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

NCT ID: NCT04178434

Last Updated: 2025-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-11

Study Completion Date

2025-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Internet-based CBT intervention

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

Group Type ACTIVE_COMPARATOR

Internet-based CBT intervention

Intervention Type BEHAVIORAL

A nine step intervention including internet-based feedback by psychologists

Treatment as usual

Regular follow-up with two doctor and one nurse appointment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Internet-based CBT intervention

A nine step intervention including internet-based feedback by psychologists

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Per Tornvall

OTHER

Sponsor Role lead

Uppsala University

OTHER

Sponsor Role collaborator

Mid Sweden University

OTHER

Sponsor Role collaborator

Responsible Party

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Per Tornvall

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Södersjukhuset

Stockholm, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Per Tornvall, MD

Role: CONTACT

+46861611000

Patrik Lyngå, RN

Role: CONTACT

Facility Contacts

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Per Tornvall

Role: primary

References

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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.

Reference Type DERIVED
PMID: 35910688 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35883115 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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20191111

Identifier Type: -

Identifier Source: org_study_id

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