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NCT Number: NCT04178434

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

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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Key information

Conditions

Myocardial Infarction Cardiomyopathies Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Takotsubo Cardiomyopathy Vascular Diseases Ventricular Dysfunction Ventricular Dysfunction, Left

Age range

35 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Södersjukhuset

Stockholm, 11883, Sweden

Location status: Recruiting

Location contact

Per Tornvall

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Internet-based CBT intervention

Behavioral

A nine step intervention including internet-based feedback by psychologists

Primary outcomes

  1. Self-rated stress as determined by Perceived Stress Scale 14 (PSS-14)

    Time frame: 12-14 weeks after the acute event

    Normalisation of PSS-14 (<25 on a scale 0-56 with high numbers indicating increased stress)

  2. Self-rated anxiety as determined by Hospital Anxiety and Depression Scale (HADS)

    Time frame: 12-14 weeks after the acute event

    Normalisation of HADS-A (<8 on a scale 0-21 with high numbers indicating increased anxiety)

Secondary outcomes

  1. Self-rated stress as determined by Perceived Stress Scale 14 (PSS-14)

    Time frame: 10, 20 and 50 weeks after randomisation

    PSS-14 (<25 on a scale 0-56 with high numbers indicating increased stress)

  2. Self-rated anxiety as determined by Hospital Anxiety and Depression Scale (HADS)

    Time frame: 10, 20 and 50 weeks after randomisation

    HADS-A (<8 on a scale 0-21 with high numbers indicating increased anxiety)

  3. Self-rated quality-of-life determined by Research ANd Development-36 (RAND-36)

    Time frame: 10, 20 and 50 weeks after randomisation

    RAND-36: 0-100 with high numbers indicating better quality-of-life

  4. Self-rated cardiac anxiety determined by Cardiac Anxiety Questionnaire (CAQ)

    Time frame: 10, 20 and 50 weeks after randomisation

    CAQ: 0-72 with high numbers indicating increased cardiac anxiety

  5. Self-rated post-traumatic symptoms determined by Impact of Event Scale-6 (IES-6)

    Time frame: 10, 20 and 50 weeks after randomisation

    IES-6: 0-30 with high numbers indicating increased post-traumatic symptoms

  6. Sick leave

    Time frame: 10, 20 and 50 weeks after randomisation

    Self-reported total number of days

  7. Health-care visits

    Time frame: 10, 20 and 50 weeks after randomisation

    Self-reported total number of visits

  8. Cortisol in hair

    Time frame: 10 weeks after randomisation

    Hair cortisol will be determined by RIA-technique in pg/mg

  9. Physiological recovery after stress determined by Heart Rate Variability (HRV)

    Time frame: 10 weeks after randomisation

    HRV will be measured by time and frequency domains and by non-linear methods

  10. Physiological recovery after stress determined by salivary cortisol

    Time frame: 10 weeks after randomisation

    Salivary cortisol will be determined by RIA-technique in pg/mg

Study contacts

Contact information is provided by the study sponsor or research team.

Patrik Lyngå, RN

CONTACT

[email protected]

Per Tornvall, MD

CONTACT

[email protected]

+46861611000

Sponsors and collaborators

Lead sponsor

Per Tornvall

Other

Collaborators

  • Mid Sweden University
  • Uppsala University

Registry information

Official study title

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

Acronym: e-SMINC

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Nov 26, 2019
Registry last updated
Mar 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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