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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorBeth Israel Deaconess Medical Center

About 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 accepts healthy volunteers

Qualifiers

None

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

14 Participants
are divided into 1 treatment group
Group A: Arm 1Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Participant Adherence to the Inner Engineering (IE) Intervention

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

Time frame
7 weeks (from baseline assessment to post-intervention follow-up)
2

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.

Time frame
7 weeks (from baseline assessment to post-intervention follow-up)
3

Study Retention Rate

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

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

Secondary outcomes

1

Changes in Perceived Stress

Changes in perceived stress will be assessed using the Perceived Stress Scale (PSS) to measure perceived stress levels. The PSS ranges from 0 to 40, with higher scores indicating higher levels of perceived stress.

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

Changes in Psychological distress related to traumatic events

Changes in Psychological distress related to traumatic events will be assessed using the Impact of Event Scale-Revised (IES-R). The IES-R ranges from 0 to 88, with higher scores indicating greater levels of distress related to traumatic events.

Time frame
7 weeks (baseline, weeks 2, 4, and 6 post-intervention)
3

Changes in Anxiety and Depressive symptoms

Changes in anxiety and depressive symptoms will be assessed using the Patient Health Questionnaire-4 (PHQ-4). The PHQ-4 ranges from 0 to 12, with higher scores indicating higher levels of depressive symptoms and anxiety.

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

Changes in Caregivers' Interpersonal Connection

Caregivers' Interpersonal connection will be assessed using the Interpersonal Mindfulness Scale (IMS). The IMS total score involves reverse scoring indicated items and calculating the mean score (between 1 to 5). Higher scores indicate greater mindfulness and interpersonal connection.

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

Other outcomes

Sponsors and contacts

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