Relationship, FamilyRESTORE-ICUNCT06867367
REducing pSychological diSTress To Optimize Recovery of Elderly ICU Survivors and Caregivers (RESTORE-ICU)
A study testing Isha Kriya and Naddi Shuddhi in people with Relationship, Family and Well-Being, Psychological, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Relationship, Family, Well-Being, Psychological
- What is being tested?
- Isha Kriya and Naddi Shuddhi
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- Provide signed and dated informed consent and understand the nature of the study sufficiently to allow completion of all study assessments.
- Caregivers who either live in the same household as the survivor or visit more than three times a week.
- Age ≥18 years old.
Who cannot join
- 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.
Show all 36Show fewer
- 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).
- Caregiver Inclusion/Exclusion Criteria
- 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 with limited internet access, which would prevent access to online guided meditation
- Prisoners.
- Individuals who refuse to participate in the study.
- Diagnosed with severe psychiatric disorders, such as schizophrenia, bipolar disorder, or ongoing substance abuse, that could interfere with participation.
- Individuals actively receiving treatment for recent trauma
- Scores ≥ 5 on either the anxiety or depression subscales suggesting severe symptom levels.
- severe or acute medical illness
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Siddhartha R Janga contact
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Somnath Bose, MD, MPH, [617] 754-2175, sbose2@bidmc.harvard.edu
About this study
Official title: REducing pSychological diSTress To Optimize Recovery of Elderly ICU Survivors and Caregivers (RESTORE-ICU): A Pilot Feasibility Study
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.
Read more
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.
Read the detailed description
Overview of the Study This study will evaluate the feasibility of implementing a mindfulness-based intervention, Inner Engineering (IE) practices, with concurrent EEG measurements among elderly ICU survivors aged 60 to 85 years and their caregivers. The intervention includes Isha Kriya and Nadi Shuddhi, two simple and accessible meditation practices delivered via a secure digital platform. The study aims to assess feasibility, acceptability, and barriers to implementation while testing paired EEG hyperscanning to explore neural congruency between participants. Conducted in two phases, the study will refine the research infrastructure and optimize the delivery of IE practices, first in the hospital setting and then remotely in home environments.
Overall Study Design This proof-of-concept pilot study utilizes an interventional, mixed-methods design combining experimental feasibility testing, EEG hyperscanning, and qualitative assessments. The study is divided into two phases: Phase 1 focuses on refining infrastructure for delivering IE and EEG monitoring in the hospital, while Phase 2 transitions to evaluating the feasibility of remote intervention delivery and monitoring in participants' homes.
Intervention 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. The study interventions will be introduced in-person for patients and either in-person or remotely for their caregivers. After the initial introduction, the interventions will be administered via the 3Cs app. This application has been used for meditation interventions and allows accurate tracking of usage metrics.
Nadi Shuddhi - a gentle 4-minute breathing practice for creating mental balance and relaxation, to be practiced for a minimum of 4 minutes daily.
https://www.youtube.com/watch?v=q5m6tMjcF8k
Isha Kriya - a 15-minute guided meditation that incorporates the breath and the awareness to create mental clarity and health, to be practiced at least once (ideally twice) daily. https://www.youtube.com/watch?v=EwQkfoKxRvo
Phase 1: Refining Hospital-Based Procedures Phase 1 focuses on establishing the research infrastructure within the hospital setting to optimize the implementation of Inner Engineering (IE) practices and EEG hyperscanning. Two ICU survivor-caregiver dyads will be recruited, with survivors defined as individuals aged 60-85 years who experienced an ICU stay of five or more days, and caregivers who self-identify as such and either live with or frequently visit the survivor. Baseline data collection will include high-fidelity EEG hyperscanning and psychological surveys. After learning and practicing IE, participants will complete another EEG hyperscanning data collection and post-intervention assessments. Semi-structured interviews will provide critical feedback on the intervention's acceptability and feasibility, helping to refine study processes for future phases.
