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Recruiting NCT04178434

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

No phase Interventional Myocardial Infarction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Internet-based CBT intervention.
Who it may be relevant to
Registry conditions: Myocardial Infarction. Basic parameters: 35 years — 79 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Self-rated stress as determined by Perceived Stress Scale 14 (PSS-14) [Time frame: 12-14 weeks after the acute event]
  • Self-rated anxiety as determined by Hospital Anxiety and Depression Scale (HADS) [Time frame: 12-14 weeks after the acute event]
Secondary outcome measures (10)
  • Self-rated stress as determined by Perceived Stress Scale 14 (PSS-14) [Time frame: 10, 20 and 50 weeks after randomisation]
  • Self-rated anxiety as determined by Hospital Anxiety and Depression Scale (HADS) [Time frame: 10, 20 and 50 weeks after randomisation]
  • Self-rated quality-of-life determined by Research ANd Development-36 (RAND-36) [Time frame: 10, 20 and 50 weeks after randomisation]
  • Self-rated cardiac anxiety determined by Cardiac Anxiety Questionnaire (CAQ) [Time frame: 10, 20 and 50 weeks after randomisation]
  • Self-rated post-traumatic symptoms determined by Impact of Event Scale-6 (IES-6) [Time frame: 10, 20 and 50 weeks after randomisation]
  • Sick leave [Time frame: 10, 20 and 50 weeks after randomisation]
  • Health-care visits [Time frame: 10, 20 and 50 weeks after randomisation]
  • Cortisol in hair [Time frame: 10 weeks after randomisation]
  • Physiological recovery after stress determined by Heart Rate Variability (HRV) [Time frame: 10 weeks after randomisation]
  • Physiological recovery after stress determined by salivary cortisol [Time frame: 10 weeks after randomisation]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Sweden · 1 center
  • Södersjukhuset — Stockholm

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. PMID 35910688
  • 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. PMID 35883115

Identifiers

NCT: NCT04178434 · 20191111

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