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Recruiting Not applicable

Internet-based Treatment of Stress and Anxiety in Myocardial Infarction With Non-obstructive Coronary Arteries

NCT04178434 · tracked via the Priya Life Science Sweden tracker
Sponsor
Per Tornvall
Phase
Not applicable
Started
2021-11-11
Last updated
2025-03-07

Condition(s) studied

Myocardial Infarction

Investigational drug(s) / intervention(s)

Internet-based CBT intervention

Internet-based CBT intervention: A nine step intervention including internet-based feedback by psychologists

Study summary

Patient with myocardial infarction with non-obstructive coronary arteries and takotsubo syndrome often have high levels of stress and anxiety. At present there are no treatment alternatives in this group of patients. Previously, cognitive behavioral therapy (CBT), primarily aiming at relieving stress, has been shown to decrease morbidity in patient with myocardial infarction with obstructive coronary arteries. The present open randomized study aims to decrease stress and anxiety in patients with myocardial infarction with non-obstructive coronary arteries and takotsubo syndrome by an internet-based CBT focusing on stress and anxiety.

Eligibility

Sex
ALL
Min age
35 Years
Max age
79 Years
Healthy volunteers
No
Inclusion Criteria: * a suspected diagnosis of MINOCA or takotsubo syndrome with coronary angiography without diameter stenosis ≥50% * age 35-80 years * admission-ECG with sinus rhythm * PSS-14 ≥ 25 and/or HADS-A ≥ 8 during admission * reading and writing proficiency in Swedish * computer/Internet access and literacy Exclusion Criteria: * strong clinical suspicion of myocarditis * spontaneous coronary artery dissection * acute pulmonary embolism * acute myocardial infarction type 2 * cardiomyopathy other than takotsubo syndrome * a previous myocardial infarction due to CAD * expected poor compliance to behavioural therapy * not likely to survive \> one year due to for example cancer

Primary outcome measure(s)

  • Self-rated stress as determined by Perceived Stress Scale 14 (PSS-14) — 12-14 weeks after the acute event
    Normalisation of PSS-14 (\<25 on a scale 0-56 with high numbers indicating increased stress)
  • Self-rated anxiety as determined by Hospital Anxiety and Depression Scale (HADS) — 12-14 weeks after the acute event
    Normalisation of HADS-A (\<8 on a scale 0-21 with high numbers indicating increased anxiety)

Trial sites (1)

FacilityCityRegionStatus
Södersjukhuset Stockholm Sweden Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04178434 on ClinicalTrials.gov ↗ ← All trials in Sweden