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

NCT04178434 | Recruiting

• 1 other identifier: 20191111
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Infarction

Keywords

Myocardial infarction; Non-obstructive coronary arteries; Takotsubo syndrome

Outcome Measures

Primary Outcomes (2)

• 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)

  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)

  12-14 weeks after the acute event

Secondary Outcomes (10)

• Self-rated stress as determined by Perceived Stress Scale 14 (PSS-14)

  10, 20 and 50 weeks after randomisation

• Self-rated anxiety as determined by Hospital Anxiety and Depression Scale (HADS)

  10, 20 and 50 weeks after randomisation

• Self-rated quality-of-life determined by Research ANd Development-36 (RAND-36)

  10, 20 and 50 weeks after randomisation

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

  10, 20 and 50 weeks after randomisation

• Self-rated post-traumatic symptoms determined by Impact of Event Scale-6 (IES-6)

  10, 20 and 50 weeks after randomisation

Study Arms (2)

Internet-based CBT intervention

ACTIVE COMPARATOR

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

Behavioral: Internet-based CBT intervention

Treatment as usual

NO INTERVENTION

Regular follow-up with two doctor and one nurse appointment

Interventions

Internet-based CBT intervention BEHAVIORAL

A nine step intervention including internet-based feedback by psychologists

Internet-based CBT intervention

Eligibility Criteria

• Age: 35 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Per Tornvall: lead
• Uppsala University: collaborator
• Mid Sweden University: collaborator

Study Sites (1)

Södersjukhuset

Stockholm, 11883, Sweden

RECRUITING

Related Publications (2)

• 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.

  PMID: 35910688 DERIVED

• 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.

  PMID: 35883115 DERIVED

MeSH Terms

Conditions

Myocardial Infarction; Takotsubo Cardiomyopathy

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Cardiomyopathies; Ventricular Dysfunction, Left; Ventricular Dysfunction

Central Study Contacts

Per Tornvall, MD

CONTACT

+46861611000; per.tornvall@ki.se

Patrik Lyngå, RN

CONTACT

patrik.lynga@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 11, 2019
• First Posted: November 26, 2019
• Study Start: November 11, 2021
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2025
• Last Updated: March 7, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)