AnxietyNCT05065476
Assessing the Impact of Isha Kriya Meditation on Anxiety and Depression - a Pilot Study
An observational study of Anxiety and Depression, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
This study aims to assess the impact of Isha Kriya, a freely available guided meditation, on mental health - specifically anxiety and depression. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Depression
- How many people
- 267 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2021to 30 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Age 18-70 years
- Interest in Isha Kriya
Who cannot join
- Low English proficiency
- Not currently residing in United States
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
This study aims to assess the impact of Isha Kriya, a freely available guided meditation, on mental health - specifically anxiety and depression.
Read the 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.
- Conditions
- Anxiety, Depression
- Keywords
- meditation, anxiety, depression, Isha Kriya
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance
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.
Measured: Changes from baseline to 6 weeks
Secondary outcomes (2)
PROMIS - Anxiety Short Form
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.
Measured: Changes from baseline to 6 weeks
Center for Epidemiological Studies Depression Scale (CES-D-10)
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.
Measured: Changes from baseline to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2021
- Study start1 May 2021
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Balachundhar Subramaniam, Beth Israel Deaconess Medical Center
- Investigators
- Sepideh Hariri, PhD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05065476
- Sponsor's protocol ID
- 2021P000359
- Status last verified
- Dec 2022
- First submitted
- 23 Sep 2021
- Last updated
- 5 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Terlizzi EP, Villarroel MA. Symptoms of Generalized Anxiety Disorder Among Adults: United States, 2019. NCHS Data Brief. 2020 Sep;(378):1-8.
PubMed 33054928Kessler 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.
PubMed 15939837Abbott 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.
PubMed 33536600Saeed 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.
PubMed 31083878Saeed SA, Antonacci DJ, Bloch RM. Exercise, yoga, and meditation for depressive and anxiety disorders. Am Fam Physician. 2010 Apr 15;81(8):981-6.
PubMed 20387774Gonzalez-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.
PubMed 31717682Rangasamy 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.
PubMed 32665843Hariri 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.
PubMed 36213913
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Impact of Isha Kriya Meditation on Anxiety and Depression - a Pilot Study
- ClinicalTrials.gov ID
- NCT05065476
- Acronym / sponsor ID
- 2021P000359
- Conditions
- Anxiety, Depression
- Keywords
- meditation, anxiety, depression, Isha Kriya
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 267 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 4 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Age 18-70 years
- Interest in Isha Kriya
Key exclusion criteria (2 listed)
- Low English proficiency
- Not currently residing in United States
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
PROMIS - Anxiety Short Form
Time frame: Changes from baseline to 6 weeks
Center for Epidemiological Studies Depression Scale (CES-D-10)
Time frame: Changes from baseline to 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2022.
- Background: PubMed 33054928Terlizzi EP, Villarroel MA. Symptoms of Generalized Anxiety Disorder Among Adults: United States, 2019. NCHS Data Brief. 2020 Sep;(378):1-8.
- Background: PubMed 15939837Kessler 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.
- Background: PubMed 33536600Abbott 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.
- Background: PubMed 31083878Saeed 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.
- Background: PubMed 20387774Saeed SA, Antonacci DJ, Bloch RM. Exercise, yoga, and meditation for depressive and anxiety disorders. Am Fam Physician. 2010 Apr 15;81(8):981-6.
- Background: PubMed 31717682Gonzalez-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.
- Background: PubMed 32665843Rangasamy 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.
- Derived from this study: PubMed 36213913Hariri 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sepideh Hariri, PhD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety and Depression, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance (time frame: Changes from baseline to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05065476, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2022.