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e-SMINC: Internat-based Treatment of Stress and Anxiety in Myocardial Infarction With Non-obstructive Coronary Arteries

Sponsor
Per Tornvall (Other)
Overall Status
Recruiting
CT.gov ID
NCT04178434
Collaborator
Uppsala University (Other), Mid Sweden University (Other)
64
Enrollment
1
Location
2
Arms
15.6
Anticipated Duration (Months)
4.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Internet-based CBT intervention
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
64 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
E-health Treatment of Stress and Anxiety in Stockholm Myocardial Infarction With Non-obstructive Coronaries Study
Actual Study Start Date :
Nov 11, 2021
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Internet-based CBT intervention

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

Behavioral: Internet-based CBT intervention
A nine step intervention including internet-based feedback by psychologists
No Intervention: Treatment as usual

Regular follow-up with two doctor and one nurse appointment

Outcome Measures

Primary Outcome Measures

  1. Self-rated stress as determined by Perceived Stress Scale 14 (PSS-14) [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) [12-14 weeks after the acute event]

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

Secondary Outcome Measures

  1. Self-rated stress as determined by Perceived Stress Scale 14 (PSS-14) [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) [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) [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) [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) [10, 20 and 50 weeks after randomisation]

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

  6. Sick leave [10, 20 and 50 weeks after randomisation]

    Self-reported total number of days

  7. Health-care visits [10, 20 and 50 weeks after randomisation]

    Self-reported total number of visits

  8. Cortisol in hair [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) [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 [10 weeks after randomisation]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
35 Years to 79 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Södersjukhuset Stockholm Sweden 11883

Sponsors and Collaborators

  • Per Tornvall
  • Uppsala University
  • Mid Sweden University

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Per Tornvall, Professor, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT04178434
Other Study ID Numbers:
  • 20191111
First Posted:
Nov 26, 2019
Last Update Posted:
Feb 4, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Per Tornvall, Professor, Karolinska Institutet
Myocardial infarction
Non-obstructive coronary arteries
Takotsubo syndrome
Additional relevant MeSH terms:
Myocardial Infarction
Infarction

Study Results

No Results Posted as of Feb 4, 2022