ClinicalTrials.gg
RecruitingNCT04178434e-SMINCUpdated Mar 7, 2025

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

An interventional study of Internet-based CBT intervention in Myocardial Infarction, sponsored by Per Tornvall. Recruiting at 1 site in Sweden. Open to participants aged 35 Years to 79 Years. Per ClinicalTrials.gov, last updated 2025-03-07.

Sponsored by Per Tornvall · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Nov 2021; still recruiting 5 years later.

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Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
35 Years to 79 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 90 studies in Myocardial Infarction with a site in Sweden — 13 open to participants now, 22 under way, 4 of them phase 3. Myocardial Infarction · Sweden.

Planned enrollment
61st of 70
64 · median 875
Started
2021
with 5 others
No phase
23 of 90
6 open now
Primary completion
2024-11
later than 2 of 21 live
Registered
61st of 90
by date

Among the 90 studies in Myocardial Infarction with a site in Sweden, this one is the 61st largest by planned enrollment of the 70 interventional ones that give a count, is one of 6 that started in 2021, is one of 23 with no phase, reaches primary completion later than 2 of the 21 other live ones, and was the 61st registered.

Myocardial Infarction

2,272 studies on the registry are indexed under Myocardial Infarction; 371 are open to participants now.

Browse Myocardial Infarction studies →

Open to participants now

13 of the 90 studies in Myocardial Infarction with a site in Sweden are open now. Recruiting first, the newest first:

7 more — sign in →

All 13 open studies →

A study can be open while its sites in Sweden have not opened yet or have stopped. Only those recruiting at a site in Sweden →

Who these studies take

Of the 255 Myocardial Infarction studies recruiting now, 172 (67%) set no upper age limit and 26 (10%) stop at 75 or younger; 16 take children under 18; 27 take healthy volunteers.

This study: 35 Years to 79 Years · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 90 studies in Myocardial Infarction with a site in Sweden, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Myocardial Infarction

Keywords

  • Myocardial infarction
  • Non-obstructive coronary arteries
  • Takotsubo syndrome
04

Who can participate

Ages eligible
35 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • a suspected diagnosis of MINOCA or takotsubo syndrome with coronary angiography without diameter stenosis ≥50%
  • age 35-80 years
  • admission- 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

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
64 participants (estimated)

Study arms

  • Active comparator
    Internet-based CBT intervention

    A nine step internet-based intervention with focus on stress and anxiety

    Behavioral: Internet-based CBT intervention

  • No intervention
    Treatment as usual

    Regular follow-up with two doctor and one nurse appointment

Interventions

  • BehavioralInternet-based CBT intervention

    A nine step intervention including internet-based feedback by psychologists

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 12-14 weeks after the acute event

  2. 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)

    Time frame: 12-14 weeks after the acute event

Secondary outcomes

  1. 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)

    Time frame: 10, 20 and 50 weeks after randomisation

  2. 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)

    Time frame: 10, 20 and 50 weeks after randomisation

  3. 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

    Time frame: 10, 20 and 50 weeks after randomisation

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

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

    Time frame: 10, 20 and 50 weeks after randomisation

  5. 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

    Time frame: 10, 20 and 50 weeks after randomisation

  6. Sick leave

    Self-reported total number of days

    Time frame: 10, 20 and 50 weeks after randomisation

  7. Health-care visits

    Self-reported total number of visits

    Time frame: 10, 20 and 50 weeks after randomisation

  8. Cortisol in hair

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

    Time frame: 10 weeks after randomisation

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

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

    Time frame: 10 weeks after randomisation

  10. Physiological recovery after stress determined by salivary cortisol

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

    Time frame: 10 weeks after randomisation

07

Study locations

1 of 1 sites recruiting
08

References and documents

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. PubMed 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. PubMed 35883115 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2021 to primary completion in Nov 2024, 36 months.

Of 321 non-industry interventional studies with no phase under Myocardial Infarction, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 58. This study's 36 months is close to that.

Counting every sponsor, half of 354 studies reached it within 34 months; a quarter within 15 and three quarters within 57.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 11, 2019
First posted
Nov 26, 2019
StartActual
Nov 11, 2021
Primary completionActual
Nov 30, 2024
CompletionEst.
Nov 30, 2025
Last update
Mar 7, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 7, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04178434
Lead sponsor
Per Tornvall
Collaborators
Uppsala University, Mid Sweden University
Responsible party
Per Tornvall (Professor, Karolinska Institutet) — Sponsor-investigator
First posted
Nov 26, 2019
Start date
Nov 11, 2021
Primary completion
Nov 30, 2024
Completion
Nov 30, 2025 (estimated)
Last update
Mar 7, 2025

Study contacts

Per Tornvall, MD
Contact
per.tornvall@ki.se
+46861611000
Patrik Lyngå, RN
Contact
patrik.lynga@ki.se

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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