Phase 2: Post-Discharge Implementation Phase 2 evaluates the feasibility of implementing IE practices after hospital discharge, focusing on participants' adherence to daily meditation practices. Five ICU survivor-caregiver dyads will be enrolled. At the hospital, baseline data collection will include EEG hyperscanning with the high-density R-Net system and psychological surveys. Participants will then learn the IE practices, with instructions to practice ideally twice or at least once daily. Post-intervention data will be collected afterwards, including EEG hyperscanning and surveys. After discharge to home, participants will be instructed to practice surveys will be completed at weeks 2, 4, and 6. At the end of week 6, a semi-structured interview will gather feedback on the intervention's feasibility, acceptability, and barriers to enrollment or retention.
- Conditions
- Relationship, Family, Well-Being, Psychological
- Being tested
- Isha Kriya and Naddi Shuddhi
- Keywords
- mental health, relationship quality, ICU recovery
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isha Kriya and Naddi ShuddhiBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Isha Kriya and Naddi Shuddhi |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Adherence to the Inner Engineering (IE) Intervention
Adherence will be assessed based on the number of IE sessions each participant completes.
Measured: 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.
Measured: 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.
Measured: 7 weeks (from baseline assessment to post-intervention follow-up)
Secondary outcomes (6)
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.
Measured: 7 weeks (baseline, weeks 2, 4, and 6 post-intervention)
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.
Measured: 7 weeks (baseline, weeks 2, 4, and 6 post-intervention)
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.
Measured: 7 weeks (baseline, weeks 2, 4, and 6 post-intervention)
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.
Measured: 7 weeks (baseline, weeks 2, 4, and 6 post-intervention)
Changes in Caregivers' Compassion for Self and Others
Caregiver's compassion for self and others will be assessed using the Compassion for Self and Others Scale (CS). The total score involves reverse scoring indicated items and calculating the mean score (between 1 to 5). Higher scores indicate greater compassion for self and others.
Measured: 7 weeks (baseline, weeks 2, 4, and 6 post-intervention)
Changes in Relationship Quality
Relationship quality between caregivers and patients between patients and caregivers will be assessed using the Dyadic Relationship Scale (DRS). The DRS includes two subscales: dyadic strain and positive dyadic interaction, which are measured using a four-option response scale (1 to 4). Higher scores on both subscales indicate higher levels of dyadic strain or positive dyadic interaction, respectively.
Measured: 7 weeks (baseline, weeks 2, 4, and 6 post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study startDec 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relationship, FamilyStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Somnath Bose, MD, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06867367
- Sponsor's protocol ID
- 2024P000984
- Acronym
- RESTORE-ICU
- Status last verified
- Jul 2026
- First submitted
- 26 Feb 2025
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REducing pSychological diSTress To Optimize Recovery of Elderly ICU Survivors and Caregivers (RESTORE-ICU): A Pilot Feasibility Study
- ClinicalTrials.gov ID
- NCT06867367
- Acronym / sponsor ID
- RESTORE-ICU / 2024P000984
- Conditions
- Relationship, Family, Well-Being, Psychological
- Keywords
- mental health, relationship quality, ICU recovery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 10 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Overview of the Study This study will evaluate the feasibility of implementing a mindfulness-based intervention, Inner Engineering (IE) practices, with concurrent EEG measurements among elderly ICU survivors aged 60 to 85 years and their caregivers. The intervention includes Isha Kriya and Nadi Shuddhi, two simple and accessible meditation practices delivered via a secure digital platform. The study aims to assess feasibility, acceptability, and barriers to implementation while testing paired EEG hyperscanning to explore neural congruency between participants. Conducted in two phases, the study will refine the research infrastructure and optimize the delivery of IE practices, first in the hospital setting and then remotely in home environments.
Overall Study Design This proof-of-concept pilot study utilizes an interventional, mixed-methods design combining experimental feasibility testing, EEG hyperscanning, and qualitative assessments. The study is divided into two phases: Phase 1 focuses on refining infrastructure for delivering IE and EEG monitoring in the hospital, while Phase 2 transitions to evaluating the feasibility of remote intervention delivery and monitoring in participants' homes.
Intervention 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. The study interventions will be introduced in-person for patients and either in-person or remotely for their caregivers. After the initial introduction, the interventions will be administered via the 3Cs app. This application has been used for meditation interventions and allows accurate tracking of usage metrics.
