Menu
Recruiting NCT07143357

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

No phase Interventional Emotional Distress Cardiac Arrest (CA) Anxiety Depression

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Recovering Together after Cardiac Arrest 1, Recovering Together after Cardiac Arrest 2.
Who it may be relevant to
Registry conditions: Emotional Distress, Cardiac Arrest (CA), Anxiety, Depression. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Development of a Dyadic Mind-body Program for Cardiac Arrest Survivors and Their Caregivers: Recovering Together After Cardiac Arrest (RT-CA).

Overview

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.

Interventions

  • Behavioral 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.
  • Other 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.

Primary outcome measures

  • Feasibility of Recruitment [Time frame: pre-test]
  • Feasibility of Randomization [Time frame: The end of treatment at 6 weeks]
  • Feasibility of Assessment Completion [Time frame: pre-test, the end of treatment at 6 weeks, and 3 months after the end of treatment]
  • Feasibility of Program Adherence (RT-CA 1) [Time frame: the end of treatment at 6 weeks]
  • Therapist Fidelity [Time frame: the end of treatment at 6 weeks]
  • Treatment Satisfaction (RT-CA 1) [Time frame: the end of treatment at 6 weeks]
  • Credibility (RT-CA 1) [Time frame: pre-test]
  • Expectancy (RT-CA 1) [Time frame: pre-test]
  • Study safety [Time frame: at the end of treatment at 6 weeks and 3 months after the end of treatment]

Eligibility criteria

Inclusion criteria

  • 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).

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Massachusetts General Hospital — Boston

Identifiers

NCT: NCT07143357 · 2025P002063 · 5K23AT012487

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