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

Starting soon · Not applicable

Conditions studied: Relationship, Family, Well-Being, Psychological

In brief

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.

Key facts

Study ID

NCT06867367

Run by

Beth Israel Deaconess Medical Center

People needed

14

Starts

2026-12-01

Expected to finish

2027-12-01

Last updated by the study team

2026-07-08

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• Co-enrollment in other interventional studies will not be allowed.
• 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.
• Individuals with limited internet access, which would prevent access to online guided meditation
• Prisoners.
• Individuals who refuse to participate in the study.
• Not on vasopressor or inotropic support at the time of enrollment.
• Not on non-invasive ventilation, high-flow nasal cannula (HFNC), or mechanically ventilated.
• Not on continuous renal replacement therapy (CRRT).
• Failure to pass Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) screening (>3.6; Justification: Cognitive decline would limit the ability to engage with and complete the study interventions and assessments).
• Scores ≥ 5 on either the anxiety or depression subscales suggesting severe symptom levels.
• Known diagnosis of moderate or severe dementia.
• Neurological injury.
• Residing in a medical institution before admission.
• Patient on hospice at or before the time of enrollment.
• Mechanical ventilation at baseline or solely for airway protection.
• Patient not expected to go home (e.g., transfer to a facility).
• Patient not expected to survive two months or expected to transition to hospice.
• Patient died in hospital before enrollment.
• Attending physician declined enrollment.
• Patient discharged before being approached for consent.
• Either the patient or caregiver in the dyad declined participation (based on IQCODE or consent).

Where it is running

• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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