Emotional DistressNCT06517394
Open Pilot Trial of a Mind-body Program for Cardiac Arrest Survivors and Their Caregivers
A study testing Recovering Together after Cardiac Arrest in people with Emotional Distress and Cardiac Arrest, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The purpose of this study is to pilot a mind-body intervention for cardiac arrest survivors and their informal caregivers, Recovering Together after Cardiac Arrest. The data the investigators gather in this study will be used to further refine our intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emotional Distress, Cardiac Arrest
- What is being tested?
- Recovering Together after Cardiac Arrest
- 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
- 1 Aug 2024to 16 Apr 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Out-of-hospital or in-hospital CA survivor (must have new diagnosis of "cardiac arrest" in electronic medical record from index hospitalization with documented loss of pulse) with an identified caregiver (identified by the survivor who is their primary source of emotional and functional support)
- Score ≥4 on Short Form of the Mini Mental State Exam
- Ability and willingness to participate in a hybrid in-person/live video or phone intervention
- English speaking adults, 18 years or older
- At least one member of the dyad endorses clinically significant emotional distress during screening (>7 on Hospital Anxiety and Depression Scale subscales)
Who cannot join
- 1. Active psychosis, mania, substance dependence, or suicidal intent or plan
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Open Pilot Trial of a Dyadic Mind-body Program for Cardiac Arrest Survivors and Their Caregivers: Recovering Together After Cardiac Arrest
The purpose of this study is to pilot a mind-body intervention for cardiac arrest survivors and their informal caregivers, Recovering Together after Cardiac Arrest. The data the investigators gather in this study will be used to further refine our intervention.
Read the detailed description
The goal of this study is to refine our proposed intervention Recovering Together after Cardiac Arrest (RT-CA) through an open pilot. The investigators will deliver an open pilot of the intervention (N=5 dyads; 10 participants total) to evaluate initial feasibility and acceptability using exit interviews and pre-post assessments.
The open pilot will take place at Massachusetts General Hospital intensive care units and step-down units. Study clinicians will deliver 6, 30 minute sessions of the intervention (at bedside or on Zoom/telephone, depending on participant preference and access). All participants will complete measures at baseline, and after completion of program (6 weeks). At the completion of the program, participants will engage in an exit interview where they will provide feedback of the intervention.
- Conditions
- Emotional Distress, Cardiac Arrest
- Being tested
- Recovering Together after Cardiac Arrest
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recovering Together after Cardiac ArrestBehavioural
The intervention will teach resiliency skills (mindfulness, coping, etc.) to dyads and provider anticipatory guidance and resources to manage stressors specific to cardiac arrest. These sessions will take place in person or on Zoom/telephone, depending on the participant's preference and access to technology.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Dyads will participate in 6 30-minute skills-based sessions. Sessions will also include provision of anticipatory guidance and and resources to manage cardiac arrest-specific stressors. A clinical psychologist will deliver all of the sessions. The main intervention goal is to provide dyads with resiliency skills and resources to reduce emotional distress and prevent chronic distress. Receives: Behavioral: Recovering Together after Cardiac Arrest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Feasibility Assessed by the Number of Eligible Dyads Enrolled
Proportion of eligible CA survivor-caregiver dyads that enroll in the intervention amongst those who screen in to the study.
Measured: 0 weeks
Assessment Feasibility Assessed by the Number of Participants With no Measures Missing on All Self-report Questionnaires.
Assessment feasibility was assessed by the number of individual participants (not dyads) that have no measures missing on all self-report questionnaires.
Measured: Pre-test (0 weeks) to post-test (6 weeks)
Adherence Feasibility Assessed by the Number of CA Survivor-caregiver Dyads Who Begin the Intervention and Complete at Least 4 of 6 Intervention Sessions.
Adherence feasibility was assessed by the number of CA survivor-caregiver dyads who begin the intervention and adhere to it by completing at least 4 of 6 intervention sessions.
