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

Mass General Brigham

Status: Enrolling

Conditions: Emotional Distress; Cardiac Arrest

Treatments: Behavioral: Recovering Together after Cardiac Arrest

Study type: Interventional

Funder types: Other

Identifiers

NCT06517394

2024P001877

Details and patient eligibility

About

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.

Full description

The goal of this study is to refine our proposed intervention Recovering Together after Cardiac Arrest (RT-CA) through an open pilot. The investigators will deliver an open pilot of the intervention (N=5 dyads; 10 participants total) to evaluate initial feasibility and acceptability using exit interviews and pre-post assessments.

The open pilot will take place at Massachusetts General Hospital intensive care units and step-down units. Study clinicians will deliver 6, 30 minute sessions of the intervention (at bedside or on Zoom/telephone, depending on participant preference and access). All participants will complete measures at baseline, and after completion of program (6 weeks). At the completion of the program, participants will engage in an exit interview where they will provide feedback of the intervention.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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. Score ≥4 on Short Form of the Mini Mental State Exam
3. Ability and willingness to participate in a hybrid in-person/live video or phone intervention
4. English speaking adults, 18 years or older
5. At least one member of the dyad endorses clinically significant emotional distress during screening (>7 on Hospital Anxiety and Depression Scale subscales)

Exclusion criteria

1. Active psychosis, mania, substance dependence, or suicidal intent or plan

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Recovering Together after Cardiac Arrest