Myocardial Infarction
Conditions
Keywords
Myocardial infarction, Non-obstructive coronary arteries, Takotsubo syndrome
Brief 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.
Interventions
BEHAVIORALInternet-based CBT intervention
A nine step intervention including internet-based feedback by psychologists
Sponsors
Uppsala University
Mid Sweden University
Per Tornvall
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-rated quality-of-life determined by Research ANd Development-36 (RAND-36) | 10, 20 and 50 weeks after randomisation | RAND-36: 0-100 with high numbers indicating better quality-of-life |
| Self-rated cardiac anxiety determined by Cardiac Anxiety Questionnaire (CAQ) | 10, 20 and 50 weeks after randomisation | CAQ: 0-72 with high numbers indicating increased cardiac anxiety |
| Self-rated post-traumatic symptoms determined by Impact of Event Scale-6 (IES-6) | 10, 20 and 50 weeks after randomisation | IES-6: 0-30 with high numbers indicating increased post-traumatic symptoms |
| Sick leave | 10, 20 and 50 weeks after randomisation | Self-reported total number of days |
| Self-rated stress as determined by Perceived Stress Scale 14 (PSS-14) | 10, 20 and 50 weeks after randomisation | PSS-14 (\<25 on a scale 0-56 with high numbers indicating increased stress) |
| Cortisol in hair | 10 weeks after randomisation | Hair cortisol will be determined by RIA-technique in pg/mg |
| Physiological recovery after stress determined by Heart Rate Variability (HRV) | 10 weeks after randomisation | HRV will be measured by time and frequency domains and by non-linear methods |
| Physiological recovery after stress determined by salivary cortisol | 10 weeks after randomisation | Salivary cortisol will be determined by RIA-technique in pg/mg |
| Health-care visits | 10, 20 and 50 weeks after randomisation | Self-reported total number of visits |
| Self-rated anxiety as determined by Hospital Anxiety and Depression Scale (HADS) | 10, 20 and 50 weeks after randomisation | HADS-A (\<8 on a scale 0-21 with high numbers indicating increased anxiety) |
Countries
Sweden
Contacts
Primary ContactPer Tornvall, MD
Backup ContactPatrik Lyngå, RN
Outcome results
None listed