Myocardial Infarctione-SMINCNCT04178434
Internet-based Treatment of Stress and Anxiety in Myocardial Infarction With Non-obstructive Coronary Arteries
A study testing Internet-based CBT intervention in people with Myocardial Infarction, run by Per Tornvall at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 79 years
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Internet-based CBT intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteSweden
- Study dates
- 11 Nov 2021to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Patrik Lyngå, RN contact
Sweden1 site, 1 recruiting
- Recruiting
Södersjukhuset
Stockholm, 11883
Per Tornvall, per.tornvall@ki.se
About this study
Official title: 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.
- Conditions
- Myocardial Infarction
- Being tested
- Internet-based CBT intervention
- Keywords
- Myocardial infarction, Non-obstructive coronary arteries, Takotsubo syndrome
- Medical subject headings
- Myocardial Infarction, Takotsubo Cardiomyopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-based CBT interventionBehavioural
A nine step intervention including internet-based feedback by psychologists
| Study group | Role | What they receive |
|---|---|---|
| Internet-based CBT intervention | Active comparator | A nine step internet-based intervention with focus on stress and anxiety Receives: Behavioral: Internet-based CBT intervention |
| Treatment as usual | No intervention | Regular follow-up with two doctor and one nurse appointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 12-14 weeks after the acute event
Secondary outcomes (10)
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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 10, 20 and 50 weeks after randomisation
Sick leave
Self-reported total number of days
Measured: 10, 20 and 50 weeks after randomisation
Health-care visits
Self-reported total number of visits
Measured: 10, 20 and 50 weeks after randomisation
Cortisol in hair
Hair cortisol will be determined by RIA-technique in pg/mg
Measured: 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
Measured: 10 weeks after randomisation
Physiological recovery after stress determined by salivary cortisol
Salivary cortisol will be determined by RIA-technique in pg/mg
Measured: 10 weeks after randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start11 Nov 2021
- Primary completion30 Nov 2024
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Per Tornvall
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala University, Mid Sweden University
- Responsible party
- Sponsor-investigator, Per Tornvall, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04178434
- Sponsor's protocol ID
- 20191111
- Acronym
- e-SMINC
- Status last verified
- Mar 2025
- First submitted
- 11 Nov 2019
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 35910688Olsson 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 at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- E-health Treatment of Stress and Anxiety in Stockholm Myocardial Infarction With Non-obstructive Coronaries Study
- ClinicalTrials.gov ID
- NCT04178434
- Acronym / sponsor ID
- e-SMINC / 20191111
- Conditions
- Myocardial Infarction
- Keywords
- Myocardial infarction, Non-obstructive coronary arteries, Takotsubo syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Per TornvallUniversity, hospital or other
- Collaborators
- Uppsala University, Mid Sweden University
- Study start
- 11 Nov 2021 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 26 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internet-based CBT intervention | Active comparator | Behavioral: Internet-based CBT interventionA nine step internet-based intervention with focus on stress and anxiety |
| Treatment as usual | No intervention | –Regular follow-up with two doctor and one nurse appointment |
Who may qualify
- Ages
- 35 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- strong clinical suspicion of myocarditis
- spontaneous coronary artery dissection
- acute pulmonary embolism
- acute myocardial infarction type 2
- cardiomyopathy other than takotsubo syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-based CBT interventionA nine step intervention including internet-based feedback by psychologists | Behavioural | Internet-based CBT intervention |
Primary outcome
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)
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)
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Derived from this study: PubMed 35910688Rondung 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.
- Derived from this study: PubMed 35883115Olsson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Patrik Lyngå, RN contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-based CBT intervention in people with Myocardial Infarction, run by Per Tornvall at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Per Tornvall, MD (+46861611000, per.tornvall@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-rated stress as determined by Perceived Stress Scale 14 (PSS-14) (time frame: 12-14 weeks after the acute event). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04178434, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.