Online Cognitive Behavioral Therapy Targeting Cardiac Anxiety (MI-CBT)

Karolinska Institute

Status: Active, not recruiting

Conditions: Online CBT Targeting Cardiac Anxiety

Treatments: Behavioral: MI-CBT

Study type: Interventional

Funder types: Other

Identifiers

NCT05580718

MI-RCT1

Details and patient eligibility

About

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.

Full description

In the present research project, the investigators have tailored a CBT protocol to target the hypothesized mechanisms of how cardiac anxiety affects the clinical course of MI; by using exposure therapy to reduce fear, hypervigilance, and misinterpretations of cardiac symptoms to reduce MI-related avoidance and increasing physical activity.

Participants (estimated N=100) are randomized to internet-delivered CBT for 8 weeks or to a waitlist offered treatment as usual. Patients in the control arm will be crossed over to CBT treatment 3 months after the experimental group has completed treatment. Assessments will be conducted pre-treatment, post-treatment, 3 months (primary endpoint), 1-, 2 - and 5 years after treatment. These measurement points will also include the control group as it is crossed over to CBT after the 3-month follow-up

Enrollment: 96 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Inclusion criteria:
• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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96 participants in 2 patient groups

Online CBT targeting cardiac anxiety

Experimental group

Description:

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.

Treatment:

Behavioral: MI-CBT

Waitlist control

No Intervention group

Description:

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