Mind-body Resilience Program for Cardiac Arrest Survivors and Their Caregivers: Recovering Together After Cardiac Arrest

NCT ID: NCT07143357

Last Updated: 2025-10-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-17
• Study Completion Date: 2028-07-31

Brief Summary

The purpose of this study is to pilot two resilience interventions for cardiac arrest survivors and their informal caregivers, Recovering Together after Cardiac Arrest 1 and Recovering Together after Cardiac Arrest 2 . The data the investigators gather in this study will be used to further refine the interventions.

Detailed Description

The goal of this study is to test the feasibility of our proposed interventions through a pilot RCT. The investigators will deliver the RCT intervention (N=42 dyads; 84 participants total) and evaluate feasibility and acceptability based on a priori benchmarks.

The RCT will initially take place at Massachusetts General Hospital intensive care units and step-down units. Cardiac arrest survivor-caregiver dyads will be randomly assigned to one of two groups - Recovering Together after Cardiac Arrest 1 (RT-CA 1) or Recovering Together after Cardiac Arrest 2 (RT-CA 2).

RT-CA 1 involves six, 30-minute weekly sessions beginning at bedside and continuing over Zoom after the survivor is discharged. RT-CA 2 involves one, 30 minute session at bedside.

All participants will complete psychosocial survey measures at baseline, six weeks, and 3 months.

Conditions

Emotional Distress; Cardiac Arrest (CA); Anxiety; Depression; Caregivers; Survivorship; Resilience; Mindfulness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Recovering Together after Cardiac Arrest 1

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 1

Intervention Type: BEHAVIORAL

The intervention will teach resiliency skills (mindfulness and coping) to dyads and provider anticipatory guidance and resources to manage stressors specific to cardiac arrest. These sessions will take place in person until the survivor is discharged; remaining sessions will occur over Zoom.

Recovering Together after Cardiac Arrest 2

Recovering Together after Cardiac Arrest is a minimally enhanced usual care control. Dyads will participate in one 30-minute session with a clinician reviewing available psychosocial resources for cardiac arrest survivors and their caregivers.

Group Type: OTHER

Recovering Together after Cardiac Arrest 2

Intervention Type: OTHER

In this minimally enhanced usual care control, dyads will participate in one 30-minute session with a clinician at beside to review a pamphlet of available psychosocial resources for cardiac arrest survivors and their caregivers.

Interventions

Recovering Together after Cardiac Arrest 1

The intervention will teach resiliency skills (mindfulness and coping) to dyads and provider anticipatory guidance and resources to manage stressors specific to cardiac arrest. These sessions will take place in person until the survivor is discharged; remaining sessions will occur over Zoom.

Intervention Type: BEHAVIORAL

Recovering Together after Cardiac Arrest 2

In this minimally enhanced usual care control, dyads will participate in one 30-minute session with a clinician at beside to review a pamphlet of available psychosocial resources for cardiac arrest survivors and their caregivers.

Intervention Type: OTHER

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. survivor must score >5 on Short Form of the Mini Mental State Exam for sufficient cognitive function for meaningful participation

3. ability and willingness to participate in a hybrid in-person/live video intervention

4. English speaking adults (18 year or older)

5. at least one member of the dyad endorses clinically significant emotional distress during screening (>7 on either of the Hospital Anxiety and Depression Scale subscales).

Exclusion Criteria

1. active psychosis, mania, substance dependence, or suicidal intent or plan that would require a higher level of care

2. any other psychiatric or neurological condition that would preclude meaningful participation

3. the caregiver must not be a cardiac arrest survivor

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

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Alexander Presciutti

Member of the Faculty

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Alexander Presciutti, PhD

Role: CONTACT

apresciutti@mgh.harvard.edu

617-726-7913

Sara Bogan, BA

Role: CONTACT

sbogan@mgh.harvard.edu

617-724-1312

Facility Contacts

Alexander Presciutti, PhD

Role: primary

apresciutti@mgh.harvard.edu

617-726-7913

Other Identifiers

5K23AT012487

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2025P002063

Identifier Type: -

Identifier Source: org_study_id