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

NCT06517394 | Completed Results DMC

• 1 other identifier: 2024P001877
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Emotional Distress; Cardiac Arrest

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (12)

• Mean Change in the Hospital Depression and Anxiety Scale Total Score.

  Pre-test (0 weeks), Post-Test (6 weeks)

• Mean Change in Post-Traumatic Stress Disorder Checklist - 5 Total Score.

  Pre-test (0 weeks), Post-Test (6 weeks)

• Mean Change in The Cognitive and Affective Mindfulness Scale-Revised Total Score

  Pre-test (0 weeks), Post-Test (6 weeks)

• Mean Change in Enhancing Recovery in Coronary Heart Disease Social Support Inventory Total Score

  Pre-test (0 weeks), Post-Test (6 weeks)

• Mean Change in Measure of Current Status Part A (MOCS-A) Average Score.

  Pre-test (0 weeks), Post-Test (6 weeks)

Study Arms (1)

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.

Behavioral: Recovering Together after Cardiac Arrest

Interventions

Recovering Together after Cardiac Arrest 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.

Intervention

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)
• 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)

You may not qualify if:

• \. Active psychosis, mania, substance dependence, or suicidal intent or plan

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• 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.

  PMID: 41062056 DERIVED

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Principal investigator
• Organization: Center for Health Outcomes and Interdisciplinary Research, Massachusetts General Hospital

apresciutti@mgh.harvard.edu

6177267913

Study Officials

• Alexander M Presciutti, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: July 24, 2024
• Study Start: August 1, 2024
• Primary Completion: April 9, 2025
• Study Completion: April 16, 2025
• Last Updated: November 5, 2025
• Results First Posted: November 5, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)