Measured: Pre-test (0 weeks) to post-test (6 weeks)
Therapist Fidelity Assessed by the Proportion of 9 Randomly Selected Sessions in Which the Study Clinician Delivered Fully Delivered All Key Session Content.
Number of sessions in which the therapist adhered 100% to the treatment manual. The study coordinator listened to 9 random RT-CA sessions, and, using a checklist, identified whether the study clinician fully adhered to the content of each session by delivering each key ingredient of the session.
Measured: Pre-test (0 weeks) to post-test (6 weeks)
Number of Participants With Client Satisfaction Score Greater Than the Midpoint (7.5).
The proportion of participants that scored above the midpoint on the Client Satisfaction Questionnaire-3 (CSQ-3), which assesses satisfaction with a program. Total scores range from 3-12 (midpoint 7.5); higher scores indicate greater satisfaction.
Measured: Post-test (6 weeks)
Credibility and Expectancy Assessed by the Number of Individuals That Score Above the Midpoint on Each Sub-scale of the Credibility and Expectancy Questionnaire
Number of individuals that score above the midpoint on each sub-scale of the Credibility and Expectancy Questionnaire (CEQ). Through two subscales, the CEQ assesses participants' perceptions that a program is logical (credible) and their expectancy that participation would lead to improvements (expectancy). Scores on the credibility subscale range from 3-27 (midpoint 15) and scores on the expectancy factor range from 3-31 (midpoint 17); higher scores on each indicate greater credibility and expectancy.
Measured: Pre-test (0 weeks)
Secondary outcomes (12)
Mean Change in the Hospital Depression and Anxiety Scale Total Score.
Assesses emotional distress in medical patients; total scale ranges from 0-42, higher scores represent worse distress. A negative mean change in the total score means emotional distress improved.
Measured: Pre-test (0 weeks), Post-Test (6 weeks)
Mean Change in Post-Traumatic Stress Disorder Checklist - 5 Total Score.
20-item questionnaire that measures post-traumatic stress disorder symptoms. Scores range from 0 to 80, with higher scores indicating greater severity and intensity of symptoms. A negative change in the total score represents improvement in symptoms.
Measured: Pre-test (0 weeks), Post-Test (6 weeks)
Mean Change in The Cognitive and Affective Mindfulness Scale-Revised Total Score
Measures dispositional mindfulness, total scores range from 12-48, higher values reflect higher levels of mindfulness. A positive mean change in the total score reflected increased dispositional mindfulness.
Measured: Pre-test (0 weeks), Post-Test (6 weeks)
Mean Change in Enhancing Recovery in Coronary Heart Disease Social Support Inventory Total Score
7-item measure that assesses perceived social support. Higher scores indicate greater social support. Total scores range from 8 to 34. A positive mean change in the total score indicates increases in perceived social support.
Measured: Pre-test (0 weeks), Post-Test (6 weeks)
Mean Change in Measure of Current Status Part A (MOCS-A) Average Score.
Assesses ability to engage in a series of healthy coping skills (e.g., relaxation, social support, adaptive thinking). Higher scores indicate a stronger ability to recognize stress and cope. Scores are averaged and range from 0-4. A positive change in the MOCS-A average score indicates improvements in coping.
Measured: Pre-test (0 weeks), Post-Test (6 weeks)
Mean Change in the World Health Organization Quality of Life-Brief Sub Scale Scores
26-item measure assessing quality of life across four domains: physical health, psychological health, social relationships, and environment. Higher scores indicate higher quality of life for all domains. Scores in each domain range from 4 to 20. Scores were assessed at pre- and post-test; a positive mean change score in each domain indicates improved quality f life.
Measured: Pre-test (0 weeks), Post-Test (6 weeks)
Mean Change in Dyadic Relationship Scale Sub Scales
Questionnaire that assesses perceptions of dyadic interactions from both members of the relationship. The caregiver version is 11 items and the patient version is 10 items. Scores are calculated for two subscales: dyadic strain (scores range from 0-15) and positive interactions (scores range from 0-18). Lower scores on the dyadic strain subscale and greater scores on the positive interactions subscale indicate fewer relationship stressors and more positive aspects of the relationship.
