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| Name | Class |
|---|---|
| Uppsala University | OTHER |
| Mid Sweden University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Internet-based CBT intervention | Active Comparator | A nine step internet-based intervention with focus on stress and anxiety |
|
| Treatment as usual | No Intervention | Regular follow-up with two doctor and one nurse appointment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Internet-based CBT intervention | Behavioral | A nine step intervention including internet-based feedback by psychologists |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Per Tornvall, MD | Contact | +46861611000 | per.tornvall@ki.se | |
| Patrik Lyngå, RN | Contact | patrik.lynga@ki.se |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Södersjukhuset | Recruiting | Stockholm | 11883 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35910688 | Derived | Rondung E, Humphries SM, Olsson EMG, Sundelin R, Norlund F, Held C, Spaak J, Tornvall P, Lynga P. Reducing stress and anxiety in patients with myocardial infarction with non-obstructive coronary arteries or Takotsubo syndrome: A non-randomized feasibility study. Internet Interv. 2022 Jul 21;29:100562. doi: 10.1016/j.invent.2022.100562. eCollection 2022 Sep. | |
| 35883115 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 24, 2023 | Aug 24, 2023 | Prot_SAP_002.pdf |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D054549 | Takotsubo Cardiomyopathy |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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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 |
| Olsson EMG, Norlund F, Rondung E, Humphries SM, Held C, Lynga P, Spaak J, Sundin O, Sundelin R, Leissner P, Kovamees L, Tornvall P. The e-mental health treatment in Stockholm myocardial infarction with non-obstructive coronaries or Takotsubo syndrome study (E-SMINC): a study protocol for a randomised controlled trial. Trials. 2022 Jul 26;23(1):597. doi: 10.1186/s13063-022-06530-3. |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D009202 | Cardiomyopathies |
| D018487 | Ventricular Dysfunction, Left |
| D018754 | Ventricular Dysfunction |