ID Numbers:
    • 2021P000359
    First Posted:
    Oct 4, 2021
    Last Update Posted:
    Dec 9, 2021
    Last Verified:
    Nov 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Balachundhar Subramaniam, Professor of Anesthesia, Beth Israel Deaconess Medical Center
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 9, 2021