Mind-body Resilience Program for Cardiac Arrest

(RT-CA Trial)

Overseen By Alexander Presciutti, PhD

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

84 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two programs designed to help cardiac arrest survivors and their primary caregivers build resilience. The programs, "Recovering Together after Cardiac Arrest 1" and "Recovering Together after Cardiac Arrest 2," aim to reduce emotional distress and provide support by teaching stress management skills related to cardiac arrest. The study involves two groups: one receives six 30-minute sessions with a psychologist, while the other attends a single session reviewing available resources. It seeks cardiac arrest survivors who have experienced emotional distress and have a supportive caregiver. As an unphased trial, this study offers participants a unique opportunity to contribute to innovative approaches in emotional recovery and support.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on resilience interventions for cardiac arrest survivors and their caregivers.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that resilience programs like "Recovering Together after Cardiac Arrest 1" and "Recovering Together after Cardiac Arrest 2" support emotional well-being after a cardiac arrest. These programs teach stress management skills and provide emotional support.

Specific data on the safety of these programs is unavailable because they differ from traditional medical treatments such as drugs or surgeries. However, psychological programs generally carry low risk. They primarily involve talking and learning coping strategies, which are typically safe and well-tolerated. No reports of serious side effects have emerged from these types of programs.

This study does not test a new drug or device, so concerns about physical side effects do not apply. The focus is on helping survivors and their caregivers manage emotional challenges, which is crucial for recovery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Mind-body Resilience Program for Cardiac Arrest because it offers a fresh approach to supporting cardiac arrest survivors and their caregivers by focusing on emotional and psychological well-being. Unlike standard care, which often centers on medical and physical recovery, this program includes two unique treatments. "Recovering Together after Cardiac Arrest 1" provides six skills-based sessions delivered by a clinical psychologist, aiming to equip participants with resiliency skills to manage stress and reduce emotional distress. Meanwhile, "Recovering Together after Cardiac Arrest 2" offers a single session focusing on available psychosocial resources, acting as a minimally enhanced usual care control. This emphasis on mental resilience is what sets these treatments apart and holds promise for preventing chronic distress in survivors and caregivers.

What evidence suggests that this trial's treatments could be effective for cardiac arrest survivors?

Research shows that mind-body resilience programs can help reduce emotional distress in cardiac arrest survivors and their caregivers. In this trial, participants will join one of two programs. The "Recovering Together after Cardiac Arrest 1" program builds resilience through practical sessions, drawing on similar successful programs. Early results suggest that learning these resilience skills can enhance emotional and mental well-being for both survivors and caregivers. The "Recovering Together after Cardiac Arrest 2" program serves as a minimally enhanced usual care control, offering a single session with a clinician to review available psychosocial resources. By focusing on stress management and mental health, these programs aim to prevent long-term distress. This approach acknowledges the significant emotional impact of cardiac arrest on survivors and their families. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for cardiac arrest survivors and their informal caregivers. It aims to help them manage emotional distress, depression, anxiety, and improve resilience through mind-body techniques.

Inclusion Criteria

I am willing and able to join both in-person and live video sessions.

I am 18 or older and speak English.

Out-of-hospital or in-hospital cardiac arrest survivor with documented loss of pulse and identified caregiver

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive resilience interventions through the Recovering Together after Cardiac Arrest programs, with RT-CA 1 involving six 30-minute weekly sessions and RT-CA 2 involving one 30-minute session.

6 weeks

6 visits (combination of in-person and virtual for RT-CA 1), 1 visit (in-person for RT-CA 2)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 6 weeks and 3 months post-treatment.

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Recovering Together after Cardiac Arrest 1
• Recovering Together after Cardiac Arrest 2

Trial Overview The study is testing two programs called 'Recovering Together after Cardiac Arrest 1' and 'Recovering Together after Cardiac Arrest 2'. These are pilot interventions designed to enhance the well-being of both survivors and caregivers.

How Is the Trial Designed?

Group I: Recovering Together after Cardiac Arrest 2 Experimental Treatment 1 Intervention

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.

Group II: Recovering Together after Cardiac Arrest 1 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+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S245186542400173X

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).

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9999209/

Family experiences and health outcomes following a loved ... Family members of adult cardiac arrest patients, both co-survivors and bereaved, reported significant uncertainty and persistent psychological ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0300957225003673

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- ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11937936/

Recovery Potential in Patients After Cardiac Arrest Who ... In 227 cases (15.9%; 95% CI, 14.0%-17.9%), all experts agreed that recovery potential was at least 1% if life-sustaining therapy had been ...

5. journals.sagepub.com journals.sagepub.com/doi/10.1177/1545968317697032

Long-term Outcome After Survival of a Cardiac Arrest Conclusions. Overall, long-term outcome in terms of activities, participation, and quality of life after cardiac arrest is reassuring.

6. cpr.heart.org cpr.heart.org/en/resources/cpr-facts-and-stats

CPR Facts and Stats The 2023 Heart Disease and Stroke Statistics state that among the over 356,000 OHCA that occurred, 40.2% received bystander CPR. Explore the 2023 Heart Disease ...

7. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK321499/

In-Hospital Cardiac Arrest and Post-Arrest Care - NCBI - NIH Additionally, post-arrest care focuses on providing a timely and accurate prognosis for neurologic recovery and managing multisystem organ failure. Studies have ...

8. ahajournals.org ahajournals.org/doi/10.1161/CIR.0000000000001163

Critical Care Management of Patients After Cardiac Arrest Identifying mechanisms of autoregulation failure, brain hypoxia, and inadequate brain perfusion or brain hyperemia and developing strategies to ...

9. massgeneral.org massgeneral.org/psychiatry/news/mental-health-after-cardiac-arrest

Improving Cardiac Arrest Survivorship: A Mental Health ... Most survivors did not anticipate experiencing non-cardiac symptoms, including executive function and attention deficits, memory problems ...

10. resuscitationjournal.com resuscitationjournal.com/article/S0300-9572(24)00089-3/fulltext

Improving Outcomes After Post–Cardiac Arrest Brain Injury First a heart attack, then a cardiac arrest. ... In summary, the reasons for failure to translate preclinical animal data into clinical results ...