Breathing Techniques + Guided Meditations for Mental Health

(RESTORE-ICU Trial)

Overseen By Nashaw Jafari, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Beth Israel Deaconess Medical Center

Disqualifiers: Age ≥85, Non-English, Non-US, Dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether simple breathing techniques and guided meditations can improve mental well-being and relationships for ICU survivors and their caregivers. It incorporates Isha Kriya, a short meditation, and Nadi Shuddhi, a breathing exercise, to assess their potential in reducing stress and anxiety. Participants will practice these techniques via a mobile app or in group sessions, and researchers will monitor their brain activity using an EEG device, which measures brainwaves. Ideal participants include ICU survivors over 60 who experienced a long hospital stay and their caregivers who visit frequently. As an unphased trial, this study provides a unique opportunity to explore innovative methods for enhancing mental well-being and strengthening relationships.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on meditation and breathing techniques, so it's likely you can continue your medications, but you should confirm with the study team.

What prior data suggests that these breathing techniques and guided meditations are safe for ICU survivors and their caregivers?

A previous study found that Isha Kriya meditation improved mood and reduced stress and burnout. Participants generally received it well, reporting increased happiness and balance, with no major side effects.

For Nadi Shuddhi, research has shown that this breathing technique can lower stress and help regulate body functions. It is considered safe and supports overall well-being, with practitioners not reporting any serious negative effects. Based on available evidence, both practices appear safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Isha Kriya and Nadi Shuddhi for mental health because these techniques offer a fresh approach that combines meditation and breathing exercises. Unlike typical treatments such as medication or cognitive behavioral therapy, these practices focus on enhancing mental well-being through mindfulness and balanced breathing, which can be easily integrated into daily life. The use of a mobile app for delivery means these practices are accessible and convenient, allowing participants to practice anywhere and track their progress. This innovative method holds promise for improving psychological well-being and relationship quality, offering a potentially transformative experience for users.

What evidence suggests that these breathing techniques and guided meditations are effective for improving mental health in ICU survivors and their caregivers?

Research has shown that Isha Kriya and Nadi Shuddhi, which participants in this trial will practice, can greatly reduce stress and anxiety while improving overall well-being. Studies have found that practicing Isha Yoga, which includes Isha Kriya, lowers stress levels, increases mindfulness, and improves emotional health. One study found that Isha Kriya noticeably enhances well-being and reduces stress and heart rates. Practicing these techniques online has also led to a lasting decrease in stress and an increase in positive emotions over 12 weeks. These findings suggest that these simple practices might help improve mental health for ICU survivors and their caregivers in this trial. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for ICU survivors and their caregivers who are experiencing stress, anxiety, or depression post-discharge. Participants must enroll together as a dyad (patient-caregiver pair) and be willing to practice guided meditation and breathing techniques using an app or in group sessions.

Inclusion Criteria

Provide signed and dated informed consent and understand the nature of the study sufficiently to allow completion of all study assessments

I am over 60 and was in the ICU for more than 5 days.

I am a caregiver living with or visiting the survivor more than three times a week.

Exclusion Criteria

Co-enrollment in other interventional studies will not be allowed

Not on non-invasive ventilation, high-flow nasal cannula (HFNC), or mechanically ventilated

I am not on medication to increase my blood pressure or heart function.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Phase 1: Hospital-Based Procedures

Establishing research infrastructure and implementing Inner Engineering practices and EEG hyperscanning in the hospital setting.

2 weeks

Multiple in-person sessions for EEG and intervention introduction

Phase 2: Post-Discharge Implementation

Evaluating the feasibility of remote delivery of Inner Engineering practices and monitoring adherence at home.

5 weeks

Remote monitoring and surveys at weeks 2, 4, and 6

Follow-up

Participants are monitored for safety and effectiveness after the intervention, including feedback interviews.

1 week

1 in-person or virtual interview

What Are the Treatments Tested in This Trial?

Interventions

• Isha Kriya and Naddi Shuddhi

Trial Overview

The study tests if Isha Kriya (guided meditation) and Nadi Shuddhi (breathing technique), delivered via mobile app or group setting, can improve mental health and relationships of ICU survivors/caregivers. It includes EEG recordings to monitor brain activity changes.

How Is the Trial Designed?

Group I: Arm 1 Experimental Treatment 1 Intervention

This arm involves ICU survivor-caregiver dyads engaging in the Inner Engineering (IE) intervention, including Isha Kriya (15-minute guided meditation) and Nadi Shuddhi (3-5 minute alternate-nostril breathing). The intervention is delivered through a mobile app or group sessions. Participants will complete surveys and EEG recordings to assess changes in psychological well-being, relationship quality, and neural activity. Both patients and caregivers will be introduced to the interventions either remotely or in-person, followed by remote delivery via the 3Cs app. The app tracks usage metrics. Nadi Shuddhi - A 4-minute breathing practice for mental balance and relaxation, to be practiced daily. Isha Kriya - A 15-minute meditation incorporating breath and awareness, to be practiced at least once (ideally twice) daily

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

Published Research Related to This Trial

After 30 days of practicing Santhi Kriya, participants showed a significant reduction in body weight and an increase in brain alpha activity, indicating enhanced calmness.

The practice also led to a notable increase in oral temperature and a decrease in respiratory rate, suggesting potential benefits for overall physiological relaxation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Santhi Kriya on certain psychophysiological parameters: a preliminary study. Satyanarayana, M., Rajeswari, KR., Rani, NJ., et al.[2022]

Sudarshan Kriya Yoga (SKY) is a low-risk and cost-effective adjunct treatment for various conditions such as stress, anxiety, PTSD, and depression, supported by clinical observations and studies.

Regular practice of SKY, ideally for 30 minutes daily under skilled guidance, enhances well-being, mood, and stress tolerance, making it a valuable tool for health care providers to recommend to patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sudarshan Kriya Yogic breathing in the treatment of stress, anxiety, and depression. Part II--clinical applications and guidelines. Brown, RP., Gerbarg, PL.[2022]

A study involving 21 U.S. male veterans with PTSD found that those who practiced Sudarshan Kriya yoga showed significant reductions in PTSD symptoms and anxiety, with a large effect size (d = 1.16).

The intervention also led to decreased startle responses, indicating a reduction in hyperarousal symptoms, which were maintained at a 1-year follow-up, suggesting long-term benefits of this breathing-based meditation approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breathing-based meditation decreases posttraumatic stress disorder symptoms in U.S. military veterans: a randomized controlled longitudinal study. Seppälä, EM., Nitschke, JB., Tudorascu, DL., et al.[2021]

A clinical trial involving 40 hospitalized cancer patients tested two meditation practices, Isha Kriya (IK) and meditative slow breathing (MSB), showing that both practices were acceptable, with 12 out of 15 participants responding positively to the meditation experience by day 7.

The study faced challenges in feasibility, as only 39% of eligible patients participated, and factors like high morbidity and limited time for meditation hindered consistent practice, suggesting that future research should focus on shorter-term outcomes and better support for participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Feasibility Study of Meditative Practices in Hospitalized Cancer Patients. Narayanan, S., Reddy, A., Lopez, G., et al.[2021]

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