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NCT Number: NCT07143357

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

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.

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Key information

Conditions

Emotional Distress Anxiety Anxiety Disorders Behavior Behavioral Symptoms Cardiac Arrest (CA) Cardiovascular Diseases Caregivers Depression Heart Arrest Heart Diseases Mental Disorders Mindfulness Resilience Survivorship

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location status: Recruiting

Location contact

Alexander Presciutti, PhD

CONTACT

[email protected]

617-726-7913

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 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.

Primary outcomes

  1. Feasibility of Recruitment

    Time frame: pre-test

    Proportion of eligible dyads that consent to participation

  2. Feasibility of Randomization

    Time frame: The end of treatment at 6 weeks

    Proportion of randomized participants who submit post-test assessments

  3. Feasibility of Assessment Completion

    Time frame: 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

  4. Feasibility of Program Adherence (RT-CA 1)

    Time frame: 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.

  5. Therapist Fidelity

    Time frame: 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

  6. Treatment Satisfaction (RT-CA 1)

    Time frame: 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

  7. Credibility (RT-CA 1)

    Time frame: 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

  8. Expectancy (RT-CA 1)

    Time frame: 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

  9. Study safety

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alexander Presciutti, PhD

CONTACT

[email protected]

617-726-7913

Sara Bogan, BA

CONTACT

[email protected]

617-724-1312

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

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

Acronym: RT-CA

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Aug 27, 2025
Registry last updated
Oct 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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