Psychosocial Support for Cardiomyopathy

Overseen By Dolores Reynolds, BSN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Psychotherapy, Prisoners, Non-English, Pregnant, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether joining a virtual support group can reduce anxiety in people with Takotsubo Syndrome, a temporary heart condition often triggered by stress. The focus is on determining if participation in this group decreases anxiety after one year. The trial seeks individuals diagnosed with Takotsubo Syndrome who are not currently receiving psychotherapy. As an unphased trial, it offers a unique opportunity to contribute to understanding the benefits of virtual support groups for anxiety reduction.

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 support group is safe for participants with Takotsubo Syndrome?

Research has shown that support groups can help people with Takotsubo Syndrome, also known as stress-induced cardiomyopathy or broken heart syndrome. These groups offer a space to share experiences and learn from one another. Since this support doesn't involve medication or medical procedures, safety concerns are minimal.

Participants often feel less anxious and enjoy a sense of community, typically without experiencing negative effects. As support groups don't involve surgery or medical treatments, they are considered very safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Takotsubo Support Group because it's a fresh approach to managing Takotsubo Syndrome, also known as "broken heart syndrome." Unlike traditional treatments that focus on medications like beta-blockers or ACE inhibitors, this group offers psychosocial support, which can help address the emotional and psychological stressors often linked to this condition. By fostering a supportive community environment, participants may experience improved emotional resilience and potentially quicker recovery times. This approach highlights the importance of mental health in cardiomyopathy management, offering a holistic alternative to purely medical treatments.

What evidence suggests that the Takotsubo Support Group might be effective for reducing anxiety in cardiomyopathy patients?

Research shows that support groups can help people with Takotsubo Syndrome, also known as "broken heart syndrome." This condition affects the heart's ability to pump effectively. In this trial, participants will join a Takotsubo Support Group to share experiences and advice, which can benefit emotional health. While specific data on reducing anxiety is lacking, sharing feelings in a group often lowers stress. Medications like beta-blockers have not been proven to prevent Takotsubo, but emotional and social support play a crucial role in managing it. Joining a support group might help reduce anxiety and improve the overall quality of life for those affected. ^{1 6 7 8 9}

Who Is on the Research Team?

Jim Cheung, MD

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a confirmed diagnosis of Takotsubo Syndrome, which is a type of heart condition. It's not open to those already in psychotherapy, non-English speakers, prisoners, pregnant women, or anyone unable to consent.

Exclusion Criteria

Vulnerable populations such as prisoners, non-English speaking subjects, pregnant women, and subjects unable to provide written informed consent will not be included in this research.

I have Takotsubo Syndrome and am either in psychotherapy or choose not to participate.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are enrolled in a virtual Takotsubo support group to receive psychosocial support

12 months

Virtual group sessions

Follow-up

Participants are monitored for changes in anxiety, quality of life, and depression

12 months

Virtual assessments at baseline and one year

What Are the Treatments Tested in This Trial?

Interventions

• Takotsubo Support Group

Trial Overview

The trial is testing if joining a virtual support group can reduce anxiety among people with Takotsubo Syndrome after one year compared to those who don't participate in the group.

How Is the Trial Designed?

Group I: Takotsubo Support Group Experimental Treatment 1 Intervention

Participants diagnosed with Takotsubo Syndrome will be enrolled into the study.

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Published Research Related to This Trial

A randomized controlled trial involving 118 patients with implantable cardioverter-defibrillators (ICDs) found that a web-based intervention (WBI) significantly improved aspects of psychosocial well-being, such as depression and anxiety, compared to usual care over a year.

While the primary outcome measuring heart-focused fear, depression, and mental quality of life showed no significant difference between groups at 6 weeks, the WBI demonstrated benefits in specific areas like self-management and social support mobilization, indicating its potential as a valuable treatment option for ICD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a web-based intervention for improving psychosocial well-being in patients with implantable cardioverter-defibrillators: the randomized controlled ICD-FORUM trial. Schulz, SM., Ritter, O., Zniva, R., et al.[2022]

Psychological disorders, particularly anxiety and depression, are prevalent among adults with Takotsubo syndrome and various inherited cardiomyopathies, with anxiety rates ranging from 26% to 56% in Takotsubo syndrome and 50% in dilated cardiomyopathy.

In hypertrophic cardiomyopathy, nearly half of the patients reported that emotional stress triggered physical symptoms like chest pain and dyspnea, highlighting the significant impact of psychological factors on their condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological disorders in adults with inherited cardiomyopathies and Takotsubo syndrome. Suárez Bagnasco, M., Núñez-Gil, IJ.[2017]

A 6-week psychosocial group intervention for Japanese women with recurrent breast cancer showed short-term improvements in quality of life, particularly in mood and body image, as measured by various scales.

