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Psychosocial Support for Patients With Takotsubo Syndrome

ConditionTakotsubo Cardiomyopathy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWeill Medical College of Cornell University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Patients with a diagnosis of Takotsubo Syndrome already undergoing Psychotherapy or those who choose not to participate.

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Takotsubo Support Group

    Behavioral

    Participants will undergo virtual group therapy/education. Participants will meet once every other week (at minimum), for 1 - 1.5 hours (on average). The frequency and/or length of the support group sessions may be adjusted according to participants' needs.

Treatment groups

24 Participants
are divided into 1 treatment group
Group A: Takotsubo Support GroupOther 1 intervention

Trial outcomes

Primary outcomes

1

Change in anxiety level as measured by the STAI.

State Trait Anxiety Inventory (STAI): Score of 20-39 = Low Anxiety; Score of 40-59 = Moderate Anxiety; Score of 60 - 80 = High Anxiety

Time frame
Baseline, One year

Secondary outcomes

1

Changes in depression as measured by the PHQ-8.

Patient Health Questionnaire depression scale (PHQ-8): Score of 0-2 = No Depression; Score of 3-5 = Mild Depression; Score of 6-8 = Moderate Depression; Score of 9-12 = Severe Depression

Time frame
Baseline, One year
2

Changes in quality of life as measured by the KCCQ.

Kansas City Quality of Life Questionnaire (KCCQ): Score of 0-24 = Very poor to poor quality of life; Score of 25-49 = Poor to fair quality of life; Score of 50-74 = Fair to good quality of life; Score of 75-100 = Good to excellent quality of life

Time frame
Baseline, One year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Weill Medical College of Cornell University

Lead sponsor

Source ClinicalTrials.gov
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