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

NCT ID: NCT06517394

Last Updated: 2025-11-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2025-04-16

Brief 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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Recovering Together after Cardiac Arrest

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Alexander Presciutti

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alexander M Presciutti, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 41062056 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2024P001877

Identifier Type: -

Identifier Source: org_study_id