Measured: Pre-test (0 weeks), Post-Test (6 weeks)
Mean Change in Dyadic Coping Inventory Sub Scales
Measures perceived quality of dyad's communication and proficiency in using adaptive dyadic coping skills. Subscales are summed for a total subscale score. Higher scores indicate greater quality communication and/or coping.
Stress communicated by oneself measures how well stress is communicated by oneself to their partner Range 4-20.
Stress communicated by one's partner Measures how well one's partner communicates about their stress. Range 4-20.
Supportive coping provided by one's partner Measures the quality of emotional and/or problem-focused support provided by one's partner Range 5-25.
Negative dyadic coping by one's partner Measures the degree that one's partner uses hostile, ambivalent, and superficial actions/words that have deleterious intentions. Range 4-20.
Joint or common coping Measures the degree to which dyads work together to manage stress.Range 5-25.
Evaluation of dyadic coping Measures perception of the quality of the dyad's approach to coping.Range 2-10.
Measured: Pre-test (0 weeks), Post-Test (6 weeks)
Mean Change in Applied Mindfulness Scale Total Score.
15-item questionnaire measuring how participants use mindfulness when facing stressors. Scores range from 0 to 60 with higher scores indicating greater use of mindfulness practices.
Measured: Pre-test (0 weeks), Post-Test (6 weeks)
Mean Change in Preparedness for Caregiving Scale Total Score
For caregivers, this scale measures caregiver preparedness to care for survivor. In this study, for survivor participants, we adapted the language to measure preparedness to care for oneself. Scores range from 0 to 32 Higher scores indicate greater perceived readiness for caregiving (for caregivers) or for survivorship (for survivors).
Measured: Pre-test (0 weeks), Post-Test (6 weeks)
Mean Change in Meaning in Life Questionnaire Sub Scales
10 items measuring presence of meaning and purpose in life. Assesses two dimensions: presence and search. Items are rated on a 7-point scale from 1 (Absolutely Untrue) to 7 (Absolutely True). Both presence of meaning and search for meaning subscale scores range from 5-35. Higher scores indicate greater presence and search.
Measured: Pre-test (0 weeks), Post-Test (6 weeks)
Gratitude Questionnaire Six Item Form
Measures participant's gratitude disposition. Each item is rated on a 7-point Likert scale. Scores range from 6 to 42. Higher scores indicate a more grateful disposition.
Measured: Pre-test (0 weeks), Post-Test (6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start1 Aug 2024
- Primary completion9 Apr 2025
- Study completion16 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Emotional DistressStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Presciutti, Massachusetts General Hospital
- Investigators
- Alexander M Presciutti, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06517394
- Sponsor's protocol ID
- 2024P001877
- Status last verified
- Oct 2025
- First submitted
- 18 Jul 2024
- Last updated
- 5 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Presciutti AM, La Camera D, Perman SM, Elmer J, Donnino MW, Wu O, Parker RA, Vranceanu AM. Single-arm feasibility trial of a resilience intervention for cardiac arrest survivors and their family caregivers, Recovering Together after Cardiac Arrest. Resuscitation. 2025 Nov;216:110855. doi: 10.1016/j.resuscitation.2025.110855. Epub 2025 Oct 6.
PubMed 41062056
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Pilot Trial of a Dyadic Mind-body Program for Cardiac Arrest Survivors and Their Caregivers: Recovering Together After Cardiac Arrest
- ClinicalTrials.gov ID
- NCT06517394
- Acronym / sponsor ID
- 2024P001877
- Conditions
- Emotional Distress, Cardiac Arrest
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 9 Apr 2025 (actual)
- Study completion
- 16 Apr 2025 (actual)
- First posted
- 24 Jul 2024 (actual)
- Results
- Posted 5 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to pilot a mind-body intervention for cardiac arrest survivors and their informal caregivers, Recovering Together after Cardiac Arrest. The data the investigators gather in this study will be used to further refine our intervention.
