24 Participants Needed

Psychosocial Support for Cardiomyopathy

HG
DR
Overseen ByDolores Reynolds, BSN
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Weill Medical College of Cornell University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

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 Takotsubo Support Group for cardiomyopathy?

Research on support groups for cardiac patients suggests they can help improve coping skills and life satisfaction, even if the changes aren't always measurable in studies. This implies that support groups might offer emotional benefits for people with cardiomyopathy as well.12345

Is psychosocial support for cardiomyopathy safe for humans?

The research does not provide specific safety data for psychosocial support in cardiomyopathy, but it suggests that patients with Takotsubo Cardiomyopathy (a type of heart condition) may benefit from psychotherapeutic support to help with mental health and stress, similar to those with myocardial infarction (heart attack).678910

How does psychosocial support differ from other treatments for cardiomyopathy?

Psychosocial support for cardiomyopathy is unique because it focuses on addressing the mental and emotional aspects of the condition, such as depression, anxiety, and stress, which are often linked to cardiomyopathy. Unlike traditional medical treatments that target the physical symptoms, this approach aims to improve overall well-being by helping patients develop coping strategies and resilience.611121314

What is the purpose of this trial?

The study hypothesis is that participants enrolled in a virtual Takotsubo support group will have significantly less anxiety at one year.

Research Team

Jim W. Cheung, M.D. | Patient Care

Jim Cheung, MD

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

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

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

Treatment Details

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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Takotsubo Support GroupExperimental Treatment1 Intervention
Participants diagnosed with Takotsubo Syndrome will be enrolled into the study.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials
1,103
Recruited
1,157,000+

Findings from Research

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.
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.
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]
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.
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]

References

Review of outcomes of cardiac support groups after cardiac events. [2011]
The Monitoring of Psychosocial Factors During Hospitalization Before and After Cardiac Surgery Until Discharge From Cardiac Rehabilitation: A Research Protocol. [2023]
Efficacy of a web-based intervention for improving psychosocial well-being in patients with implantable cardioverter-defibrillators: the randomized controlled ICD-FORUM trial. [2022]
The psychosocial effects of support group intervention on AICD recipients and their significant others. [2015]
A feasibility study of psychosocial group intervention for breast cancer patients with first recurrence. [2018]
Psychosocial and physical long-term outcome in patients with a history of takotsubo cardiomyopathy or myocardial infarction - a multi-centered case control study. [2021]
Women's experiences of Takotsubo cardiomyopathy in a short-term perspective--a qualitative content analysis. [2018]
Prevalence of cancer in Takotsubo cardiomyopathy: Short and long-term outcome. [2022]
Clinical Features and Outcomes of Patients With Malignancy and Takotsubo Syndrome: Observations From the International Takotsubo Registry. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Lack of efficacy of drug therapy in preventing takotsubo cardiomyopathy recurrence: a meta-analysis. [2021]
Psychological distress and personality factors in takotsubo cardiomyopathy. [2020]
12.United Statespubmed.ncbi.nlm.nih.gov
Four cases of takotsubo cardiomyopathy linked with exacerbations of psychiatric illness. [2021]
Psychological disorders in adults with inherited cardiomyopathies and Takotsubo syndrome. [2017]
Anxiodepressive disorders and chronic psychological stress are associated with Tako-Tsubo cardiomyopathy- New Physiopathological Hypothesis. [2022]
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