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

Myocardial Infarction Clinical Trial

— e-SMINC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04178434
• Other study ID #: 20191111
• Status: Recruiting
• Phase: N/A
• Start date: November 11, 2021
• Est. completion date: May 2024

Study information

• Verified date: August 2023
• Source: Karolinska Institutet
• Contact: Per Tornvall, MD
• Phone: +46861611000
• Email: per.tornvall[@]ki.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

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

Locations

Country	Name	City	State
Sweden	Södersjukhuset	Stockholm

Sponsors (3)

Lead Sponsor	Collaborator
Per Tornvall	Mid Sweden University, Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Sick leave	Self-reported total number of days	10, 20 and 50 weeks after randomisation
Secondary	Health-care visits	Self-reported total number of visits	10, 20 and 50 weeks after randomisation
Secondary	Cortisol in hair	Hair cortisol will be determined by RIA-technique in pg/mg	10 weeks after randomisation
Secondary	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
Secondary	Physiological recovery after stress determined by salivary cortisol	Salivary cortisol will be determined by RIA-technique in pg/mg	10 weeks after randomisation