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

Not Applicable

Recruiting

• Conditions: Myocardial Infarction
• Interventions: Behavioral: Internet-based CBT intervention

• Registration Number: NCT04178434
• Lead Sponsor: Per Tornvall

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-11
• Study First Submitted QC: 2019-11-25
• Study First Posted: 2019-11-26
• Study Start: 2021-11-11
• Primary Completion: 2024-11-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-06
• Last Update Posted: 2025-03-07
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Internet-based CBT intervention	Internet-based CBT intervention	A nine step internet-based intervention with focus on stress and anxiety

Primary Outcome Measures

Name	Time	Method
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)
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)

Secondary Outcome Measures

Name	Time	Method
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)
Cortisol in hair	10 weeks after randomisation	Hair cortisol will be determined by RIA-technique in pg/mg
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
Physiological recovery after stress determined by salivary cortisol	10 weeks after randomisation	Salivary cortisol will be determined by RIA-technique in pg/mg
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
Sick leave	10, 20 and 50 weeks after randomisation	Self-reported total number of days
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
Health-care visits	10, 20 and 50 weeks after randomisation	Self-reported total number of visits
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
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)

Trial Locations

Locations (1)

Södersjukhuset; 🇸🇪 Stockholm, Sweden