Open Pilot Trial of a Mind-body Program for Cardiac Arrest Survivors and Their Caregivers

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Arrest; Emotional Distress
• Intervention / Treatment: Behavioral: Recovering Together after Cardiac Arrest

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 Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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)
2. Score ≥4 on Short Form of the Mini Mental State Exam
3. Ability and willingness to participate in a hybrid in-person/live video or phone intervention
4. English speaking adults, 18 years or older
5. At least one member of the dyad endorses clinically significant emotional distress during screening (>7 on Hospital Anxiety and Depression Scale subscales)

Exclusion Criteria:

1. Active psychosis, mania, substance dependence, or suicidal intent or plan

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention; 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.

Behavioral: Recovering Together after Cardiac Arrest; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	Pre-test (0 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Pre-test (0 weeks), Post-Test (6 weeks)
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.	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.	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.	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.	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.	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.	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.	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.	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.	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).	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.	Pre-test (0 weeks), Post-Test (6 weeks)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Barthel Index	A 10-item ordinal scale that measures functional independence in the domains of personal care and mobility. Specifically, it measures self-care, transfers and locomotion.	Pre-test (0 weeks), Post-Test (6 weeks)
Modified Rankin Scale	Assesses degree of disability after a neurological injury on a scale of 0 to 6. Higher scores indicate greater disability.	Pre-test (0 weeks), Post-Test (6 weeks)
Telephone Interview for Cognitive Status 40	Cognitive screening assessment administered over the phone. Lower scores indicate greater cognitive impairment.	Pre-test (0 weeks), Post-Test (6 weeks)
Cerebral Performance Category Scale	Assesses cardiac arrest patient's post-arrest neurologic functioning. The scale ranges from 1 to 5. 1 indicate good cerebral performance and 5 indicate brain death.	Pre-test (0 weeks), Post-Test (6 weeks)

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Alexander M Presciutti, PhD, Massachusetts General Hospital

Publications and helpful links

General Publications

• Presciutti AM, 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 Oct 6:110855. doi: 10.1016/j.resuscitation.2025.110855. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Actual): April 9, 2025
• Study Completion (Actual): April 16, 2025

Study Registration Dates

• First Submitted: July 18, 2024
• First Submitted That Met QC Criteria: July 18, 2024
• First Posted (Actual): July 24, 2024

Study Record Updates

• Last Update Posted (Estimated): November 5, 2025
• Last Update Submitted That Met QC Criteria: October 21, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Arrest
• Other Study ID Numbers: 2024P001877

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No