Detailed description
The goal of this study is to refine our proposed intervention Recovering Together after Cardiac Arrest (RT-CA) through an open pilot. The investigators will deliver an open pilot of the intervention (N=5 dyads; 10 participants total) to evaluate initial feasibility and acceptability using exit interviews and pre-post assessments.
The open pilot will take place at Massachusetts General Hospital intensive care units and step-down units. Study clinicians will deliver 6, 30 minute sessions of the intervention (at bedside or on Zoom/telephone, depending on participant preference and access). All participants will complete measures at baseline, and after completion of program (6 weeks). At the completion of the program, participants will engage in an exit interview where they will provide feedback of the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Recovering Together after Cardiac ArrestDyads will participate in 6 30-minute skills-based sessions. Sessions will also include provision of anticipatory guidance and and resources to manage cardiac arrest-specific stressors. A clinical psychologist will deliver all of the sessions. The main intervention goal is to provide dyads with resiliency skills and resources to reduce emotional distress and prevent chronic distress. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Out-of-hospital or in-hospital CA survivor (must have new diagnosis of "cardiac arrest" in electronic medical record from index hospitalization with documented loss of pulse) with an identified caregiver (identified by the survivor who is their primary source of emotional and functional support)
- Score ≥4 on Short Form of the Mini Mental State Exam
- Ability and willingness to participate in a hybrid in-person/live video or phone intervention
- English speaking adults, 18 years or older
- At least one member of the dyad endorses clinically significant emotional distress during screening (>7 on Hospital Anxiety and Depression Scale subscales)
Key exclusion criteria (1 listed)
- 1. Active psychosis, mania, substance dependence, or suicidal intent or plan
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 |
|---|---|---|
| Recovering Together after Cardiac ArrestThe intervention will teach resiliency skills (mindfulness, coping, etc.) to dyads and provider anticipatory guidance and resources to manage stressors specific to cardiac arrest. These sessions will take place in person or on Zoom/telephone, depending on the participant's preference and access to technology. | Behavioural | Intervention |
Primary outcome
Recruitment Feasibility Assessed by the Number of Eligible Dyads Enrolled
Time frame: 0 weeks
Proportion of eligible CA survivor-caregiver dyads that enroll in the intervention amongst those who screen in to the study.
Assessment Feasibility Assessed by the Number of Participants With no Measures Missing on All Self-report Questionnaires.
Time frame: Pre-test (0 weeks) to post-test (6 weeks)
Assessment feasibility was assessed by the number of individual participants (not dyads) that have no measures missing on all self-report questionnaires.
Adherence Feasibility Assessed by the Number of CA Survivor-caregiver Dyads Who Begin the Intervention and Complete at Least 4 of 6 Intervention Sessions.
Time frame: Pre-test (0 weeks) to post-test (6 weeks)
Adherence feasibility was assessed by the number of CA survivor-caregiver dyads who begin the intervention and adhere to it by completing at least 4 of 6 intervention sessions.
Therapist Fidelity Assessed by the Proportion of 9 Randomly Selected Sessions in Which the Study Clinician Delivered Fully Delivered All Key Session Content.
Time frame: Pre-test (0 weeks) to post-test (6 weeks)
Number of sessions in which the therapist adhered 100% to the treatment manual. The study coordinator listened to 9 random RT-CA sessions, and, using a checklist, identified whether the study clinician fully adhered to the content of each session by delivering each key ingredient of the session.
Number of Participants With Client Satisfaction Score Greater Than the Midpoint (7.5).
Time frame: Post-test (6 weeks)
The proportion of participants that scored above the midpoint on the Client Satisfaction Questionnaire-3 (CSQ-3), which assesses satisfaction with a program. Total scores range from 3-12 (midpoint 7.5); higher scores indicate greater satisfaction.
