Clinical trial NCT04178434: Internet-based Treatment of Stress and Anxiety in Myocardial Infarction With Non-obstructive Coronary Arteries
Official title: E-health Treatment of Stress and Anxiety in Stockholm Myocardial Infarction With Non-obstructive Coronaries Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myocardial Infarction
Keywords: Myocardial infarction
Non-obstructive coronary arteries
Takotsubo syndrome
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Uppsala University
name: Mid Sweden University
First posted: 2019-11-26
Enrollment: 64
Sex: ALL
Minimum age (years): 35
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Self-rated stress as determined by Perceived Stress Scale 14 (PSS-14)
timeFrame: 12-14 weeks after the acute event
measure: Self-rated anxiety as determined by Hospital Anxiety and Depression Scale (HADS)
timeFrame: 12-14 weeks after the acute event
Secondary outcomes:
measure: Self-rated stress as determined by Perceived Stress Scale 14 (PSS-14)
timeFrame: 10, 20 and 50 weeks after randomisation
measure: Self-rated anxiety as determined by Hospital Anxiety and Depression Scale (HADS)
timeFrame: 10, 20 and 50 weeks after randomisation
measure: Self-rated quality-of-life determined by Research ANd Development-36 (RAND-36)
timeFrame: 10, 20 and 50 weeks after randomisation
measure: Self-rated cardiac anxiety determined by Cardiac Anxiety Questionnaire (CAQ)
timeFrame: 10, 20 and 50 weeks after randomisation
measure: Self-rated post-traumatic symptoms determined by Impact of Event Scale-6 (IES-6)
timeFrame: 10, 20 and 50 weeks after randomisation
measure: Sick leave
timeFrame: 10, 20 and 50 weeks after randomisation
measure: Health-care visits
timeFrame: 10, 20 and 50 weeks after randomisation
measure: Cortisol in hair
timeFrame: 10 weeks after randomisation
measure: Physiological recovery after stress determined by Heart Rate Variability (HRV)
timeFrame: 10 weeks after randomisation
measure: Physiological recovery after stress determined by salivary cortisol
timeFrame: 10 weeks after randomisation
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Södersjukhuset
Study officials:
References:
citation: 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.
citation: 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.