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

NCT06867367 | Not Yet Recruiting

• 1 other identifier: 2024P000984
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Relationship, Family; Well-Being, Psychological

Keywords

mental health; relationship quality; ICU recovery

Outcome Measures

Primary Outcomes (3)

• Participant Adherence to the Inner Engineering (IE) Intervention

  Adherence will be assessed based on the number of IE sessions each participant completes.

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

• Participant Engagement with the Inner Engineering (IE) Intervention

  Engagement will be measured by the frequency of practice logged in the mobile app, indicating participant involvement in the intervention.

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

• Study Retention Rate

  Retention will be assessed by tracking the percentage of participants who complete the full study period, including all study assessments.

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

Secondary Outcomes (6)

• Changes in Perceived Stress

  7 weeks (baseline, weeks 2, 4, and 6 post-intervention)

• Changes in Psychological distress related to traumatic events

  7 weeks (baseline, weeks 2, 4, and 6 post-intervention)

• Changes in Anxiety and Depressive symptoms

  7 weeks (baseline, weeks 2, 4, and 6 post-intervention)

• Changes in Caregivers' Interpersonal Connection

  7 weeks (baseline, weeks 2, 4, and 6 post-intervention)

• Changes in Caregivers' Compassion for Self and Others

  7 weeks (baseline, weeks 2, 4, and 6 post-intervention)

Study Arms (1)

Arm 1

EXPERIMENTAL

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

Behavioral: Isha Kriya and Naddi Shuddhi

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.

Arm 1

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not 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.
• 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).

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Central Study Contacts

Somnath Bose, MD, MPH

CONTACT

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

Siddhartha R Janga

CONTACT

sjanga@bidmc.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: There is no masking in this study. All participants (caregiver-patient dyads) are aware of the intervention they are receiving (Inner Engineering practices, including Isha Kriya and Nadi Shuddhi)
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesia

Model Details: This is a single-group interventional study in which ICU survivor-caregiver dyads participate in Inner Engineering (IE) practices, including guided meditation (Isha Kriya) and a breathing technique (Nadi Shuddhi). All participants receive the same intervention, delivered via a mobile app or group sessions. The study assesses psychological well-being, relationship quality, and neurological effects using EEG recordings

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: March 10, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

US (1)