The study involved 28 consenting patients, with final evaluations conducted on 19 subjects, indicating that while the intervention had positive effects at 3 months, the small sample size limits the conclusiveness of the results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A feasibility study of psychosocial group intervention for breast cancer patients with first recurrence. Chujo, M., Mikami, I., Takashima, S., et al.[2018]

Cardiac support groups may help improve adjustment and quality of life after cardiac events, but the evidence from four reviewed studies shows that most outcomes were not statistically significantly better than control groups.

There is a clear psychosocial need for support among patients post-cardiac events, highlighting the importance of stress management and social support, but more research is necessary to identify effective support group formats and measurable outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of outcomes of cardiac support groups after cardiac events. Song, Y., Lindquist, R., Windenburg, D., et al.[2011]

This study aims to gather comprehensive psychosocial data from cardiac surgery patients at different stages of their hospitalization, including admission, rehabilitation, and discharge, to better understand their psychological needs.

By identifying key psychosocial factors such as anxiety, depression, and social support, the research seeks to inform tailored interventions that could improve patient outcomes during critical moments of cardiac care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Monitoring of Psychosocial Factors During Hospitalization Before and After Cardiac Surgery Until Discharge From Cardiac Rehabilitation: A Research Protocol. Callus, E., Pagliuca, S., Bertoldo, EG., et al.[2023]

In a study of 45 patients with Tako-tsubo cardiomyopathy (TTC), 78% were found to have anxiodepressive disorders (ADD), significantly higher than the 26% in a control group of 50 patients with acute coronary syndrome (ACS).

The study also revealed that chronic psychological stress (CPS) was present in 44% of TTC patients compared to 18% in ACS patients, suggesting that psychological factors may play a significant role in the development of TTC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anxiodepressive disorders and chronic psychological stress are associated with Tako-Tsubo cardiomyopathy- New Physiopathological Hypothesis. Delmas, C., Lairez, O., Mulin, E., et al.[2022]

A study involving 14 women who experienced Takotsubo cardiomyopathy revealed that their journey involved a complex process of understanding and adapting to their symptoms, which often mimicked those of a heart attack.

The findings suggest that these women need more comprehensive education and support from healthcare professionals to effectively manage their condition, indicating a need for longer follow-up and holistic care approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Women's experiences of Takotsubo cardiomyopathy in a short-term perspective--a qualitative content analysis. Dahlviken, RM., Fridlund, B., Mathisen, L.[2018]

In a pilot study involving 26 participants (11 AICD recipients and 10 spouses), support group interventions did not show significant changes in quantitative measures of anxiety or health, suggesting limited efficacy in those areas.

Qualitative feedback indicated that participants in the support groups reported better coping skills and increased life satisfaction, although it was unclear if these improvements were due to the support groups or simply the passage of time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The psychosocial effects of support group intervention on AICD recipients and their significant others. Molchany, CA., Peterson, KA.[2015]

A study comparing 68 patients with Takotsubo Cardiomyopathy (TTC) to 68 patients with myocardial infarctions (MI) found that both groups experienced significant long-term negative impacts on mental health, including higher levels of depression, anxiety, and chronic stress, as well as lower quality of life scores compared to normative values.

The research indicates that stressful life events prior to the onset of TTC or MI significantly affect long-term mental health outcomes, suggesting that both conditions should be taken seriously and may benefit from psychotherapeutic support alongside medical care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychosocial and physical long-term outcome in patients with a history of takotsubo cardiomyopathy or myocardial infarction - a multi-centered case control study. Olliges, E., Burgdorf, C., Ladwig, KH., et al.[2021]

This study presents four cases of Takotsubo cardiomyopathy in women aged 53-67, where the condition was linked to exacerbations of pre-existing psychiatric illnesses rather than acute stress events, suggesting a new understanding of its triggers.

Patients showed improvement in heart function within 1 to 3 weeks after diagnosis with supportive care, highlighting the potential for recovery and the need for awareness among healthcare providers regarding the connection between psychiatric conditions and Takotsubo cardiomyopathy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Four cases of takotsubo cardiomyopathy linked with exacerbations of psychiatric illness. Corrigan, FE., Kimmel, MC., Jayaram, G.[2021]

In a study of 1604 patients with takotsubo syndrome (TTS), 16.6% had a history of malignancy, which was associated with older age and a higher likelihood of physical triggers for TTS, but fewer emotional triggers.

