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

10 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Recovering Together after Cardiac Arrest for cardiac arrest survivors?

Research shows that rehabilitation programs focusing on physical, psychological, and social recovery can help cardiac arrest survivors manage ongoing challenges and improve their quality of life. Programs like SCARF, which address fatigue and psychological consequences, have shown promising results in aiding recovery. ^{1 2 3 4 5}

Is the mind-body program for cardiac arrest survivors safe?

The research articles provided do not contain specific safety data for the mind-body program for cardiac arrest survivors or similar programs under different names. They focus on the experiences and challenges of cardiac arrest survivors, but do not address the safety of the mind-body program. ^{5 6 7 8 9}

How is the 'Recovering Together after Cardiac Arrest' treatment different from other treatments for cardiac arrest survivors?

The 'Recovering Together after Cardiac Arrest' treatment is unique because it focuses on a mind-body approach, addressing both psychological and social aspects of recovery, which are often overlooked in traditional medical treatments. This program likely emphasizes the importance of mental health and family support in the recovery process, which is not typically the focus of standard cardiac arrest treatments. ^{2 4 5 10 11}

What is the purpose of this trial?

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.

Research Team

Alexander M Presciutti, PhD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Effectiveness of rehabilitation interventions on the secondary consequences of surviving a cardiac arrest: a systematic review and meta-analysis. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Longitudinal recovery following sudden cardiac arrest and internal cardioverter defibrillator implantation: survivors and their families. [2007]

3. Ireland 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. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Psychological Distress After Sudden Cardiac Arrest and Its Impact on Recovery. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Getting better or getting by?: A qualitative study of in-hospital cardiac arrest survivors long-term recovery experiences. [2022]

6. England 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). [2021]

7. England pubmed.ncbi.nlm.nih.gov

A comprehensive description of self-reported health and life satisfaction in cardiac arrest survivors. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Surviving Sudden Cardiac Arrest: A Pilot Qualitative Survey Study of Survivors. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Qualitative Study of Long-Term Cardiac Arrest Survivors' Challenges and Recommendations for Improving Survivorship. [2023]

10. England 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. [2019]

11. Ireland pubmed.ncbi.nlm.nih.gov

Life after cardiac arrest: A very long term follow up. [2015]