Internet-based Treatment of Stress and Anxiety in Myocardial Infarction With Non-obstructive Coronary Arteries (e-SMINC)
Primary Purpose
Myocardial Infarction
Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Internet-based CBT intervention
Sponsored by
About this trial
This is an interventional treatment trial for Myocardial Infarction focused on measuring Myocardial infarction, Non-obstructive coronary arteries, Takotsubo syndrome
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
Sites / Locations
- SödersjukhusetRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Internet-based CBT intervention
Treatment as usual
Arm Description
A nine step internet-based intervention with focus on stress and anxiety
Regular follow-up with two doctor and one nurse appointment
Outcomes
Primary Outcome Measures
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)
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)
Secondary Outcome Measures
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)
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)
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
Self-rated cardiac anxiety determined by Cardiac Anxiety Questionnaire (CAQ)
CAQ: 0-72 with high numbers indicating increased cardiac anxiety
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
Sick leave
Self-reported total number of days
Health-care visits
Self-reported total number of visits
Cortisol in hair
Hair cortisol will be determined by RIA-technique in pg/mg
Physiological recovery after stress determined by Heart Rate Variability (HRV)
HRV will be measured by time and frequency domains and by non-linear methods
Physiological recovery after stress determined by salivary cortisol
Salivary cortisol will be determined by RIA-technique in pg/mg
Full Information
NCT ID
NCT04178434
First Posted
November 11, 2019
Last Updated
August 24, 2023
Sponsor
Per Tornvall
Collaborators
Uppsala University, Mid Sweden University
1. Study Identification
Unique Protocol Identification Number
NCT04178434
Brief Title
Internet-based Treatment of Stress and Anxiety in Myocardial Infarction With Non-obstructive Coronary Arteries
Acronym
e-SMINC
Official Title
E-health Treatment of Stress and Anxiety in Stockholm Myocardial Infarction With Non-obstructive Coronaries Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 11, 2021 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Per Tornvall
Collaborators
Uppsala University, Mid Sweden University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
Myocardial infarction, Non-obstructive coronary arteries, Takotsubo syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Internet-based CBT intervention
Arm Type
Active Comparator
Arm Description
A nine step internet-based intervention with focus on stress and anxiety
Arm Title
Treatment as usual
Arm Type
No Intervention
Arm Description
Regular follow-up with two doctor and one nurse appointment
Intervention Type
Behavioral
Intervention Name(s)
Internet-based CBT intervention
Intervention Description
A nine step intervention including internet-based feedback by psychologists
Primary Outcome Measure Information:
Title
Self-rated stress as determined by Perceived Stress Scale 14 (PSS-14)
Description
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
Title
Self-rated anxiety as determined by Hospital Anxiety and Depression Scale (HADS)
Description
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 Outcome Measure Information:
Title
Self-rated stress as determined by Perceived Stress Scale 14 (PSS-14)
Description
PSS-14 (<25 on a scale 0-56 with high numbers indicating increased stress)
Time Frame
10, 20 and 50 weeks after randomisation
Title
Self-rated anxiety as determined by Hospital Anxiety and Depression Scale (HADS)
Description
HADS-A (<8 on a scale 0-21 with high numbers indicating increased anxiety)
Time Frame
10, 20 and 50 weeks after randomisation
Title
Self-rated quality-of-life determined by Research ANd Development-36 (RAND-36)
Description
RAND-36: 0-100 with high numbers indicating better quality-of-life
Time Frame
10, 20 and 50 weeks after randomisation
Title
Self-rated cardiac anxiety determined by Cardiac Anxiety Questionnaire (CAQ)
Description
CAQ: 0-72 with high numbers indicating increased cardiac anxiety
Time Frame
10, 20 and 50 weeks after randomisation
Title
Self-rated post-traumatic symptoms determined by Impact of Event Scale-6 (IES-6)
Description
IES-6: 0-30 with high numbers indicating increased post-traumatic symptoms
Time Frame
10, 20 and 50 weeks after randomisation
Title
Sick leave
Description
Self-reported total number of days
Time Frame
10, 20 and 50 weeks after randomisation
Title
Health-care visits
Description
Self-reported total number of visits
Time Frame
10, 20 and 50 weeks after randomisation
Title
Cortisol in hair
Description
Hair cortisol will be determined by RIA-technique in pg/mg
Time Frame
10 weeks after randomisation
Title
Physiological recovery after stress determined by Heart Rate Variability (HRV)
Description
HRV will be measured by time and frequency domains and by non-linear methods
Time Frame
10 weeks after randomisation
Title
Physiological recovery after stress determined by salivary cortisol
Description
Salivary cortisol will be determined by RIA-technique in pg/mg
Time Frame
10 weeks after randomisation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Per Tornvall, MD
Phone
+46861611000
Email
per.tornvall@ki.se
First Name & Middle Initial & Last Name or Official Title & Degree
Patrik Lyngå, RN
Email
patrik.lynga@ki.se
Facility Information:
Facility Name
Södersjukhuset
City
Stockholm
ZIP/Postal Code
11883
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Per Tornvall
Email
per.tornvall@ki.se
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35910688
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.
Results Reference
derived
PubMed Identifier
35883115
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.
Results Reference
derived
Learn more about this trial
Internet-based Treatment of Stress and Anxiety in Myocardial Infarction With Non-obstructive Coronary Arteries
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