Mind-body Program for Cardiac Arrest Survivors

Overseen By Danielle La Camera, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Psychosis, Mania, Substance dependence, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

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. ^{1 2 3 4 5}

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. ^{1 4 6 7 8}

Who Is on the Research Team?

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.

Exclusion Criteria

Active psychosis

Substance dependence

Mania

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?

Group I: Intervention Experimental Treatment 1 Intervention

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.

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological Distress After Sudden Cardiac Arrest and Its Impact on Recovery. Agarwal, S., Birk, JL., Abukhadra, SL., et al.[2023]

The DANCAS survey aims to assess the long-term physical and psychological issues faced by out-of-hospital cardiac arrest (OHCA) survivors and their relatives, using a comprehensive set of validated questionnaires to gather data from survivors identified through the Danish Cardiac Arrest Registry.

By analyzing the survey results, the study seeks to identify predictors of these issues and unmet rehabilitation needs, which will help inform future rehabilitation interventions for OHCA survivors and their families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term physical and psychological outcomes after out-of-hospital cardiac arrest-protocol for a national cross-sectional survey of survivors and their relatives (the DANCAS survey). Joshi, VL., Tang, LH., Borregaard, B., et al.[2021]

A study of 212 cardiac arrest survivors showed that, six months post-resuscitation, they reported generally high levels of health and life satisfaction, with median scores indicating good overall well-being.

Despite the positive general health outcomes, many survivors experienced specific health issues, such as tiredness, pain, and anxiety, highlighting the need for detailed assessments of individual symptoms rather than relying solely on composite health scores.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comprehensive description of self-reported health and life satisfaction in cardiac arrest survivors. Hellström, P., Årestedt, K., Israelsson, J.[2021]

A pilot survey of 196 sudden cardiac arrest survivors and their family members revealed key themes about their experiences, including the importance of sharing experiences and the need to establish a 'new normal' after the event.

Family members expressed concerns about memory loss in their loved ones and a lack of information provided at discharge, highlighting the need for better communication and support for both survivors and their families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surviving Sudden Cardiac Arrest: A Pilot Qualitative Survey Study of Survivors. Sawyer, KN., Brown, F., Christensen, R., et al.[2022]

This systematic review included 14 studies with a total of 721 participants and aimed to evaluate the effectiveness of rehabilitation interventions for adult survivors of cardiac arrest, focusing on health-related quality of life (HRQoL) and neurological function.

The review found low-quality evidence indicating that rehabilitation interventions had no significant effect on physical or mental HRQoL, but suggested potential improvements in neurological function for survivors with acquired brain injury, highlighting the need for further high-quality research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of rehabilitation interventions on the secondary consequences of surviving a cardiac arrest: a systematic review and meta-analysis. Joshi, VL., Christensen, J., Lejsgaard, E., et al.[2021]

A study involving semi-structured interviews with 19 survivors of in-hospital cardiac arrest (IHCA) revealed that these individuals face ongoing recovery challenges and often need to redefine their independence to re-engage in social and physical activities.

The findings emphasize the importance of personalized intervention programs and follow-up care that address the long-term, holistic needs of IHCA survivors, including physical, cognitive, psychological, and social goals beyond just the immediate effects of the cardiac event.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Getting better or getting by?: A qualitative study of in-hospital cardiac arrest survivors long-term recovery experiences. Harrod, M., Kamphuis, LA., Hauschildt, K., et al.[2022]

Survivors of cardiac arrest often feel unprepared for the challenges they face after recovery due to a lack of resources, education, and clear expectations about their recovery process, as identified through interviews with 15 survivors.

To improve the recovery experience, recommendations include enhancing systemic support (like better education for healthcare providers), fostering social connections (such as peer support groups), and encouraging individual coping strategies (like acceptance and seeking treatment).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Qualitative Study of Long-Term Cardiac Arrest Survivors' Challenges and Recommendations for Improving Survivorship. Presciutti, A., Siry-Bove, B., Newman, MM., et al.[2023]

The SCARF intervention, aimed at addressing fatigue and psychological effects after cardiac arrest, showed high participant retention (87.5%) and satisfaction, indicating its feasibility for future studies.

After 3 months, participants reported small to moderate improvements in fatigue, quality of life, anxiety, and physical capacity, suggesting that SCARF may effectively enhance recovery outcomes post-cardiac arrest.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promising results from a residential rehabilitation intervention focused on fatigue and the secondary psychological and physical consequences of cardiac arrest: The SCARF feasibility study. Joshi, VL., Tang, LH., Kim, YJ., et al.[2022]

The ALASCA trial is designed to evaluate a new early intervention service for cardiac arrest survivors and their caregivers, focusing on cognitive screening and support, with participants followed for one year to assess quality of life and societal participation.

This randomized controlled trial will provide crucial evidence on the effectiveness and cost-effectiveness of the intervention, addressing a significant gap in rehabilitation programs for cardiac arrest survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Activity and Life After Survival of a Cardiac Arrest (ALASCA) and the effectiveness of an early intervention service: design of a randomised controlled trial. Moulaert, VR., Verbunt, JA., van Heugten, CM., et al.[2019]

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