Clinical trial NCT05065476: Assessing the Impact of Isha Kriya Meditation on Anxiety and Depression - a Pilot Study
Official title: Assessing the Impact of Isha Kriya Meditation on Anxiety and Depression - a Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anxiety
Depression
Keywords: meditation
anxiety
depression
Isha Kriya
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2021-10-04
Enrollment: 267
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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

Eligibility criteria: Inclusion Criteria:

* Age 18-70 years
* Interest in Isha Kriya

Exclusion Criteria:

* Low English proficiency
* Not currently residing in United States

Primary outcomes:
measure: Compliance
timeFrame: Changes from baseline to 6 weeks
Secondary outcomes:
measure: PROMIS - Anxiety Short Form
timeFrame: Changes from baseline to 6 weeks
measure: Center for Epidemiological Studies Depression Scale (CES-D-10)
timeFrame: Changes from baseline to 6 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Sepideh Hariri, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Terlizzi EP, Villarroel MA. Symptoms of Generalized Anxiety Disorder Among Adults: United States, 2019. NCHS Data Brief. 2020 Sep;(378):1-8.
citation: Kessler RC, Berglund P, Demler O, Jin R, Merikangas KR, Walters EE. Lifetime prevalence and age-of-onset distributions of DSM-IV disorders in the National Comorbidity Survey Replication. Arch Gen Psychiatry. 2005 Jun;62(6):593-602. doi: 10.1001/archpsyc.62.6.593.
citation: Abbott A. COVID's mental-health toll: how scientists are tracking a surge in depression. Nature. 2021 Feb;590(7845):194-195. doi: 10.1038/d41586-021-00175-z. No abstract available.
citation: Saeed SA, Cunningham K, Bloch RM. Depression and Anxiety Disorders: Benefits of Exercise, Yoga, and Meditation. Am Fam Physician. 2019 May 15;99(10):620-627.
citation: Saeed SA, Antonacci DJ, Bloch RM. Exercise, yoga, and meditation for depressive and anxiety disorders. Am Fam Physician. 2010 Apr 15;81(8):981-6.
citation: Gonzalez-Valero G, Zurita-Ortega F, Ubago-Jimenez JL, Puertas-Molero P. Use of Meditation and Cognitive Behavioral Therapies for the Treatment of Stress, Depression and Anxiety in Students. A Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2019 Nov 10;16(22):4394. doi: 10.3390/ijerph16224394.
citation: Rangasamy V, Thampi Susheela A, Mueller A, F H Chang T, Sadhasivam S, Subramaniam B. The effect of a one-time 15-minute guided meditation (Isha Kriya) on stress and mood disturbances among operating room professionals: a prospective interventional pilot study. F1000Res. 2019 Mar 26;8:335. doi: 10.12688/f1000research.18446.1. eCollection 2019.
citation: Hariri S, Vishnubhotla RV, Reed PU, Rayapuraju A, Orui H, Balachundhar P, Sadhasivam S, Subramaniam B. Online guided meditation training (Isha Kriya) improves self-reported symptoms of anxiety and depression within 2 weeks of practice-An observational study. Front Psychiatry. 2022 Sep 23;13:944973. doi: 10.3389/fpsyt.2022.944973. eCollection 2022.