Patients with malignancy experienced significantly higher long-term mortality compared to those without malignancy, indicating that a history of cancer may be an important factor to consider in the management and screening of TTS patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Features and Outcomes of Patients With Malignancy and Takotsubo Syndrome: Observations From the International Takotsubo Registry. Cammann, VL., Sarcon, A., Ding, KJ., et al.[2021]

In a study of 114 patients with Takotsubo Cardiomyopathy (TTC), 14% had a pre-existing cancer diagnosis, and an additional 11 patients were diagnosed with cancer during a follow-up period of 4.2 years, indicating a high prevalence of malignancies in TTC patients.

Cancer diagnosis was linked to a higher rate of adverse outcomes, including increased overall mortality and reduced event-free survival, suggesting that screening for cancer should be a routine part of the evaluation for patients presenting with TTC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence of cancer in Takotsubo cardiomyopathy: Short and long-term outcome. Sattler, K., El-Battrawy, I., Lang, S., et al.[2022]

In a meta-analysis of 511 patients, only 4.5% experienced recurrences of takotsubo cardiomyopathy (TTC), indicating that while recurrences are relatively rare, the effectiveness of drug therapy in preventing them is unclear.

The analysis found no significant evidence that common medications like β-blockers, ACE inhibitors, statins, or aspirin effectively reduce the risk of TTC recurrences, suggesting a need for more robust randomized studies to explore this issue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lack of efficacy of drug therapy in preventing takotsubo cardiomyopathy recurrence: a meta-analysis. Santoro, F., Ieva, R., Musaico, F., et al.[2021]

Patients with Takotsubo cardiomyopathy (TCC) exhibit significantly higher levels of depressive symptoms and illness-related anxiety compared to healthy controls, indicating a strong psychological component to the condition.

The study found that TCC patients had lower levels of openness as a personality trait compared to healthy individuals, suggesting that certain personality factors may be linked to the development of TCC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological distress and personality factors in takotsubo cardiomyopathy. Smeijers, L., Szabó, BM., Kop, WJ.[2020]

Citations

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takotsubo.net

takotsubo.net/people-with-takotsubo/takotsubo-support-group/

Takotsubo Support Group

A support group was launched on Facebook that enables people who have had a diagnosis of TTS to share experiences and knowledge with others.

2.

nejm.org

nejm.org/doi/full/10.1056/NEJMoa1406761

Clinical Features and Outcomes of Takotsubo (Stress) ...

... Outcomes of Takotsubo (Stress) Cardiomyopathy ... These data suggest that beta-blockers are not effective in preventing takotsubo cardiomyopathy.

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10978169/

Smidt Heart Institute Takotsubo Registry – Study design ...

The Takotsubo Registry is a retrospective and prospective observational registry of individuals with a prior history of TTS.

4.

ahajournals.org

ahajournals.org/doi/10.1161/JAHA.124.037219

High Mortality and Complications in Patients Admitted With ...

Takotsubo cardiomyopathy is associated with high mortality and complications with no improvement in outcome over the 5-year study with higher mortality in men.

5.

acc.org

acc.org/latest-in-cardiology/articles/2024/12/01/42/cover-story-takotsubo-syndrome-expanding-insights-unanswered-questions

Cover Story | Takotsubo Syndrome: Expanding Insights, ...

TTS, also known as takotsubo cardiomyopathy, stress cardiomyopathy and "broken heart syndrome," is a reversible form of left ventricular (LV) dysfunction.

6.

cardiomyopathy.org

cardiomyopathy.org/takotsubo-online

Takotsubo Online Support Group

Join us for this online support group for those affected by Takotsubo. People with Takotsubo as well as their loved ones are welcome.

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8733363/

Takotsubo Syndrome: A Review of Presentation, Diagnosis ...

Takotsubo Syndrome (TTS) is a condition of transient left ventricular dysfunction that is typically triggered by emotional or physical stress.

8.

ijcva.org

ijcva.org/articles/current-clinical-perspectives-on-takotsubo-syndrome-comprehensive-analysis-of-diagnosis-management-and-pathophysiology/ijca.2024.63825

Current Clinical Perspectives on Takotsubo Syndrome

Takotsubo syndrome (TTS), commonly referred to as stress-induced cardiomyopathy or broken heart syndrome, is a disorder characterized by acute left ventricular ...

9.

sciencedirect.com

sciencedirect.com/science/article/pii/S2352906722000392

Update of Takotsubo cardiomyopathy: Present experience ...

This article aims to review the current situation of TTS, briefly summarize pathophysiological mechanisms, discuss various risk factors, propose a diagnostic ...