Not Yet RecruitingNot Applicable

REducing pSychological diSTress To Optimize Recovery of Elderly ICU Survivors and Caregivers (RESTORE-ICU)

United States14 participantsStarted 2026-05

Plain-language summary

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.

Who can participate

Age range18 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. Provide signed and dated informed consent and understand the nature of the study sufficiently to allow completion of all study assessments.
✕. Elderly ICU survivors aged over 60 years who have experienced long ICU stays of more than five days.
✕. Caregivers who either live in the same household as the survivor or visit more than three times a week.
✕. Age \>=85 years (Justification: Assessment instruments not validated in this age group and patients in extremes of age may have limited proficiency to engage in proposed meditative practices)
✕. Non-English speaking/Low-English proficiency (Justification: assessment instruments are not validated in a sufficient range of languages, and the research team lacks polylingual capabilities or the financial resources to hire interpreters for the duration of all proposed assessments.)
✕. Non-US resident
✕. Recent or current meditation, yoga, breathwork or associated MBI intervention practice (\> 2 times per week). (Justification: as the primary outcome is to evaluate the feasibility and adherence of patients to a multicomponent MBI, recent or current practice of the individual or combined components would directly influence the endpoint).
✕. Individuals discharged to a non-home location, such as a rehabilitation center, nursing home, or long-term acute care facility.

What they're measuring

Participant Adherence to the Inner Engineering (IE) Intervention

Timeframe: 7 weeks (from baseline assessment to post-intervention follow-up)

Participant Engagement with the Inner Engineering (IE) Intervention

Timeframe: 7 weeks (from baseline assessment to post-intervention follow-up)

Study Retention Rate

Timeframe: 7 weeks (from baseline assessment to post-intervention follow-up)

Trial details

NCT IDNCT06867367

SponsorBeth Israel Deaconess Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12

Contact for this trial

Somnath Bose, MD, MPH

[617] 754-2175 sbose2@bidmc.harvard.edu

View on ClinicalTrials.gov More Relationship, Family trials

Plain-language summary

Who can participate

Age range18 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. Provide signed and dated informed consent and understand the nature of the study sufficiently to allow completion of all study assessments.
✕. Elderly ICU survivors aged over 60 years who have experienced long ICU stays of more than five days.
✕. Caregivers who either live in the same household as the survivor or visit more than three times a week.
✕. Age \>=85 years (Justification: Assessment instruments not validated in this age group and patients in extremes of age may have limited proficiency to engage in proposed meditative practices)
✕. Non-English speaking/Low-English proficiency (Justification: assessment instruments are not validated in a sufficient range of languages, and the research team lacks polylingual capabilities or the financial resources to hire interpreters for the duration of all proposed assessments.)
✕. Non-US resident
✕. Recent or current meditation, yoga, breathwork or associated MBI intervention practice (\> 2 times per week). (Justification: as the primary outcome is to evaluate the feasibility and adherence of patients to a multicomponent MBI, recent or current practice of the individual or combined components would directly influence the endpoint).
✕. Individuals discharged to a non-home location, such as a rehabilitation center, nursing home, or long-term acute care facility.