Mind-body Program for Cardiac Arrest Survivors

AM
DL
Overseen ByDanielle La Camera, BA
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Massachusetts General Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mind-body program designed for cardiac arrest survivors and their primary caregivers. The program, "Recovering Together after Cardiac Arrest," includes six sessions with a psychologist to reduce stress and build resilience. It suits survivors who have lost a pulse and have emotional and practical support. Participants should experience significant emotional distress and be able to attend sessions in person or virtually. As an unphased trial, this study offers a unique opportunity to explore innovative support methods for emotional recovery.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this mind-body program is safe for cardiac arrest survivors?

Research shows that the "Recovering Together after Cardiac Arrest" program helps cardiac arrest survivors and their caregivers build resilience and manage stress more effectively. Studies have found that this program teaches skills and provides resources to reduce emotional distress.

Participants have reported positive experiences, noting the program's ease of use. Earlier studies have not reported any major negative effects. Sessions led by a clinical psychologist ensure a controlled and supportive environment for all involved.

In summary, based on available data, the program appears safe and well-tolerated, with no major safety concerns identified in previous research.12345

Why are researchers excited about this trial?

Researchers are excited about the "Recovering Together after Cardiac Arrest" program because it offers a fresh approach to supporting cardiac arrest survivors. Unlike traditional treatments, which often focus on medications or physical rehabilitation, this program emphasizes mental and emotional recovery through mind-body techniques. Delivered by a clinical psychologist, it provides dyads—pairs of individuals, such as a survivor and their partner—with resiliency skills and resources to manage stress specific to cardiac arrest. This approach aims to reduce emotional distress and prevent it from becoming chronic, a novel focus compared to standard medical treatments.

What evidence suggests that this mind-body program is effective for cardiac arrest survivors?

Research shows that the "Recovering Together after Cardiac Arrest" program, which participants in this trial will undergo, helps cardiac arrest survivors and their caregivers build resilience. This program addresses both mind and body to reduce the emotional stress that often follows such a traumatic event. Studies have found that similar programs can lower stress and improve mental health by teaching coping strategies. Although specific data on this program's effectiveness is limited, it employs proven stress management methods. The aim is to support both survivors and caregivers in overcoming challenges, potentially leading to better overall well-being.14678

Who Is on the Research Team?

AM

Alexander M Presciutti, PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for cardiac arrest survivors with a new diagnosis, who have someone to support them emotionally and functionally. Participants must be adults able to communicate in English, willing to join a mind-body program either in person or via video/phone, and show signs of emotional distress. Both the survivor and caregiver can join.

Inclusion Criteria

Out-of-hospital or in-hospital CA survivor with a new diagnosis of 'cardiac arrest' in electronic medical record from index hospitalization with documented loss of pulse and an identified caregiver
Score ≥4 on Short Form of the Mini Mental State Exam
I am willing and able to join sessions either in person or via video/phone.
See 1 more

Exclusion Criteria

Active psychosis
Substance dependence
Mania
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 6, 30-minute skills-based sessions focusing on resiliency skills and resources to manage cardiac arrest-specific stressors

6 weeks
6 sessions (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including exit interviews and feedback collection

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Recovering Together after Cardiac Arrest
Trial Overview The study tests 'Recovering Together after Cardiac Arrest,' a mind-body intervention designed for those who've survived cardiac arrests and their caregivers. It aims to refine the program based on participants' experiences during this initial pilot phase.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials
3,066
Recruited
13,430,000+

Published Research Related to This Trial

Out of 104 individuals who survived cardiac arrest, only 14 were available for follow-up, and among those, 8 participated, showing that long-term survival after cardiac arrest is rare, with a median follow-up time of 17 years.
Participants exhibited cognitive impairments, as indicated by low scores on cognitive tests, despite reporting overall contentment with their life situation and quality of life, suggesting that cardiac arrest may lead to lasting cognitive challenges.
Life after cardiac arrest: A very long term follow up.Andersson, AE., Rosén, H., Sunnerhagen, KS.[2015]
Survivors of sudden cardiac arrest experienced high levels of anxiety, depression, and confusion immediately after hospital discharge, but these symptoms generally decreased over the year, although denial remained consistently high.
Family adjustment and coping strategies were initially strong but declined over the year, with spouses reporting lower satisfaction and fewer coping strategies compared to survivors, highlighting the need for targeted support for both survivors and their families.
Longitudinal recovery following sudden cardiac arrest and internal cardioverter defibrillator implantation: survivors and their families.Dougherty, CM.[2007]
Survivors of sudden cardiac arrest often experience significant psychological distress, including depression, anxiety, and posttraumatic stress, which can lead to increased monitoring of heart-related symptoms and behavioral avoidance.
This heightened anxiety and avoidance behavior may contribute to a greater risk of secondary cardiovascular disease and negatively impact the survivors' quality of life, highlighting the need for targeted psychological interventions, as current clinical guidelines do not address these issues.
Psychological Distress After Sudden Cardiac Arrest and Its Impact on Recovery.Agarwal, S., Birk, JL., Abukhadra, SL., et al.[2023]

Citations

A mind-body resilience intervention for emotional distress ...We developed Recovering Together after Cardiac Arrest (RT-CA), an intervention to increase resiliency in CA survivor-caregiver dyads (pairs).
Mind-body Resilience Program for Cardiac Arrest Survivors ...The purpose of this study is to pilot two resilience interventions for cardiac arrest survivors and their informal caregivers, Recovering Together after ...
3.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/41062056/
Single-arm feasibility trial of a resilience intervention for ...Single-arm feasibility trial of a resilience intervention for cardiac arrest survivors and their family caregivers, Recovering Together after Cardiac Arrest.
Sudden Cardiac Arrest Survivorship: A Scientific Statement ...Survival to hospital discharge after IHCA is 25.8% (≈53 922 individuals per year). These survival rates have increased over time, partly from ...
Long-term Outcome After Survival of a Cardiac ArrestAt 1 year, 14 (13%) survivors scored below cutoff on the Cog-log. Both anxiety and depression were present in 16 (15%) survivors, 29 (28%) ...
6.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/39866903/
A mind-body resilience intervention for emotional distress in ...We developed Recovering Together after Cardiac Arrest (RT-CA), an intervention to increase resiliency in CA survivor-caregiver dyads (pairs).
Single-arm feasibility trial of a resilience intervention for ...To address this, we adapted a resilience intervention for survivors and their caregivers, entitled Recovering Together after Cardiac Arrest (RT- ...
Duration of cardiopulmonary resuscitation and outcomes ...The probabilities decreased over time and were <1% for survival at 39 minutes and <1% for favorable functional outcome at 32 minutes' duration ...
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