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

Study Overview
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Brief Summary
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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.

Official Title
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E-health Treatment of Stress and Anxiety in Stockholm Myocardial Infarction With Non-obstructive Coronaries Study

Conditions
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Myocardial Infarction

Intervention / Treatment
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* Behavioral: Internet-based CBT intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Internet-based CBT intervention<br>A nine step internet-based intervention with focus on stress and anxiety | Behavioral: Internet-based CBT intervention<br>* A nine step intervention including internet-based feedback by psychologists<br>|
| No Intervention: Treatment as usual<br>Regular follow-up with two doctor and one nurse appointment | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-rated stress as determined by Perceived Stress Scale 14 (PSS-14) | PSS-14 (<25 on a scale 0-56 with high numbers indicating increased stress) | 10, 20 and 50 weeks after randomisation | 
| Self-rated anxiety as determined by Hospital Anxiety and Depression Scale (HADS) | HADS-A (<8 on a scale 0-21 with high numbers indicating increased anxiety) | 10, 20 and 50 weeks after randomisation | 
| Self-rated quality-of-life determined by Research ANd Development-36 (RAND-36) | RAND-36: 0-100 with high numbers indicating better quality-of-life | 10, 20 and 50 weeks after randomisation | 
| Self-rated cardiac anxiety determined by Cardiac Anxiety Questionnaire (CAQ) | CAQ: 0-72 with high numbers indicating increased cardiac anxiety | 10, 20 and 50 weeks after randomisation | 
| Self-rated post-traumatic symptoms determined by Impact of Event Scale-6 (IES-6) | IES-6: 0-30 with high numbers indicating increased post-traumatic symptoms | 10, 20 and 50 weeks after randomisation | 
| Sick leave | Self-reported total number of days | 10, 20 and 50 weeks after randomisation | 
| Health-care visits | Self-reported total number of visits | 10, 20 and 50 weeks after randomisation | 
| Cortisol in hair | Hair cortisol will be determined by RIA-technique in pg/mg | 10 weeks after randomisation | 
| Physiological recovery after stress determined by Heart Rate Variability (HRV) | HRV will be measured by time and frequency domains and by non-linear methods | 10 weeks after randomisation | 
| Physiological recovery after stress determined by salivary cortisol | Salivary cortisol will be determined by RIA-technique in pg/mg | 10 weeks after randomisation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myocardial infarction, Non-obstructive coronary arteries, Takotsubo syndrome