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

Not Applicable

Not yet recruiting

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

• Registration Number: NCT07143357
• Lead Sponsor: Massachusetts General Hospital

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.

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-05
• Study First Submitted QC: 2025-08-19
• Last Update Submitted: 2025-08-19
• Study First Posted: 2025-08-27
• Last Update Posted: 2025-08-27
• Study Start: 2025-09-01
• Primary Completion: 2028-06
• Study Completion: 2028-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 84

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Credibility (RT-CA 1)	pre-test	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
Expectancy (RT-CA 1)	pre-test	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
Study safety	at the end of treatment at 6 weeks and 3 months after the end of treatment	The proportion of participants that report no adverse events related to study participation.
Feasibility of Recruitment	pre-test	Proportion of eligible dyads that consent to participation
Feasibility of Randomization	The end of treatment at 6 weeks	Proportion of randomized participants who submit post-test assessments
Feasibility of Assessment Completion	pre-test, the end of treatment at 6 weeks, and 3 months after the end of treatment	Proportion of participants with no assessment measures missing at pre-test, post-test, and 3 month follow-up
Feasibility of Program Adherence (RT-CA 1)	the end of treatment at 6 weeks	Proportion of RT-CA 1 dyads that initiate the program by attending session 1 and complete at least 4 of 6 sessions.
Therapist Fidelity	the end of treatment at 6 weeks	Proportion of 20% randomly-selected RT-CA 1 sessions in which the therapist fully adheres to program content, ascertained by a fidelity checklist
Treatment Satisfaction (RT-CA 1)	the end of treatment at 6 weeks	Proportion of RT-CA 1 participants that endorse satisfaction, defined as above the midpoint on the Client Satisfaction Questionnaire-3

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States