Online Cognitive Behavioral Therapy Targeting Cardiac Anxiety

NCT05580718 | Active Not Recruiting

• 1 other identifier: MI-RCT1
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the present study is to evaluate an internet-delivered exposure-based cognitive behavioral therapy (CBT) protocol tailored for patients following myocardial infaction (MI) to increase Quality of Life (Qol) and physical activity by reducing cardiac anxiety.

Conditions

Online CBT Targeting Cardiac Anxiety

Keywords

Myocardial infarction; Cardiac Anxiety; internet-CBT; Secondary prevention

Outcome Measures

Primary Outcomes (1)

• Seattle Angina Questionnaire

  A measure of coronary artery disease on five scales: physical limitation scale, anginal stability scale, anginal frequency scale, treatment satisfaction scale, and the disease. perception scale with a score ranging from 0 to 100. A higher score indicating a better quality of life.

  From baseline to 5 months

Secondary Outcomes (66)

• Seattle Angina Questionnaire

  From baseline to 8 weeks

• Seattle Angina Questionnaire

  Change over 8 measurement points measured from baseline and weekly for 8 weeks during treatment

• Seattle Angina Questionnaire

  From baseline to 1 year and 2 months

• Seattle Angina Questionnaire

  From baseline to 2 years and 2 months

• Seattle Angina Questionnaire

  From baseline to 5 years and 2 months

Other Outcomes (23)

• Number of Participants With Abnormal Laboratory Values

  From Baseline to 8 weeks

• Number of Participants With Abnormal Laboratory Values

  From Baseline to 5 months

• Algometry (Somedic AB, Hörby, Sweden)

  From Baseline to 8 weeks

Study Arms (2)

Online CBT targeting cardiac anxiety

EXPERIMENTAL

CBT for MI primarily targets two processes of MI-related disability: fear of cardiac-related symptoms avoidance behavior and physical inactivity. The CBT is therapist-guided and lasts for 8 weeks.

Behavioral: MI-CBT

Waitlist control

NO INTERVENTION

Participants randomised to waitlist can have no other concurrent psychological treatment but are free to use any medical treatment as usual. Participants on the waitlist also complete pre- and post-treatment, the follow-up measurement as well as weekly instruments (with exception of the treatment process measures Credibility scale and WAI). After the 3-month follow-up assessments, participants will receive internet-CBT for MI over 8 weeks

Interventions

MI-CBT BEHAVIORAL

* Education Common reactions following MI and general lifestyle advice on e.g., physical activity. The role of cardiac anxiety and avoidance behavior on quality of life and physical health. Brief training in self-observation. * Goal setting Identifying life areas impaired by MI-related disability or symptom fear. Set health behavioral goals i.e., increased physical activity and gradually take steps towards them. * Exposure therapy Exposure to physical sensations (e.g., palpitations due to physical activity) to reduce fear of these symptoms. Gradual exposure to avoided situations, activities and increase in physical activity. * Relapse prevention Prevention of relapse into avoidance behaviors by identifying risk situations and conduct a plan forward on maintaining a healthy physically and active lifestyle.

Online CBT targeting cardiac anxiety

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Myocardial infarction ≥ 6 months before assessment (type 1 STEMI/NSTEMI)
• Age 18-80 years;
• Clinically significant cardiac anxiety that leads to severe distress and/or interferes with daily life
• On adequate medical treatment(21); (E) Able to read and write in Swedish.

You may not qualify if:

• heart failure with severe systolic dysfunction (ejection fraction ≤ 35%)
• Significant valvular disease
• Planned coronary artery bypass surgery or percutaneous interventions
• Any medical restriction to physical exercise
• Severe medical illness
• Grade 3 hypertension (i.e., blood pressure ≥ 180 systolic and/or 110 diastolic)
• Severe psychiatric disorder or risk of suicide
• Alcohol dependency
• Ongoing psychological treatment.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Swedish Heart Lung Foundation: collaborator
• The Swedish Research Council: collaborator
• Sahlgrenska University Hospital: collaborator

Study Sites (1)

Karolinska University Hospital

Stockholm, 11635, Sweden

Location

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, PhD

Study Record Dates

• First Submitted: October 7, 2022
• First Posted: October 14, 2022
• Study Start: October 17, 2022
• Primary Completion: March 14, 2025
• Study Completion: March 14, 2025
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)