Nadi Shuddhi - a gentle 4-minute breathing practice for creating mental balance and relaxation, to be practiced for a minimum of 4 minutes daily.
https://www.youtube.com/watch?v=q5m6tMjcF8k
Isha Kriya - a 15-minute guided meditation that incorporates the breath and the awareness to create mental clarity and health, to be practiced at least once (ideally twice) daily. https://www.youtube.com/watch?v=EwQkfoKxRvo
Phase 1: Refining Hospital-Based Procedures Phase 1 focuses on establishing the research infrastructure within the hospital setting to optimize the implementation of Inner Engineering (IE) practices and EEG hyperscanning. Two ICU survivor-caregiver dyads will be recruited, with survivors defined as individuals aged 60-85 years who experienced an ICU stay of five or more days, and caregivers who self-identify as such and either live with or frequently visit the survivor. Baseline data collection will include high-fidelity EEG hyperscanning and psychological surveys. After learning and practicing IE, participants will complete another EEG hyperscanning data collection and post-intervention assessments. Semi-structured interviews will provide critical feedback on the intervention's acceptability and feasibility, helping to refine study processes for future phases.
Phase 2: Post-Discharge Implementation Phase 2 evaluates the feasibility of implementing IE practices after hospital discharge, focusing on participants' adherence to daily meditation practices. Five ICU survivor-caregiver dyads will be enrolled. At the hospital, baseline data collection will include EEG hyperscanning with the high-density R-Net system and psychological surveys. Participants will then learn the IE practices, with instructions to practice ideally twice or at least once daily. Post-intervention data will be collected afterwards, including EEG hyperscanning and surveys. After discharge to home, participants will be instructed to practice surveys will be completed at weeks 2, 4, and 6. At the end of week 6, a semi-structured interview will gather feedback on the intervention's feasibility, acceptability, and barriers to enrollment or retention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Behavioral: Isha Kriya and Naddi ShuddhiThis 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- Provide signed and dated informed consent and understand the nature of the study sufficiently to allow completion of all study assessments.
- Caregivers who either live in the same household as the survivor or visit more than three times a week.
Key exclusion criteria (36 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isha Kriya and Naddi ShuddhiIsha 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. | Behavioural | Arm 1 |
Primary outcome
Participant Adherence to the Inner Engineering (IE) Intervention
Time frame: 7 weeks (from baseline assessment to post-intervention follow-up)
Adherence will be assessed based on the number of IE sessions each participant completes.
Participant Engagement with the Inner Engineering (IE) Intervention
Time frame: 7 weeks (from baseline assessment to post-intervention follow-up)
Engagement will be measured by the frequency of practice logged in the mobile app, indicating participant involvement in the intervention.
Study Retention Rate
Time frame: 7 weeks (from baseline assessment to post-intervention follow-up)
Retention will be assessed by tracking the percentage of participants who complete the full study period, including all study assessments.
6 secondary outcomes
Changes in Perceived Stress
Time frame: 7 weeks (baseline, weeks 2, 4, and 6 post-intervention)
Changes in Psychological distress related to traumatic events
Time frame: 7 weeks (baseline, weeks 2, 4, and 6 post-intervention)
Changes in Anxiety and Depressive symptoms
Time frame: 7 weeks (baseline, weeks 2, 4, and 6 post-intervention)
Changes in Caregivers' Interpersonal Connection
Time frame: 7 weeks (baseline, weeks 2, 4, and 6 post-intervention)
Changes in Caregivers' Compassion for Self and Others
Time frame: 7 weeks (baseline, weeks 2, 4, and 6 post-intervention)
Changes in Relationship Quality
Time frame: 7 weeks (baseline, weeks 2, 4, and 6 post-intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Siddhartha R Janga contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isha Kriya and Naddi Shuddhi in people with Relationship, Family and Well-Being, Psychological, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Somnath Bose, MD, MPH ([617] 754-2175, sbose2@bidmc.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Adherence to the Inner Engineering (IE) Intervention (time frame: 7 weeks (from baseline assessment to post-intervention follow-up)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.