Recruiting

Recovering Together

Sponsor:

Massachusetts General Hospital

Code:

NCT07143357

Conditions

Emotional Distress

Cardiac Arrest (CA)

Anxiety

Depression

Caregivers

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Recovering Together after Cardiac Arrest 1

Recovering Together after Cardiac Arrest 2

Study Details

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.

Conditions

Emotional Distress

Cardiac Arrest (CA)

Anxiety

Depression

Caregivers

Study ID

NCT07143357

Start date

Oct 17, 2025

Status verified date

Oct, 2025

Completion date

Jul, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

84 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Recovering Together after Cardiac Arrest 1

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.

other: Recovering Together after Cardiac Arrest 2

Recovering Together after Cardiac Arrest is a minimally enhanced usual care control. Dyads will participate in one 30-minute session with a clinician reviewing available psychosocial resources for cardiac arrest survivors and their caregivers.

Interventions

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.

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 measure

  • 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 ]

Central Contacts and Locations

Central contacts

Alexander Presciutti, PhD

617-726-7913apresciutti@mgh.harvard.edu

Sara Bogan, BA

617-724-1312sbogan@mgh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Alexander Presciutti, PhD

617-726-7913apresciutti@mgh.harvard.edu

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Oct 23, 2025

Last verified

Oct, 2025

Keywords

  • emotional distress
  • cardiac arrest
  • cardiac arrest survivorship
  • caregivers
  • resilience
  • mindfulness
  • mind-body
  • behavioral interventions
  • anxiety
  • depression

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2025-10-23.