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

Conditions

• Relationship, Family
• Well-Being, Psychological

Eligibility Criteria

Sex

ALL

Age

18 Years - 85 Years

Healthy Volunteers

Accepted

Interventions

• Isha Kriya and Naddi Shuddhi — BEHAVIORAL
  Isha Kriya, a 15-minute guided meditation, and Nadi Shuddhi, a 3-5-minute alternate-nostril breathing practice. Participants in the intervention groups will be instructed to practice ideally twice or at least once daily.

Study Details

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 Dates

Start date

May 31, 2026

Status verified

Apr 2026

Primary completion

Dec 31, 2026

Completion

Dec 31, 2027

Study Design

Enrollment

14 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Arms

• Experimental: Arm 1
  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

Primary Outcome Measure

Participant Adherence to the Inner Engineering (IE) Intervention [ Time Frame: 7 weeks (from baseline assessment to post-intervention follow-up) ]

Central Contacts

• Somnath Bose, MD, MPH
  [617] 754-2175
  [email protected]
• Siddhartha R Janga
  [email protected]

Locations (1)

Find similar trials in Boston, MA

Related Studies

• The PREGNANT (Pregnant Resident Empowerment, GuidaNce, and Advocacy iN Training) Coaching Project
  Recruiting · Massachusetts General Hospital · Boston, Massachusetts
• Ending the HIV Epidemic: An All-facility Intervention for Patient and Healthcare Staff Well-being
  Recruiting · Columbia University · New York, New York
• A Study of Latin Dance for Post- Lung Transplant
  Recruiting · Mayo Clinic · Jacksonville, Florida
• The Impact of the Family Room App on Caregivers
  Recruiting · University of Nebraska · Omaha, Nebraska