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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Myocardial Infarction
• Intervention / Treatment: Behavioral: Internet-based CBT intervention

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Per Tornvall, MD; Phone Number: +46861611000; Email: per.tornvall@ki.se
• Study Contact Backup: Name: Patrik Lyngå, RN; Email: patrik.lynga@ki.se

Study Locations

• Sweden
  • Stockholm, Sweden, 11883
    • Recruiting
    • Södersjukhuset
    • Contact: Per Tornvall; Email: per.tornvall@ki.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Per Tornvall
• Collaborators: Uppsala University; Mid Sweden University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2021
• Primary Completion (Actual): November 30, 2024
• Study Completion (Estimated): November 30, 2025

Study Registration Dates

• First Submitted: November 11, 2019
• First Submitted That Met QC Criteria: November 25, 2019
• First Posted (Actual): November 26, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 6, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Myocardial infarction; Non-obstructive coronary arteries; Takotsubo syndrome
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Necrosis; Myocardial Ischemia; Ischemia; Myocardial Infarction; Infarction
• Other Study ID Numbers: 20191111

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No