Breathing Techniques + Guided Meditations for Mental Health
(RESTORE-ICU Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Beth Israel Deaconess Medical Center

No Placebo Group

Trial Summary

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.

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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

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Treatment Details

Interventions

Isha Kriya and Naddi Shuddhi (Behavioral Intervention)

Trial OverviewThe 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

1Treatment groups

Experimental Treatment

Group I: Arm 1Experimental Treatment1 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