Credibility and Expectancy Assessed by the Number of Individuals That Score Above the Midpoint on Each Sub-scale of the Credibility and Expectancy Questionnaire
Time frame: Pre-test (0 weeks)
Number of individuals that score above the midpoint on each sub-scale of the Credibility and Expectancy Questionnaire (CEQ). Through two subscales, the CEQ assesses participants' perceptions that a program is logical (credible) and their expectancy that participation would lead to improvements (expectancy). Scores on the credibility subscale range from 3-27 (midpoint 15) and scores on the expectancy factor range from 3-31 (midpoint 17); higher scores on each indicate greater credibility and expectancy.
12 secondary outcomes
Mean Change in the Hospital Depression and Anxiety Scale Total Score.
Time frame: Pre-test (0 weeks), Post-Test (6 weeks)
Mean Change in Post-Traumatic Stress Disorder Checklist - 5 Total Score.
Time frame: Pre-test (0 weeks), Post-Test (6 weeks)
Mean Change in The Cognitive and Affective Mindfulness Scale-Revised Total Score
Time frame: Pre-test (0 weeks), Post-Test (6 weeks)
Mean Change in Enhancing Recovery in Coronary Heart Disease Social Support Inventory Total Score
Time frame: Pre-test (0 weeks), Post-Test (6 weeks)
Mean Change in Measure of Current Status Part A (MOCS-A) Average Score.
Time frame: Pre-test (0 weeks), Post-Test (6 weeks)
Mean Change in the World Health Organization Quality of Life-Brief Sub Scale Scores
Time frame: Pre-test (0 weeks), Post-Test (6 weeks)
Mean Change in Dyadic Relationship Scale Sub Scales
Time frame: Pre-test (0 weeks), Post-Test (6 weeks)
Mean Change in Dyadic Coping Inventory Sub Scales
Time frame: Pre-test (0 weeks), Post-Test (6 weeks)
Mean Change in Applied Mindfulness Scale Total Score.
Time frame: Pre-test (0 weeks), Post-Test (6 weeks)
Mean Change in Preparedness for Caregiving Scale Total Score
Time frame: Pre-test (0 weeks), Post-Test (6 weeks)
Mean Change in Meaning in Life Questionnaire Sub Scales
Time frame: Pre-test (0 weeks), Post-Test (6 weeks)
Gratitude Questionnaire Six Item Form
Time frame: Pre-test (0 weeks), Post-Test (6 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41062056Presciutti AM, La Camera D, Perman SM, Elmer J, Donnino MW, Wu O, Parker RA, Vranceanu AM. Single-arm feasibility trial of a resilience intervention for cardiac arrest survivors and their family caregivers, Recovering Together after Cardiac Arrest. Resuscitation. 2025 Nov;216:110855. doi: 10.1016/j.resuscitation.2025.110855. Epub 2025 Oct 6.
- Individual participant dataSharing planned: No
Related trials for Emotional Distress
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruitingObservational study
Development and Multicenter Validation of an Explainable System for Neonatal ARDS-Compatible Phenotyping
Acute Respiratory Distress Syndrome
RecruitingObservational study
Assessment of Blood Viscosity in ARDS (Acute Respiratory Distress Syndrome)
ARDS
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
Recruiting
The Trans-Led Care Study
Substance Abuse, Substance Addiction
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. This study is not recruiting at the moment.
Alexander M Presciutti, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recovering Together after Cardiac Arrest in people with Emotional Distress and Cardiac Arrest, run by Massachusetts General Hospital 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 5 inclusion and 1 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: finished, as of the sponsor's last update on 5 Nov 2025. 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?
Yes. Results are posted in the registry (first posted 5 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Feasibility Assessed by the Number of Eligible Dyads Enrolled (time frame: 0 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06517394, which also lists 1 linked publication.
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 5 Nov 2025.