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

Per Tornvall

Status: Enrolling

Conditions: Myocardial Infarction

Treatments: Behavioral: Internet-based CBT intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04178434

20191111

Details and patient eligibility

About

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.

Enrollment: 64 estimated patients

Sex: All

Ages: 35 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

Internet-based CBT intervention

Active Comparator group

Description:

A nine step internet-based intervention with focus on stress and anxiety

Treatment:

Behavioral: Internet-based CBT intervention

Treatment as usual

No Intervention group

Description:

Regular follow-up with two doctor and one nurse appointment