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

14 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Isha Kriya and Naddi Shuddhi for mental health?

Research shows that breathing-based meditation, similar to the techniques used in Isha Kriya and Naddi Shuddhi, has been effective in reducing symptoms of anxiety and PTSD in various groups, including veterans. Additionally, yogic breathing techniques have shown promise in improving symptoms of generalized anxiety disorder and obsessive-compulsive disorder. ^{1 2 3 4 5}

Is the combination of breathing techniques and guided meditations safe for humans?

Research on similar practices like Isha Kriya and Sudarshan Kriya suggests they are generally safe, with studies showing positive effects on mental health and stress without significant adverse effects. ^{2 6 7 8 9}

How does the treatment of Isha Kriya and Naddi Shuddhi differ from other treatments for mental health?

Isha Kriya and Naddi Shuddhi are unique because they combine specific breathing techniques and guided meditations to balance the nervous system and improve mental health. Unlike standard treatments, these practices focus on enhancing well-being and stress resilience through daily practice, offering a low-risk, low-cost alternative to traditional therapies. ^{4 10 11 12 13}

What is the purpose of this trial?

This research study aims to explore whether a set of simple breathing techniques and guided meditations can improve the psychological well-being and recovery of ICU survivors and their caregivers. ICU survivors and their caregivers often experience high levels of stress, anxiety, and depression after discharge. This study investigates whether practicing Isha Kriya, a guided meditation, and Nadi Shuddhi, a breathing technique, can support their mental health and relationship quality. These practices are delivered through a mobile app or in a group setting. Participants enroll as a caregiver-patient dyad and will engage in these techniques throughout the study. In addition to the practices, brain activity will be recorded using a safe, non-invasive EEG device. The EEG, a lightweight cap with small sensors, measures brainwaves to assess potential changes in brain function and connection. EEG recordings will take place in the hospital during two sessions, each lasting approximately 40 minutes. Participants will also complete short surveys at five time points throughout the study, assessing mood, stress, and relationship quality. Baseline demographic information will be collected, and at the conclusion of the study, a brief interview will be conducted to gather feedback on the experience. The study spans approximately seven weeks, with the overall goal of determining whether these breathing and meditation practices can provide accessible and scalable mental health support for ICU survivors and their caregivers.

Eligibility Criteria

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

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

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. India pubmed.ncbi.nlm.nih.gov

Yogic Breathing Instruction in Patients with Treatment-Resistant Generalized Anxiety Disorder: Pilot Study. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Breathing-based meditation decreases posttraumatic stress disorder symptoms in U.S. military veterans: a randomized controlled longitudinal study. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Feasibility, acceptability and evaluation of meditation to augment yoga practice among persons diagnosed with schizophrenia. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

An introduction to Kundalini yoga meditation techniques that are specific for the treatment of psychiatric disorders. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Clinical case report: efficacy of yogic techniques in the treatment of obsessive compulsive disorders. [2019]

6. India pubmed.ncbi.nlm.nih.gov

Effect of Santhi Kriya on certain psychophysiological parameters: a preliminary study. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Randomized Feasibility Study of Meditative Practices in Hospitalized Cancer Patients. [2021]

8. India pubmed.ncbi.nlm.nih.gov

Impact of breathing and relaxation training (Sudarshan Kriya) on cases of alcohol dependence syndrome. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Positive Psychological Changes at High Altitude Shown by the Low Landers after the Yoga Intervention-Sudarshan Kriya Yoga (SKY). [2023]

10. United States pubmed.ncbi.nlm.nih.gov

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

11. United States pubmed.ncbi.nlm.nih.gov

Yoga breathing, meditation, and longevity. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Breathing practices for treatment of psychiatric and stress-related medical conditions. [2022]

13. Germany pubmed.ncbi.nlm.nih.gov

Oxygen consumption and respiration during and after two yoga relaxation techniques. [2022]