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

NCT07143357 | Recruiting DMC

• 2 other identifiers: 2025P0020635K23AT012487
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

emotional distress; cardiac arrest; cardiac arrest survivorship; caregivers; resilience; mindfulness; mind-body; behavioral interventions; anxiety; depression

Outcome Measures

Primary Outcomes (9)

• Feasibility of Recruitment

  Proportion of eligible dyads that consent to participation

  pre-test

• Feasibility of Randomization

  Proportion of randomized participants who submit post-test assessments

  The end of treatment at 6 weeks

• Feasibility of Assessment Completion

  Proportion of participants with no assessment measures missing at pre-test, post-test, and 3 month follow-up

  pre-test, the end of treatment at 6 weeks, and 3 months after the end of treatment

• Feasibility of Program Adherence (RT-CA 1)

  Proportion of RT-CA 1 dyads that initiate the program by attending session 1 and complete at least 4 of 6 sessions.

  the end of treatment at 6 weeks

• Therapist Fidelity

  Proportion of 20% randomly-selected RT-CA 1 sessions in which the therapist fully adheres to program content, ascertained by a fidelity checklist

  the end of treatment at 6 weeks

• Treatment Satisfaction (RT-CA 1)

  Proportion of RT-CA 1 participants that endorse satisfaction, defined as above the midpoint on the Client Satisfaction Questionnaire-3

  the end of treatment at 6 weeks

• Credibility (RT-CA 1)

  Proportion of RT-CA 1 participants that endorse program credibility at pre-test, defined as scoring above the midpoint on the Credibility sub scale of the Credibility/Expectancy Questionnaire

  pre-test

• Expectancy (RT-CA 1)

  Proportion of RT-CA 1 participants that endorse expectancy to improve. from the program at pre-test, defined as scoring above the midpoint on the Expectancy sub scale of the Credibility/Expectancy Questionnaire

  pre-test

• Study safety

  The proportion of participants that report no adverse events related to study participation.

  at the end of treatment at 6 weeks and 3 months after the end of treatment

Study Arms (2)

Recovering Together after Cardiac Arrest 1

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.

Behavioral: Recovering Together after Cardiac Arrest 1

Recovering Together after Cardiac Arrest 2

OTHER

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.

Other: Recovering Together after Cardiac Arrest 2

Interventions

Recovering Together after Cardiac Arrest 1 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 1

Recovering Together after Cardiac Arrest 2 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.

Recovering Together after Cardiac Arrest 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• survivor must score \>5 on Short Form of the Mini Mental State Exam for sufficient cognitive function for meaningful participation
• ability and willingness to participate in a hybrid in-person/live video intervention
• English speaking adults (18 year or older)
• 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).

You may not qualify if:

• active psychosis, mania, substance dependence, or suicidal intent or plan that would require a higher level of care
• any other psychiatric or neurological condition that would preclude meaningful participation
• the caregiver must not be a cardiac arrest survivor

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Heart Arrest; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Central Study Contacts

Alexander Presciutti, PhD

CONTACT

617-726-7913; apresciutti@mgh.harvard.edu

Sara Bogan, BA

CONTACT

617-724-1312; sbogan@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Member of the Faculty

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: August 27, 2025
• Study Start: October 17, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: October 23, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: IPD will be available from trial end through three years after the publication of all study results.
• Access Criteria: Individuals will be able to access the data after signing a data sharing agreement.

Locations

US (1)